Podcasts about fierce pharma

Each year, the global oncology community flocks to Chicago to convene at the American Society of Clinical Oncology’s annual meeting for a weekend of buzzy data drops, practice-changing posters and insightful sessions. In this week’s episode of "The Top Line," Fierce Biotech and Fierce Pharma’s Darren Incorvaia, Zoey Becker and Angus Liu break down the biggest takeaways from their weekend of reporting live from the Windy City. From “nutty” in vivo CAR-T data to a historic first for a Chinese biotech asset, ASCO 2026 reflected new and continuing trends within the evolving state of cancer care today. To learn more about the topics in this episode: ASCO: Revolution Medicines confident in RAS leadership as rivals square up ASCO: Lilly exec points to ‘nutty’ 100% response rate for in vivo CAR-T as justifying Kelonia buyout ASCO preview: With expectations jacked up, Akeso's ivonescimab to face scrutiny in high-stakes plenary See omnystudio.com/listener for privacy information.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we explore a series of transformative events shaping the industry landscape, from scientific breakthroughs to regulatory shifts and strategic realignments. Eisai's progress with its Alzheimer's treatment, Leqembi, marks a significant milestone in addressing one of the most challenging neurological disorders. With a sales forecast of $900 million, this development underscores the growing demand for effective Alzheimer's treatments. Eisai's partnership with Biogen plays a crucial role in this context, aiming to provide a solution to a disease that has long eluded effective therapeutic intervention. This collaboration highlights the intricate interplay between scientific innovation and strategic alliances in tackling complex health challenges. Biogen's recent data on Alzheimer's disease advances our understanding of neurodegenerative disorders by reinforcing the tau hypothesis alongside longstanding amyloid-beta research. This insight opens new avenues for therapeutic interventions targeting tau proteins—a potentially pivotal shift given prior limited success with amyloid-centric approaches. Denali Therapeutics may benefit from this paradigm shift thanks to its proprietary technology that enhances central nervous system drug delivery—a crucial factor for effective tau-targeting therapies. Concurrently, organizational restructuring at Novartis reflects broader industry trends. As companies increasingly focus on optimizing operations and honing in on core therapeutic areas, Novartis's strategy to streamline its biomedical research arm could potentially impact innovation timelines and resource allocation. This move is indicative of a wider industry shift aimed at enhancing research efficiency and maintaining competitive edges in a rapidly evolving market. Regulatory updates continue to be pivotal, as seen with the U.S. Supreme Court's decision to temporarily restore telehealth access to the abortion pill mifepristone. This ruling not only underscores the intersection between healthcare access and legal frameworks but also highlights potential implications for patient accessibility to medications across the U.S. Meanwhile, AstraZeneca's Imfinzi received swift regulatory endorsement from NICE for perioperative use in stomach cancer just 17 days post UK approval. Such rapid endorsements are crucial in expanding treatment options and improving patient outcomes, particularly in oncology where timely interventions can be life-saving. In market dynamics, Novo Nordisk's Wegovy pill has experienced its first decline in total prescriptions, as tracked by Fierce Pharma through their new oral GLP-1 tracker. This development suggests shifting preferences among clinicians and patients within the competitive landscape of weight management therapies. It points to an environment where continuous innovation and adaptation are necessary to maintain market presence. Biopharmaceutical pipelines are increasingly dominated by biologics, presenting both opportunities and challenges. A report highlights manufacturing complexities that pose hurdles for new product launches, emphasizing the industry's shift from small molecules to biologically-derived therapies. As demand grows, advancements in manufacturing technologies and processes become essential to meeting these needs effectively. Aardvark Therapeutics' decision to unblind its phase 3 Prader-Willi syndrome study data following an FDA-imposed hold illustrates the regulatory hurdles that can occur during drug development. These holds often delay critical data analyses but also present opportunities for reevaluating trial strategies, ensuring that patient safety remains paramount. Aardvark Therapeutics faces regulatory challenges as its Prader-Willi syndrome trials encounter an FDA-imposed hold due to cardiac safety concerns. These developments highlight both scientific promise and the stringent safety standards essential within drug development processes. Technological innovation is reshaping drug discovery efforts through targeted protein degradation—a method allowing researchers to address previously "undruggable" targets. This approach signifies a potential revolution in developing novel therapeutic modalities across various diseases, highlighting the industry's capacity for groundbreaking advancements. On the policy front, bipartisan lawmakers have reintroduced legislation aimed at preventing pharmacy benefit managers from owning retail pharmacies. This legislation seeks to address conflicts of interest that could impact drug pricing and access, underscoring the ongoing scrutiny on practices affecting healthcare costs. In oncology, Genmab's recalibration of its antibody-drug conjugate pipeline signals competitive pressures within this innovative space where differentiation is key to maintaining market leadership. Similarly, Create Medicines' entry into CAR T-cell therapies—backed by substantial funding—reflects ongoing investment in breakthrough cancer treatments while balancing immediate clinical opportunities with strategic long-term goals. Amidst these transformative developments are broader industry trends involving employment shifts and funding dynamics. Despite workforce reductions like those at Takeda as part of its transformation strategy, there remains strong momentum within sectors such as California's vibrant biotech scene—illustrating resilience amid economic pressures. These stories exemplify an industry characterized by transformation driven by scientific insights into disease mechanisms coupled with regulatory vigilance ensuring patient safety remains paramount throughout all stages—from discovery through commercialization—ultimately striving towards improved patient care outcomes addressing various unmet medical needs worldwide.Support the show

Despite a prolonged period of policy uncertainty in the U.S.—and the ripple effects across the global life sciences and healthcare industries—executives at health companies are still seeing opportunities amid the tumult. In many cases, they’re finding that the resilient business models they built through disruptions like the pandemic have positioned their companies not just to survive, but to thrive in a new normal for the industry. In this episode of “The Top Line,” Fierce Pharma’s Fraiser Kansteiner chats with Glenn Hunzinger, PwC’s U.S. health industries leader, about results from the firm’s recent survey on investor sentiment. Focusing on health companies, Hunzinger explains how many innovative drugmakers have managed to capitalize on the shifting environment. Still, he warns that a more uncertain landscape for U.S. innovation and continued tariff pressures on sectors such as medtech could pose challenges down the line. To learn more about the topics in this episode: AstraZeneca CEO's conservative MFN model excludes reference markets from forecast As Johnson & Johnson navigates changing tariff landscape, execs lay out their expectations Trump eyes 100% tariff rate for companies that have not struck MFN deals: Bloomberg See omnystudio.com/listener for privacy information.

After months of mixed messaging from the White House, the pharmaceutical industry has gained more clarity on the second Trump administration’s import tariff policy for drugs. While many of the industry’s biggest firms have navigated the trade threat through investment pledges and drug pricing deals, the current landscape remains murkier for small- and mid-sized drugmakers. In this episode of “The Top Line,” Fierce Pharma’s Fraiser Kansteiner sits down with Chris Young, a principal in KPMG’s trade and customs practice, to discuss the pharma tariff landscape following President Donald Trump’s announcement in early April of a potential 100% tariff on imported drugs. Young explains how the policy could affect smaller drugmakers that haven’t inked high-profile pricing deals with the government and shares best practices for navigating the rapidly evolving U.S. trade environment. To learn more about the topics in this episode: An update on the pharma industry’s reshoring effort Trump eyes 100% tariff rate for companies that have not struck MFN deals: Bloomberg Trump's tariff threats, measured by manufacturing UK signs off on US pharma deal, ensuring tariff reprieve as Britain aims to reattract investments See omnystudio.com/listener for privacy information.

President Donald Trump has struck a deal with the UK that exempts prescription drugs imported to the United States from tariffs for three years. In exchange, Britain’s National Health Service will pay 25% more for new drugs. The question now is: Can the U.S. negotiate similar deals with other countries? In this week’s episode of "The Top Line," we examine the drug pricing agreement between the UK and the U.S. Fierce Pharma’s Kevin Dunleavy explores the issue with Jeffrey Gerrish, who served as deputy U.S. trade representative for Asia, Europe and the Middle East during the first Trump administration. They break down the specifics of the UK-U.S. partnership and whether the deal could be applied to other countries to bring drug prices more in line with those in the U.S. They also discuss Trump’s other attempts to use America’s economic power to secure drug pricing agreements. To learn more about the topics in this episode: UK signs off on US pharma deal, ensuring tariff reprieve as Britain aims to reattract investments Merck executes its own Brexit, moving all R&D operations out of UK AstraZeneca's Soriot is considering move of stock listing to the US: Times See omnystudio.com/listener for privacy information.

Send us Fan MailWhy does it take five years to diagnose a child with a genetic disease when the answer is available in 48 hours?In this clip from our episode “How Genomics Is Transforming Rare Disease Care”, host John Driscoll and guest Katherine Stueland, CEO of GeneDx, expose one of the most frustrating gaps in pediatric medicine today.

Send us Fan MailOne in six children has a developmental delay, and it takes an average of five years to get a diagnosis for a genetic disease. But it doesn't have to. The technology to get answers in 48 hours already exists.Katherine Stueland, CEO, GeneDx joins host John Driscoll to discuss why rare genetic diseases are far more common than most people realize, how whole genome sequencing is transforming pediatric care, and what it will take to bring precision medicine to every child who needs it.

Dr. Tasha Golden is a singer/songwriter turned behavioral scientist and a leading expert in creativity, leadership, and change. She has spoken and consulted for Google, the Mayo Clinic, the US Conference of Mayors, SXSW, and POLITICO, among many others—helping leaders and organizations link science and creative practice to drive innovation and growth. Dr. Golden was the first Director of Research for the International Arts + Mind Lab at Johns Hopkins School of Medicine, is adjunct faculty in the University of Florida's Center for Arts in Medicine, and lead author of Arts on Prescription: A Field Guide for US Communities. Named one of Fierce Pharma's "Fierce 50" for innovative work integrating arts and health, she publishes regularly in Psychology Today and her research has been featured in The Guardian, NPQ, and the CBC.

