Podcasts about fierce pharma

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