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Ever wondered who's really behind the regulations you follow in pharma and medical devices? In this episode of Let's ComBinate, Subhi Saadeh breaks down the five categories of organizations that influence how we develop, test, and release products:Regulatory Authorities (like FDA, EMA, PMDA)Harmonization Bodies (like ICH, IMDRF, and PIC/S)Standards Organizations (ISO, ASTM, etc.)Pharmacopoeias (USP, JP, Ph. Eur.)Industry Groups (like PDA, MDIC, PhRMA, and more)Subhi dives into how each type contributes to the rules, expectations, and gray areas that define your work — and how to figure out which ones really matter when you're reviewing SOPs, guidance docs, and regulatory submissions.00:00 – Intro01:23 – Regulatory Bodies04:03 – Harmonization Organizations10:01 – Standards Organizations12:07 – Pharmacopoeias13:59 – Industry Groups16:11 – Wrap-up and TakeawaysSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.
Stati Uniti e Cina hanno concordato una moratoria di 90 giorni per sospendere i nuovi dazi reciproci introdotti ad aprile. Gli USA abbasseranno le tariffe doganali dal 145% al 30%, mentre la Cina le ridurrà dal 125% al 10%. La sospensione riguarda anche le ordinanze esecutive e gli annunci doganali successivi al 2 aprile. Pechino si è inoltre impegnata a revocare le contromisure non tariffarie adottate contro gli USA. Il nuovo accordo arriva dopo un periodo di tensioni che aveva generato un crollo delle Borse e timori di recessione globale. Secondo l'editorialista Fubini, la pressione dei mercati ha spinto Trump a cercare un compromesso per evitare ulteriori danni economici. Seppur temporaneo, l'accordo riflette l'urgenza di evitare ripercussioni sul commercio, sull'inflazione e sul consenso politico, con l'obiettivo di stabilizzare i rapporti e scongiurare effetti a lungo termine su occupazione, prezzi e produzione. Ne abbiamo parlato con Luca Veronese, Il Sole 24 ore, (da Milano) Lucio Miranda, Presidente Export USA, (da Washington).TUTTOFOOD MILANO 2025: oltre 95.000 presenze e una nuova alleanza globale del foodSi è conclusa l'8 maggio la prima edizione di TUTTOFOOD MILANO organizzata da Fiere di Parma, che ha accolto oltre 95.000 visitatori professionali, di cui il 25% provenienti dall'estero. L'evento ha visto la partecipazione di 4.200 aziende espositrici distribuite su 10 padiglioni per oltre 150.000 metri quadrati, coprendo l'intera filiera agroalimentare. Il Buyers Program, realizzato con ICE-Agenzia, ha favorito la presenza di 3.000 top buyer e 7.000 operatori esteri. Oltre il 70% delle aziende ha già confermato la partecipazione per l'edizione 2026. L'evento segna l'avvio del nuovo hub Parma-Milano-Colonia grazie alla partnership strategica tra Fiere di Parma e Koelnmesse (Anuga). TUTTOFOOD 2025 ha generato un impatto economico di oltre 150 milioni di euro su Milano. Grande riscontro anche per la prima TUTTOFOOD Week, con eventi diffusi in città, tra cui la mostra “Essenziale e Quotidiano” all'ADI Design Museum. A evento concluso, il team organizzativo parte per un roadshow internazionale verso le principali fiere globali, con tappe ad Amsterdam, Bangkok, New York e Colonia, in preparazione delle prossime edizioni di TUTTOFOOD MILANO 2026 e CIBUS 2027. Interviene in trasmissione Antonio Cellie, Amministratore Delegato Fiere di Parma.Trump ha firmato ordine per ridurre prezzi farmaci fino all 80%Donald Trump ha annunciato la firma di un ordine esecutivo per ridurre il costo dei farmaci negli Stati Uniti, con tagli che vanno dal 30% all'80%, introducendo anche un sistema di “nazione più favorita” per cui gli USA pagheranno il prezzo più basso applicato a livello mondiale. Si tratta di una misura simile a quella proposta nel suo primo mandato ma mai attuata. Trump ha dichiarato di non farsi influenzare dall'industria farmaceutica, pur avendo ricevuto donazioni da quel settore. L'associazione PhRMA ha criticato duramente la misura, sostenendo che i controlli governativi penalizzano i pazienti e scoraggiano la ricerca. Durante il mandato Biden, l'Inflation Reduction Act ha introdotto una clausola simile per negoziare i prezzi su dieci farmaci selezionati, con risparmi previsti fino a 100 miliardi di dollari, nonostante le azioni legali avviate dall'industria. Trump ha respinto le critiche del settore, accusando le aziende di gonfiare i prezzi per gli americani, e ha promesso un cambiamento equo grazie all'ordine esecutivo. Alcuni repubblicani, incluso lo Speaker della Camera, si sono detti contrari all'inserimento del provvedimento nella legge di bilancio. Ne abbiamo discusso con Alessandro Plateroti, Direttore Newsmondo.it
Today, the Democrats and the media attempt to create a crisis over signal. From fake outrage to calls for resignation, Democrats can't help but be-clown themselves. Jasmine Crockett makes a distasteful remark towards Governor Greg Abbott. The fellas provide a Hack Madness update. Find out the true power of America's oil and natural gas. Go to LightsOnEnergy.org Call Congress and urge them to end the Biden pill penalty. Call 202-224-3121 Congress should make sure medicine savings should go directly to patients not middlemen. Go to PHRMA.org/middlemen to learn more! Stop Dick Durbin's government takeover of credit cards before it's too late. Learn more at: GuardYourCard.com
What are the top 5 most unhinged anti-Trump takes? Will the champion finally meet his match in King of the Hill? ESPN's Tom Crean joins the progrum. Tell your senator and member of Congress to work with President Trump and sell more spectrum. Go to EndTheCableopoly.org. Find out the true power of America's oil and natural gas. Go to LightsOnEnergy.org Call Congress and urge them to end the Biden pill penalty. Call 202-224-3121 Congress should make sure medicine savings should go directly to patients not middlemen. Go to PHRMA.org/middlemen to learn more! Stop Dick Durbin's government takeover of credit cards before it's too late. Learn more at: GuardYourCard.com
Democrats can't decide on whether they want to shutdown the government. Trump buys a Tesla. Space X embarks to rescue trapped astronauts. King of the Hill gets very dark. AFP's Megan Novak joins the Progrum. Stop Dick Durbin's government takeover of credit cards before it's too late. Learn more at: GuardYourCard.com Tell your senator and member of Congress to work with President Trump and sell more spectrum. Go to EndTheCableopoly.org. Congress should make sure medicine savings should go directly to patients not middlemen. Go to PHRMA.org/middlemen to learn more! Find out the true power of America's oil and natural gas. Go to LightsOnEnergy.org
President Donald Trump delivers an impeccable speech in his address to Congress. Democrats react to all of the positive patriotic messaging in the worst ways possible. The media proves there is no level to which they won't stoop. Senator Tommy Tuberville joins the progrum. Call Congress and urge them to end the Biden pill penalty. Call 202-224-3121 Congress should make sure medicine savings should go directly to patients not middlemen. Go to PHRMA.org/middlemen to learn more! Be ready for what's down the road. Go to Chevron.com/Anchor Find out the true power of America's oil and natural gas. Go to LightsOnEnergy.org Stop Dick Durbin's government takeover of credit cards before it's too late. Learn more at: GuardYourCard.com
Karoline Leavitt joins the progrum to discuss her role as White House Press Secretary and to play a friendly game of Dem Or Journo. Senate Majority Leader John Thune joins the progrum to talk about the record-breaking pace of the Senate and the achievements in implementing the President's agenda.The fellas play a game of game or journo. Call Congress and urge them to end the Biden pill penalty. Call 202-224-3121 Congress should make sure medicine savings should go directly to patients not middlemen. Go to PHRMA.org/middlemen to learn more! Let's build a better future together. Go to API.org
Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.President Trump has threatened big pharma with tariffs unless they reshore manufacturing. He also refused to promise pharma executives that he would hamstring the IRA's drug negotiation program. RNA editing is fueling hope for rare and common diseases, with experts calling for more efficiency and breakthroughs in delivery methods. The FDA is rehiring scientists after Trump's firing spree, with around 300 staff being asked to return. Vertex's Journavx is changing the pain treatment landscape, but opioids are still prevalent. Trilink offers mRNA designs for reliable performance in various applications. In other news, a small Harvard start-up is fighting antimicrobial resistance, and OpinionAI is focusing on small molecules in the I&I space. Bluebird is going private, Mirum receives FDA approval for a rare disease, and PhRMA is meeting with Trump on various policies.Vertex's Journavx is changing the landscape of pain treatment, but opioids are still widely used. Non-opioid pain therapies, including Journavx, have been approved by the FDA, but their uptake remains uncertain. Meanwhile, RNA editing is showing promise in clinical trials for treating rare and common diseases, and artificial intelligence is making small molecules more attractive in the inflammatory and immunology disease space. The FDA is facing low morale after job cuts under Trump's administration, raising concerns about delays in new medicine approvals. Additional news includes Sanofi challenging Novo with an FDA approval for a biosimilar, FDA rare cancer approvals, and Lead passing on an option for Arcus' cancer drug.Thank you for tuning in to Pharma and Biotech Daily.
Pharmacy benefit managers are powerful middlemen that control what medicines patients can get, the price they pay out-of-pocket and what hoops they have to jump through to get the medicine their doctor prescribed. Scott LaGanga, PhRMA Executive vice president, joins CONN to discuss the survey and more....
As we approach Medicare's Open Enrollment period, NP Pulse welcomes AANP's president elect Valerie Fuller to discuss the big changes that have happened — and will happen starting Jan. 1 of 2025— to Medicare Part D. Learn how seniors can opt in to the program and what changes will be taking place with regard to costs for medications, vaccines and more. This podcast is made possible by PhRMA.