Deb (00:03.606)Within the next seven months, up to 1.5 million Americans could lose access to a medication that they’ve relied on for decades. Not because it’s dangerous, but because a pharmaceutical giant may have lobbied the FDA to eliminate their competition. And if you’re one of them, your doctor may already have told you about this issue and stopped prescribing it.This isn’t a conspiracy theory. This is documented in federal court filings. This is happening right now. And the company that stands to profit, well, they’re the same ones manufacturing the only product that might survive.Today on Let’s Talk Wellness Now, we’re exposing the desiccated thyroid extract crisis, the corporate manipulation behind it, and what you need to do right now to protect your health. Stay with me because I’m about to share what could save your access to the medication keeping you alive.Welcome back to Let’s Talk Wellness Now, the show where we uncover the root causes of chronic illness, expose regulatory capture in healthcare, and empower you with the tools to advocate for yourself. I’m Dr. Deb, naturopathic doctor, your medical detective, and today we’re diving into one of the most consequential and corrupt healthcare decisions affecting patients right now. If you or someone you love takes Armour thyroid, NP thyroid, or any desiccated thyroid extract,for hypothyroidism or if you’ve struggled to find a thyroid medication that actually works for your body, this episode is absolutely critical. And if you have celiac disease, gluten sensitivity or corn allergies, what I’m about to reveal will make your blood boil. Now grab your cup of coffee, don’t forget your notebook and settle in because what’s happening to this medication right now is a masterclass in how pharmaceutical companies use regular Deb (02:06.544)agencies to eliminate competition, control markets, and price gouge patients. And I have all the receipts. Deb (02:20.982)Let me start with what might surprise you. Desiccated thyroid extract, or DTE as we call it, is actually one of the most oldest thyroid medications in the world. And I mean old. From the 1890s through 1970, this was the standard treatment for hypothyroidism.Now let’s really dive into that. From the 1890s to the 1970s, this was standard hypothyroidism treatment.In 1965 alone, and this is documented in peer-reviewed literature published in the Journal of Clinical Endocrinology and Metabolism, approximately four out of every five prescriptions for thyroid hormone in the United States were of natural desiccated thyroid preparations.The Journal of Clinical Endocrinology and Metabolism is a very high-end journal. Now think about that. This wasn’t some fringe therapy. This was mainstream medicine. Armour Thyroid, the most recognizable brand name, has been manufactured since the early 1900s, well over a century ago.and this is cited again in NIH bookshelf. When the FDA was officially established in 1938, Arbor thyroid was already on the market. And this is important and I want you to understand why. Under the federal Food, Drug and Cosmetic Act, any drug that was already being marketed before 1938 was automatically grandfathered into the system. That means it didn’t have to Deb (04:08.112)go through the formal FDA approval process. And this again is cited under the Federal Food, Drug and Cosmetic Act, grandfathered drugs and exemptions. And this is crucial to understanding what happens next. By the 1970s, synthetic levothyroxine, brand name Synthroid and generics became the preferred treatment. Hmm, wonder why?It was easier to standardize, came into consistent doses, and worked well for most patients, and could be mass manufactured. By the 1980s, levothyroxine had largely replaced desiccated thyroid in clinical practice, according to the American Thyroid Association 2014 guidelines for the treatment of hypothyroidism. But here’s what matters. Some patients…a very significant minority of them, never felt right on levothyroxine alone. Despite their lab work looking normal, they still had fatigue, brain fog, weight gain, cold intolerance, and depression.These patients often found relief when they switched back to their desiccated thyroid, which contains both T4 and T3 hormones, the way human thyroid naturally produces them. And this is not anecdotal. This is documented in randomized double-blind crossover studies published in Endocrine Practice.For decades, that was fine. Their doctors prescribed it, insurance sometimes covered it, patients were getting better, and the system worked really well. Until August 6th of 2025, just a short time ago, everything changed. On that date, the FDA sent letters to manufacturers, importers, and distributors of desiccated thyroid extract products stating that these medications would need an approval. Deb (06:04.654)a biologics licensed application, a BLA, to remain legally on the market. And this is cited in the FDA’s official statement, FDA’s actions to address unapproved thyroid medications. understand it says unapproved thyroid medications. However, desiccated thyroid, specifically Armour, has been approved since 1938. And this was dated August 6th through 7th, 2025.This wasn’t a guideline. This wasn’t a suggestion. It was an endorsement of action. And the timeline they gave them? Well, just 12 months to transition patients to another medication before enforcement action could begin.This was also cited by an FDA notice to the industry, animal derived thyroid products notice to industry, August 6th, 2025. Now do the math, that means August 2026, seven months from now, 1.5 million Americans currently taking this medication. And this number comes from the FDA official statement, citing that it’s an estimation of 1.5 million patients receiving prescriptions for these medications.could potentially lose their thyroid access. Now, here’s where it gets interesting. The FDA didn’t wake up in August of 2025 and decide to regulate desiccated thyroid after a century. This decision has a much longer backstory. And understanding that backstory is critical to understanding what’s really happening in this industry.The shift started in 2022. Back in September of 2022, over three years ago, an FDA branch chief sent a letter to the National Associations of Boards of Pharmacy noting that the agency had decided to designate DTE as a biological product, which would affect its eligibility for compounding. Deb (08:13.972)This also is cited in an FDA letter to the National Association of Boards of Pharmacy September 2022.Then two months later, in November of 2022, the FDA’s Office of Compounding Quality and Compliance sent a softer letter acknowledging that many Americans take medication to treat hypothyroidism and some choose to take DTE products. The letter stated that the FDA would focus enforcement on cases that pose the greatest public health risks, such as serious adverse offense or serious product quality or adulteration.also is cited by an FDA letter from Francis G. Bromel, the director, Office of Compounding Quality and Compliance, November of 2022. Now, let me just think about this for a second. If this drug has been on the market since the 1800s, been FDA approved since 1938, would we not have seen a health crisis long before 2022?I honestly don’t know of any other drug that’s been around this long that’s used by this many people. Now granted, I haven’t done the research on it either, which I can do for you guys, but I’m just thinking if a drug is on the market today and it causes harm, it doesn’t make it three years, five years before you see lawsuits everywhere. Why are there no lawsuits on this drug? Why are there no major reactions that people are seen having?Hmm, just thought. But here’s the pattern. The FDA was already laying the groundwork back in 2022, testing the waters, signaling where this was headed. The August 2025 action. Then this came down. Deb (10:09.806)August 6, 2025, the FDA announced its position publicly and sent formal letters to all DTE manufacturers, importers, and distributors. This was cited by the FDA Enforcement Action August 6, 2025, letters to manufacturers, importers, distributions of DTE products. The agency stated several concerns. First, DTE products have experienced quality and dosing issues.The FDA cited, and I’m quoting directly from their statement, over 500 adverse events reported associated with DTE products from 1968 to 2025. From 1968 to 2025, we had 500 adverse reactions? What is that math equate to?A couple a year? Come on guys, this is insane! With a substantial increase, you, between 2019 and 2020 that the agency suggested was related to voluntary recalls of sub-potent or super-potent products.This was cited in the FDA statement, over 500 adverse events reported associated with ADT products from 1968 through 2025.Second, the agency expressed concern about batch inconsistency. According to the FDA’s official statements, tablets made from the same manufacturing batches may not always provide the same thyroid hormone levels. Okay, this was cited in the FDA statement, tablets made from the same manufacturing batches may not always provide the same thyroid hormone levels. Thirdly, and I want to actually let’s back up. I want you to remember I said that Deb (12:11.216)because further down in this podcast, we’re going to talk about this. This is an important point to remember. Thirdly, the agency raised concerns about potential impurities from animal source material, including potential for viral contamination due to the animal source and supraphysiological levels of T3.the FDA statement on impurities, viral contamination and super physiological T3 levels. Now I will tell you, I’ve been prescribing armarithograde for 20 years. I’ve rarely seen a super physiological dose given of T3 in lab results, unless the patient takes their medication like four or five hours before you do the blood test, then you’ll see a false rise because you’re actually seeing the medication. You’re not seeing people walking aroundsuperphysiological T3 levels. Nobody would like that feeling. So anyway, I digress. Now let me pause here because this is where I need to give you some context that the FDA hasn’t quite emphasized yet. Of course, we have another connection and it is the China connection.So the FDA’s concerns about contaminated drugs and quality issues don’t exist in a vacuum. In 2024, the U.S. over 828,000 metric tons of pharmaceuticals, seven times the level from 2000. And here’s the kicker. China and India supply the majority of active pharmaceutical ingredients. APIs for U.S. generics accounting for 70 to 80 % of the total genericdrug supply. According to Reuters industry report in 2024, they state that China supplies 82 % of the APIs for critical drugs. Deb (14:08.204)Got to question that, right? Why are we giving all of our drug formulas to China and allowing them to import them into our country? In fact, roughly 20 % of the critical drugs have APIs exclusively sourced from China. And China controls 80 to 90 % of the global production for antibiotics and other key compounds. This was also cited by Reuters industry data thatcontrols 80 to 90 percent of the global production for antibiotics and other key compounds. Now just think about this. They control 80 to 90 percent of our medication. They control 20 percent of our critical drugs and we just put what kind of tariff on them? Hmm.In 2025 alone, the FDA issued multiple warning letters to foreign manufacturers for contamination issues and failure to follow good manufacturing practices. This is also cited by the FDA warning letters 2024 through 2025 and multiple citations to foreign manufacturing facilities. This is a systematic problem affecting the entire US drug supply, not just desiccated thyroid.So when the FDA suddenly became concerned about DTE quality and contamination, part of that concern was legitimate. But this is crucial. The same inconsistencies and contamination issues exist across the entire generic drug supply. And the FDA has not taken the same enforcement action against them. Let that sink in.They have not taken the same enforcement action against the other drug companies. So what’s behind all of this? Where is this all coming from? Hmm. Let’s address something directly, because you deserve to know it. And I’m going to cite my sources precisely so that when the medical boards have something to say about this, and they might, I have a documentation for every single word that I am about to speak. Deb (16:24.878)According to the court documents filed in October 2025, in the case ofa urine, a urine. I’m going to say that wrong. Pharmaceuticals versus Dr. George Tidmarsh from ABBV, the multinational pharmaceutical company that manufactures armor thyroid, reportedly petitioned the FDA in 2024, asking the agency to reclassify DTE as a biologic and to prohibit other manufacturers from selling unlicensed DTE products unless they havehad an investigational new drug application, we call this an IND, and a clinical development program aimed at eventual approval. This is cited in the court filing a Urena pharmaceuticals lawsuit versus Dr. George Tidmarsh, October 2025, reported by Fierce Pharma. Now let me explain why this matters and why this is one of the most brazen examples of regulatory capture I’ve ever seen in my career.AbbeVee is one of the world’s largest pharmaceutical companies. In 2024, they reported over $54 billion in revenue. Drop the mic on that one.They have the resources, the regulatory expertise, the legal teams, and the financial capacity to navigate a biologics license application process that costs between $500 million and $1 billion. Let that sink in. Deb (18:07.882)A drug that’s been on the market since the 1800s that was grandfathered in 1938 that’s making plenty of money right now. They’re going to spend 500 million to $1 billion to get a biologics license application. Why would they do that? Well, we’re about to find out. Most otherDTE manufacturers, smaller companies like Acela Pharmaceuticals, which makes NP-thyroid, and RLC Labs, which made WP-thyroid, do not have those same resources. And this is cited in Pharma Voice in 2025. Why a treatment older than the FDA is getting new regulatory scrutiny. So when you petition the FDA to reclassify a drug in a way that requires this type of expensivetime-consuming biological approval, you’re not just asking for safety. You’re asking to eliminate your competitors from the marketplace. Now, I want to be very precise here. These allegations are documented in federal court filings, and it hasn’t been approved in court. It’s also been reported by multiple industry sources, including Fierce Pharma. But I’m telling you,what has been reported in legal proceedings, not stating it as an absolute fact because you deserve to know the difference and because I have to protect my license. Now, what do we know for certain?AbbeVee is working on a biologics license application for Armour thyroid through clinical trials called Avantia. This is cited by the AbbeVee corporate statement 2025 Avantia clinical trial for Armour thyroid. A cell of pharmaceuticals has been pursuing BLA approval for NP thyroid for seven years since 2017 and it completed its phase two trials successfully in 2025. They’re now moving Deb (20:15.448)into Phase 3 trials. This is also cited by the Acela Pharmaceuticals CEO statement 2025 seven-year pursuit for BLA approval completed Phase 2 trials moving to Phase 3.RLC Labs, which manufactured WP thyroid, has made no public announcement about pursuing BLA approval and really probably don’t have a plan to do this since they’ve been off the market for some time now. About five years, I think maybe a little longer. Here’s the market manipulation.If only ABBV is successful and obtains a BLA approval for Armour thyroid, that company would effectively have a monopoly on the DDT market. And in pharmaceutical markets, monopolies historically lead to price increases.We’ve seen this pattern over and over again when turning pharmaceuticals acquired Daraprim and raised their price from $13.50 to $750 per tablet overnight. When Myelin raised EpiPen increased prices by 400 % when insulin manufacturers colluded to raise prices in lockstep. This is the playbook.use regulatory barriers to eliminate your competition and then exploit pricing power. For a drug that’s been on the market since the 1800s, guess corporate greed is everywhere. They’re not making enough money on this product already and they’re taking advantage of the rules that they can manipulate their competition by. And here’s what really makes me furious. The American Thyroid Association, the professional organization Deb (22:06.672)representing endocrinologists sent letters to the FDA commissioner on October 8th of 2025 and September 18th of 2025.advocating for continued patient access to DTEs. This is cited in the American Thyroid Association statement and letter to the FDA commissioner dated October 8th, 2025 and September 18th, 2025. The American Association of Clinical Endocrinologists issued a statement on September 9th of 2025 supporting equitable access and personalized medicine for DTE. This was also cited in the American AssociationAssociation of Clinical Endocrinologists, AACE, statement dated September 9th, 2025. Even the medical establishment, which has historically favored levothyroxine, is saying, wait, this is going too far. Patients need access to this medication. But the FDA is moving forward anyway. Why? Well, where does it always lead us? Follow the money trail.Okay, so I need to explain what a biologics license application actually is because this is where the rubber meets the road for what’s going to happen to pricing and availability. What is a BLA?A BLA is a biologics license application. It’s a formal request submitted to the FDA to market a biologic product in the United States. A biologic is defined under the Public Health Service Act section 351 as a product derived from or made using living material, in this case, animal thyroid glands. And this is cited in the FDA definition for biologic products. So they’re putting armor thyroid right Deb (23:57.377)right up with stem cells and exosomes. Think about that. Stem cells and exosomes cost thousands of dollars per application because of how they have to be harvested, stored, freezed, all of that. But we’re talking about a thyroid gland. Good Lord, people.Unlike regular drug applications for synthetic medications which follow a simpler pathway, the BLA process is designed for complex biological products like monoclonal antibodies, vaccines, and gene therapy products. It’s a much more expensive, much more time-consuming process. The BLA processis what manufacturers have to do. And we’re going to talk about that. So according to Reprocell and Forge Biologics analysis of the FDA’s BLA process, here’s what companies need to submit. First, they need to complete a clinical trial data, phase one, two, and three trials, proving safety and efficacy for desiccated thyroid. Haven’t we done that since it’s been on the market since the 1800s? Just saying.This means they have to conduct large randomized controlled trials comparing it to levothyroxine, measuring safety outcomes, efficacy outcomes, and quality of life metrics. Second,Chemistry, Manufacturing and Controls, CMC’s data. Detailed information about how the product is manufactured, quality control measures, stability testing and specifications that must be met for every batch. Third, preclinical and animal safety data. Fourth, labeling and product information. Now, I think we have labeling and product information. Deb (25:53.717)since the 1800s? But just saying. Fifth, they need Pharma Covigilance Plan, a detailed plan for monitoring safety after the product is on the market. Haven’t they had to do that since the 1800s? And they have to have a timeline. And this is the critical part. The FDA’s standard review time for a BLA is 10 months.That’s after the application is deemed complete and accepted for filing. So this is cited by the FDA standard review timeline, BLA submission, and FDA review.Now, before you even get to filing, you need to conduct the clinical trials and compile all the data that’s typically several years of work. How are you going to prove safety and effectiveness in a large clinical trial long term? What do they consider? What do they deem long term? Three months, six months, a year, two years. These companies had 10 months.Well, maybe 12. They did it a year in advance. But unless you knew this was coming, how are you going to put together a trial, enroll the people, have all the trial components set up and ready to go in less than 12 months unless you knew it was coming beforehand? Even ifhad started all their clinical trials in 2024, completing them, compiling the data, and getting a complete application ready for submission, this would likely take you through mid-2026, then add another 10 months for FDA review. We’re looking at 2027 at the earliest for most of these companies to receive a BLA application. Deb (27:54.319)But the FDA gave the manufacturers until August of 2026. That’s approximately 19 months from when the August 2025 letters were sent. Most companies cannot reasonably complete the BLA approval in that timeframe. And when I’m talking about the 19 months, I’m talking about the information they would have had earlier. Now the cost.This gets me even more frustrated. Why are we spending this kind of money? The BLL process is extraordinarily expensive. The current FDA user fee for a BLA submission is approximately $483,560 just for the filing fee. And this is cited at the FDA user fees prescription drug user fee rates for 2025.The full cost of conducting clinical trials, CMC studies, and all the supporting documentation typically ranges from $500 million to over $1 billion, depending on the scope of the trials and the complexity. And this is cited in JAMA’s network, Open2023. A cell of pharmaceuticals has been pursuing the BLA approval since 2017. That’s eight years. And it’s just now.moving into phase three trials with a planned enrollment of approximately 300 patients. This is cited by the Acela Pharmacies CEO statement of 2025. Now that’s unusual. That’s typical for this process. This is not unusual. This is typical for this process to take seven, 10 years to get approval for this. So if Abby’s the one that requested this,Abby V. And Acela started this in 2017. Was Abby V threatened by Acela that Acela might get this approval and it would be quietly done without anybody seeing it? And maybe Abby V would be left out of the market after a century? Who knows? It’s possible. Deb (30:13.112)But for smaller manufacturers without billions in revenue, this cost is completely prohibitive. And this is why this matters. When you push an old established medication through an extraordinary, expensive approval process with a compromised timeline, one of three things happen. First, only the largest companies can afford it, creating a monopoly. And when that happens, the company that holds the only approved product can set pricing withminimal competitive pressures. Two, smaller manufacturers can’t afford it and their products disappear and the market shrinks and access decreases. Three, we see a combination of both and who pays the price? Literally, patients do. Now here’s whereThere’s something I want you to really think about because this is where the regulatory argument falls apart when you look at it carefully. The FDA’s concern about DTE is that, and I’m quoting their official statement, tablets from the same manufacturing batches may not always provide the same thyroid hormone levels. This is from their FDA statement.And that’s a legitimate quality concern, right? It is. Thyroid medications have a narrow therapeutic window like any other hormone, meaning the difference between an effective dose and the dose that causes problems can be quite small. But here’s what the FDA doesn’t emphasize. Generic drugs have the exact same dosing inconsistency issue, and it’s considered acceptable and has been since we allowed generics on the market.So how does a generic drug dose work anyway? Well, for generic drugs to be approved as bioequivalent to a brand name medication, the FDA requires that the generic drugs bioavailability fall within 80 to 125 % of the brand name product. Isn’t that a dose inconsistency? Deb (32:22.894)from the brand name medication? 800 or sorry, 80 to 125%. According to the pharmacy times analysis of the FDA’s bioequivalent standards, the 80 to 125 % bioequivalence rule means that a generic drug can have 20 to 45 % variability compared to the original brand product.Now, most generics are much closer than that. The FDA study data shows that the mean difference for an AUC value between generic and reference products is about three and a half percent in the two year post-Waxman hatch period, and 80 % of the generics fall within a five percent range. But the FDA’s regulations allow for that much higher variability. And this is cited in an FDA study data mean difference for AUC.Now, let me put this in plain language. A patient could take a generic levothyroxine tablet where one batch provides, say, 75 micrograms of an active thyroid hormone. And the next batch from a different manufacturer, a different generic manufacturer, could provide up to 93.75 micrograms, 125 % of that 75. That’s an 18 microgram difference.in the same prescribed dose. Now, this is considered acceptable and patients tolerate it and this system works.Yet the FDA’s argument against DTE is that batch-to-batch inconsistency is unacceptable and requires this expensive biologic approval? That’s a double standard. So why is batch inconsistency acceptable for generic levothyroxine, but supposedly unacceptable for desiccated thyroid? I’ll give you the regulatory answer. Deb (34:29.366)because DDT is a biological product derived from an animal tissue and the FDA considers biological products to require more rigorous control. That’s the regulatory answer, but I’ll give you the real answer.because there’s no billion dollar pharmaceutical company with a patent pending on generic levothyroxine who petitioned the FDA to regulate their competitors more strictly. The inconsistency argument is legitimate, but it’s selectively applied. And that matters when you’re trying to understand whether this is really about patient safety or whether it’s about market control.Now I want to talk about something that hasn’t gotten nearly enough attention in this discussion and it’s something that makes me absolutely furious. What is Armour Thyroid? According to the official prescribing information published by AbbeV and available through rxabbev.com and the FDA’s daily med database, Armour Thyroid contains the following inactive ingredients. Calcium steroid,dextrose derived from corn, mycocrystalline cellulose,sodium starch glycolate and a opadri white coating. Now let’s talk about dextrose. Dextrose is a sugar derived from corn and while manufacturers claim that the corn derived dextrose in armor thyroid is gluten free, here’s the problem. Cross contamination during corn processing can introduce gluten proteins especially if the corn is processed in facilities that also handle Deb (36:18.808)wheat, barley, or rye. Corn sensitivity is extremely common in patients with celiac disease and non-celiac gluten sensitivity, and studies show that up to 50 % of the celiac patients react to corn proteins due to molecular mimicry, and the corn proteins look similar enough to gluten that the immune system attacks them. And this is cited by RestartMD.com.And here’s what’s documented in peer-reviewed medical literature in a 2023 case report published in Case Reports in Endocrinology. These researchers documented five patients with gluten intolerance or celiac who were taking natural desiccated thyroid. Three of those patients also reported lactose intolerance. Now these patients had to switch from DTE to liquid levothyroxine formulations to avoid the inactiveSo here’s my question. If AbbeV becomes the only manufacturer with an approved DTE product and their formulations contain corn-derived dextrose that triggers reactions in celiac patients, what are those patients supposed to do? They can’t take armor because of the corn. They can’t take compounded DTE because the FDA is banning compounding of these biologics. They can’t take NPKsor WP thyroid because those companies may not survive the BLA process. So they’re left with a synthetic version of levothyroxine which may not work for them.Now the NP thyroid and WP thyroid difference. Now here’s what’s interesting according to drugs.com comparison of inactive ingredients and P thyroid and P thyroid has calcium steroid dextrose also derived from corn, mineral oil, multi-crystalline cellulose. Deb (38:19.31)cross carmelicin sodium and a opadri to white. So NP thyroid also has corn-derived dextrose. WP thyroid on the other hand was specifically formulated to be hypoallergenic according to ROC labs, but it’s no longer available and its ingredients were inulin from chicory root and medium chain triglycerides. No corn, no gluten, no common allergies. So todayWe do not have a glandular thyroid, a DTE, that is not potentially contaminated with gluten. Yet, patients with autoimmune thyroid disease are supposed to avoid gluten.Now, some of these people can handle a DTE and many cannot, so that argument could be a mute point. But at the end of the day, the one product that we had that was designated for patients with multiple chemical sensitivities, celiac disease and coron allergies, has been off the market for a long time already.We have a monopoly problem. So if ABBV becomes the only approved manufacturer, patients with these celiac diseases and corn allergies will either be forced to take a medicine that makes them sick and triggers their immune reaction or switch to a synthetic that doesn’t adequately treat their hypothyroidism or choose to go without treatment. This is not hypothetical. This is real patients with real medical needs who are about to lose accessto the only formulation that works for their body. And the FDA’s response is silence. Deb (40:07.69)Now I want to highlight something that hasn’t gotten nearly enough attention in this discussion. Compounding pharmacies. What is a compounding pharmacy? Compounded medications are custom made by licensed pharmacists to meet a patient’s specific needs. Maybe you need a different strength that was commercially available, but you have an allergy to a filler or a dye in the commercial product. Maybe you need a liquid formulation or instead of a tablet or you need a capsule. That’s when compoundingin. And the FDA’s, this is the FDA’s definition of compounding. And for decades, compounding pharmacies have been making desiccated thyroid extract for patients who needed customization. Some patients couldn’t take the commercial products because of the dyes and the fillers, and some needed strengths that were not available. And these compounding pharmacies filled the gap.But reclassification changes everything. When the FDA reclassified DTE as a biologic in 2022 and reinforced that decision in August of 2025, explicitly stated, and I’m quoting directly from the FDA’s official statement, these unapproved animal-derived thyroid medications are not eligible for compounding because these products are regulated as biologic products under the Public Health Service Act.How can that be? These products have been approved since 1938 and the Biologics Act didn’t go into effect or doesn’t go into effect until August of 2026.So how in 2022 were they able to say that the compounding pharmacies could not make these products? Anyway, what this means is after August 2026, compounding pharmacies will no longer be permitted to compound a desiccated thyroid extract, even for patients with specific medical needs. Now, compounding pharmacies can still compound T4 and T3 separately, synthetic versions of levothyroxine and liothyronine, according to Deb (42:12.728)healing dose compounding pharmacy. These pharmacists can create custom ratios of these two synthetic hormones to approximate what a patient was receiving from a DTE. But that’s not the same thing. Some patients respond better to the whole DTE preparation than to a compounded synthetic combination. And for patients with specific allergies to standard fillers like your celiac patients that I just talked about, losing the ability to get a compounded DTE alternative isreal hardship. This is going to be a ripple effect. For a subset of patients, maybe 5 to 10 percent of those on DTE compounding was their lifeline and it was their way to get a medication formulation that worked for their unique body. When compounding goes away, these patients lose that option as well and for some it will be a significant problem. Now let’s talk about what this likely means for your wallet.The current pricing right now, according to SingleCare and GoodRx, Armour Thyroid costs approximately $150 to $157 for a 90-day supply of 60-milligram tablets, about $1.67 per tablet. With discount cards, some patients can get it down to $101 to $152 for a 90-day supply.Generic levon thyroxine costs about $70 for a 90 day supply, less than half that price. And p-thyroid costs approximately $133 for a 90 day supply of 60 milligrams with a discount card about $83 to $101.What happens after we get BLA approval? Well, here’s the pharmaceuticals pricing model. When a company spends 500 million to $1 billion to bring a product to market, including conducting massive clinical trials, the cost tens of millions of dollars they recoup in that investment through pricing power. And this is cited in the pharmaceutical pricing models. If ABBIEV is the only company with an approved BLA of DTE, Deb (44:18.248)They have pricing power. They don’t have competitors. They can set their price, whatever they want. And historically, when drugs transition from grandfather status, which is basically unregulated to formal formally approved status, prices often increase significantly, not always, but often. And typically they have to get re-approval for insurance. SoTouring Pharmaceuticals acquired DARPM and raised the price again from $1,350 to $750 overnight, a 5,000 % increase. This is the playbook.Let’s talk about insurance coverage. This is the other consideration. Insurance companies sometimes have different coverage policies for approved versions versus unapproved drugs. And right now, many insurance plans cover armor thyroid or NP thyroid, even though they’re technically unapproved because they’ve been on the market for decades and patients are on them. Once a drug becomes formally approved, insurance companies may have new contractual relationships, prior authorization requirements, or preferred drugs.list that could affect your coverage. If 1.5 million people have to get a prior auth for their insurance to cover this new medication, this is going to drive the doctor’s offices crazy. We do not have the staff to man this. We do not have the manpower. We do not have the time. This is going to interrupt people’s ability to get their medications. This is going to create chaos within the system. And some patients might see better coverage, but manymost likely are going to see worse coverage and some might find themselves in a situation where they need to try to get the drug approved first or get an approval for something else like levothyroxine and they’re going to have to document that it didn’t work and the documentation that they had from 20 years ago is probably not going to be enough because it’s not documented anywhere. It’s lost in the system after 10 years. So for patients the practical takeaway is expect Deb (46:25.774)a price increase. I would say possible, but I don’t think that’s true. think you’re going to see a price increase if they get approved. Expect possible insurance complexities, budget accordingly, talk to your insurance company now about what your coverage is going to look like in 2027 if they even know. And if you want my honest assessment of what is likely to happen,I’ll give you a scenario, 30 % likelihood. The FDA enforces the August 26 deadline and DTE products not approved by then are pulled from the market. Patients will have 30 to 90 days to transition to other medications. Some patients suffer significant symptom relapse. Compounding for DTE becomes illegal and this disruptiveness of the system creates a real hardship. Scenario two.which is 50 % likely. This is actually what the FDA commissioner, Marty McCreary suggested on August 13th of 2025 when he posted on social media. The FDA is committed to pursuing the first ever approval of desiccated thyroid access pending results of the ongoing clinical trials. In the meantime, we’ll ensure access for all Americans. Hopefully that continues. What this likely means is the FDA uses enforcement discretion to allow continuedsales while approvals are being pursued and the deadline gets extended. Maybe patients get access for another two to three years while companies work on a BLA approval. This would be the least disruptive scenario, but it’s also legally uncertain because the enforcement letters have been formally rescinded. And scenario three, which is 20 % likelihood, one or two companies get BLA approval. Those products stay on the market at higher product prices and companies, products, other companiescompanies, products are pulled, the market shrinks, availability is limited, prices are higher, but patients can still get something. This is likely if a seller successfully completes phase three trials for NP-thyroid. And my assessment is based on the regulatory language and the enforcement letters that have not been rescinded yet, that the pattern of FDA enforcement, I believe scenario two enforcement discretion with an extended time frame is most likely what we’re going to see. Deb (48:49.488)doesn’t mean patients should sit back and do nothing. It means you should be prepared for change while advocating for access. If you want to keep Arm or Thigh Right on the market, 1.5 million people need to start talking about this publicly and flooding our Congress people, Bobby Kennedy, the FDA, with what you want to see happen. We have the ability to shape this and to change this with our voice. But if we sit back on our laurels and we do absolutelynothing. What is going to happen is what the FDA wants to have happen and ABV wants to have happen because they’re going to simply think people don’t give a shit. And if the American people are going to be lazy and not want to step forward and actually start using their voice for some good and instead of just going to social media and bitching and hoping something is going to happen, well, then we’re going to get what we deserve. But if you start taking someaction and you start advocating for the things that you want. Contacting your representatives, contacting your U.S. tell them the FDA has done this. Many of them may not know this, may not be on their radar. Tell them what you want. Start going after this. Start writing to the FDA Commissioner’s Office. They have a website. They have a Commissioner’s Office at fda.hhs.gov. Be responsible.respectful, but be firm. Explain your scenario. How long you’ve been on DTE. Why levothyroxine doesn’t work. What symptoms you experience when not adequately treated. How this decision will affect your quality of life and your pocketbook. Let’s do something proactive. So let’s consider this. Moving forward, work with your provider who understands the regulatory landscape around DTE. You can discuss the evidence for and against combination therapy.You can monitor for thyroid function with free T3 and free T4 testing, not just TSH. If you’re willing to try individualized approaches, you can do that. If you need help finding a functional medicine provider who understands this issue, come to serenityhealthcarecenter.com or explorethevanari.com. It’s a self-directed functional medicine support group. And right now what is happening is going to shape how history Deb (51:19.024)is made with not just armor thyroid, but many drugs to come. And it is important for you to take action. So I want to thank you for joining me today on Let’s Talk Wellness Now. This episode is about far more than thyroid medication. It’s about your right to personalized medical treatment. It’s about your regulatory capture and corporate influence. And it’s about what happens when billion dollar companies shape healthcare policy in ways that reduce patient choice and increase their profits.this episode resonates with you or you know somebody who’s going to be affected by desiccated thyroid, please share it. Post it on social media, send it to your doctor, email it to your representatives, tag AbbeVee, tag FDA. Make noise because the only way we stop this is if we make it too politically costly for them to continue. Your voice truly matters. Your health truly matters and you deserve access to treatments that work best for your unique body.If you’re ready to explore comprehensive personalized health care that puts you in control, visit us at SerenityHealthCareCenter.com. Learn more about functional medicine approaches to thyroid and beyond and explore my new platform, Venari.com, which is a self-directed functional medicine tool. Thank you for joining me today. Until next time, I’m Dr. Deb reminding you, your health is your responsibility, your choice, and your right. Be well, stay informed, fight back.and I’ll see you in the next episode. And if you’re looking for a full citation list of this episode, you can head over to letstalkwellnessnow.com and I will post all the citations for you so you have them in your arsenal as well. Thank you again.The post Episode 259 – The Desiccated Thyroid Crisis: FDA's Unseen Impact & Corporate Manipulation first appeared on Let's Talk Wellness Now.

While Lilly’s position in the obesity market and wider GLP-1 space has remained largely unshakeable in recent months, a crack in the company’s armor may be forming, according to at least one analyst. As that assessment dealt a blow to the company’s stock price in recent weeks, Lilly is plowing forward all the same with more details on its next wave of potential incretin drugs. In this week’s episode of "The Top Line," the Fierce Pharma team breaks down Lilly’s recent HSBC downgrade, what it signals for the GLP-1 and obesity markets, and the data shaping the company’s next wave of diabetes and weight loss products. Fierce’s Eric Sagonowsky is joined by Kevin Dunleavy and Fraiser Kansteiner to unpack the latest and assess the commercial narrative around GLP-1s so far. To learn more about the topics in this episode: With downgrade, HSBC casts doubt about Lilly's 'stairway to heaven' trajectory Lilly's triple-G bet lowers blood sugar, prompts 16.8% weight loss in phase 3 diabetes trial Lilly's obesity triple threat smashes efficacy expectations in phase 3 but proves intolerable for some Novo’s CagriSema tops semaglutide in ph. 3 diabetes study See omnystudio.com/listener for privacy information.

In this week’s episode of “The Top Line,” we take a deep dive into the fourth-quarter performance of the biopharma industry and how the sector fared in 2025 overall. As the world’s 25 largest biopharma companies reported earnings, attention quickly shifted to their outlook for 2026. Only five drugmakers expect faster growth than in 2025, and some are projecting sales declines. One of the most surprising outlooks came from Novo Nordisk, which expects a significant drop in sales. Several other companies are also facing the loss of patent protection for blockbuster drugs, leading them to forecast either declining revenue or slower growth. Fierce Pharma’s Kevin Dunleavy and Eric Sagonowsky discuss the trends emerging from fourth-quarter earnings and how the industry’s performance compares with previous quarters. They also examine the intensifying GLP-1 competition between Novo Nordisk and Eli Lilly and how the two companies appear to be heading in opposite directions. To learn more about the topics in this episode: Eli Lilly, Novo Nordisk lead revenue boom in the 'always tricky' Q4 As Lilly flourishes in Q4, peer projections signal looming sector slowdown in 2026 Biopharma industry gathers momentum in Q3 In Q3, drugmakers saw a marked decline in US vaccine sales as Eli Lilly kicked into higher gear See omnystudio.com/listener for privacy information.

For more than a decade, CAR-T therapy has been the miracle of oncology, turning end-stage blood cancers into curable diseases. But the application of these engineered cell therapies is expanding to reset the immune system for patients living with lupus, stiff person syndrome and other autoimmune conditions. And with new frontiers come new rules. In this week’s episode of "The Top Line," Fierce Pharma’s Angus Liu chats with Harpreet Singh, M.D., chief medical officer at Precision for Medicine and a former director of the FDA's Division of Oncology, about a recent article by FDA officials led by CBER Director Vinay Prasad, M.D., laying out the agency’s perspective on its regulation of autoimmune CAR-T therapies. Singh discusses how the agency’s "case-by-case" approach, as indicated in the article, could be similar to—and different from—CAR-T for oncology indications. She also talks about how drug developers should follow existing development experience, as well as prepare for specific requirements for long-term patient follow-up and potential new clinical endpoints from the agency. To learn more about the topics in this episode: FDA signals tailored approach to ‘carefully shepherd’ CAR-T therapy for autoimmune diseases Kyverna gains clear view to first CAR-T approval for autoimmune disease after 'truly remarkable' SPS readout Cabaletta CAR-T wipes out B cells without preconditioning in small autoimmune trial See omnystudio.com/listener for privacy information.

Though uncertainty still surrounds the Trump administration’s pharmaceutical import tariffs, the trade rhetoric set off a clear response across the industry in 2025. Drugmakers accelerated U.S. manufacturing plans, pushing production higher as companies looked to insulate their supply chains. Now, with many of those moves already underway, that breakneck pace is expected to level off through 2026 and 2027, according to a recent outlook from Atradius. In this week’s episode of "The Top Line," Fierce Pharma’s Fraiser Kansteiner speaks with Brady McKinney, an underwriter for Atradius' pharmaceuticals sector focusing on the Americas, about the credit insurer's recent industry report. McKinney explains how tariff concerns drove last year’s manufacturing surge and why Atradius expects a period of stabilization ahead. He also discusses how companies are weighing the risk of future trade flare-ups and what that could mean for production, investment and credit conditions across the sector. To learn more about the topics in this episode: Global pharma manufacturing output surged in '25 in 'front-loading' response to US tariff threats: report FDA emphasizes drug ingredients, production pledges as it debuts PreCheck manufacturing program In quick reversal, Trump calls off tariff threat related to Greenland pursuit 3 biopharma CEOs explain why they are 'authentically optimistic' for 2026 See omnystudio.com/listener for privacy information.

Every clinical setback carries lessons. That’s why Fierce revisits major trial failures each year: not to dwell on disappointment, but to understand what went wrong and what it signals for the road ahead. The 2025 edition of Fierce Biotech’s clinical trial flops report highlights a familiar pattern. Large drugmakers account for a disproportionate share of high-profile misses, reflecting the reality that many of the industry’s most ambitious late-stage programs now sit inside big pharma portfolios. On this episode of "The Top Line," Fierce Biotech's James Waldron and Fierce Pharma's Fraiser Kansteiner discuss the failures that stood out in 2025 and what they suggest about the challenges facing drug development. To learn more about the topics in this episode: 2025's top 10 clinical trial flops Sanofi ousts Paul Hudson after 'bumpy ride,' enlists Merck KGaA CEO to lead the French pharma See omnystudio.com/listener for privacy information.

In this week’s episode of “The Top Line,” Fierce checks in with professional services juggernaut KPMG on the biopharma rebound many industry watchers predicted in the closing months of 2025. Fierce Pharma’s Fraiser Kansteiner sits down with Kristin Cirello Pothier, principal and U.S. and Americas region life sciences sector leader, as well as global deal advisory and strategy leader for health and life sciences at KPMG, to discuss the firm’s latest industry outlook. Pothier also explains how drugmakers are cutting through the noise and reflects on the technology, indication and valuation factors shaping today’s dealmaking appetite. To learn more about the topics in this episode: 2026 forecast: After a surge of M&A in Q4, will the trend continue? Halozyme catches M&A wave to snap up Surf Bio in delivery tech deal worth up to $400M Global pharma manufacturing output surged in '25 in 'front-loading' response to US tariff threats: report In quick reversal, Trump calls off tariff threat related to Greenland pursuit See omnystudio.com/listener for privacy information.

With this year’s iteration of the J.P. Morgan Healthcare Conference in the rearview mirror, the biopharma industry has officially closed the door on 2025 as it heads into what is sure to be another eventful year. In this week’s episode of "The Top Line," Fierce Pharma's Zoey Becker sits down with Angus Liu and Fierce Biotech's Gabrielle Masson to unpack the key topics and trends that stood out at this year's conference in San Francisco. The conversation offers an early look at the themes and questions that could shape the year ahead. To learn more about the topics in this episode: All the meetings, none of the megadeals: Is JPM's purpose evolving? JPM26: What’s in a biopharma? CEO says Teva has the goods JPM26: Astellas CEO resists 'rescue BD' as $6B Xtandi patent cliff nears See omnystudio.com/listener for privacy information.

After a turbulent 2025, the biopharma industry is heading into the new year with major questions still unresolved. A tough biotech investing environment, aggressive direct-to-consumer drug marketing and sweeping U.S. policy changes reshaped the landscape last year. Many of those pressures are expected to persist into 2026, even as early signs point to a thaw in venture capital. At the same time, the industry is testing whether DTC drug sales can meaningfully affect pricing for patients and whether broad manufacturing onshoring goals can realistically apply to advanced therapies like cell and gene treatments and radiopharmaceuticals. In this week’s episode of "The Top Line," Fierce Pharma’s Fraiser Kansteiner sits down with three biopharma CEOs to unpack what defined 2025 and what comes next. He’s joined by Thijs Spoor, CEO of Perspective Therapeutics; Brian Culley, CEO of Lineage Cell Therapeutics; and Rich Daly, CEO of Catalyst Pharmaceuticals. Together, they tackle issues from DTC sales and onshore manufacturing to drug pricing, regulatory uncertainty at the FDA and the broader innovations the leaders are most excited about this year. To learn more about the topics in this episode: 2026 forecast: After a surge of M&A in Q4, will the trend continue? Editor's Corner: Fierce Biotech's 10 most-read stories of 2025 What a year: Here are the stories that captivated our audience in 2025 Editor's Corner: The top 10 Fierce Pharma Marketing stories of 2025 2026 forecast: Pharma clicks with patients as direct sales model shifts marketing strategies See omnystudio.com/listener for privacy information.

As 2025 closes, biopharma and healthcare are learning to live on shifting ground. In this special year-end episode of "The Top Line," Fierce reporters take stock of a year defined by federal research cuts, vaccine policy fights and leadership churn at the FDA, then push the conversation forward into the questions that will shape 2026. The through line is that uncertainty has become an operating environment, and the industry is recalibrating in real time. Fierce Biotech’s Gabrielle Masson, joined by Darren Incorvia, traces how funding decisions can narrow the pipeline years before the consequences are visible. Fierce Pharma’s Fraiser Kansteiner sits down with Angus Liu and Eric Sagonowsky to unpack the new center of gravity inside federal agencies, where vaccine recommendations, review norms and new FDA pilots are colliding with questions about capacity and outside influence. From there, Ben Adams and James Waldron bring the lens to Europe, where Jefferies in London captured a cautiously optimistic market still wrestling with tariffs, pricing pressure and investment hesitation. The episode closes with Fierce Healthcare’s Heather Landi and Paige Minemyer sharing their outlook on 2026, from the fight over ACA subsidies and Medicaid headwinds to the next phase of AI adoption, where the promise is real but the payoff may be slower, messier and more uneven than the hype suggests. To learn more about the topics in this episode: 'Unprecedented turmoil' engulfing FDA threatens public health: mRNA coalition speaks out FDA names Tracy Beth Høeg, fresh from vaccine safety probe, as acting head of drug center A dozen former FDA commissioners blast Prasad's proposed vaccine policy changes In letter to Makary, biotech CEOs push for FDA stability and say volatility threatens US innovation NIH grant cuts have disrupted hundreds of clinical trials, study finds 'Alternative history' of the NIH shows how a 40% budget cut may thwart new medicines House passes healthcare affordability bill without subsidy extension AMA: A look at concentration in commercial insurance, MA markets 2025 Outlook: Hospital finances show signs of stability, but rising costs will be a major headwind See omnystudio.com/listener for privacy information.

Within the last few days, there has been breaking news regarding the war on gonorrhea. Nuzolvence (zoliflodacin) was FDA approved on December 13, 2025, and Blujepa (gepotidacin) was FDA approved on December 11, 2025.These new oral treatments are particularly important given the global rise in gonococcal drug resistance and the convenience they offer over injectable options, potentially improving patient adherence and public health outcomes. Listen in for details. 1. FDA News Release. FDA Approves Two Oral Therapies to Treat Gonorrhea. fda.gov2. Innoviva Specialty Therapeutics. U.S. FDA Approves NUZOLVENCE® (zoliflodacin), a First-in-Class, Single-Dose Oral Antibiotic, for the Treatment of Uncomplicated Urogenital Gonorrhea in Adults and Adolescents. innovivaspecialtytherapeutics.com3. CNN. New gonorrhea treatments approved by FDA for first time in decades. 4. The New York Times. F.D.A. Approves Two New Drugs to Treat Gonorrhea. 5. STAT. FDA approves zoliflodacin, a gonorrhea pill marketed as Nuzolvence. 6. Fierce Pharma. FDA endorses another gonorrhea treatment, blessing Innoviva's Nuzolvence.