Alex Schriver, Senior Vice President of Public Affairs at the Pharmaceutical Research and Manufacturers of America (PhRMA), explains how he builds trust with key stakeholder audiences through internal and external localization efforts. He shares how he applies a campaign-style approach to communicate and engage with his team to “win the day.” Additionally, Alex emphasizes how leaders can ensure their employees' voices are genuinely heard and valued.
Novo Nordisk CEO Lars Fruergaard Jørgensen testified Tuesday in front of Sen. Bernie Sanders' Senate health committee regarding the prices of Ozempic and Wegovy—with some interesting takeaways. Meanwhile, PhRMA scored a rare win as the Fifth Circuit Court of Appeals ruled in the trade group's favor, sending its complaint against the Inflation Reduction Act (IRA) back to a lower Texas court. Looking ahead, 15 more drugs are expected to be negotiated under the IRA next year, including Novo's Ozempic. Last week, the Federal Reserve cut the federal interest rate by half a percentage point—a move that was expected and met with a collective shrug from the biotech market, with experts skeptical of its impact. Elsewhere, the schizophrenia space is gearing up for an FDA decision on BMS' KarXT. If approved, KarXT would be the first novel drug for the neuropsychiatric disease in decades. And on the obesity front, Novo's oral cannabinoid receptor 1 drug elicited impressive weight loss in a Phase IIa trial, with some adverse events, and young startup Metsera touted robust Phase I data for its injectable GLP-1 candidate.
Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.On September 23, 2024, Lifespan, a healthcare organization, laid off 20% of its executive team as part of a restructuring effort to save $6 million. The FTC sued major pharmacy benefit managers over alleged anticompetitive practices related to insulin prices. Texas Attorney General settled with a generative AI company over accuracy allegations. Steps to minimize the threat of legacy medical devices and the challenges faced by telehealth providers in navigating insurance, compliance, and cash-only models amid state regulations were discussed. The changing landscape of healthcare requires workforce planning strategies to address staffing challenges. Placing AI at the heart of healthcare to improve efficiency and patient care is also highlighted. Additionally, news on cybersecurity risks posed by legacy medical devices, challenges faced by telehealth providers, and industry developments such as new diet plans and games for falls prevention were shared. Healthcare Dive provides in-depth journalism on topics such as health IT, policy & regulation, insurance, digital health, payer-provider partnerships, and value-based care for decision-makers in the healthcare industry.In other news, AstraZeneca and Daiichi's dato-dxd failed to extend lives in breast cancer, adding to previous setbacks in lung cancer. Bristol Myers Squibb is targeting the first new type of schizophrenia drug in three decades. A recent court ruling has revived PhRMA's legal challenge to the Inflation Reduction Act. BMS is laying off employees in New Jersey as part of cost-saving measures. BMS' karxt could soon be the first new schizophrenia drug in decades. Sanofi secured approval for Sarclisa in multiple myeloma and Athira Pharma laid off 70% of its workforce. The BACE credential can help advance a career in biotech. The ongoing battle over drug pricing was also discussed, specifically focusing on insulin and the role of pharmacy benefit managers (PBMs) in inflating costs. The U.S. Federal Trade Commission filed a lawsuit against three major PBMs for allegedly rigging the supply chain to increase insulin prices. Insulin makers like Eli Lilly have set price caps, but the FTC warned all drugmakers about raising list prices for medicines. Big pharma companies are being scrutinized for their efforts in providing access to drugs like insulin in low- and middle-income countries. A report examined the patient reach efforts of 20 major pharma companies in these regions. Overall, the industry is facing pressure to address both pricing and access issues.
In November 2021, Arkansas enacted a law, known as Act 1103, that prohibited drugmakers from placing restrictions on 340B contract pharmacies and child sites. The Pharmaceutical Research and Manufacturers of America (PhRMA) immediately filed suit to block implementation of Act 1103, delaying enforcement of the law for nearly 2 years. However, on March 12, 2024, the U.S. Court of Appeals for the Eighth Circuit rejected PhRMA's arguments and ruled Act 1103 is valid and enforceable. In the podcast, we talk about the implications of the ruling for the broader 340B program and covered entities nationwide. The information presented during the podcast reflects solely the opinions of the presenter. The information and materials are not, and are not intended as, a comprehensive source of drug information on this topic. The contents of the podcast have not been reviewed by ASHP, and should neither be interpreted as the official policies of ASHP, nor an endorsement of any product(s), nor should they be considered as a substitute for the professional judgment of the pharmacist or physician.
Jocelyn Ulrich, VP of Innovation Policy and Research at PhRMA, joins the For Your Health News podcast to discuss the importance of diversity in clinical research. Ulrich discusses PhRMa's work to improve health equity and equitable access to medicines, as well as its efforts to represent minoritized populations within its research. Join us for this conversation on clinical research diversity. Learn more about PhRMA and its efforts to drive patient-centered progress in innovation and access to life saving medicines at phrma.org. Visit fyh.news for more healthcare information that empowers minoritized communities. Learn more about NMQF at nmqf.org. 00:00 Introductions 00:30 Socioeconomic Factors & Health Care 00:50 Grant Programs 01:45 Clinical Trial Diversity 03:29 Engaging with the Community 04:45 Upcoming Community Report
Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. On February 22, 2024, significant developments in the biopharma industry were reported. Ori Capital raised a new biotech fund to support startups working on innovative drugmaking approaches. The Biden administration pledged $100 million towards women's health research as part of an initiative led by First Lady Jill Biden. Moderna faced challenges in transitioning but pitched a new RSV shot and vaccines for the future. Novavax agreed to pay Gavi in a settlement over a COVID vaccine contract. A paper in NEJM highlighted the "remarkable" results of CAR-T therapy in treating autoimmune diseases, shedding light on its potential benefits and remaining challenges. Moderna is banking on an experimental RSV vaccine to drive future sales. The state of biosimilars in 2024 was discussed, noting that while the U.S. market had initially fallen short of expectations, more products have entered the market recently after a slow start.Moderna reported a surprise profit in Q4 despite a 43% decline in COVID-19 vaccine revenue. The company beat analyst estimates thanks to deferred payments and cost savings. Pfizer and Moderna both exceeded expectations in COVID-19 sales but face challenges with declining revenues in the future. Novavax settled a $400 million agreement with Gavi for their COVID-19 vaccine. Bristol Myers Squibb is focusing on advanced modalities to combat cancer. Protagonist published promising phase II data for a blood cancer therapy. The biopharma industry is seeing an increase in data analysts as data becomes more important. Gilead CEO O'Day was named the new board chair of PhRMA.This week's Commercialization Weekly highlights several key developments in the biopharma industry. United Therapeutics has taken the unusual step of suing the FDA over a rival's drug application, alleging that the agency is allowing rule violations. The FDA is set to review expanded use of Sarepta's Duchenne gene therapy, while Iovance prepares for the launch of its 'TIL' cell therapy after receiving approval. Astrazeneca also received a new approval for Tagrisso in lung cancer treatment. Additionally, Abbvie's proposed acquisition is facing delays due to a "second request" from the FTC. These developments showcase the ongoing challenges and advancements in the biopharma sector.
Pink Sheet reporters and editors discuss the dismissal of PhRMA's suit challenging the Medicare price negotiation provisions (:30), the US FTC and HHS investigation of drug shortages (12:01), and the potential for FDA-approved marijuana products (23:47). More On These Topics From The Pink Sheet PhRMA's Lawsuit Against Medicare Trips Over ‘Administrative Remedy' Standard; Will Others? https://pink.citeline.com/PS149791/PhRMAs-Lawsuit-Against-Medicare-Trips-Over-Administrative-Remedy-Standard-Will-Others FTC, HHS Probe GPO Contracting Practices As Source Of Generic Drug Shortages: https://pink.citeline.com/PS149790/FTC-HHS-Probe-GPO-Contracting-Practices-As-Source-Of-Generic-Drug-Shortages Prescription Marijuana? FDA Rescheduling Memo Sets Stage To Test Whether There's A Viable Market: https://pink.citeline.com/PS149781/Prescription-Marijuana-FDA-Rescheduling-Memo-Sets-Stage-To-Test-Whether-Theres-A-Viable-Market
Recorded at NC Life Sciences Organization's 2023 annual meeting, hosts Heather and Matthew welcome Christine Harhaj, the Senior Director for Pharmaceutical Research and Manufacturers of America (PhRMA). They have an insightful conversation about the pharmaceutical industry and advocating for policies that enable a patient-centered ecosystem. Listen to episode 168 now!
Just over a month ago we lost Bob Barker, the man who taught us all about the brutal nature of capitalism one pricing game at a time. Now, thanks to the Inflation Reduction Act, the federal government is going to be playing a role in determining the prices for some of our favorite products. No, we're not talking about cars or family vacations to the Bahamas – we're talking about the prescription drugs that keep us alive! As the Biden Administration enters its own Showcase Showdown with Big Pharma, we're taking a full episode to break down what that means and whether the result will be prices we can actually afford. https://www.youtube.com/watch?v=cnxbIhEPhs0&t=1s Show Notes Our first (and only) contestant is Alex Lawson! He is the Executive Director of Social Security Works, the convening member of the Strengthen Social Security Coalition— a coalition made up of over 340 national and state organizations representing over 50 million Americans. Alex's organization played a critical role in moving the Democratic Party (mostly!) away from efforts to cut Social Security, and has been shifting the momentum towards expanding Social Security. Social Security Works is also a key ally of ours in the national fight for Medicare for All! Alex, come on down! Alex starts by telling us about the time he took a camera to PhRMA's (the Pharmaceutical Research and Manufacturers of America) office the day of the Inflation Reduction Act signing ceremony. He conducted person-on-the-street interviews, asking if they knew PhRMA spent hundreds of millions of dollars to keep Medicare from being able to negotiate drug prices, and if they had any messages for the folks in the building? Most of the responses were of the "f-you PhRMA, we got you!" variety. PhRMA has literally never lost until the Inflation Reduction Act was passed. Even though it's modest, Medicare went from having no authority over drug prices to the authority and mandate to find the fairest price for certain drugs is a huge loss to the industry. Alex wants listeners to understand that this win is as simple as it sounds. Who buys the most drugs in the world? Medicare. Why doesn't Medicare tell the pharmaceutical companies what they're willing to pay? This is called the Maximum Fair Price. No other peer nation doesn't have some kind of negotiated standard for drug prices. While our guest and hosts would prefer that Medicare be allowed to negotiate the prices of all drugs used by beneficiaries, PhRMA was successful in limiting the Inflation Reduction Act drug provisions to only apply to ten pharmaceuticals. (Still, pharmaceutical companies are suing to block the implementation of price negotiations.) Negotiating the prices for only ten drugs may seem like a drop in the bucket, but the cost of those ten drugs alone make up a huge amount of Medicare's spending on Medicare Part D. And in coming years Medicare will be able to negotiate over ten more drugs, and so on. This will squish the most excessive profiteering of the pharmaceutical industry and deliver savings of $9 or $10 billion dollars a year. We give President Biden credit for taking an aggressive stance against PhRMA to finally make good on an evergreen Democratic campaign promise to lower drug prices. But we also give ourselves some credit. First there was the debate in Congress in 2019 over HR3, the Lower Drug Costs Now Act. Advocacy by groups likes ours resulted in the House passing a robust bill that would have dramatically lowered drug costs. Then in 2021 both Healthcare-NOW and Social Security Works fought hard to win major expansions of Medicare in the Build Back Better bill (we were on track to win a lot more than prices for ten drugs). But Senators Joe Manchin and Kyrsten Sinema tanked the whole bill in the Senate. Those two battles led us to the Inflation Reduction Act aiming high from the start, and resulting in a bill that will make a big impact on drug spending by Medicare.
Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in the Pharma and Biotech world. Today, we'll be discussing some key news in the industry.## Addressing the Opioid CrisisThe biopharma industry is currently facing the challenge of addressing the opioid crisis, which is a complex and devastating issue. Researchers at the University of Chicago have made progress in finding a new pathway for pain relief without the risk of addiction and overdose. They have targeted the acetylcholine receptor in the brain instead of the dopamine receptor triggered by opioids, leading to extended periods of analgesic effects in mice, even in those with opioid tolerance. However, it may take time before these discoveries lead to the development of a new painkiller. In the meantime, there is an urgent need for opioid addiction disorder drugs like Brixadi from Braeburn, which offers long-lasting addiction treatment. It's crucial to work with the community to find the right recovery plan for each patient.## Drug Costs and the Opioid CrisisThe blame game between pharmacy benefit manager lobby PCMA and drugmaker lobby PhRMA continues over drug costs in the prescription supply chain. As the opioid crisis continues to rage, the launch of Brixadi provides patients with a new tool to overcome addiction.## The Life Sciences Generative AI SummitThe Life Sciences Generative AI Summit is a virtual event that aims to explore the use of generative AI in the field of life sciences. The summit will feature interactive discussions on how generative AI can accelerate product development and improve health outcomes. Dr. Bertalan Mesko, the Medical Futurist and Director of the Medical Futurist Institute, will be the keynote speaker at the event. The summit agenda includes sessions on various topics related to generative AI, including real-world examples of adoption and operational workflows for implementing generative AI solutions. Attendees will have the opportunity to take advantage of a 50% discount on Dr. Mesko's course on artificial intelligence in medicine and healthcare. The event will take place on September 28th in a virtual format, with on-demand viewing available for those unable to attend the live broadcast.## Mercalis: Support for Life Sciences CompaniesMercalis, formerly known as TrialCard, is a company that provides support to life sciences companies in the commercialization process. With 23 years of experience and a range of capabilities, Mercalis aims to help both life science companies and patients achieve their goals in the complex healthcare marketplace. The company offers end-to-end support, including strategic consulting, business initiatives, and patient support services. They also provide late-stage clinical trial supply management, post-marketing healthcare provider engagement services, and commercial data and insights. Mercalis is positioned as a comprehensive solution for life sciences companies, providing support throughout the commercialization process and leveraging its expertise in the healthcare marketplace.## Reliable Preservation with PHCBIThe importance of reliable preservation of samples and biologics in laboratories and scientific research is discussed. Failures and variances in temperature control can lead to the destruction of years of hard work. PHCBI brand high-performance refrigerators and ultra-low temperature and cryogenic freezers are highlighted as solutions that provide uniform protection. The advances in ultra-low temperature freezer technology are mentioned, emphasizing energy efficiency without compromising performance. Vaccine storage options, including undercounter refrigerators and freezers, as well as combination units with sliding and hinged doors, are also mentioned. These options are designed to safely store vaccines and biologics. Biomedical storage options are discussed next, with purpose-built models suitable for storing enzymes, reagents, and ot
Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Today's episode covers a range of updates in the industry.First, we turn our attention to the commercial hurdles facing RSV vaccines. Public health officials and drugmakers are working to raise awareness of RSV among older adults at risk. They are also encouraging them to get an additional respiratory shot alongside those for COVID-19 and flu. This rollout poses a test for the industry.In a recent House hearing, the pharmacy benefit manager lobby PCMA and drugmaker lobby PhRMA traded blame over problems in the prescription supply chain. They discussed the high costs of drugs and the role that PBMs play in driving up prices. This ongoing debate highlights the challenges within the industry.Moving on, Alvotech has received a new FDA review for its biosimilar of Humira. The regulator had previously rejected Alvotech's copycat drug due to manufacturing issues with a plant in Europe. This new review brings hope for Alvotech's biosimilar.Novartis has canceled its partnership with Beigene as its cancer drug gains EU approval. This decision leaves Novartis without a PD-1 inhibitor, marking a significant development for the company.Orchard is nearing an FDA decision on its rare disease gene therapy, Libmeldy. Three years after gaining European approval, Libmeldy is now under review in the US. This therapy has the potential to make a difference in the lives of patients.Shifting gears, an FDA panel has backed Alnylam's drug Onpattro for cardiomyopathy of ATTR amyloidosis, despite doubts over its benefit. This endorsement provides support for this drug's use in treating this condition.We also have various resources for further reading and upcoming events available. Check out Biopharma Dive and its publications for more information.In another news story, Roche's Genentech has partnered with PeptiDream to develop targeted radioisotopes for certain cancers. This collaboration expands their efforts in radiopharmaceuticals and shows promise for future treatments.Taysha has made the decision to drop its lead gene therapy, TSHA-120, following feedback from the FDA. The agency proposed additional studies that Taysha determined would be too challenging to pursue. Additionally, Taysha's partner, Astellas, has declined to pick up an option for the therapy. These developments mark a setback for Taysha.The FDA has also rejected ARS Pharmaceuticals' Neffy as a nasal spray for allergic reactions. Despite receiving backing from the Pulmonary-Allergy Drugs Advisory Committee, this rejection is a setback for ARS. The nasal spray was seen as an alternative to the EpiPen for severe allergic reactions.In other news, Genentech and PeptiDream have signed a potential $1 billion deal for the development of macrocyclic peptide-radioisotope drug conjugates. This partnership has the potential to advance cancer treatments and improve patient outcomes.Recode Therapeutics has raised $260 million in a series B financing round to advance its mRNA therapies. This funding will support further development in this promising field.The clearance of the Amgen-Horizon merger has been seen as a setback to the FTC's antitrust enforcement plans. The consent agreement between Amgen, Horizon Therapeutics, and the FTC could have significant implications for future merger and acquisition challenges.Lastly, Verisim Life has released an ebook on how artificial intelligence can transform R&D with early-stage translational insights in model-informed drug development. This resource provides valuable information on the potential of AI in drug development.That's all for today's episode. Thank you for tuning in to Pharma and Biotech Daily. Stay informed and stay ahead in the industry.
In this vital health podcast, we're speaking with Amy M. Miller, the recently appointed President of the PhRMA Foundation. Amy has held nonprofit leadership roles for nearly 20 years in DC, including President and CEO of the Society for Women's Health Research and Executive Vice President of the Personalized Medicine Coalition. The PhRMA Foundation catalyzes the careers of promising researchers through competitive peer-reviewed grants and fellowships in the drug delivery, drug discovery, translational medicine, health outcomes research, and value assessment fields. Since its founding in 1965, the Foundation has awarded over $110 million to over 2,700 researchers from diverse backgrounds at more than 300 institutions.See omnystudio.com/listener for privacy information.