Uncertainty reigned early this year with the inauguration of President Donald Trump and his threats to impose tariffs and slash prescription drug prices. But as players in the biopharma industry have gotten a better handle on the impact of these measures and the overall investment landscape, valuations have become more predictable and dealmakers have focused on larger, lower-risk acquisitions. The recent trends bode well for the business development landscape in 2026 and beyond. In this week’s episode of “The Top Line,” Arda Ural, EY Americas life sciences sector leader, joins Fierce Pharma’s Kevin Dunleavy to discuss the dealmaking landscape in the biopharma industry. They dig into the Federal Trade Commission’s scrutiny of M&A transactions, revitalized therapeutic areas, artificial intelligence investment and the emergence of China as an innovation powerhouse. To learn more about the topics in this episode: 2025 M&A up in value and deal count after year of 'conservatism and recovery': Leerink Partners After a 'reset' year for M&A, expect bigger deals in 2025: reports See omnystudio.com/listener for privacy information.

GCI Health, Fersen and Fierce Pharma, hosts Ryan Kurzman and Wendy Lund explore the fast-shifting landscape of cancer care with Pam Traxel of the American Cancer Society Cancer Action Network. Traxel outlines the growing complexity facing patients—from navigating an expanding range of treatment options to managing rising costs—and explains why access to reliable insurance remains one of the most urgent challenges. As she notes, even with groundbreaking innovation, patients still struggle with affordability, systemic barriers and an overwhelming amount of information that is not always credible or tailored to their specific diagnosis. The conversation also examines the evolving role of patient advocacy and the partnerships needed to drive meaningful change. Traxel emphasizes the importance of integrating lived experiences into policy, improving the credibility of patient-facing communication and strengthening early, ongoing collaboration between biopharma, policymakers and advocacy organizations. She also highlights two top priorities for U.S. cancer policy by 2030: reducing out-of-pocket costs and improving nationwide screening rates. For healthcare and life sciences professionals seeking deeper insight into how access, innovation and policy must intersect to improve patient outcomes, this is a must-listen episode.See omnystudio.com/listener for privacy information.

In this week’s episode of "The Top Line," we take a deep dive into the top-line performance of the biopharma industry in the third quarter. After a slow start to the year, U.S. drugmakers in particular have recovered, led by Eli Lilly. We examine which companies are hot and which are not. We also look at trends that emerged in the third quarter, such as the shortfall in vaccine sales, especially in the U.S., and companies’ sales projections for the rest of the year. Fierce Pharma’s Kevin Dunleavy and Eric Sagonowsky discuss their observations from the third quarter and put the industry’s performance in perspective compared with previous quarters. They also examine the biopharma outlook for the fourth quarter. To learn more about the topics in this episode: Q1 biopharma layoff trends, plus expectations for Q2 7 top pharmas posted revenue declines in Q1. The common thread? All are US firms Several US pharma giants stage Q2 sales turnaround after subpar results earlier in year See omnystudio.com/listener for privacy information.

The Friday Five for November 14, 2025: iPhone Pocket Brings Back… Pockets. CMS Rural Health Transformation Program Government Shutdown Update Most-Favored Nation Drug Pricing CMS GENEROUS Model   Get Connected:

As the prospect of import tariffs and drug price reform marshals billions of biopharma investment dollars into the U.S., the feasibility of rapid domestic manufacturing buildouts could hinge on a new program cooking at the FDA. How that program, dubbed PreCheck, will work in practice—and on what timeline—are key questions as the U.S. looks to bolster its local pharmaceutical production base. This week on “The Top Line,” we dive into comments from a recent public meeting on the industry’s hopes for PreCheck, which is being designed to streamline the process by which new biopharma manufacturing facilities are built in the U.S. Fierce Pharma’s Fraiser Kansteiner sits down with Christopher Shilling, chief regulatory officer at gene therapy CDMO Forge Biologics—who attended the meeting—to offer an on-the-ground perspective and explore the aspects of the plan that could have the biggest impact on manufacturers. Shilling also outlines what he sees as FDA’s next steps, plus regulatory considerations that could most benefit CDMOs and the broader industry. To learn more about the topics in this episode: Amid tariff-fueled onshoring push, Trump signs order to boost US stockpiling of certain drug ingredients FDA launches generics pilot program, advances facility PreCheck proposal in bid to incentivize US drug manufacturing Amid pharma's US investment spree, FDA unveils new program to streamline domestic plant build-outs Trump signs executive order to boost US drug manufacturing amid threat of tariffs See omnystudio.com/listener for privacy information.

On October 6, the Host of the 4th annual global, virtual Medical Innovation Olympics, recognized as one of the top 4 innovation challenges across the globe by Fierce Pharma in 2025, Tim Mikhelashvili, CEO and Co-Founder of Amedea Pharma, welcomed all the guests and competitors at this 16-day competition along with two industry executives on the Board and Expert Judges - Melissa Norcross, Vice President, Corporate Strategy, Hyland Software, and Eddie Power, CEO, emPower medical.0:00 Welcome - Tim Mikhelashvili, CEO, Amedea Pharma, Host #MIO20251:38 Power of Gathering Leaders who do not usually Interact Together1:58 Layer the Science - Horizontal Innovation to Master Consistency2:21 Power of Creating Momentum - Lorne Whitehead's Domino Experiment3:13 Leap with Defiance - Healthcare Ecosystem is hostile to Innovation3:47 Advances in Neurocircuitry, Alzheimer's biomarkers, Wearable Devices4:58 Why Humans are Resilient and Innovators by Design5:36 Today We have to be More Responsible than ever, not only Resilient6:14 Innovation in Medicine is like Building a Tall Jenga Block Tower6:54 Why MIO2025 requires Competitors to Present Multiple Times x 16 days7:54 Goal = Feel Like Healthcare Champions Ready for Future Challenges8:25 Melissa Norcross, PhD - Peer Group to Bring out Your Best9:20 Eddie Power, CEO, emPower Medical - Power of Learning, Curiosity

With a new president of U.S. pharma at the helm—and two key FDA approvals now in the books—Boehringer Ingelheim is sharpening its focus on the lucrative American market. In this week’s episode of “The Top Line,” we dive into Boehringer Ingelheim’s latest regulatory successes, two crucial launches, and the German company’s expanding commercialization push in the U.S. Fierce Pharma’s Fraiser Kansteiner sits down with Brian Hilberdink—who joined Boehringer as president of U.S. human pharma in February—to discuss his game plan to further unlock the American market and capitalize on key BI green lights in idiopathic pulmonary fibrosis and lung cancer. To learn more about the topics in this episode: Boehringer Ingelheim breaks into oncology with FDA approval for lung cancer med Hernexeos Boehringer Ingelheim breathes new life into lung fibrosis field with FDA approval for Jascayd 'Crossing fingers': Boehringer awaits key FDA decisions to spearhead 'maturing' pipeline Chutes & Ladders—Boehringer snatches up LEO exec for US pharma team See omnystudio.com/listener for privacy information.

Tariffs, drug pricing reform, a government shutdown and a major turnover at one of the world’s largest drugmakers all converged this week, leaving plenty to unpack for the industry as it heads into fall. Greater clarity on President Donald Trump’s tariff and pricing strategies has likely come as something of a relief for those companies operating in the U.S., but that news was tempered by a shutdown of the federal government on Wednesday. Meanwhile, big changes are likely on the way at GSK, whose longtime CEO Emma Walmsley is headed for the exit. In this week’s episode of "The Top Line," we break down some of the biggest stories across Fierce Pharma for the week—which may very well be some of the biggest stories of the year—touching on critical policy updates in the U.S., the furloughing of federal employees at agencies like the FDA and NIH and the imminent departure of GSK’s chief executive. Fierce Life Sciences’ Ben Adams sits down with Fierce Pharma's Fraiser Kansteiner to discuss the latest headlines and go over the key points from each major development that has played out. To learn more about the topics in this episode: FDA avoids the worst amid government shutdown, but new applications put on hold NIH research grinds to a halt as government shuts down Pfizer offers price concessions, $70B US outlay in Trump's 'most favored nation' push Trump's pharma tariffs on hold amid administration's effort to secure pricing concessions, industry investment: Stat GSK's Emma Walmsley to step down as CEO in shock move, giving way to commercial lead Luke Miels See omnystudio.com/listener for privacy information.

Despite a challenging year, the biotech industry has continued to push boundaries, taking bold risks in pursuit of groundbreaking science. If anything, this year has only strengthened our conviction in the rising stars leading the next wave of innovation. Fierce Biotech’s Fierce 15 class of 2025 is defined by their resilience, diversity in both strategy and leadership, and treatments that hold life-changing potential for underserved patients around the world. In this week’s episode of "The Top Line," Fierce Biotech’s Gabrielle Masson and Fierce Pharma’s Andrea Park discuss what went into picking this year’s winners and some highlights from the special report. To learn more about the topics in this episode: Introducing Fierce Biotech's 2025 Fierce 15 See omnystudio.com/listener for privacy information.

With Pfizer discontinuing Beqvez and BioMarin scaling back the commercial focus of Roctavian, the curative promise of hemophilia gene therapies is tempered by significant barriers that discourage widespread adoption. In this week’s episode of “The Top Line,” Fierce Pharma’s Zoey Becker speaks with Glenn Pierce, M.D., Ph.D., vice president of medical at the World Federation of Hemophilia, about the complexities behind these innovative therapies and the multifaceted reasons for their slow uptake. Pierce discusses the competitiveness of the current hemophilia gene therapy market, why Pfizer’s product couldn’t keep up, and the patient populations that risk being left behind. To learn more about the topics in this episode: As Pfizer backs out of hemophilia gene therapy space, CSL hopes Hemgenix is here to stay Pfizer discontinues hemophilia treatment Beqvez, emptying its gene therapy portfolio BioMarin downsizes Roctavian efforts but keeps hemophilia gene therapy for 3 markets See omnystudio.com/listener for privacy information.

After many U.S. biopharma companies posted sales declines in the first quarter, the domestic pharma industry largely bounced back to growth in the second quarter. In this episode of "The Top Line," Fierce Pharma's Eric Sagonowsky and Kevin Dunleavy break down the numbers behind the industry’s second-quarter performance. Among U.S. pharma heavyweights, J&J, AbbVie, Pfizer, Regeneron, Bristol Myers Squibb and Biogen each eked out gains this past quarter. Their results varied, with individual stories worth highlighting at each of these major companies. Beyond earnings, Sagonowsky and Dunleavy also discuss the growing competition in diabetes and obesity treatments between Eli Lilly and Novo Nordisk, as well as Merck’s rising financial reliance on its blockbuster cancer drug Keytruda, among other topics. To learn more about the topics in this episode: Several US pharma giants stage Q2 sales turnaround after subpar results earlier in year The battle of the obesity drug heavyweights 7 top pharmas posted revenue declines in Q1. The common thread? All are US firms Biopharma briefing: Q1 trends, gene therapy updates and ASCO preview See omnystudio.com/listener for privacy information.

While it’s been easy to grow a bit desensitized to the seemingly unstoppable sales growth of Novo Nordisk and Eli Lilly’s GLP-1s quarter after quarter, this most recent earnings season delivered a few surprises. It’s a good moment to jump back in and assess where the two rivals stand in the market and where their pipelines are headed in the near term. In this week’s episode of "The Top Line," we break down the recent commercial performances of Novo’s and Lilly’s drugs for diabetes and obesity, plus the status of their oral obesity med prospects. Fierce Biotech’s James Waldron sits down with Fierce Pharma’s Fraiser Kansteiner to discuss the latest in the companies’ ongoing obesity duel, as well as some recent pitfalls that seem common to GLP-1 development and commercialization more broadly. To learn more about the topics in this episode: Novo's outgoing CEO prepares to hand off business as sales threats from Lilly, GLP-1 compounders persist Amid MFN talks, Lilly chief warns US adoption of international drug prices could bring 'worst of two worlds' Novo Nordisk drops 2 obesity drugs as part of major pipeline clearout Lilly's oral GLP-1 data 'as good as it gets' at 12% weight loss, exec says Pfizer's embattled obesity program loses another GLP-1 over poor data and strong competition See omnystudio.com/listener for privacy information.

Following a barrage of letters from President Donald Trump urging 17 large pharmaceutical companies to implement Most Favored Nation drug pricing reforms in the U.S., analysts and industry watchers are questioning how far the president’s authority extends, while several drugmakers have signaled a willingness to negotiate. In this week’s episode of "The Top Line," we break down the latest Most Favored Nation pricing pressures in the U.S., how companies are responding and which facets of the proposal might fall short of Trump’s goals. Fierce Pharma’s Eric Sagonowsky and Fraiser Kansteiner discuss the current state of those reform efforts and past attempts to rein in U.S. drug costs, followed by a brief discussion on tariffs. To learn more about the topics in this episode: Pfizer CEO touts 'extremely productive' talks with Trump administration as MFN pricing, tariff threats close in White House threatens to 'deploy every tool in our arsenal' to implement most-favored-nation drug pricing All branded drugs not facing generic, biosimilar competition must abide by MFN order in 'all markets,' HHS tells pharma Trump ups the ante on pharma tariffs, saying they will reach 250% See omnystudio.com/listener for privacy information.

Over a whirlwind three weeks, Sarepta Therapeutics has faced tough safety questions around its commercial gene therapy Elevidys and growing scrutiny over the company’s transparency following multiple patient deaths. In this week’s episode of "The Top Line," we explore Sarepta’s brief standoff with the FDA over Elevidys, a short-lived marketing pause, and the regulator’s surprise reversal on the treatment. Fierce Pharma’s Fraiser Kansteiner and Angus Liu sit down with Fierce Biotech’s Gabrielle Masson to recap the story and discuss the broader implications the Elevidys saga may have for gene therapy, the FDA and the pharmaceutical industry. To learn more about the topics in this episode: Sarepta pivots to siRNA and lays off 500 staffers as Elevidys gets box warning Sarepta LGMD trials all hit by FDA hold amid newly surfaced safety concerns over gene therapy Sarepta, bowing to FDA pressure, pauses shipments of Duchenne gene therapy Elevidys FDA takes U-turn on Sarepta's Elevidys, backing Duchenne gene therapy again in ambulatory patients Analysts demand transparency after Sarepta's roundabout disclosure of 3rd patient death Roche won't throw in the towel after DMD gene therapy Elevidys' rebuff in Europe See omnystudio.com/listener for privacy information.

With an uptick in licensing deals and promising data emerging from China-based biopharmas, especially in oncology, it’s clear the country is poised to play a major role in life sciences for the foreseeable future. In this week’s episode of "The Top Line," we trace China’s ascent in R&D and drug discovery and examine how U.S. and European drugmakers are capitalizing on the momentum through a surge in licensing activity. Fierce Pharma’s Fraiser Kansteiner sits down with Mark Lansdell, director at Evaluate, to break down the policies fueling China’s growth, how global companies are engaging with Chinese assets and which modalities and indications are commanding the most attention. To learn more about the topics in this episode: China approves 4 new drugs, including a global first-in-class medicine With China approval, Lilly and Innovent's mazdutide breaks into new class for GLP-1 obesity drugs China biotechs ‘reshaping’ US biopharma as outlicensing deals rise 11%: Jefferies report China proposes shorter clinical trial reviews in efforts to accelerate drug development See omnystudio.com/listener for privacy information.

In dieser Folge spricht Patrick Heinen mit Demen Selcan über die besonderen Herausforderungen in der Healthcare and Life Sciences Branche und darüber, warum KI hier mehr ist als nur ein Effizienz-Booster.Demen zeigt auf, wie sich regulatorischer Druck, kurze Zeitfenster im ärztlichen Alltag und komplexe Datenstrukturen auf die Arbeit von Pharmaunternehmen auswirken und wie KI helfen kann, diese Hürden zu überwinden.Außerdem spricht er über die Life Sciences Cloud und die Frage, wie sich globale Märkte und nationale Regularien in Einklang bringen lassen.Was ihr in dieser Folge lernt:✅ Warum die Änderungen in der Health and Life Sciences Branche jeden betrifft✅ Wo KI konkret Zeit spart: bei Pharmaunternehmen, im Außendienst und bei Ärzt:innen✅ Warum Standardisierung in HLS so schwierig, aber gleichzeitig so entscheidend istDemens Folgetipp der Folge:Blog: Too long didn't read – tech:https://tldr.tech/ Fierce Pharma:https://www.fiercepharma.com/Kapitel00:00 - 01:15 Intro01:15 - 02:40 KI-Lebenslauf02:40 - 06:37 Was ist die Health and Life Science Branche?06:37 - 12:51 Was sind Herausforderungen in HLS?12:51 - 24:05 Wo kann die heutige KI-Technologie zum Einsatz kommen?24:05 - 25:29 Warum hat mir das KIner gesagt?25:29 - 31:54 Datenplattformen31:54 - 34:24 Der Folgetipp der Folge34:24 - 36:31 OutroMehr zu Salesforce:Website: https://www.salesforce.com/de/LinkedIn: https://www.linkedin.com/company/salesforce/

Two and a half years into his tenure as Teva’s CEO, Richard Francis is breaking down the strategy that’s powered the company through nine consecutive quarters of growth. On this week’s episode of "The Top Line," Fierce Pharma’s Fraiser Kansteiner sits down with Francis to talk about the progress made so far on Teva’s “Pivot to Growth” strategy and what comes next. They dig into the strategies behind the company’s chief commercial medicines, its pipeline darlings and the way Teva’s generic and biosimilar backbone is expected to evolve through the end of the decade. To learn more about the topics in this episode: As Austedo, Ajovy and Uzedy gain steam, Teva banks on $5B-plus in 2030 innovative drug sales Teva plots thousands of job cuts as restructuring drive enters 'acceleration' phase Teva taps Matthew Shields to oversee manufacturing and supply division amid company revamp This week's episode is sponsored by Cencora. See omnystudio.com/listener for privacy information.