Florida Gov and GOP 2024 also-ran Ron DeSantis looks to lead in wake of violence and major hurricane | Former SC Gov and UN Ambassador under President Trump, Nikki Haley is having a moment, kind of | President Biden names first 10 drugs subject to negotations with Medicare | 60th anniversary of the March on WashingtonSong playsIntro by hostWelcome to Heartland Pod Wednesday!Support this show and all the work in the Heartland POD universe by going to heartlandpod.com and clicking the link for Patreon, or go to Patreon.com/HeartlandPod to sign up. Membership starts at $1/month, with even more extra shows and special access at the higher levels. No matter the level you choose, your membership helps us create these independent shows as we work together to change the conversation.Alright! Let's get into it: Hurricane in Florida / Shooting in FloridaPOLITICO: DeSantis knows how to handle a hurricane. The racist shooting poses a bigger dilemma.A racially-motivated Jacksonville tragedy, couple with a looming storm, pose big tests for the governor.Florida Gov. Ron DeSantis, center and his wife Casey, right, bow their heads during a prayer.Florida Gov. Ron DeSantis (center) and his wife Casey bow their heads during a prayer at a vigil for the victims of Saturday's mass shooting on Sunday, Aug. 27, 2023, in Jacksonville. | John Raoux/AP PhotoBy KIMBERLY LEONARD08/28/2023 04:14 PM EDTUpdated: 08/28/2023 05:12 PM EDTMIAMI — Florida Gov. Ron DeSantis' handling of back-to-back crises — a racist mass shooting and a potentially catastrophic hurricane — could help burnish his image as a can-do, effective governor or further damage his standing with Black Americans who have grown livid over his policies.Already, DeSantis' attempts to show leadership in the immediate aftermath of the Saturday shooting were poorly received by some Black lawmakers, Democrats and residents in Florida. In the hours after a 21-year-old white man killed three Black Floridians near a historically Black college in Jacksonville, several state Democrats blamed DeSantis, who is running for president, for creating an environment, through policies such as loosening gun laws and ending diversity programs, that helped hate fester.DeSantis has condemned the shooting and said “targeting people due to their race has no place in this state of Florida.” But attending a Sunday night vigil in Jacksonville, he was jeered and booed by people who had come out to remember the victims. At one point, a Jacksonville Democratic councilmember stepped in to calm the crowd, urging people to “put parties aside.” Later during the event, a pastor took issue with DeSantis describing the gunman as a “scumbag,” and said he should have used the word “racist” instead.The vigil stood in contrast to press conferences in Tallahassee on Sunday and Monday, when DeSantis appeared visibly tired but spoke authoritatively about preparations overseeing Tropical Storm Idalia, which is forecast to become a major hurricane. He canceled campaign appearances and fundraisers, and told Floridians Sunday they could “rest assured” because “I am here” and would “get the job done.”DeSantis says politics won't interfere with storm response“He needs to be in Florida for as long as it takes,” said Adam Hollingsworth, the former chief of staff to Sen. Rick Scott (R-Fla.), who served as governor before DeSantis. “His presidential ambitions could be a distraction, but first Gov. DeSantis has to dance with the one who brought him. Right now, that's the people of Florida.”Though the shooting and looming storm are taking DeSantis away from campaigning for president following a high-profile debate, they'll also allow voters and donors to see the governor at work leading the hurricane response, letting the public assess how he balances multiple priorities, displays empathy and projects leadership in moments of tragedy. At the same time, the shooting has shined a spotlight on DeSantis' record and vulnerabilities on race, one of the areas for which he has faced the most criticism and controversy as governor.In times of tragedy, opponents are “looking for a misstep,” acknowledged Craig Fugate, who led Florida's emergency division under Gov. Jeb Bush and oversaw FEMA during the Obama administration.“They're looking for something to go wrong — particularly for the opponents; they're looking for something to capitalize on,” Fugate said.DeSantis began his Monday morning hurricane preparedness press conference by first addressing the mass shooting. He pledged $1 million in security funding to Edward Waters University, a historically Black university that the gunman is believed to have initially targeted, as well as $100,000 toward a charity for the families of the victims. He also deployed state law enforcement officials to evaluate the campus' security and make additional recommendations, pledging to continue to assist in the “days and weeks ahead.”But many Democrats in the state panned his response. They pointed to laws he enacted in Florida to carve up representation in a Black-majority district that eventually led a Black Democratic congressman, Rep. Al Lawson, to lose his seat. They also pointed to his policies, approved by the GOP-led Legislature, banning what he calls “critical race theory” in schools, as well as his defense of a public school curriculum on Black history that required middle-school teachers to instruct that enslaved people “developed skills which, in some instances, could be applied for their personal benefit.”Florida Minority House Leader Fentrice Driskell, a Black Democrat of Tampa, said it was “absolutely” the right decision for DeSantis to attend the vigil but added that she didn't want to give him a pass.“The reality is, a number of wrongheaded decisions about the state of Florida, and who we are as a people, I think contributed to this charged political climate that resulted in the violence that we saw,” Driskell said in an interview.The accused gunman, identified as Ryan Palmeter, had a racist manifesto and drew swastikas on his weapons. He also had a history of mental illness, having been involuntarily institutionalized for emergency mental health services as a teenager, police said.During DeSantis' vigil remarks Sunday, Democratic state Rep. Angela Nixon, who represents the district where the shooting took place, could be seen glaring at the governor in videos and photos widely shared on social media.“We feel the same,” the NAACP wrote on X, the social media platform formerly known as Twitter.AXIOS: Biden set to name first 10 drugs subject to Medicare negotiations.The blood-thinners Eliquis and Xarelto are among the 10 prescription medicines the Biden administration will seek lower Medicare prices for as part of a new program allowing the government to negotiate drug prices for America's seniors.Why it matters: The administration's landmark announcement Tuesday detailed the first-ever set of drugs subject to Medicare price negotiations, a longtime Democratic priority included in last year's Inflation Reduction Act over drug companies' fervent objections.Other drugs up for negotiation include:Jardiance, a diabetes drug.Januvia, also for diabetes.Farxiga, another diabetes drug.Entresto, for heart failure.Enbrel, for arthritis and psoriasis.Imbruvica, a blood cancer drug.Stelara, used on psoriasis, Crohn's disease and other illnesses.Fiasp, also used for diabetes.Of note: Insulin is already subject to a $35 monthly co-pay cap for Medicare prescription drug plan enrollees under a different provision of the IRA.State of play: The drugs' manufacturers will have just over a month to decide whether to participate in negotiations — which the industry is battling in court — or sit out the process, at the risk of significant financial penalty.Drugmakers who refuse to negotiate with Medicare face an excise tax of up to 95% of their U.S. sales, or they can withdraw their drugs from Medicare and Medicaid coverage, shutting them out of huge markets.What they're saying: "The cancer moonshot will not succeed if this administration continues to dismantle the innovation rocket we need to get there," Stephen Ubl, CEO of industry trade group PhRMA, said in a statement following the release of the list.Zoom out: The medicines up for negotiation were chosen from a list of the 50 products with the highest spending in Medicare's prescription drug program, Part D.The selected drugs accounted for 20% of Part D prescription costs between June 1, 2022 and May 31, 2023, according to the Health and Human Services Department.Some of the highest-cost Medicare drugs were not eligible for this round of negotiations, either because they still have market exclusivity, they're the only option for a rare disease or another factor.The prices won't take effect before the 2024 elections, but Democrats are expected to tout the negotiations, along with other drug cost reforms in the IRA, as part of their campaign messaging.What's next: The Centers for Medicare and Medicaid Services will submit price offers to the drug companies by Feb. 1, with negotiations continuing until next August.CMS will publish the drugs' final maximum fair prices by Sept. 1, 2024, and prices will go into effect in 2026.What we're watching: Ongoing legal challenges could draw out or halt the negotiation process.Drugmakers and allied groups have already filed eight lawsuits against the Medicare drug negotiation process, and more lawsuits could follow Tuesday's announcement.President Biden and his health officials committed this morning to fighting industry lawsuits."Let me be clear: I am not backing down. There is no reason why Americans should be forced to pay more than any developed nation for life-saving prescriptions just to pad Big Pharma's pockets," Biden said in a statement.Nikki HaleyDAILY BEAST: Is it time for Republicans to take Nikki Haley seriously?According to a new Emerson College Polling survey, “Haley saw the largest increase in support among Republican candidates, jumping 5 points from 2 percent to 7 percent” following last week's debate.“Nikki Haley's support increased from about 2 percent to 9 percent among voters over 50 [years of age],” said Spencer Kimball, executive director of Emerson College Polling, “while Trump's support dropped within this age group from about 56 percent to 49 percent after the debate.”Republican Debaters Agreed on One Thing: They Hate Vivek RamaswamyThis jump is modest, inasmuch as it still leaves Haley in the single digits. But it's also no outlier. According to a poll conducted by The Washington Post, FiveThirtyEight, and Ipsos released last Thursday, voters were persuaded to at least give her a second look. “Pre-debate, 29 percent of GOP primary voters who watched the debate said they were considering voting for her,” according to the survey, “and that increased to 46 percent after the debate.”So how did she do it? Haley caught our attention by being first to hit Trump (from the right), when she criticized him for “adding eight trillion to our debt.” This surprised everyone, demonstrated courage, and put to rest the notion that she is merely running to be Trump's vice president.Haley also staked out a strong position on abortion. While stressing her pro-life beliefs, she made the pragmatic case that a federal abortion ban would require 60 votes. Instead, Haley urged Republicans to focus on consensus issues, like banning late-term abortions, making sure contraception is widely available, and supporting adoption as an alternative.Trump's former veep, Mike Pence, who supports a 15-week federal ban on abortion, took umbrage with this. “Nikki, you're my friend, but consensus is the opposite of leadership,” Pence scolded. (As the Never Trump conservative writer Jonah Goldberg has pointed out on his podcast, building consensus is often a key attribute of leadership.)The Republican Debate Was a Futile Pudding Wrestling MatchThis exchange, like others during that same debate, made it clear that in a general election Nikki Haley would likely be Joe Biden's most challenging opponent.Having served as governor of South Carolina and ambassador to the United Nations, she has the experience needed for the office. She also has sharp elbows. (“You have no foreign policy experience and it shows,” she told Vivek Ramaswamy.)At 51, Haley would present a stark contrast in terms of generational change, assuming that Joe Biden was still the Democratic nominee. And (unlike others) she is not staking out an abortion position that might render her effectively unelectable, should she become the Republican nominee.Haley (who frequently cites Margaret Thatcher's line, “If you want something said, ask a man. If you want something done, ask a woman”) was the only woman on that stage. Her identity, temperament, and policy positions could help chip away at the gender gap that has only grown in recent years.The obvious caveat here is that all of these things would make Haley a great candidate to beat Joe Biden if she somehow wins the Republican nomination. But that's an awfully big “if.”Kareem Abdul-Jabbar: GOP Debate Showed How Not to Pick a PresidentHaley's answer to this is to make the electability argument: “We have to face the fact that Trump is the most disliked politician in America,” she—and she, alone—averred during last week's debate.But will that dog hunt?Right now, the electability argument isn't persuading Republicans to jump off the Trump bandwagon, even though that argument is likely the only one that could ever work. At some point (perhaps after Donald Trump goes on trial and it's too late), Republicans might be convinced that, as entertaining as Trump is, he simply can't win.Based on all of this, you might expect me to suggest that it's time to clear the field—to rally every freedom conservative, Reagan Republican, and Never Trump conservative to coalesce around Haley as the GOP's last, best hope.Some of my colleagues are already there. The New York Times columnist David Brooks, for example, declared last week that “Wednesday's debate persuaded me that the best Trump alternative is not [Tim] Scott, it's Nikki Haley.”But here's my problem. Haley has been all over the map for years now. One day she's courageous and impressive, and the next day she's a pathetic Trump toady.Haley is a political chameleon, which makes me reluctant to ever trust her again.Trump and Ramaswamy Show Us How the Worst Get to the TopOn the other hand, anyone looking for purity (as it pertains to Trump) can also dismiss Pence and Chris Christie—both of whom supported Trump until Jan. 6—and a vast swath of today's leading Never Trumpers. As the Good Book says, “Who then can be saved?”Nikki Haley's got a long way to go before she clears the not-Trump lane of candidates, much less taking on the final boss himself. And though nothing has yet made a dent in Trump's domination of the GOP voter base, he's never run as a candidate on trial before. But the whole 91-felony indictment thing might just do the trick.If Haley can prove herself by stringing together two or three of these kinds of courageous performances—in which she not only characterizes Trump as the guy who already lost to Biden, but also that she's as real a conservative as any of the other contenders—there is a path to success.It's hardly guaranteed, and as I've noted, courage comes and goes with Haley. But in the “Matt Lewis primary,” you can count me among the 46 percent who are now considering voting for her.Read more at The Daily Beast.SEMAFOR: Nikki Haley's abortion message could catch on in the GOPMorgan Chalfant and Kadia GobaRepublicans worried about Democrats leveraging abortion (again) to make gains in 2024 want GOP candidates to take a page out of Nikki Haley's debate prep playbook.Haley dismissed the idea that a 15-week national abortion ban could pass through Congress. Instead, she argued the focus should be on finding “consensus” around banning “late-term abortions,” sustaining access to contraception, allowing doctors who don't support abortion refuse to perform them, and preventing women who get abortions from being penalized.Defeated Michigan gubernatorial candidate Tudor Dixon bluntly said on Fox News that Republicans would lose the messaging war in 2024 unless they followed Haley's “perfect response” in the debate.“No one really understood how important abortion would be in 2022 because no one had run in a post-Roe world, so we suddenly got attacked, viciously attacked, by the Democrats, and it is a winning message for them,” she said. Gov. Gretchen Whitmer highlighted Dixon's opposition to rape exceptions in abortion bans in their contest, which took place alongide a ballot initiative guaranteeing abortion rights that passed by a wide margin.“The only candidate on the stage that talked about how we should protect women and not demonize them was Nikki Haley,” Rep. Nancy Mace, R-S.C. said Sunday on CBS of the first GOP presidential debate. “And that is a message that we have to carry through. We have to be pro-woman and pro-life. You cannot go after women and attack them because they make a choice that you don't like or don't agree with.”And Rep. George Santos, R-N.Y., who represents a district President Biden won in 2020, told Semafor at a watch party last week: “She had probably the best-packaged message on abortion that I've heard, I want to say, in my entire adult life.”Haley might have won herself some fans, but her position wasn't a favorite within the anti-abortion movement, which has rallied around a 15-week federal ban as a minimum ask for candidates.
Florida Gov and GOP 2024 also-ran Ron DeSantis looks to lead in wake of violence and major hurricane | Former SC Gov and UN Ambassador under President Trump, Nikki Haley is having a moment, kind of | President Biden names first 10 drugs subject to negotations with Medicare | 60th anniversary of the March on WashingtonSong playsIntro by hostWelcome to Heartland Pod Wednesday!Support this show and all the work in the Heartland POD universe by going to heartlandpod.com and clicking the link for Patreon, or go to Patreon.com/HeartlandPod to sign up. Membership starts at $1/month, with even more extra shows and special access at the higher levels. No matter the level you choose, your membership helps us create these independent shows as we work together to change the conversation.Alright! Let's get into it: Hurricane in Florida / Shooting in FloridaPOLITICO: DeSantis knows how to handle a hurricane. The racist shooting poses a bigger dilemma.A racially-motivated Jacksonville tragedy, couple with a looming storm, pose big tests for the governor.Florida Gov. Ron DeSantis, center and his wife Casey, right, bow their heads during a prayer.Florida Gov. Ron DeSantis (center) and his wife Casey bow their heads during a prayer at a vigil for the victims of Saturday's mass shooting on Sunday, Aug. 27, 2023, in Jacksonville. | John Raoux/AP PhotoBy KIMBERLY LEONARD08/28/2023 04:14 PM EDTUpdated: 08/28/2023 05:12 PM EDTMIAMI — Florida Gov. Ron DeSantis' handling of back-to-back crises — a racist mass shooting and a potentially catastrophic hurricane — could help burnish his image as a can-do, effective governor or further damage his standing with Black Americans who have grown livid over his policies.Already, DeSantis' attempts to show leadership in the immediate aftermath of the Saturday shooting were poorly received by some Black lawmakers, Democrats and residents in Florida. In the hours after a 21-year-old white man killed three Black Floridians near a historically Black college in Jacksonville, several state Democrats blamed DeSantis, who is running for president, for creating an environment, through policies such as loosening gun laws and ending diversity programs, that helped hate fester.DeSantis has condemned the shooting and said “targeting people due to their race has no place in this state of Florida.” But attending a Sunday night vigil in Jacksonville, he was jeered and booed by people who had come out to remember the victims. At one point, a Jacksonville Democratic councilmember stepped in to calm the crowd, urging people to “put parties aside.” Later during the event, a pastor took issue with DeSantis describing the gunman as a “scumbag,” and said he should have used the word “racist” instead.The vigil stood in contrast to press conferences in Tallahassee on Sunday and Monday, when DeSantis appeared visibly tired but spoke authoritatively about preparations overseeing Tropical Storm Idalia, which is forecast to become a major hurricane. He canceled campaign appearances and fundraisers, and told Floridians Sunday they could “rest assured” because “I am here” and would “get the job done.”DeSantis says politics won't interfere with storm response“He needs to be in Florida for as long as it takes,” said Adam Hollingsworth, the former chief of staff to Sen. Rick Scott (R-Fla.), who served as governor before DeSantis. “His presidential ambitions could be a distraction, but first Gov. DeSantis has to dance with the one who brought him. Right now, that's the people of Florida.”Though the shooting and looming storm are taking DeSantis away from campaigning for president following a high-profile debate, they'll also allow voters and donors to see the governor at work leading the hurricane response, letting the public assess how he balances multiple priorities, displays empathy and projects leadership in moments of tragedy. At the same time, the shooting has shined a spotlight on DeSantis' record and vulnerabilities on race, one of the areas for which he has faced the most criticism and controversy as governor.In times of tragedy, opponents are “looking for a misstep,” acknowledged Craig Fugate, who led Florida's emergency division under Gov. Jeb Bush and oversaw FEMA during the Obama administration.“They're looking for something to go wrong — particularly for the opponents; they're looking for something to capitalize on,” Fugate said.DeSantis began his Monday morning hurricane preparedness press conference by first addressing the mass shooting. He pledged $1 million in security funding to Edward Waters University, a historically Black university that the gunman is believed to have initially targeted, as well as $100,000 toward a charity for the families of the victims. He also deployed state law enforcement officials to evaluate the campus' security and make additional recommendations, pledging to continue to assist in the “days and weeks ahead.”But many Democrats in the state panned his response. They pointed to laws he enacted in Florida to carve up representation in a Black-majority district that eventually led a Black Democratic congressman, Rep. Al Lawson, to lose his seat. They also pointed to his policies, approved by the GOP-led Legislature, banning what he calls “critical race theory” in schools, as well as his defense of a public school curriculum on Black history that required middle-school teachers to instruct that enslaved people “developed skills which, in some instances, could be applied for their personal benefit.”Florida Minority House Leader Fentrice Driskell, a Black Democrat of Tampa, said it was “absolutely” the right decision for DeSantis to attend the vigil but added that she didn't want to give him a pass.“The reality is, a number of wrongheaded decisions about the state of Florida, and who we are as a people, I think contributed to this charged political climate that resulted in the violence that we saw,” Driskell said in an interview.The accused gunman, identified as Ryan Palmeter, had a racist manifesto and drew swastikas on his weapons. He also had a history of mental illness, having been involuntarily institutionalized for emergency mental health services as a teenager, police said.During DeSantis' vigil remarks Sunday, Democratic state Rep. Angela Nixon, who represents the district where the shooting took place, could be seen glaring at the governor in videos and photos widely shared on social media.