Antibody drug conjugates, or ADCs, are still holding on to their spot as one of the hottest areas in cancer care—and AbbVie, like many of its peers, has embraced the trend head-on. In this week’s episode of "The Top Line," Fierce Pharma’s Zoey Becker speaks with Daejin Abidoye, M.D., AbbVie’s vice president and therapeutic area head for solid tumor oncology. They discuss the company’s evolution, trends from this year’s American Society of Clinical Oncology meeting and what’s ahead for ADCs in oncology. AbbVie, a newer player in the ADC space, recently earned FDA approval for Emrelis in adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have previously received systemic therapy. With a robust pipeline of ADCs in development, Abidoye envisions a bright future for the class—one that could herald “a new era” of cancer treatment beyond traditional chemotherapy. To learn more about the topics in this episode: AbbVie advances solid tumor agenda with FDA nod for lung cancer ADC Emrelis AbbVie pays $10B to acquire ImmunoGen, doubling down on red-hot ADC cancer field Replacing chemotherapy with ADCs? AbbVie rebuilds next-gen assets after Rova-T flop See omnystudio.com/listener for privacy information.

President Donald Trump put the pharmaceutical industry on notice early Monday with the signing of his "most favored nation" (MFN) executive order on drug prices. The order seeks to tie U.S. prices to significantly lower costs overseas. Many questions remain about how the measure will be implemented, and legal challenges are almost certain. To assess the seriousness of the threat, Fierce Pharma assembled a team of reporters and editors to break down the executive order and the industry’s response. After examining the MFN executive order, the group dives into other recent policy developments in Washington, D.C., and beyond, including tariffs, Medicare drug price negotiations and more. To learn more about the topics in this episode: Trump signs sweeping executive order to cut US drug prices by 'up to 90%' Sanofi, Novartis CEOs lambast EU price control as Trump reportedly weighs drug cost parity with other nations As Trump threatens tariffs on drugs, industry warns EU of $100B-plus pharma exodus to US US net drug spending surged 11.4% last year, boosted by obesity and oncology meds: IQVIA This episode is sponsored by Cencora. See omnystudio.com/listener for privacy information.

After a batch of much-anticipated reciprocal tariffs spared pharmaceuticals in early April, drugmakers, medtech companies, manufacturers and other outfits across the life sciences spectrum are still scrambling to respond to mounting trade pressures. While many unknowns remain, biopharma companies should waste no time in starting to evaluate their options. In this week’s episode of “The Top Line,” we dig into the latest round of tariffs unveiled by the Trump administration and how they could impact multiple areas of the life sciences industry. Fierce Pharma’s Fraiser Kansteiner sits down with KPMG’s life sciences sector leader Kristin Pothier, who discusses how the current tariffs could pose challenges, how drugmakers and other life sciences companies should respond and whether additional sector-specific duties are on the horizon. To learn more about the topics in this episode: As Trump's 'Liberation Day' tariffs seem to spare pharmaceuticals, threat of industry-specific duties and loopholes persists Drugmakers fear Trump tariffs will drive up manufacturing costs, hurt medicine access: BIO survey Eli Lilly CEO on Trump's tariffs: 'It'll be hard to come back from here' Trump again threatens tariffs on pharmaceuticals in 'not too distant' future This episode is sponsored by Cencora.See omnystudio.com/listener for privacy information.

Johnson & Johnson’s Stelara, Regeneron’s Eylea and Amgen’s Prolia are just some of the drugs facing off against new biosimilars or generics in 2025, as featured in the latest edition of Fierce Pharma’s annual special report documenting the 10 biggest losses of U.S. exclusivity expected throughout the year. In this week’s episode of The Top Line, we dig into the report, which details the stories behind 10 key medicines that are set to face off against new generic or biosimilar competitors this year as their patents expire. Fierce’s Eric Sagonowsky and Angus Liu recap the report, sharing their perspectives on several of the drugs and discussing the industry effects of 2025’s sizable patent cliff. To learn more about the topics in this episode: The top 10 drugs losing US exclusivity in 2025 After patent settlement, Amgen scores FDA nod for its biosimilar version of J&J's Stelara Amgen grabs FDA thumbs-up for Soliris biosim, eyes 2025 launch Novartis wins 11th-hour bid to block generic version of blockbuster heart med Entresto Amgen settles Prolia patent suit with Celltrion, teeing up potential biosimilar launch in June See omnystudio.com/listener for privacy information.

Despite a rocky start for many drugmakers at the start of last year, 2024’s fourth quarter saw just two of the top 25 global pharma companies record sales declines. But that growth may be short-lived, as many of those same companies forecast more muted revenue increases in 2025. In this week’s episode of The Top Line, we dissect the unprecedented revenue growth enjoyed by many of the world’s top pharma companies by sales in the fourth quarter of last year. Fierce Pharma’s Kevin Dunleavy and Fraiser Kansteiner discuss the period’s results, examine the companies’ performance expectations going into 2025 and consider whether the momentum seen in Q4 is repeatable or more of an anomaly. To learn more about the topics in this episode: Eli Lilly, Novo Nordisk lead revenue boom in the 'always tricky' Q4 Eli Lilly logs massive Q4 revenue jump—but it's not just thanks to Mounjaro and Zepbound Pfizer harnesses COVID fluctuations to clinch Q4 gains as RSV vaccine sales plummet Astellas takes $760M charge, reveals slowdown for eye drug Izervay after regulatory stumbles This episode is brought to you by Cencora.See omnystudio.com/listener for privacy information.

In the latest episode of The Top Line, Chris Hayden of Fierce Pharma sits down with Mary Lou Glotzbach, senior manager of drug delivery partnerships at Grand River Aseptic Manufacturing (GRAM). They explore the evolving landscape of biologics, the increasing importance of cold chain management, and how contract development and manufacturing organizations (CDMOs) are adapting to industry shifts. Glotzbach highlights a growing trend in biotech: transitioning patient treatments from infusion centers to home delivery. This shift demands innovative drug delivery solutions, including wearable devices and auto-injectors, capable of handling high-viscosity biologics. She also emphasizes the industry's push for smaller batch sizes due to the high cost and complexity of producing biologics, which challenges traditional manufacturing processes. Another key discussion point is the rising demand for transparency and early collaboration between pharmaceutical companies, CDMOs, and device manufacturers. Glotzbach notes that CDMOs are now being brought into the development process earlier than ever, allowing for better alignment on formulation, container design, and regulatory compliance. The conversation also touches on Annex 1 compliance and the need for standardization in primary containers like syringes and cartridges. Glotzbach envisions a future where standardized components streamline production, making drug development more efficient. For anyone interested in the intersection of biologics, manufacturing, and drug delivery innovation, this episode offers valuable insights into how GRAM is helping shape the future of the industry. Tune in to learn more about the latest advancements and challenges in aseptic manufacturing.See omnystudio.com/listener for privacy information.

Dr. Tasha Golden is a speaker, consultant, & internationally-recognized leader in the science of Creativity x Wellbeing.  Named one of 2024's “Fierce 50” by Fierce Pharma for her innovative work integrating arts and healthcare, she has supported paradigm shifts in health and wellbeing—exemplified by leadership in “Arts on Prescription”: a model of care that's reshaping how health is defined and created.  Holding a PhD in Public Health, Dr. Golden's work is informed by her history as a singer/songwriter, founder of Project Uncaged (trauma-informed program for incarcerated youth), and developer of “How We Human” (a mental health training for creatives).  Bridging research and action, Dr. Golden's unique frameworks help leaders grow their work and ignite positive change.

This year’s edition of the annual J.P. Morgan Healthcare Conference has come to a close, with attendees enjoying sunny skies and a heavy police presence throughout the San Francisco-set event. In this week’s episode of The Top Line, Fierce Pharma’s Zoey Becker and Angus Liu join Fierce Biotech’s Darren Incorvaia to break down the biggest news stories out of the conference. From Johnson & Johnson’s blockbuster acquisition of Intra-Cellular Therapies to former First Lady Jill Biden’s appearance at Fierce JPM Week just days before she left the White House, this year’s conference set the stage for what will surely be an eventful 2025. To learn more about the topics in this episode: ‘Own JP Morgan, don't let JP Morgan own you’: Biopharma—and Jill Biden—show up for JPM25 JPM25: Johnson & Johnson makes a splash, buying out Intra-Cellular Therapies for $14.6B JPM25: First Lady Jill Biden committed to improving women's health as White House tenure winds down JPM25: Strategist GSK acquires IDRx for $1B in hopes of bringing GIST patients new standard of care GSK-backed Ouro Medicines launches into T-cell engager space with $120M and a clinical-stage asset This episode is brought to you by Cencora. Learn more at cencora.com/breakthrough.See omnystudio.com/listener for privacy information.

Following the strange year for the biopharma industry that was 2024, insiders and analysts alike are waiting expectantly to see how trends in layoffs, drug shortages, clinical trials and more play out in 2025. Meanwhile, a second Trump term and a spree of related health agency nominations raise serious questions about how health policy could shift over the next 12 months and beyond. In this week’s episode of “The Top Line,” we explore the trends that defined the industry in 2024 and tackle predictions about how 2025 could shake out for biopharmas big and small. Fierce Pharma’s Fraiser Kansteiner and Fierce Biotech’s Gabrielle Masson discuss 2024’s layoff count, the state of GLP-1 supplies, the future of clinical trial research, potential policy shakeups and more. To learn more about the topics in this episode: Analysts predict M&A, IPO uptick in 2025 but don't expect 'floodgates to suddenly open' Big Pharma layoff rounds jump 281% in '24, but overall industry rates similar to '23 2025 forecast: After Novo, Lilly expansion sprees, 'positive signals' emerge around future supply of GLP-1 drugs From AI and layoffs to supply chains and political unknowns, Deloitte outlines key areas for biopharma to watch in 2025 See omnystudio.com/listener for privacy information.

A review of the FDA’s drug approvals of 2024 shows that small companies loomed large—both in the sheer number of nods gained and the significance of the new drugs and biologics that these firms are bringing to the market. In this week’s episode of “The Top Line,” we take a deep dive into the FDA’s list of drugs that were approved in 2024. Fierce Pharma’s Kevin Dunleavy and Eric Sagonowsky discuss why biotechs emerged with more approvals than large drugmakers and which new drugs figure to have the most impact for patients. To learn more about the topics in this episode: 2024 drug approvals: Small companies loom large with several key FDA nods For Bristol Myers Squibb's newly approved schizophrenia drug, what a long, strange trip it's been 2023 drug approvals: After a down year, FDA signs off on a bounty of new meds, including 7 from Pfizer This episode is brought to you by Cencora. Learn more at cencora.com/breakthrough.See omnystudio.com/listener for privacy information.

As the 2024 U.S. presidential election nears, the choice between Democratic nominee Vice President Kamala Harris and Republican nominee former President Donald Trump will shape the future of drug pricing policy.   While both candidates have pledged to reduce drug costs, their approaches are likely to differ significantly.   In this week's episode of "The Top Line," Fierce Pharma's Zoey Becker chats with John Barkett, managing director of BRG's healthcare transactions and strategy practice and former senior policy advisor for healthcare delivery system reform on the White House Domestic Policy Council, about what we can expect from each candidate's potential presidency and how the Inflation Reduction Act could play a pivotal role.   To learn more about the topics in this episode:  With election nearing, BMO analysts don't expect major pharma shake-ups from either candidate Biden touts drug pricing achievements as he steps down from reelection campaign 2024 forecast: Biden admin efforts show there's no pricing relief on the horizon for pharma See omnystudio.com/listener for privacy information.

Since the introduction of the BIOSECURE Act in January, named companies and U.S.-based biopharmas alike have speculated on what the legislation could mean for the life sciences industry.  In this week's episode of "The Top Line," Fierce Pharma staff writer Fraiser Kansteiner sits down with Arnold & Porter's Life Sciences practice chair Dan Kracov to discuss the broader implications of the bill, and what the likely next steps are for the legislation to become law.  Kracov also breaks down what measures life sciences companies are already taking in light of the bill and concessions that may need to be made to appease lawmakers on both sides of the aisle.   To learn more about the topics in this episode:  After BIOSECURE Act passes in House, targeted Chinese companies say they're 'deeply' concerned Despite looming BIOSECURE threat, pharma contracting giant WuXi Bio scoops up new projects Lawmakers urge FDA to investigate clinical trials run in tandem with China's military See omnystudio.com/listener for privacy information.

At the recent World Conference on Lung Cancer and European Society for Medical Oncology annual meetings, two packages of lung cancer data from a partnership between Akeso and Summit Therapeutics and another collaboration between iTeos Therapeutics and GSK showed much promise of disrupting the current standard of care. But they also drew some questions and debate.  In this week's episode of “The Top Line,” Angus Liu from Fierce Pharma and Gabrielle Masson from Fierce Biotech discuss the key issues behind those two readouts.    To learn more about the topic in this episode:  iTeos-GSK's TIGIT combo shows 30% more tumor shrinkage than Jemperli, but safety signals scare investors Akeso, Summit's PD-1 bispecific crushes Merck's Keytruda in study, signaling potential new standard in lung cancer 'Cooking with gas': Regeneron sees its Opdualag rival as next big thing for treating solid tumors ESMO: Bristol Myers moves Opdualag into phase 3 trials in competitive first-line lung cancer field See omnystudio.com/listener for privacy information.

In this week's episode of "The Top Line," we're looking at what goes into manufacturing and supply of flu vaccines.  Fierce Pharma's Zoey Becker chats with Stefan Merlo, vice president of commercial operations, North America at CSL Seqirus. He discusses the company's differentiated flu vaccine portfolio and how its manufacturing process has evolved over the decades to create and distribute vaccines offering targeted protection each year. To learn more about the topics in this episode:  Driving flu vaccine uptake in the post-pandemic era Flu vaccine makers CSL Seqirus, Sanofi and GSK kick off initial shipments ahead of upcoming season See omnystudio.com/listener for privacy information.

In this week's episode of "The Top Line," we look at factors driving the continuing decline of flu vaccination rates in the U.S. and beyond.  Fierce Pharma's Zoey Becker chats with Gregg Sylvester, M.D., Chief Health Officer at CSL Seqirus, to get insight on what we might expect to see from this upcoming flu season. He also explains efforts to increase vaccine uptake through awareness and education campaigns.   To learn more about the topics in this episode:  Flu vaccine makers CSL Seqirus, Sanofi and GSK kick off initial shipments ahead of upcoming season CDC starts 'Wild to Mild' campaign to reverse falling flu vaccine use in key groups American Lung Association, Sanofi urge high-risk communities to grab their flu shots in 'United Against Flu' campaign See omnystudio.com/listener for privacy information.

For the last 40 years, when federal legislation was ambiguous or left an administrative gap, courts were required to defer to the interpretation of agencies. This stipulation, called the Chevron deference, gave agencies room to advance their regulatory priorities.  The Supreme Court overturned the doctrine in June, bringing significant implications for the healthcare industry and federal regulators like the FDA.  In this week's episode of "The Top Line," Fierce Pharma's Kevin Dunleavy chats with Project Farma President Anshul Mangal about the potential impact on the biopharma industry.  To learn more about the topics in this episode:  Supreme Court overrules Chevron deference, dealing blow to federal healthcare agencies The Supreme Court just limited federal power. Healthcare is feeling the shock waves How Chevron's demise could impact employers, purchasers and health payers See omnystudio.com/listener for privacy information.

The TROP2 antibody-drug conjugate race has heated up among three Big Pharma companies: Gilead Sciences, AstraZeneca and Merck.  Fierce Pharma's Angus Liu recently took a deep dive into the three TROP2 front-runners. In a feature article, he examined the strengths and potential challenges facing each candidate, as well as the considerations behind their extensive phase 3 programs and their various development strategies. In this week's episode of “The Top Line,” Fierce executive editor Eric Sagonowsky chats with Liu about his feature story on the three TROP2 front-runners. To learn more about the topics in this episode: 3 Big Pharma companies, 33 phase 3 trials: The race for supremacy in an ADC field ASCO: Gilead looks for silver lining in Trodelvy's failed lung cancer trial. But will the FDA play ball? AstraZeneca-Daiichi's Enhertu follow-up Dato-DXd unable to prove overall survival benefit in phase 3 See omnystudio.com/listener for privacy information.

This week on “The Top Line,” we discuss two studies in HIV research that were presented at the 25th International AIDS Conference in Germany. One of them is the report of a 7th person who has likely been cured of HIV. And there's something unique about this case that has sparked excitement among scientists. The other one is the report of a long-acting injection that showed 100% efficacy in preventing HIV infection in a phase 3 trial. Some experts have hailed the PrEP candidate as a game-changer. To dive deeper into these studies, Fierce Pharma's Angus Liu interviews Jared Baeten, M.D., Ph.D., senior vice president and head of clinical development of the virology therapeutic area at Gilead Sciences.  To learn more about the topics in this episode:  With seventh person seemingly cured of HIV, signs of hope for a broader cure  Watch out, GSK. Gilead's twice-yearly PrEP drug shows 100% efficacy for HIV prevention  See omnystudio.com/listener for privacy information.

Back in February, Novo Holdings laid out a $16.5 billion deal to snap up contract manufacturing giant Catalent. In this week's episode of "The Top Line," we dive into the current state and implications of the proposed buyout.   Fierce Pharma's Fraiser Kansteiner is joined by former FTC policy director David Balto. They discuss the likelihood of the deal going through, potential regulatory hurdles and what the transaction could mean for the greater CDMO landscape. To learn more about the topics in this episode:  Another day, another delay for Novo's Catalent acquisition as FTC imposes 'Second Request' Novo antes up $16.5B to poach CDMO giant Catalent amid Wegovy surge See omnystudio.com/listener for privacy information.

Pharmaceutical CEOs often earn pay packages worth tens of millions of dollars for leading the top drugmaking companies in the industry. Every year, some new faces enter the rankings while others leave.  In this week's episode of "The Top Line," Fierce Pharma's Eric Sagonowsky and Fraiser Kansteiner discuss Fierce's annual special report, “Big Pharma's 10 highest-paid CEOs.”  Aside from digging into the specific numbers surrounding CEO pay packages, the discussion also touches on CEO-to-worker pay ratios for 2023 and more.   To learn more about the topics in this episode:  Big Pharma's 10 highest-paid CEOs of 2023 See omnystudio.com/listener for privacy information.