“We feel the same,” the NAACP wrote on X, the social media platform formerly known as Twitter.AXIOS: Biden set to name first 10 drugs subject to Medicare negotiations.The blood-thinners Eliquis and Xarelto are among the 10 prescription medicines the Biden administration will seek lower Medicare prices for as part of a new program allowing the government to negotiate drug prices for America's seniors.Why it matters: The administration's landmark announcement Tuesday detailed the first-ever set of drugs subject to Medicare price negotiations, a longtime Democratic priority included in last year's Inflation Reduction Act over drug companies' fervent objections.Other drugs up for negotiation include:Jardiance, a diabetes drug.Januvia, also for diabetes.Farxiga, another diabetes drug.Entresto, for heart failure.Enbrel, for arthritis and psoriasis.Imbruvica, a blood cancer drug.Stelara, used on psoriasis, Crohn's disease and other illnesses.Fiasp, also used for diabetes.Of note: Insulin is already subject to a $35 monthly co-pay cap for Medicare prescription drug plan enrollees under a different provision of the IRA.State of play: The drugs' manufacturers will have just over a month to decide whether to participate in negotiations — which the industry is battling in court — or sit out the process, at the risk of significant financial penalty.Drugmakers who refuse to negotiate with Medicare face an excise tax of up to 95% of their U.S. sales, or they can withdraw their drugs from Medicare and Medicaid coverage, shutting them out of huge markets.What they're saying: "The cancer moonshot will not succeed if this administration continues to dismantle the innovation rocket we need to get there," Stephen Ubl, CEO of industry trade group PhRMA, said in a statement following the release of the list.Zoom out: The medicines up for negotiation were chosen from a list of the 50 products with the highest spending in Medicare's prescription drug program, Part D.The selected drugs accounted for 20% of Part D prescription costs between June 1, 2022 and May 31, 2023, according to the Health and Human Services Department.Some of the highest-cost Medicare drugs were not eligible for this round of negotiations, either because they still have market exclusivity, they're the only option for a rare disease or another factor.The prices won't take effect before the 2024 elections, but Democrats are expected to tout the negotiations, along with other drug cost reforms in the IRA, as part of their campaign messaging.What's next: The Centers for Medicare and Medicaid Services will submit price offers to the drug companies by Feb. 1, with negotiations continuing until next August.CMS will publish the drugs' final maximum fair prices by Sept. 1, 2024, and prices will go into effect in 2026.What we're watching: Ongoing legal challenges could draw out or halt the negotiation process.Drugmakers and allied groups have already filed eight lawsuits against the Medicare drug negotiation process, and more lawsuits could follow Tuesday's announcement.President Biden and his health officials committed this morning to fighting industry lawsuits."Let me be clear: I am not backing down. There is no reason why Americans should be forced to pay more than any developed nation for life-saving prescriptions just to pad Big Pharma's pockets," Biden said in a statement.Nikki HaleyDAILY BEAST: Is it time for Republicans to take Nikki Haley seriously?According to a new Emerson College Polling survey, “Haley saw the largest increase in support among Republican candidates, jumping 5 points from 2 percent to 7 percent” following last week's debate.“Nikki Haley's support increased from about 2 percent to 9 percent among voters over 50 [years of age],” said Spencer Kimball, executive director of Emerson College Polling, “while Trump's support dropped within this age group from about 56 percent to 49 percent after the debate.”Republican Debaters Agreed on One Thing: They Hate Vivek RamaswamyThis jump is modest, inasmuch as it still leaves Haley in the single digits. But it's also no outlier. According to a poll conducted by The Washington Post, FiveThirtyEight, and Ipsos released last Thursday, voters were persuaded to at least give her a second look. “Pre-debate, 29 percent of GOP primary voters who watched the debate said they were considering voting for her,” according to the survey, “and that increased to 46 percent after the debate.”So how did she do it? Haley caught our attention by being first to hit Trump (from the right), when she criticized him for “adding eight trillion to our debt.” This surprised everyone, demonstrated courage, and put to rest the notion that she is merely running to be Trump's vice president.Haley also staked out a strong position on abortion. While stressing her pro-life beliefs, she made the pragmatic case that a federal abortion ban would require 60 votes. Instead, Haley urged Republicans to focus on consensus issues, like banning late-term abortions, making sure contraception is widely available, and supporting adoption as an alternative.Trump's former veep, Mike Pence, who supports a 15-week federal ban on abortion, took umbrage with this. “Nikki, you're my friend, but consensus is the opposite of leadership,” Pence scolded. (As the Never Trump conservative writer Jonah Goldberg has pointed out on his podcast, building consensus is often a key attribute of leadership.)The Republican Debate Was a Futile Pudding Wrestling MatchThis exchange, like others during that same debate, made it clear that in a general election Nikki Haley would likely be Joe Biden's most challenging opponent.Having served as governor of South Carolina and ambassador to the United Nations, she has the experience needed for the office. She also has sharp elbows. (“You have no foreign policy experience and it shows,” she told Vivek Ramaswamy.)At 51, Haley would present a stark contrast in terms of generational change, assuming that Joe Biden was still the Democratic nominee. And (unlike others) she is not staking out an abortion position that might render her effectively unelectable, should she become the Republican nominee.Haley (who frequently cites Margaret Thatcher's line, “If you want something said, ask a man. If you want something done, ask a woman”) was the only woman on that stage. Her identity, temperament, and policy positions could help chip away at the gender gap that has only grown in recent years.The obvious caveat here is that all of these things would make Haley a great candidate to beat Joe Biden if she somehow wins the Republican nomination. But that's an awfully big “if.”Kareem Abdul-Jabbar: GOP Debate Showed How Not to Pick a PresidentHaley's answer to this is to make the electability argument: “We have to face the fact that Trump is the most disliked politician in America,” she—and she, alone—averred during last week's debate.But will that dog hunt?Right now, the electability argument isn't persuading Republicans to jump off the Trump bandwagon, even though that argument is likely the only one that could ever work. At some point (perhaps after Donald Trump goes on trial and it's too late), Republicans might be convinced that, as entertaining as Trump is, he simply can't win.Based on all of this, you might expect me to suggest that it's time to clear the field—to rally every freedom conservative, Reagan Republican, and Never Trump conservative to coalesce around Haley as the GOP's last, best hope.Some of my colleagues are already there. The New York Times columnist David Brooks, for example, declared last week that “Wednesday's debate persuaded me that the best Trump alternative is not [Tim] Scott, it's Nikki Haley.”But here's my problem. Haley has been all over the map for years now. One day she's courageous and impressive, and the next day she's a pathetic Trump toady.Haley is a political chameleon, which makes me reluctant to ever trust her again.Trump and Ramaswamy Show Us How the Worst Get to the TopOn the other hand, anyone looking for purity (as it pertains to Trump) can also dismiss Pence and Chris Christie—both of whom supported Trump until Jan. 6—and a vast swath of today's leading Never Trumpers. As the Good Book says, “Who then can be saved?”Nikki Haley's got a long way to go before she clears the not-Trump lane of candidates, much less taking on the final boss himself. And though nothing has yet made a dent in Trump's domination of the GOP voter base, he's never run as a candidate on trial before. But the whole 91-felony indictment thing might just do the trick.If Haley can prove herself by stringing together two or three of these kinds of courageous performances—in which she not only characterizes Trump as the guy who already lost to Biden, but also that she's as real a conservative as any of the other contenders—there is a path to success.It's hardly guaranteed, and as I've noted, courage comes and goes with Haley. But in the “Matt Lewis primary,” you can count me among the 46 percent who are now considering voting for her.Read more at The Daily Beast.SEMAFOR: Nikki Haley's abortion message could catch on in the GOPMorgan Chalfant and Kadia GobaRepublicans worried about Democrats leveraging abortion (again) to make gains in 2024 want GOP candidates to take a page out of Nikki Haley's debate prep playbook.Haley dismissed the idea that a 15-week national abortion ban could pass through Congress. Instead, she argued the focus should be on finding “consensus” around banning “late-term abortions,” sustaining access to contraception, allowing doctors who don't support abortion refuse to perform them, and preventing women who get abortions from being penalized.Defeated Michigan gubernatorial candidate Tudor Dixon bluntly said on Fox News that Republicans would lose the messaging war in 2024 unless they followed Haley's “perfect response” in the debate.“No one really understood how important abortion would be in 2022 because no one had run in a post-Roe world, so we suddenly got attacked, viciously attacked, by the Democrats, and it is a winning message for them,” she said. Gov. Gretchen Whitmer highlighted Dixon's opposition to rape exceptions in abortion bans in their contest, which took place alongide a ballot initiative guaranteeing abortion rights that passed by a wide margin.“The only candidate on the stage that talked about how we should protect women and not demonize them was Nikki Haley,” Rep. Nancy Mace, R-S.C. said Sunday on CBS of the first GOP presidential debate. “And that is a message that we have to carry through. We have to be pro-woman and pro-life. You cannot go after women and attack them because they make a choice that you don't like or don't agree with.”And Rep. George Santos, R-N.Y., who represents a district President Biden won in 2020, told Semafor at a watch party last week: “She had probably the best-packaged message on abortion that I've heard, I want to say, in my entire adult life.”Haley might have won herself some fans, but her position wasn't a favorite within the anti-abortion movement, which has rallied around a 15-week federal ban as a minimum ask for candidates.
Listen now (2 mins) | Quick announcement: Drop Your Lawsuits, Drop Your Prices! Hightower is joining Public Citizen Texas, the Texas Organizing Project, Families USA and many more organizations on Wednesday, August 16th at the Federal Courthouse in Austin to demonstrate against Big Pharma’s greed. The Pharmaceutical Research and Manufacturers Association sued to prevent the Inflation Reduction Act from taking effect; many cities around the country are holding a series of actions calling on pharmaceutical corporations, PhRMA, the U.S. Chamber and other chambers of commerce to drop their lawsuits and instead negotiate lower drug prices.
In July, the Centers for Medicare & Medicaid Services made significant headway in its implementation of the drug pricing provisions of the Inflation Reduction Act (IRA). How can stakeholders respond to, implement, and comply with all these new provisions? On this episode, hear from special guest Sylvia Yu, Vice President and Senior Counsel of Federal Programs at PhRMA. Sylvia and Epstein Becker Green attorneys Connie Wilkinson and Alexis Boaz discuss the recent updates on the quickly moving implementation of the drug pricing provisions under the IRA and the industry's response. Visit our site for related resources and email contact information: https://www.ebglaw.com/dhc68. Subscribe for email notifications: https://www.ebglaw.com/subscribe. Visit: http://diagnosinghealthcare.com. This podcast is presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.
Description: Ryan Piansky, a college student and patient advocate living with eosinophilic esophagitis (EoE) and eosinophilic asthma, and Holly Knotowicz, a speech pathologist living with EoE who specializes in feeding therapy and serves on APFED's Health Sciences Advisory Council recorded this episode live at APFED's annual patient education conference in Denver, CO. They shared their experiences with this year's conference, discussed takeaways from the conference presentations, and offered ways to continue the conversation. Recordings of the conference presentations are available to watch on-demand at apfed.org/conference through December 2023. Disclaimer: The information provided in this podcast is designed to support, not replace the relationship that exists between listeners and their healthcare providers. Opinions, information, and recommendations shared in this podcast are not a substitute for medical advice. Decisions related to medical care should be made with your healthcare provider. Opinions and views of guests and co-hosts are their own. Key Takeaways: [:49] Co-host Ryan Piansky welcomes co-host Holly Knotowicz. They recorded this episode at the conclusion of APFED's Annual Patient Education Conference, held June 30 and July 1, 2023 in Denver, CO, in collaboration with Children's Hospital Colorado. [1:39] Also collaborating on this year's conference was the Consortium of Eosinophilic Gastrointestinal Disease Researchers (CEGIR). There were a lot of great sessions at the conference. Holly attended almost all the conference sessions virtually. She felt as engaged as if she were present. She loved the talks on nutrition. [2:48] Holly loved the presentation on EGID diagnostics, both current and what's coming down the pipeline. It had so much helpful information she can share with her patients that don't receive care at a major hospital. [3:14] Ryan talks about an exhibit they couldn't show virtually: a hands on transnasal endoscopy exhibit. People got to play with the controller and practice what it is like for a doctor to do a transnasal endoscopy on a model of the nasal cavity, esophagus, and stomach. Attendees of all ages were invited to try it. [3:38] Ryan found that he wasn't very good at it. It takes practice! He recalls previous podcast episodes where this technology was discussed. [4:04] Holly received lots of text messages about feeding therapy strategies and transnasal endoscopy. She received at least 13 photos from people who tried the transnasal endoscope with their children. She was jealous not to have been at the conference. Families also reached out to Holly about the string test study. [4:58] Jane Robinson, PhD, presented ways patients can cope with and overcome some of the fears surrounding these new diagnostic methods and treatment options. A lot of kids are scared of getting shots to receive biologic treatments. She also met with an on-site teen group. Ryan loved going to APFED conferences as a teen. [5:49] Dan Atkins, MD also did a Q&A session with the teens. Holly missed being there in person to connect with other EoE patients. The teen group at the conferences were helpful when she was growing up. The teen pictures Holly received were a riot. It looked like a good time. [6:31] The main conference sessions were recorded and will be available on demand to view and engage with through the end of the year. [7:11] Oral Immunotherapy (OIT) was a hot topic in the Q&As, including who could qualify for it. Ryan is excited about biologics as an option for the treatment of EoE and eosinophilic diseases. Ryan was glad the CEGIR scholars were able to present virtually at the conference. [8:12] In 2024, APFED will host the EOS Connection conference in the Washington, DC. area. Ryan hopes to see everyone there in person or virtually. [8:29] Throughout the year, APFED also hosts a webinar series. Recordings of past webinars are posted at apfed.org/webinars and shared on social media. They're a great way to stay in touch with APFED and see what research is being done. Recent webinar topics include diagnostic tools and eosinophilic disorders, the microbiome and eosinophilic esophagitis, and creative cooking with eosinophilic disorders. Holly is all about the food! [8:59] Ryan and Holly host this podcast monthly. They interview experts in all different types of eosinophilic diseases from all over the world and individuals who share their experiences with eosinophil-associated diseases. [9:34] The last podcast episode that was released was about proton pump inhibitors (PPIs) and EoE, and was co-hosted by Holly Knotowicz and APFED's Executive Director Mary Jo Strobel. Ryan is excited for the upcoming slate of podcasts including more patient perspectives. [9:59] Please check out apfed.org/conferences to access all the conference sessions on demand, including presentations to help you get caught up on the latest research and wonderful patient perspectives from the conference panels both Friday and Saturday. [10:12] Ryan thanks all of the attendees for joining, especially those who traveled to attend in person. It was wonderful to see so many people back in person. Ryan is thrilled that many were also able to access the conference remotely. You can explore the virtual conference through December 2023 at apfed.org/conference, including a virtual exhibit hall and poster hall. [10:38] Ryan hopes to see you all at the EOS Connection 2024 conference in Washington, DC. Please stay tuned for APFED emails and updates through social media. Please tune in to the podcast and webinars. You are invited to stay connected! [10:53] Holly thanks everyone for tuning in to this episode of Real Talk — Eosinophilic Diseases, and she hopes to see you at APFED's webinars and podcasts! [11:00] Special thanks to our EOS Connection 2023 collaborators and education partners CEGIR, Children's Hospital Colorado, Sanofi, Regeneron, Abbott, AstraZeneca, Ellodi, Reckitt | Mead Johnson Nutrition, Ajinomoto Cambrooke, Bristol Myers Squibb, EnteroTrack, EvoEndo, GSK, Nutricia, Allakos, and PhRMA. [11:34] To learn more about APFED, visit apfed.org and follow APFED on social media. Mentioned in This Episode: American Partnership for Eosinophilic Disorders (APFED) APFED on YouTube, Twitter, Facebook, Pinterest, Instagram Children's Hospital Colorado EOS 2023 Connection Conference CEGIR Real Talk: Eosinophilic Diseases Podcast APFED Videos and Webinars Tweetables: “We're working with Children's Hospital Colorado … and … we have been thrilled to have them collaborating with us [on the conference] this year.” — Ryan Piansky “I feel like I was so connected because I have so many people there in person that were texting me and sending me pictures.” — Holly Knotowicz
On July 6, Medicare expanded coverage for new Alzheimer's Disease treatments under their Coverage with Evidence Development (CED) policy. Here, we will discuss how CMS, is operationalizing its policy through the recently launched Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease CED Study Registry. Opening Speaker Gary A. Puckrein, PhD President and Chief Executive Officer National Minority Quality Forum Dr. Puckrein is the Founder, President and Chief Executive Officer of the National Minority Quality Forum (NMQF) — formerly the National Minority Health Month Foundation—a not-for-profit organization that he founded in 1998. NMQF addresses the critical need for strengthening preventable illness in minority populations through prevention, early detection, and control of disease complications. In April 2001, the National Minority Health Month Foundation launched National Minority Health Month in response to Healthy People 2010, the national health promotion and disease-prevention initiative. NMQF has received support from a wide variety of organizations, including federal agencies, pharmaceutical companies, payers, and trade associations. With support from the U.S. Department of Health and Human Services and the Robert Wood Johnson Foundation, NMQF undertook the Zip Code Analysis Project, developing a comprehensive database that links vital statistics and other elements—including demographic, environmental, claims, prescription, laboratory, hospital, and clinic data—in a centralized data warehouse, organized around zip codes. The Zip Code Analysis Project has enabled NMQF to develop the Health Assessment Tool, which measures and forecasts health status in small geographic areas, evaluates the impact of specific interventions, monitors changes in health outcomes, and undertakes risk assessments (health-care utilization and its financial implications). NMQF uses the Health Assessment Tool to stratify communities by geographic and health-status referents and to provide the health-disparities movement with a common set of indicators to measure and report on progress toward the elimination of disparities in health care and health status. Dr. Puckrein graduated Phi Beta Kappa from Brown University, where he received his master's degree (1974) and doctorate (1978). Between 1974 and 1992, he taught and lectured at Roger Williams College, Brown University, Connecticut College, and Rutgers University, where he was a tenured member of the faculty. Dr. Puckrein has received many awards and honors, including being named a visiting scholar and fellow at the Smithsonian's National Museum of American History and a visiting fellow at Princeton University. Speaker Amanda Bartelme, BS Executive Director, Policy Eisai, Inc. Amanda Bartelme is the Executive Director, Policy at Eisai, Inc. In her role, she serves as Eisai's lead on all engagement with the Centers for Medicare and Medicaid Services, with a particular focus on ensuring Medicare beneficiaries have appropriate access to treatments. She provides internal support on issues related to access, reimbursement, and drug pricing and represents Eisai on key PhRMA and BIO workgroups focused on drug pricing, access and reimbursement. She joined Eisai in May 2022. Prior to joining Eisai, Amanda held policy roles at GSK, supporting access to vaccines, oncology, respiratory, rheumatology, HIV, and Covid treatments; and at Baxalta where she focused on hemophilia, oncology, and plasma-based therapies. Amanda began her career in health policy and reimbursement at Avalere Health, where she spent over a decade working on access for drugs, devices, and services with a special focus on physician administered drugs, diabetes, biosimilar payment policy, and the 340B program, and the evolving drug pricing and payment landscape.