In this week's episode of “The Top Line,” Fierce Pharma's Zoey Becker sits down with Bobby Sheng, the CEO of Bora Pharmaceuticals, to discuss the concept of “friend-shoring” in drug manufacturing. "Friend-shoring" involves conducting manufacturing processes in countries considered friendly or allied. Sheng discusses the criteria for deeming a country “friendly” and explores whether this strategy could help address drug supply shortages. To learn more about the topics in this episode: Bora plants its flag in the US with $210M acquisition of generics manufacturer Upsher-Smith Emergent, pivoting away from CDMO business, sells Baltimore plant to acquisitive Bora for $30M See omnystudio.com/listener for privacy information.

Each June, the American Society of Clinical Oncology (ASCO) hosts a conference that gathers physicians, researchers and the cancer community to share their latest research on treatments, technologies and more.  The Fierce team is always on the ground at the ASCO meeting, and this year, Fierce Biotech's Gabrielle Masson and Fierce Pharma's Angus Liu covered the event.  In this week's episode of "The Top Line," they discuss the most talked-about data drops at ASCO and share on-the-ground details, including their experience with Gilead's virtual reality Trodelvy ride.  To learn more about the topics in this episode:  Akeso, Summit's Keytruda win draws 'explosive' interest at ASCO. But what does Merck think? ASCO: After Keytruda, Merck builds 3-pronged cancer strategy starring Moderna-partnered vaccine ASCO: Cautious Big Pharmas double down on past wins—steering clear of radioligands and cell therapy See omnystudio.com/listener for privacy information.

This week's episode of “The Top Line,” is the final part of a three-part series diving into the latest advancements in cell and gene therapy manufacturing.  In this episode, Fierce Pharma's Fraiser Kansteiner is joined by Bruce Levine, Ph.D., who is the co-inventor of Kymriah and the Barbara and Edward Netter Professor in Cancer Gene Therapy at the University of Pennsylvania. He's also joined by executives from CGT technology provider ScaleReady and regenerative cell therapy developer CellProthera.   They dive into novel production approaches discussed earlier in this series, with a special focus on CAR-T therapies.   To learn more about the topics in this episode: CAR-T hype faces infrastructure reality check CAR-T boxed warnings: What comes next? See omnystudio.com/listener for privacy information.

This week's episode of “The Top Line” is the second part of a three-part series exploring the latest advancements in cell and gene therapy manufacturing. In this episode, Fierce Pharma's Fraiser Kansteiner interviews Delara Motlagh, head of cell therapy at Catalent; Becky Butler Cap, senior vice president of biotherapies at Vitalant; and Kevin Kyle, CEO of Germfree. The conversation covers cell collection, the critical first step in advanced therapy manufacturing. They also discuss the importance of locking in process decisions early and how to effectively scale projects from the lab to the clinic and eventually to the market. Additionally, they talk about Germfree's recent asset acquisition from Orgenesis, which will allow the company to expand its mission of decentralized manufacturing. To learn more about the topics in this episode: Fulfilling the promise of cell & gene therapies through manufacturing (Part I) With new partnership, Galapagos takes decentralized CAR-T manufacturing quest nationwide Catalent opens cell therapy production site at Belgian 'center of excellence' After recent troubles, Catalent expands its biologics services platform  See omnystudio.com/listener for privacy information.

This week's episode of “The Top Line,” kicks off a series diving into the latest advancements in cell and gene therapy manufacturing.  In this episode, Fierce Pharma's Fraiser Kansteiner sits down with Ori Biotech CEO Jason Foster and the Cell Therapy Manufacturing Center's CEO, Jason Bock. They delve into the current state of cell and gene therapy manufacturing and consider if the existing production methods can keep up with the potential of personalized medicines. They also dive into past hurdles in the space and highlight the varied approaches—including their own—that a new generation of cell and gene therapy manufacturing companies have been pioneering.  To learn more about the topics in this episode:  Ori Biotech taps MD Anderson, National Resilience joint venture to put its automated cell and gene therapy manufacturing tech to the test See omnystudio.com/listener for privacy information.

Fierce Pharma publishes a yearly special report highlighting the top 20 pharmas based on their revenue. The most recent edition, published this month, ranks each pharma based on their total revenues for 2023.   This week on "The Top Line," Fierce Pharma Senior Editor Eric Sagonowsky and Senior Writer Kevin Dunleavy break down the numbers, highlight key trends and share some of the biggest changes at the top and bottom of the rankings year over year.   To learn more about the topics in this episode:   The top 20 pharma companies by 2023 revenue The top 20 pharma companies by 2022 revenue  See omnystudio.com/listener for privacy information.

The FDA recently asked the six marketed CAR-T therapies to add a new boxed warning item on their labels to reflect the risk of secondary T-cell cancers. This decision follows an investigation into the new safety signal from postmarketing adverse event reports and clinical trials.  In today's episode, Fierce Pharma's Angus Liu talks with Parexel regulatory experts Mwango Kashoki, M.D., Senior Vice President, Global Head of Regulatory Strategy, and Steve Winitsky, M.D., Vice President, Technical - Regulatory Strategy, to understand the rationale behind the FDA's decision and to discuss its implications for CAR-T candidates and their developers down the line.

The FDA recently asked the six marketed CAR-T therapies to add a new boxed warning item on their labels to reflect the risk of secondary T-cell cancers. This decision follows an investigation into the new safety signal from postmarketing adverse event reports and clinical trials.  In today's episode, Fierce Pharma's Angus Liu talks with regulatory experts Mwango Kashoki, M.D., SVP, Global Head of Regulatory Strategy at Parexel, and Steve Winitsky, M.D., VP, Technical, Regulatory Strategy at Parexel, to understand the rationale behind the FDA's decision and to discuss its implications for CAR-T candidates and their developers down the line.   To learn more about the topics in this episode:  FDA wants classwide boxed warning on all commercial CAR-T therapies amid secondary cancer safety probe Amid high-profile CAR-T safety probe, FDA's Peter Marks offers first glimpse at data under review  See omnystudio.com/listener for privacy information.

This week on “The Top Line,” we explore the impact of environmental, social and governance measures, commonly known as ESG, on the pharmaceutical industry.  Fraiser Kansteiner of Fierce Pharma engages in a conversation with Jim Greffet, Head of ESG Strategy at Eli Lilly, to gain insights. Greffet makes a compelling business case for integrating ESG into the core of drugmakers' DNA. He also discusses Eli Lilly's specific ESG initiatives, illustrating how these strategies connect to the company's extensive history.  To learn more about the topics in this episode:  Patient groups want pharma to improve on ESG—and are pushing for a seat at the table Setting sights on suppliers: How biopharma is tackling the environment in its ESG commitments Seeing green, AstraZeneca lays down £100M for 15-year renewable gas project in UK Gilead receives awards, pledges commitment to COVID, the environment and inclusion in 2023  See omnystudio.com/listener for privacy information.

Earlier this year, Fierce Healthcare, Fierce Pharma and Fierce Biotech recognized 50 individuals and companies that are pushing the industry forward. The Fierce 50 honorees range from tech innovators to researchers developing novel therapies to providers on the frontlines of changing care. This week on "The Top Line," senior editor Paige Minemyer sat down with staff writers Dave Muoio and Anastassia Gliadkovskaya as well as senior editor Heather Landi to discuss a few of the honorees in more detail.  To learn more about the topics in this episode:  The Fierce 50 of 2023  See omnystudio.com/listener for privacy information.

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In this episode of 'The Top Line' we reply an important show from April 28, 2023 regarding Narcan.  On March 29th, the FDA approved the Narcan nasal spray for over-the-counter sales. It is the first naloxone product approved for use without a prescription. In this episode of The Top Line, Fierce Pharma staff writer Fraiser Kansteiner launches a mini-series to explore what that means for the opioid epidemic. The series will tackle questions about using the product, its accessibility and whether the move will save lives. To learn more about the topics in this episode:  Emergent makes history with first FDA nod for over-the-counter naloxone Teva, Sandoz have launched Narcan generics, but Emergent's branded option should still thrive: analysts Adapt tests ads urging opioid users' loved ones to stock Narcan at home Eyeing $1B in annual sales, Emergent BioSolutions to buy Narcan maker Adapt for $735M Ahead of next month's FDA decision, Emergent aces AdComm for over-the-counter Narcan nod The Top Line is produced by senior podcast producer Teresa Carey. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.See omnystudio.com/listener for privacy information.

On March 29, the FDA approved the Narcan nasal spray for over-the-counter sales. It is the first naloxone product approved for use without a prescription. In this episode of "The Top Line," Fierce Pharma staff writer Fraiser Kansteiner concludes our miniseries to explore what that means for the opioid epidemic. We'll also cover a possible over-the-counter birth control, a COVID test recall, plus this week's headlines.  To learn more about the topics in this episode:  Lilly's hotly anticipated Alzheimer's data set a new high score in slowing cognitive decline Baxter breaks off biopharma solutions segment in $4.25B private equity deal Let's make a deal: Conditions are right for biopharma M&A to break out, analysts say Roche, SD Biosensor recall 500,000 at-home COVID tests due to bacteria risks Perrigo's OTC birth control pill aces FDA expert meeting Emergent makes history with first FDA nod for over-the-counter naloxone Ahead of next month's FDA decision, Emergent aces AdComm for over-the-counter Narcan nod "The Top Line" is produced by senior podcast producer Teresa Carey. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.See omnystudio.com/listener for privacy information.

On March 29th, the FDA approved the Narcan nasal spray for over-the-counter sales. It is the first naloxone product approved for use without a prescription. In this episode of The Top Line, Fierce Pharma staff writer Fraiser Kansteiner continues our mini-series to explore what that means for the opioid epidemic. The series will tackle questions about using the product, its accessibility and whether the move will save lives. To learn more about the topics in this episode:  Emergent makes history with first FDA nod for over-the-counter naloxone Teva, Sandoz have launched Narcan generics, but Emergent's branded option should still thrive: analysts Adapt tests ads urging opioid users' loved ones to stock Narcan at home Eyeing $1B in annual sales, Emergent BioSolutions to buy Narcan maker Adapt for $735M Ahead of next month's FDA decision, Emergent aces AdComm for over-the-counter Narcan nod Virtual Roundtable: Remote Therapeutic Monitoring, The Future of Virtual Care Management The Top Line is produced by senior podcast producer Teresa Carey. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.See omnystudio.com/listener for privacy information.

Iran integrates influence and cyber operations. ChatGPT use and misuse. Phishing reports increased significantly so far in 2023, while HTML attacks double. An update on the Discord Papers. Cyberstrikes against civilian targets. My conversation with our own Simone Petrella on emerging cyber workforce strategies. Tim Starks from the Washington Post joins me with reflections on the RSA conference. And, turns out, a war clause cannot be invoked in denying damage claims in the NotPetya attacks (at least not in the Garden State). For links to all of today's stories check out our CyberWire daily news briefing: https://thecyberwire.com/newsletters/daily-briefing/12/85 Selected reading. Rinse and repeat: Iran accelerates its cyber influence operations worldwide (Microsoft On the Issues) ChatGPT Confirms Data Breach, Raising Security Concerns (Security Intelligence)  Samsung Bans Generative AI Use by Staff After ChatGPT Data Leak (Bloomberg)  Malicious email campaigns abusing Telegram bots rise tremendously in Q1 2023, surpassing all of 2022 by 310% (Cofense) Threat Spotlight: Proportion of malicious HTML attachments doubles within a year (Barracuda) Zelensky says White House told him nothing about Discord intelligence leaks (Washington Post) Russia attacks civilian infrastructure in cyberspace just as it does on ground - watchdog (Ukrinform) Merck's Insurers On the Hook in $1.4 Billion NotPetya Attack, Court Says (Wall Street Journal) Merck entitled to $1.4B in cyberattack case after court rejects insurers' 'warlike action' claim (Fierce Pharma)

We'll be taking a break in May, June, and July while our host is on maternity leave. See you again in August!   This week on Pharm5: Vowst (SER-109) for recurrent C Diff Trikafta for CF in 2+ years Mounjaro for weight loss in diabetes Qalsody accelerated approval for ALS J&J talc baby powder settlement   Connect with us! Listen to our podcast: Pharm5 Follow us on Twitter: @LizHearnPharmD   References: FDA approves first orally administered fecal microbiota product for the prevention of recurrence of Clostridioides difficile infection. U.S. Food and Drug Administration. https://bit.ly/3Li7Cue. Published April 26, 2023. Accessed April 27, 2023. Feuerstadt P, Louie TJ, Lashner B, et al. Ser-109, an oral microbiome therapy for recurrent clostridioides difficile infection. New England Journal of Medicine. 2022;386(3):220-229. doi:10.1056/nejmoa2106516 Vowst [package insert]. Cambridge, MA: Seres Therapeutics, Inc.; 2023. FDA approves Trikafta for children ages 2 through 5 years with certain CF mutations. Cystic Fibrosis Foundation. https://bit.ly/44dP3QD. Published April 26, 2023. Accessed April 27, 2023. Lobo A. FDA expands its approval of Trikafta to cover younger children. Cystic Fibrosis News Today. https://bit.ly/3oSuhG0. Published April 27, 2023. Accessed April 27, 2023. CFTR modulator therapies. Cystic Fibrosis Foundation. https://bit.ly/3Az4epZ. Accessed April 27, 2023. Lilly's tirzepatide achieved up to 15.7% weight loss in adults with obesity or overweight and type 2 diabetes in surmount-2. Eli Lilly and Company. https://bit.ly/3VkD9AE. Published April 27, 2023. Accessed April 27, 2023. Galvez-Jiminez N, Goyal NA, Cudkowicz ME. Disease-modifying treatment of amyotrophic lateral sclerosis. UpToDate. http://www.utdol.com. Updated May 17, 2022. Accessed May 19, 2022. Liu A. FDA awards Biogen's ALS Drug Qalsody an accelerated approval, following its experts' feedback this time. Fierce Pharma. https://bit.ly/3VaVwrC. Published April 25, 2023. Accessed April 27, 2023. FDA approves Qalsody™ (Tofersen) as the first treatment targeting a genetic cause of ALS. PR Newswire: press release distribution, targeting, monitoring, and marketing. https://bit.ly/3ADSe6N. Published April 25, 2023. Accessed April 27, 2023. Qalsody [package insert]. Cambridge, MA: Biogen, Inc.; 2023. J&J to retain all talc-related liabilities from litigation in US, Canada. Reuters. https://bit.ly/3HjTS10. Published April 27, 2023. Accessed April 27, 2023. Spector M, Knauth D. J&J unit files for second bankruptcy to pursue $8.9 billion talc settlement. Reuters. https://bit.ly/426xfoY. Published April 5, 2023. Accessed April 27, 2023.

On March 29th, the FDA approved the Narcan nasal spray for over-the-counter sales. It is the first naloxone product approved for use without a prescription. In this episode of The Top Line, Fierce Pharma staff writer Fraiser Kansteiner launches a mini-series to explore what that means for the opioid epidemic. The series will tackle questions about using the product, its accessibility and whether the move will save lives. To learn more about the topics in this episode:  Emergent makes history with first FDA nod for over-the-counter naloxone Teva, Sandoz have launched Narcan generics, but Emergent's branded option should still thrive: analysts Adapt tests ads urging opioid users' loved ones to stock Narcan at home Eyeing $1B in annual sales, Emergent BioSolutions to buy Narcan maker Adapt for $735M Ahead of next month's FDA decision, Emergent aces AdComm for over-the-counter Narcan nod The Top Line is produced by senior podcast producer Teresa Carey. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.See omnystudio.com/listener for privacy information.

This week on Pharm5 Humira biosimilars Vyvanse, Symbicort, and more losing patents this year Rezafungin approval Senate Committee meets on drug shortages COVID-19 declassified   Connect with us! Listen to our podcast: Pharm5 Follow us on Twitter: @LizHearnPharmD   References: Sandoz receives US FDA approval for biosimilar Hyrimoz® (Adalimumab-adaz) high-concentration formulation. Novartis. http://bit.ly/3lBJ1rK. Published March 21, 2023. Accessed March 23, 2023. Humira [package insert].North Chicago, IL: AbbVie Inc. Accessed March 23, 2023. Stonehill M. Humira exclusivity expires in 2023: Will biosimilar boom benefit patients or industry? Healio. http://bit.ly/3lzQrvs. Published January 17, 2023. Accessed March 23, 2023. Amjevita™ (Adalimumab-Atto), first biosimilar to Humira®, now available in the United States. Amgen. http://bit.ly/3Z9gesm. Accessed March 23, 2023. Kansteiner F, Sagonowsky E, Becker Z, Dunleavy K, Liu A. The top 10 drugs losing us exclusivity in 2023. Fierce Pharma. https://bit.ly/3LGsm0N. Published March 13, 2023. Accessed March 23, 2023. FDA drug shortages. FDA Drug Shortages. http://bit.ly/3LLEAoY. Accessed March 23, 2023. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2022. www.ginasthma.org. Accessed March 23, 2023. Cidara Therapeutics, Inc. Cidara Therapeutics and Melinta Therapeutics announce FDA approval of Rezzayo™ (rezafungin for injection) for the treatment of Candidemia and invasive candidiasis. GlobeNewswire News Room. http://bit.ly/40utHMl. Published March 22, 2023. Accessed March 23, 2023. Thompson GR, Soriano A, Cornely OA, et al. Rezafungin versus Caspofungin for treatment of candidaemia and invasive candidiasis (ReSTORE): A multicentre, double-blind, double-dummy, randomised phase 3 trial. The Lancet. 2023;401(10370):49-59. doi:10.1016/s0140-6736(22)02324-8 FDA Approves Rezzayo, a Novel Echinocandin. Infectious Disease Special Edition. https://bit.ly/3TAbn2d. Published March 23, 2023. Accessed March 23, 2023. Gauthier T. Rezafungin (Rezzayo). IDStewardship. http://bit.ly/3LHBn9X. Accessed March 23, 2023. O'Mary L. Cases of potentially deadly fungus jump 200%: CDC. Medscape. http://bit.ly/40lSRwC. Published March 22, 2023. Accessed March 23, 2023. Drug shortage health and national security risks: Underlying causes and needed reforms. Committee on Homeland Security & Governmental Affairs. https://bit.ly/3ZdX846. Published March 22, 2023. Accessed March 23, 2023. Biden signs Bill on COVID origins declassification. AP NEWS. http://bit.ly/3JCsOKJ. Published March 20, 2023. Accessed March 23, 2023. Pradhan R. End of Covid emergency will usher in changes across the US Health System. Kaiser Health News. http://bit.ly/40xC0H0. Published March 22, 2023. Accessed March 23, 2023.

In October 2022, the Society for Immunotherapy of Cancer released a checklist for running phase 3 cancer immunotherapy combination studies. SITC's aim with these guidelines is to maximize the value of these trials. In this episode, Fierce Pharma staff writer Angus Liu discusses the checklist with Dr. Michael Atkins, the first author. To learn more about topics in this episode: Moderna checks a few boxes in phase 3 mRNA flu shot trial, but misses on B strains and safety BD issues cybersecurity alert for hacking risk found in Alaris infusion pump software Apellis wins FDA approval for first geographic atrophy drug With FDA approval for Filspari, Travere turns Bristol Myers castoff into unique drug for rare kidney disease The Top Line is produced by senior multimedia producer Teresa Carey and managing editor Querida Anderson with editor-in-chief Ayla Ellison and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.See omnystudio.com/listener for privacy information.

Last August, Moderna filed a lawsuit against Pfizer and its COVID-19 vaccine partner, BioNTech. Moderna claims that the partners copied its mRNA technology and infringed its vaccine patents. Pfizer wasn't going to sit back and take that. In September, the pharma giant dismissed the claims and accused Moderna of trying to rewrite the pandemic story to place itself in the “single, starring role,” the company's attorneys wrote in a scathing countersuit.    Kevin Noonan, Ph.D., is an intellectual property lawyer. He spoke with Fierce Pharma staff writer Zoey Becker to discuss what is likely to be the most significant patent fight from the pandemic era.    To learn more about topics in this episode: Clash of the titans: Moderna sues Pfizer, BioNTech for mRNA patent infringement Pfizer, BioNTech strike back at Moderna with mRNA vaccine patent lawsuit Moderna won't enforce COVID-19 vaccine patents during pandemic Pfizer CEO's texts with European Commission chief trigger new NYT lawsuit NuVasive, Globus Medical ink $3.1B orthopedic device merger, sending investors scrambling Big Pharma divided? Pfizer, AZ, Lilly and more support Sanofi in high-profile Amgen patent fight GSK nixes next-gen COVID-19 antibody collaboration, leaving Vir to fly solo, seek new partners Call for nominations: The most influential people in biopharma in 2023 The Top Line is produced by senior multimedia producer Teresa Carey and managing editor Querida Anderson with editor-in-chief Ayla Ellison and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.See omnystudio.com/listener for privacy information.

The dam of lies is breaking. For three years we have been lied to and deceived by the state and the media. Their lies are coming to light day by day. We have the courage to point out their lies and the dangers to our nation. We have a Duracoat Finished Firearm segment; give the gift of color this holiday season. During our Brownells Bullet Points this week we consider discounts on the pieces and parts for your winter gun build. Are you prepared, physically and mentally to deal with multiple attackers? This week's SOTG Homeroom from CrossBreed Holsters addresses a recent attack where a concealed carrier had to fight multiple attackers. Thanks for being a part of SOTG! We hope you find value in the message we share. If you've got any questions, here are some options to contact us: Send an Email Send a Text Call Us Enjoy the show! And remember…You're a Beginner Once, a Student For Life! TOPICS COVERED THIS EPISODE [0:08:25] DuraCoat Finished Firearms - DuraCoat University TOPIC: Give the Gift of Color this Year Huge thanks to our Partners:SDS Imports | Brownells | CrossBreed | Duracoat Firearm Finishes | Hi-Point Firearms [0:20:35] Brownells Bullet Points - Brownells.com TOPIC: Did you enjoy Black Rifle Friday? [0:29:40] SOTG Homeroom - CrossbreedHolsters.com TOPIC: Woman shoots attempted carjacker in head before being shot by his accomplice in Calumet Heights www.cbsnews.com [0:44:35] The Dam of Lies is breaking the truth will flood the land Vaccinated Americans a majority of COVID deaths for first time in August: analysis www.foxnews.com The FDA Misled the Public About Ivermectin and Should Be Accountable in Court, Argues the Association of American Physicians and Surgeons (AAPS) www.yahoo.com/now After WHO trial failure, influential medical group advises against Gilead's remdisvier in COVID-19 critical care: Reuters www.fiercepharma.com Cardiologist says COVID-19 vaccinations ‘must stop' due to the risk of adverse events—scientists and doctors push back cardiovascularbusiness.com World Premiere: Died Suddenly [Video] rumble.com FEATURING: Fox News, Yahoo, Fierce Pharma, Cardiovascular Business, Rumble, Madison Rising, Jarrad Markel, Paul Markel, SOTG University PARTNERS: SDS Imports, Brownells Inc, CrossBreed Holsters, DuraCoat Firearm Finishes, Hi-Point Firearms FIND US ON: Juxxi, Parler, MeWe.com, Gettr, iTunes, Stitcher, AppleTV, Roku, Amazon, GooglePlay, YouTube, Instagram, Facebook, Twitter, tumblr

This week on Pharm5: BCEMP starting in 2023 FDA hints at OTC naloxone Elahere for advanced ovarian cancer Pharmacogenomics reduces risk of ADRs Tzield delays T1DM symptom onset Connect with us! Listen to our podcast: Pharm5 Follow us on Twitter: @LizHearnPharmD References: Jean-Baptiste A. First Administration of the emergency medicine pharmacy certification examination announced for 2023. Board of Pharmacy Specialties. http://bit.ly/3EeGIQx. Published November 10, 2022. Accessed November 17, 2022. The Federal Register. Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use; Request for Comments. http://bit.ly/3tGEQLu. Published November 16, 2022. Accessed November 17, 2022. Pharmacy Practice News. http://bit.ly/3EepDq5. Published November 16, 2022. Accessed November 16, 2022. Dunleavy K. Four decades in, immunogen gets landmark green light in Advanced ovarian cancer. Fierce Pharma. http://bit.ly/3Ao8Hw9. Published November 15, 2022. Accessed November 17, 2022. Immunogen announces FDA accelerated approval of ELAHERE™ (Mirvetuximab Soravtansine-gynx) for the treatment of platinum-resistant ovarian cancer. ImmunoGen, Inc. http://bit.ly/3gjvHp5. Accessed November 17, 2022. Robinson J. Adverse drug reactions reduced by nearly one third after genetic testing, major trial results to show. The Pharmaceutical Journal. http://bit.ly/3TQK1TQ. Published November 14, 2022. Accessed November 17, 2022. FDA approves first drug that can delay onset of type 1 diabetes. U.S. Food and Drug Administration. http://bit.ly/3gd9j0G. Published November 17, 2022. Accessed November 17, 2022.

Every year, our Fierce Biotech team evaluates hundreds of early-stage companies from around the world. Only the most promising are selected for our annual list of Fierce 15 honorees. That list is based on a variety of factors like the strength of the company's technology, partnerships, venture backers and a competitive market position. This year's 15 honorees were recognized at the Fierce Biotech Summit. In this episode, we'll hear directly from them about their company's work, what makes it unique, and what drives them.   We'll also take you to the Fierce Biotech Summit. It happened in Boston on September 19 and 20, and covered drug development from the earliest stage of research to FDA approval. So if you missed the summit, this episode covers some event highlights including a panel moderated by Fierce Pharma senior staff writer Angus Liu on the future of gene editing and a session moderated by managing editor Querida Anderson on battling biotech's bear market. To learn more about topics in this episode:  Special Report: Fierce Biotech's 2022 Fierce 15 The Fierce Biotech Summit: Where Biotech Innovation Happens  Fierce Biotech Summit: As the biotech market teases turning a corner, stakeholders say we're in a 'new normal'  Servier severs CAR-T collab with Allogene, handing back rights outside the US to 3 candidates Months after exiting clinical hold, Pfizer readies to resume dosing in phase 3 gene therapy trial ESMO: BioNTech's CAR-T response rate falls in fresh cut of early-phase data The Top Line is produced by senior multimedia producer Teresa Carey with managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.See omnystudio.com/listener for privacy information.

Dr. Aarti Shah, former senior vice president and chief information and digital officer at Eli Lilly & Company, knows pharma and technology inside and out. At Eli Lilly, she led an enterprise-wide global organization with responsibilities for information technology, information security, advanced analytics, data science and digital health. Dr. Shah has been named a woman of influence by the Indianapolis Business Journal and was also named one of the fierce women in biopharma by Fierce Pharma. In this episode, Dr. Shah and Maria Whitman talk about how real-world evidence is driving faster industry innovations that have great potential to improve patient outcomes. 

This week on Pharm5: Farxiga (dapagliflozin) for HFpEF Updated boosters for COVID-19 Xenpozyme (olipudase alfa) for rare ASMD New York Times on “growing chains, falling wages” Phase III olokizumab vs. adalimumab for RA Connect with us! Listen to our podcast: Pharm5 Watch us on TikTok: @LizHearnPharmD Follow us on Twitter: @LizHearnPharmD References Solomon SD, McMurray JJV, Claggett B, et al. Dapagliflozin in heart failure with mildly reduced or preserved ejection fraction. New England Journal of Medicine. August 2022. doi:10.1056/nejmoa2206286 FDA Approves Treatment for Wider Range of Patients with Heart Failure https://bit.ly/3B20I8N. Published February 24, 2022. Accessed February 24, 2022. Coronavirus (COVID-19) update: FDA authorizes Moderna, Pfizer-BioNTech bivalent COVID-19 vaccines for use as a booster dose. U.S. Food and Drug Administration. https://bit.ly/3cDuyHd. Accessed August 31, 2022. Scheiber N. How pharmacy work stopped being so great. The New York Times. https://www.nytimes.com/2022/08/20/business/economy/pharmacists-job-inflation.html. Published August 20, 2022. Accessed September 1, 2022. FDA approves first treatment for acid sphingomyelinase deficiency, a rare genetic disease. U.S. Food and Drug Administration. https://bit.ly/3AziPS5. Accessed August 31, 2022. Dunleavy K. Sanofi's rare disease drug XENPOZYME scores FDA approval after nods in Japan and Europe. Fierce Pharma. https://bit.ly/3B3kz7F. Published August 31, 2022. Accessed August 31, 2022. Smolen JS, Feist E, Fatenejad S, et al. Olokizumab versus placebo or adalimumab in rheumatoid arthritis. New England Journal of Medicine. 2022;387(8):715-726. doi:10.1056/nejmoa2201302

This week on Pharm5: Rapid-acting Auvelity (bupropion/dextromethorphan) for MDD USPSTF's updated statin recommendations Post flu vaccination hyperglycemia in type 2 diabetes Twice annual HIV treatment lenacapavir approved in Europe; awaiting FDA approval Student loan forgiveness Connect with us! Listen to our podcast: Pharm5 Watch us on TikTok: @LizHearnPharmD Follow us on Twitter: @LizHearnPharmD References: Saro Arakelians PD. Daily medication pearl: Dextromethorphan and bupropion (Auvelity). Pharmacy Times. https://bit.ly/3QPIRY8. Published August 24, 2022. Accessed August 24, 2022. Auvelity (dextromethorphan and bupropion). Package insert. Axsome Therapeutics, Inc; 2022. @DrWestling15. “FDA just approved Auvelity (Dextromethorphan-Bupropion) for Major Depressive Disorder! What should a pharmacist know about this?” https://bit.ly/3R4WKkX. Published August 22, 2022. Accessed August 24, 2022. Mangione CM, Barry MJ, Nicholson WK, et al. Statin use for the primary prevention of cardiovascular disease in adults. JAMA. 2022;328(8):746. doi:10.1001/jama.2022.13044. Arnett DK, Blumenthal RS, Albert MA, et al. 2019 ACC/AHA guideline on the primary prevention of cardiovascular disease: A report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019;140(11). doi:10.1161/cir.0000000000000678 Blood sugars higher for flu vaccine recipients with diabetes. U.S. Pharmacist – The Leading Journal in Pharmacy. https://bit.ly/3PKbDrH. Published August 24, 2022. Accessed August 24, 2022. Hulsizer AL, Witte AP, Attridge RL, Urteaga EM. Hyperglycemia Post-Influenza vaccine in patients with diabetes. Annals of Pharmacotherapy. June 2022:106002802210981. doi:10.1177/10600280221098101 Kansteiner F. Gilead HIV prospect escapes FDA hold after glass compatibility glitch triggered regulatory setbacks. Fierce Pharma. https://bit.ly/3R3h3yY. Published May 17, 2022. Accessed August 24, 2022. Gilead announces first global regulatory approval of Sunlenca® (Lenacapavir), the only twice-yearly HIV treatment option. Gilead Announces First Global Regulatory Approval of Sunlenca® (Lenacapavir), the Only Twice-Yearly HIV Treatment Option. https://bit.ly/3dXZd2t. Accessed August 24, 2022. Duster C. How to qualify for Biden's new student loan forgiveness plan. CNN Politics. https://cnn.it/3ALjKjF. Published Wednesday August 24, 2022. Accessed August 24, 2022. Occupational Employment and Wages, May 2021 - Pharmacists. U.S. Bureau of Labor Statistics. https://bit.ly/3PObHXm. Published March 31, 2022. Accessed August 24, 2022. Smoot C. What is the average pharmacy school debt in 2022? SuperMoney. https://bit.ly/3PHqZNK. Published April 26, 2022. Accessed August 24, 2022.

Bristol Myers Squibb is once again piling on the cash for Immatics, a German immunotherapy biotech. The Big Pharma has tripled down on the collaboration, which originally kicked off in 2019 and was added to in 2021. BMS is paying $60 million upfront and $700 million in biobucks down the line for at least two new programs. And there's more: Bristol expanded the 2019 collaboration, with another $20 million plus milestones and royalties. Also under discussion is Fierce Pharma's special report on the world's 20 top-selling drugs. COVID-19 vaccines by Pfizer and Moderna are listed among the top three. And COVID treatments from Regeneron/Roche and Gilead were also in the top 20. Lastly, we have bloopers. After just over a month of creating this podcast, we finally have some “behind-the-scenes" tape to share. To learn more about the topics in this episode:  The top 20 drugs by worldwide sales in 2021 ASCO preview: How Gilead, Pfizer, AstraZeneca-Daiichi breast cancer data may—or may not—change treatment practice ASCO: Mirati cedes to Amgen's Lumakras on durability in tight KRAS battle SKYLARK sings: Sage, Biogen hatch positive phase 3 data in postpartum depression GSK strikes $3.3B Affinivax buyout to MAP out challenge to Pfizer's blockbuster pneumococcal vaccine Pfizer, already flush with cash, will reap $16B from selling shares in GSK consumer health spinoff Roche's Evrysdi ramps up SMA rivalry with Novartis and Biogen thanks to FDA nod in newborns Novartis' Kymriah bags FDA nod to face off against Gilead's Yescarta in follicular lymphoma UPDATE: Bristol Myers triples-down on Immatics, bringing deal to $4.2B total biobucks. Why not just buy it? The Top Line is produced by senior multimedia producer Teresa Carey with editor-in-chief Tracy Staton, managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. See omnystudio.com/listener for privacy information.

This week on Pharm5: Rare monkeypox spreading globally Metformin not helpful in breast cancer survival Novel, nonsteroidal Vtama (tapinarof) for plaque psoriasis Short-course antibiotics for P. aeruginosa bacteremia COVID-19 vaccine saves lives and money References: LaMotte S. What is monkeypox, its symptoms and threat to you? CNN. https://www.cnn.com/2022/05/24/health/what-is-monkeypox-virus-explainer-update-wellness/index.html. Published May 26, 2022. Accessed May 26, 2022. Goodwin PJ, Chen BE, Gelmon KA, et al. Effect of Metformin vs Placebo on Invasive Disease–Free Survival in Patients with Breast Cancer. Journal of the American Medical Association. 2022;327(20):1963-1973. doi:10.1001/jama.2022.6147. Kansteiner F. Dermavant looks to dethrone topical steroids with first FDA approval for Vtama in psoriasis. Fierce Pharma. https://www.fiercepharma.com/pharma/dermavant-looks-dethrone-topical-steroids-first-ever-fda-approval-vtama-psoriasis. Published May 24, 2022. Accessed May 26, 2022. Dermavant Sciences. Dermavant FDA Approves Dermavants VTAMA tapinarof cream 1 for the Treatment of Plaque Psoriasis in Adults First Topical Novel Chemical Entity Launched for Psoriasis in the US in 25 Years Comments. https://www.dermavant.com/u-s-fda-approves-our-novel-topical-treatment-for-adults-with-plaque-psoriasis/. Accessed May 26, 2022. Babich T, Naucler P, Valik JK, et al. Duration of treatment for pseudomonas aeruginosa bacteremia: A retrospective study. Infectious Diseases and Therapy. 2022. doi:10.1007/s40121-022-00657-1 Di Fusco M, Marczell K, Deger KA, et al. Public health impact of the pfizer-biontech COVID-19 vaccine (BNT162B2) in the first year of rollout in the United States. Journal of Medical Economics. 2022;25(1):605-617. doi:10.1080/13696998.2022.2071427.

Welcome to DigitaLee, the podcast for healthcare marketers, where we look at the digital news, tools, tips and tricks for effective healthcare communications. This week, David Shifrin and Lee Aase look at an article from Fierce Pharma that describes a marketing and ad agency building out a dedicated team to work on diversity in advertising. Then, they check in on the conventional wisdom around ways to ensure that content is broadly accessible and close by talking through the role of healthcare marketing teams and supporting the CEO. Episode Links Fierce Pharma: CMI Media Group launches new practice to help pharma reach out to diverse audiences Otter.ai Riverside.fm Descript Learn more about your ad choices. Visit megaphone.fm/adchoices

This week on Pharm5: Jardiance indicated for heart failure Drug prices in the SOTU address Vonjo approved for cytopenic myelofibrosis One Male Condom marketed for anal intercourse ASHP Phase I rank list due 11:59 PM Connect with us! Listen to our podcast: Pharm5 Watch us on TikTok: @LizHearnPharmD Follow us on Twitter: @LizHearnPharmD Thank you to Abigail Hulsizer, PharmD, BCPS and student pharmacist Kristopher S. Ingram for your contributions to this episode! References: FDA Approves Treatment for Wider Range of Patients with Heart Failure https://www.fda.gov/news-events/press-announcements/fda-approves-treatment-wider-range-patients-heart-failure. Published February 24, 2022. Accessed February 24, 2022. Jardiance.com. https://www.jardiance.com/heart-failure/. Accessed March 3, 2022. O'Brien S. Biden renews call to let Medicare negotiate drug prices, an effort that has stalled in Congress. CNBC. https://www.cnbc.com/2022/03/02/biden-renews-call-to-let-medicare-negotiate-drug-prices.html. Published March 2, 2022. Accessed March 3, 2022. Dunleavy K. A year later at the SOTU, Deja Vu all over again as Biden calls for lower drug prices, zeroing in on Insulin. Fierce Pharma. https://www.fiercepharma.com/pharma/year-later-sotu-deja-vu-all-over-again-biden-calls-lower-drug-prices-zeroing-insulin. Published March 2, 2022. Accessed March 3, 2022. FDA Approves Pacritinib for Myelofibrosis and Thrombocytopenia https://www.pharmacytimes.com/view/fda-approves-pacritinib-for-myelofibrosis-and-thrombocytopenia. Published March 1, 2022. Accessed March 2, 2022. FDA Permits Marketing of First Condom Specifically Indicated for Anal Intercourse. https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-condom-specifically-indicated-anal-intercourse. Published February 23, 2022. Accessed February 24, 2022. Schedule of dates. ASHP Match | Schedule. https://natmatch.com/ashprmp/schedule.html. Published January 6, 2022. Accessed March 3, 2022. Summary Results of the Phase I Match for Positions Beginning in 2021. American Society of Health-System Pharmacists Resident Matching Program. https://natmatch.com/ashprmp/stats/2021applstats-ph1.pdf. Accessed March 3, 2022.

In this episode we discuss the top ten blockbuster drugs with patent cliffs this decade (2020's) and how this could potentially affect your dividend stocks. Fierce Pharma article - https://www.fiercepharma.com/special-report/top-15-blockbuster-patent-expirations-coming-decade Follow Russ on Twitter - @Rustyram78 If you'd so kindly like to Buy Russ a Beer! - https://www.buymeacoffee.com/DapperDividends

Podcast está em alta diz o novo relatório da Kantar Ibope Media, outro relatório da Fierce Pharma revela as 11 indústrias com melhor aproveitamento de P&D.Conheça o Inhaler Tales, site que alerta profissionais da saúde sobre o uso errado de inaladores para asma com a Buffy, a vampira e o Stand Up To Cancer que usa do Hip Hop para convencer as comunidades negras e latinas ao diagnóstico precoce do câncer de cólon.Para finalizar, Amazon revela seus segredos para democratizar a saúde com o Halo View, Alexa Together, Astro, Amazon Pharmacy e PillPack.Todas as segundas!Acesse o Site Aqui ouhttp://bit.ly/tomouep84

Cuomo got into the car, FBI, FDA, CDC oh my, and I have a list for you, but first: Here is a fun little commercial we put together for the Politics of Sex conference: Politics of Sex Conference Andrew Cuomo has International Emmy Award rescinded following sexual harassment scandal https://www.foxnews.com/entertainment/andrew-cuomo-emmy-award-rescinded “Former New York Governor Andrew Cuomo had his 2020 International Emmy Award rescinded. "The International Academy announced today that in light of the New York Attorney General's report, and Andrew Cuomo's subsequent resignation as Governor, it is rescinding his special 2020 International Emmy® Award," the organization told Fox News in a statement. "His name and any reference to his receiving the award will be eliminated from International Academy materials going forward," it concluded.” Before Cuomo got in the car and was taken to somewhere. FBI finds scant evidence U.S. Capitol attack was coordinated - sources https://www.reuters.com/world/us/exclusive-fbi-finds-scant-evidence-us-capitol-attack-was-coordinated-sources-2021-08-20/ According to Reuters: “The FBI has found scant evidence that the Jan. 6 attack on the U.S. Capitol was the result of an organized plot to overturn the presidential election result, according to four current and former law enforcement officials. Though federal officials have arrested more than 570 alleged participants, the FBI at this point believes the violence was not centrally coordinated by far-right groups or prominent supporters of then-President Donald Trump, according to the sources, who have been either directly involved in or briefed regularly on the wide-ranging investigations. "Ninety to ninety-five percent of these are one-off cases," said a former senior law enforcement official with knowledge of the investigation. "Then you have five percent, maybe, of these militia groups that were more closely organized. But there was no grand scheme with Roger Stone and Alex Jones and all of these people to storm the Capitol and take hostages."” But remember how Amazon, Apple, and Google all kicked Parler off their platforms for supposedly being the platform that people used to coordinate the the January 6th Capitol Debacle? "Next, I want to tell our homeschool listeners about Classy Artist Box. It is a company created by a Christian art teacher who sends you everything you need to create four art projects each month. You can use their written instructions and video lessons to help guide you through each project. In addition to the four new projects each month, you'll also have access to two and a half years worth of video lessons to enjoy as a member. Each type of subscription will cover a range of art media throughout the year, which means you have your art curricular needs covered. For 30% off of your first subscription order, use code CROSS30. To see more, check out www.ClassyArtistBox.com. All the major companies requiring vaccines for workers https://fortune.com/2021/08/23/companies-requiring-vaccines-workers-vaccination-mandatory/ “Requiring vaccines is a move that most workers support (52% according to a recent Gallup poll), but a sizable chunk of the workforce (29%) is strongly opposed—likely some of the same people who are strongly opposed to the COVID vaccines in general. Here's a running list of the major U.S. corporations that have made moves to get their staff vaccinated, and the policies they've put in place.” Among the woke and morally broke corporate jokers, who have some sort of vaccine mandate, we have: At&T Bank of America Capital One Chevron Facebook Google Microsoft Texas Instruments, and two of my favorite: Johnson & Johnson The company will require that its U.S. employees and contractors be fully vaccinated before Oct. 4, according to Fierce Pharma. It will make exceptions for people with medical conditions or other reasons. Pfizer U.S. Employees will be required to get a vaccine or have to undergo weekly COVID testing, according to CNBC. Washington workers who decline vaccine mandate unlikely to qualify for unemployment https://www.krem.com/article/news/health/coronavirus/vaccine/washington-covid-19-vaccine-mandate-workers-decline-unemployment-eligibility/281-5ed52665-fbdc-4f96-a055-ba31235f08d3?utm_campaign=snd-autopilot According to KREM news: “Employees who decline the COVID-19 vaccine per workplace mandates are not likely to qualify for unemployment benefits unless they have a unique circumstance, such as approved exemptions. "Everyone is trying to make sense of this right now," said Jason Rittereier, employment attorney at HKM Employment Attorneys. Rittereier said workplaces can legally mandate a vaccine requirement as a condition of employment and for that reason, employees who do not follow workplace policy are subject to being let go. "Employees should not count on unemployment benefits if they were to be fired because they failed to get vaccinated or if they resigned because they refused to get vaccinated," he said. Information posted online by the Washington State Employment Security Department said employees may still qualify for the payments based on "unique circumstances." "Factors may include when the employer adopted the requirement, whether the employee is otherwise eligible for benefits, the specific terms of the vaccine policy including allowable exemptions, and the reason why the employee did not comply with the vaccine requirement," the online information said.” Governor Kristi Noem: Closing This is Gabriel Rench with Crosspolitic News. Support Rowdy Christian media by joining our club at fightlaughfeast.com, downloading our App, and head to our annual Fight Laugh Feast Conference next fall. With your partnership, together we will fight outdated and compromised media, engage news and politics with the gospel, and replace lies and darkness with truth and light. Go to fightlaughfeast.com to take all these actions. Have a great day. Lord bless

The Mylan pharmaceutical plant in Morgantown, West Virginia, has been in operation since 1965, producing low-cost generic drugs and providing good-paying jobs for generations of workers. On July 31, the plant (now owned by Viatris, Inc.) closed, upending the lives of over 1,400 workers, the economy of Morgantown, and the future of generic drug manufacturing in the U.S. In this mini-cast, we talk to Carla Shultz, who has worked at the plant for 13 years, and legendary journalist Laura Flanders, who recently reported on the plant closure on The Laura Flanders Show, about the last-ditch efforts to keep the plant open and what it will mean for working people in Morgantown and beyond if those efforts are unsuccessful.    Additional links/info below... Join our Working People listener hang session on Monday, August 16, from 8-9:30pm ET. Here's the zoom link  Laura's Twitter The Laura Flanders Show website, Twitter, YouTube channel, and Patreon Laura Flanders, The Laura Flanders Show, "Big Pharma vs The People: The Fight To Save America's Largest Generic Drug Manufacturer” Fraiser Kansteiner, Fierce Pharma, "Feds Throw Lifeline to Shuttered Viatris Plant in West Virginia, But Its Fate Remains Uncertain" Democracy Now!, "Workers Beg Joe Manchin to Save West Virginia Pharma Plant as His Daughter Walks Away with $31M"   Permanent links below... Working People Patreon page Leave us a voicemail and we might play it on the show! Labor Radio / Podcast Network website, Facebook page, and Twitter page In These Times website, Facebook page, and Twitter page The Real News Network website, YouTube channel, podcast feeds, Facebook page, and Twitter page   Featured Music (all songs sourced from the Free Music Archive: freemusicarchive.org) Jules Taylor, "Working People Theme Song"

E no episódio temos um eu aceito, Tiffany & Co cria anel de casamento para homens, falamos também sobre o #robotaxi na China.Você já conhece o primeiro desodorante adaptado para pessoas com deficiência visual e de membros superiores? Então venha ver o Degree Inclusive da Unilever. Quanto gasta a Farma em publicidade e quais foram os TOP 5 produtos que mais gastaram em 2020: Humira, Dupixent, Xeljanz, Skyrizi e OzempicTodas as Segundas!

533 milhões de dados vazam de usuários do Facebook, saiba se o seu também foi!A nova parceria da Uber Health para entrega de medicamentos e conheça as 20 indústrias farmacêutica por receita global segundo a Fierce Pharma.Todas as segundas, Tomou?

Recorded January 04, 2021Current Episodes at https://walkinverse.buzzsprout.com/I am moving all podcast here slowly. I will keep buzzsprout for all public reports and here for member only content.Report #30, "Meet Pfizer & A Few Connections." In this episode, we will dig a bit into Pfizer and their connections. We will look at some of the CEO comments and ask the question, why?  Why did the FDA give clearance to an untested technology never licensed for human use? Grab a pen and notebook and enjoy the report.Did you like the report?We walked into 2021 with more mandates. Genocide by vaccination became a true possibility. Now, the hour's at hand, and we must know who's behind Pfizer. Our government guarantees the demise of the American people. Through illegal taxation without representation, their demise is imminent. America's government gave away tax dollars for absolute financial destruction. They'll fund Big Pharma to combat a virus with a 99.9% survival rate. It's utter insanity.Behind these treasonous acts lies Albert Bourla. He started his career over twenty-five years (Prizer. 2020) ago at Pfizer and climbed through the ranks to CEO. With his in-depth knowledge and recent remarks, we must question his motives. Through emergency authorization (FDA. 2020), the FDA gave the green light. Inject everyone and distribute experimental therapies throughout the United States. They skipped standard animal trials and jumped to human vaccination (F. William Engdahl. 2020).The effectiveness—unknown. Even after injected, spread may occur (Baker, Sinéad. 2020). Short and long term side effects (vaccine injury) lurk in the shadows.Yet, the FDA feels the benefits outweigh the risk of ending a non-existent pandemic. A pandemic of such importance, the CEO of Pfizer sold $5.6 million, 62% of his stock (F. William Engdahl. 2020) the same day they reported positive results for their mRNA injectable technology (Paul R. La Monica. 2020). Not only did the CEO profit, so did his VP. Sally Susman walked away with $1.8 million on the same day. This came a few months after executives at Moderna dumped $30 million of their stock. Which the SEC officials wants investigated for illegal market manipulation. The press questioned Albert about the finances Pfizer received from the Trump Administration for distribution and development—he denied it; he lied. Asked if he would take part in the COVID mRNA injection rollout, he stated,“I'm 59 years old, in good health, I'm not working in the front line. So, my type is not recommended to get vaccinated…” (Daniel. 2020).But for others, they should accept the needle because the plight which he wishes, “wasn't so critical so they (the people) could have the luxury to think about it (the injection). The situation is as deadly as it could be right now..” touts Albert. He continues, “trust science and get injected to protect the ones you love.” Yet, he's 59. In good health and doesn't need the vaccine, nor do the executives of the company (CNBC Television. 2020).Watch Video => https://www.bitchute.com/video/MDOopH6fFUMt/And like Albert, the FDA maintains the narrative, “all those sixteen and older should receive the COVID vaccine.” But interestingly enough, by the CEO's admission, if not on the front lines and your vigor good, no need for their injection.I then ask why. Why must the narrative of vaccination for all continue? One answer, profits and the elite forces behind the initiative.The Gates Foundation (Speights, Keith. 2020) owns stocks in BioNTech, CureVac, Vír BioTechnology, and Pfizer. On top of his positions in these enterprises, BioNTech revealed a new partnership. The development of HIV and TB programs with an initial investment of $55 million to cap at $100 million (NA. 2019. ). An oddity with the mRNA rollout centers on HIV. A cause Bill champions throughout Africa. In Australia, several individuals tested false positive for HIV after vaccinations (Tyler Durden. 2020). Yet, an established pharmaceutical expert, Fourtillian, made it known about a patent filed in 2011 for SARS-CoV-2. On December 10, 2020, they arrested him and seized all his research. Computers taken, bank account frozen, all income confiscated. His findings showed not only the dangers of the vaccines, but how they contained four sequences of HIV (Jeanne Smits. 2020). In South Africa, over 50% of pharmaceutical funds surround drugs for HIV (ltd, Research and Markets. 2020). A shared interest between the Gates Foundation and these pharmaceutical giants.Other shareholders of Pfizer, include BlackRock, JP Morgan, Chase & Co, Morgan Stanley, Bank of America, and Bank of New York Mellon. Big Tech (a mix of Apple, Microsoft, Amazon, Facebook, and Google) represents up to 15% of their portfolios, which encompass contract tracing, censorship, and digital identification (stockzoa. 2021).These companies have one idea in mind, and it's not to benefit humanity. With the investments, Pfizer guarantees investors a hundredfold return on their new DNA based vaccine. According to Fierce Pharma, each dose, $20. Each individual needs two. Forty per person, times 7.8 billion people, you do the math (David, Emilia. 2020). And when new viruses peak, the health passport reminds, “it's time for your shot,” as the revenue flows in. If you refuse to partake, too late, your accounts offline until you comply. Disobey—destitution your home. But, the bankers move in lockstep with the future they designed for you. As propaganda continues, between 88 and 100 million people lost everything. Thrown into extreme poverty because of a pandemic orchestrated by world billionaires (Zumbrun, Josh. 2020).Before you accept any of these experimental genetic therapies, think twice. I can't tell you what to do, but I'll tell you this. The government and political figures fabricate stories daily. They removed your rights and liberties from the start. If you believe COVID can kill you, roll up your sleeve—take your shot. There's nothing I can say to show the level of propaganda you're fed continually.For those who see it at face value, take a stand. Scream from the rooftops, “No more, we won't accept tyranny!”Reject all unconstitutional and illegal orders, for there are more of us than them.Stand fast, the rides about to get bumpy.References* Prizer. 2020. “Albert Bourla, DVM, Ph.D. | Pfizer.” Company. Pfizer.Com. 2020.* FDA. 2020. “FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine.” Government. FDA. FDA. December 14, 2020.* F. William Engdahl. 2020. “What's Not Being Said About the Pfizer Coronavirus Vaccine. ‘Human Guinea Pigs'?” Global Research. December 5, 2020.* Baker, Sinéad. 2020. “Pfizer's Chairman Says It's Not Clear Whether People Who Are Vaccinated Can Still Spread COVID-19.” Business Insider. December 4, 2020.* Paul R. La Monica. 2020. “Pfizer's CEO Sold $5.6 Million in Stock the Day He Announced Promising Vaccine News.” CNN. November 11, 2020.* Daniel. 2020. “Pfizer CEO Albert Bourla Says He Will NOT Get the Vaccine — For Now, That Is.” We Love Trump. December 15, 2020.* CNBC Television. 2020. Pfizer CEO Albert Bourla on Vaccine Hesitancy: “Trust Science.”* Speights, Keith. 2020. “4 Coronavirus Vaccine Stocks the Bill & Melinda Gates Foundation Is Betting On.” The Motley Fool. September 24, 2020.* NA. 2019. “BioNTech Announces New Collaboration to Develop HIV and Tuberculosis Programs.” Business Wire. September 4, 2019.* Tyler Durden. 2020. “Australia Cancels COVID Vaccine Trial Over ‘Unexpected' False Positives For HIV.” ZeroHedge. December 11, 2020.* Jeanne Smits. 2020. “Accomplished Pharma Prof Thrown in Psych Hospital after Questioning Official COVID Narrative.” LifeSiteNews. December 11, 2020.* ltd, Research and Markets. 2020. “The Pharmaceutical Industry in South Africa 2020.” Research Database. Research and Markets. December 2020.* stockzoa. 2021. “Who Owns Pfizer? Top Stakeholders of PFE According to 13F Filings.” Finance. Stockzoa. February 15, 2021.* David, Emilia. 2020. “How Much Could Pfizer's Coronavirus Vaccine Cost?” Grunge.Com. November 9, 2020.* Zumbrun, Josh. 2020. “Coronavirus Has Thrown Around 100 Million People Into Extreme Poverty, World Bank Estimates.” Wall Street Journal, October 7, 2020, sec. Economy. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit walkinverse.substack.com/subscribe