Episode 6: Pharmacy Deserts, Corporate Greed, & a Rob RoyHave you ever wondered why some insurance plans require patients to travel to a pharmacy 20 to 30 minutes away for their prescriptions instead of covering prescriptions at the patient's local nearby pharmacy? Or, why lobbyists publish opinion articles in national news sources claiming that PBMs lower costs and save employers money, yet both prescription costs and premiums seem to be constantly rising?Welcome to this month's cocktail hour. From issues with lobbyists, brokers, & corporate greed; to state & federal politics, PhRMA, & why shopping local includes your neighborhood independent pharmacy - no area of healthcare is safe when it comes to this discussion!Featuring Special Guest John Farina with the AIDS Healthcare FoundationOpening music by JuliusHThis Month's Cocktail Menu:Rob RoyLimoncelloMargarita Hard SeltzerIPAFor cocktail recipes & additional insights, visit our website: TruthRx.org/pbm-on-the-rocks
On this week's episode of Biotech Hangout, hosts Daphne Zohar, Tim Opler, Chris Garabedian, Mike Yee and Bruce Booth discuss the week's industry news including M&A, regulatory, data and more. They highlight the continued M&A streak with Eli Lilly acquiring Dice Therapeutics. They also discuss PhRMA's lawsuit vs. the U.S. government over IRA Medicare Drug Price Negotiations, following similar suits from Merck & Bristol Myers Squibb. They also talk about several Duchenne news items including Santhera licensing its Duchenne drug to Catalyst and Sarepta's DMD therapy approval. Additional industry news covered includes the SEC's case against biotech executives and investors and conflicts of interest with PBMs and FTC's lawsuit against Amgen. The hosts also discuss what happened to big academic tech transfer deals, Leerink is back, Intercept, Alderya and Arcellx regulatory news, plus Uniqure and Roivant data. *This episode aired on June 23, 2023*
In this episode, Mindy, Ryan, and Jen discuss recent newsworthy items, including legal challenges to the Medicare Drug Price Negotiation Program established by the Inflation Reduction Act.Podcast Tags: healthcare, healthcare news, life sciences, health policy, public health, CMS, HHS, Medicare, drug pricesSource Links: Merck sues to block Medicare negotiation of drug prices Bristol Myers follows Merck's lead with its own lawsuit blasting IRA's Medicare negotiations PhRMA joins legal battle over Inflation Reduction Act's 'price-setting' measures Explaining the Prescription Drug Provisions in the Inflation Reduction Act Pfizer, BMS' Eliquis tops list of drugs destined for Medicare price negotiations in 2026: Moody's For additional discussion, please contact us at TrendingHealth.com or share a voicemail at 1-888-VYNAMIC.Mindy McGrath, Healthcare Industry Advisor and Head of Public Health Sector Mindy.McGrath@vynamic.comRyan Hummel, Executive and Head of Provider Sector Ryan.Hummel@vynamic.comJen Burke, Director Jen.Burke@vynamic.com
Too many Americans are struggling to access and afford their healthcare. But, adults largely agree on what policymakers at the state level should be doing to deliver relief to patients at the pharmacy counter. A new nationwide poll on behalf of PhRMA finds that 86 percent agree that lowering out-of-pocket costs should be a top priority. A majority in all 50 states (plus D.C.) support solutions that would help patients pay less for their medicines—and provide better oversight of middlemen. Among the most-popular solutions is ensuring that patients don't pay more for their medicine than insurance companies or their middlemen, such as pharmacy-benefit managers (PBMs): 80 percent of adults agree that lawmakers should require them to pass the rebates and discounts that they receive directly to patients. Other popular solutions include: Ensure that insurers and middlemen are held accountable for their role in creating barriers between patients and the medicines that they need. (83 percent) Require all insurance plans to cover certain medications used to treat chronic conditions from day one of the plan year. (81 percent) Require insurers to count patient assistance—such as cost-sharing assistance—toward the patient's deductibles. (76 percent) Require insurers to cover medicines from day one by offering at least some plan options that exclude medicines from deductibles and only charge set copay amounts. (76 percent) Cap the amount of cost-sharing—such as deductibles and coinsurance—that patients pay out-of-pocket for their medicines. (75 percent) As lawmakers look for ways to address affordability and access to healthcare, many are questioning abuses of the system by PBMs and insurers. Luckily, there are several solutions that state legislators can implement today that would bring real improvements and more accountability. To learn more, visit PhRMA.org/States. This poll was conducted by Morning Consult, on behalf of PhRMA, in late March, among a national sample of 20,017 adults.
340B helps health systems and hospitals stretch their resources and provide more services to patients in need. This makes 340B important to a hospital or health system leadership team's ability to plan how it will deliver care. In this episode, we speak with Matthew Perry, president and CEO of Genesis Healthcare System in Zanesville, Ohio. Matt shares his perspective about 340B and how 340B professionals can best engage with their hospital CEO. Prior to the interview, we share findings from a new 340B Health report about the effects of drug company 340B contract pharmacy restrictions on patient care. Economic ChallengesMany hospital CEOs face economic challenges in their organization. Matt shares the value that 340B leaders provide to help hospitals have the resources they need to meet their patient care mission. How to Engage Hospital CEOs in 340B Operations and Advocacy Matt provides best practices for how 340B professionals can best educate the CEO about 340B to help the CEO strategize how to use 340B savings to grow and sustain services for patients in need. He also discusses why 340B hospital CEOs should become engaged in program advocacy. Connecting 340B Professionals to the C-suite Matt describes how he and his leadership team support 340B program leadership and established an organizational structure for communication with the health system's 340B program leader. He also shares advice for 340B professionals who are interested in a health system C-suite career path. Check out all of our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you would like us to cover in this podcast, email us at podcast@340bhealth.org.Resources 340B Health March 2023 Report on Drug Company 340B Contract Pharmacy Restrictions Joint Statement from National Hospital and Pharmacist Associations on PhRMA-led Proposal to Restrict 340B Eligibility Matt Perry Op-ed about 340B Providing Stability for Hospitals Amid the COVID-19 Pandemic
California pulls its multi-million contract with Walgreens over the company's recent abortion pill decision. Lobbying group PhRMA and community health centers unite in calls for reforms to the 340B program. And, the manufacturer of a treatment to prevent preterm births pulls its drug from the market following scrutiny. That's coming up on today's episode of Gist Healthcare Daily. Hosted on Acast. See acast.com/privacy for more information.
Synopsis: Jack Bailey is the CEO of G1 Therapeutics, a commercial-stage biopharmaceutical company focused on the discovery, development and delivery of next generation therapies that improve the lives of those affected by cancer. Jack worked at Eli Lilly for 19 years followed by GSK for 12 years, and served on the company board at G1 Therapeutics before stepping into the role of CEO. Jack provides his perspective on the state of the industry and how the current macro environment is affecting financing, the supply chain, and attracting and retaining talent. He talks about his team's work at G1, the proactive approach they're taking to combat cancer, and the unique commercial aspect of the company. He also discusses the current legislative and regulatory environment, concerns he has, and opportunities for the future. Biography: As Chief Executive Officer, Jack Bailey leads G1 in its mission to fundamentally change the chemotherapy experience for patients with cancer. Mr. Bailey has over thirty years of commercial pharmaceutical experience and has an in-depth understanding of the healthcare marketplace. He has extensive experience in commercialization, health systems, health policy, and government affairs. Previously, Mr. Bailey led the GlaxoSmithKline pharmaceuticals and vaccines business as President of the U.S., with responsibility for commercialization efforts across the company—oncology, immunology/rare disease, respiratory, and vaccines portfolios. He also was a member of the company's Pharmaceutical Investment Board responsible for the clinical development investments by the company. Earlier in his career, he held various senior commercial leadership positions at Eli Lilly and Company, including Senior Vice President of the Account-Based Markets Division that included both the oncology and cardiovascular portfolios along with the managed markets groups. Mr. Bailey was appointed to the G1 Therapeutics Board of Directors in March 2020 and in September 2020, he was named CEO. He also serves on the board of the UNC Health System, Emergo Therapeutics, a privately-held biotechnology company, and is a past member of the board at Harvard T.H. Chan School of Public Health, the board of directors of PhRMA, the pharmaceutical industry trade association, and the North Carolina Biotechnology Center. He holds an MBA from the University of North Carolina and a B.S. in biology from Hobart College.
Vas Narasimhan, CEO of Novartis and the new chairman of PhRMA, joins us to discuss the industry's struggles in Washington and whether the deflated biotech sector is still overvalued. We also dive into the latest news in the life sciences, including Moderna's promise of no-cost Covid-19 vaccines and biotech entrepreneur Vivek Ramaswamy's potential run for president.
Pink Sheet reporters and editors discuss the impact of PhRMA's new push to limit Medicare price negotiations, Congress' interest in FDA advisory committee reforms, and concerns about the COVID-19 vaccine strain selection process.
The high cost of prescription drugs affects us all. But what's behind them? Is it just pharmaceutical company greed?Welcome to Lean to the Left, the podcast that explores important developments that shape our society and our world. Our guest today is Hank Laskey, PhD, a longtime adviser and consultant in the pharmaceutical industry.Hank brings a ton of knowledge and perspective about this industry and the companies that provide the life-saving drugs so important to us all. We'll tackle some of the factors that affect the prices we all pay for our prescriptions and hear his thoughts about what can, and should, be done about that.Dr. Laskey also will share with us insight that will help those who want to enter that industry, or advance within in it. That's part of the reason why he authored a book called “The Global Pharmaceutical Industry: Economic Structure, Government Regulation, and History.”The book combines the study of business and economics with medicine, science, and technology-all within a regulatory framework-and helps the reader understand the multifaceted global pharmaceutical industry.Dr. Laskey, welcome to the Lean to the Left podcast.Q. One of the major concerns that most of us have today is the high cost of prescription drugs. With insulin, for example, it got to the point where Congress capped the price at $35 per month—but only for Medicare patients. Can you walk us through what's involved here?Q. What did you think of Martin Shkreli, the Turing Pharmaceuticals owner who jacked up the price of insulin to crazy levels and who raised the cost of a decades-old drug used to treat infections in babies and people with AIDS by more than 5,000 percent?Q. Every time we turn on the TV we're bombarded with ads for pharmaceutical products for everything from HIV to cancer to skin rashes. These products are targeted to narrow segments of the population who suffer from these various diseases. Yet, those ads are within programming that is geared to a general audience. Does this make sense?Q. How does the marketing side of the industry interact with the medical side? Are these marketing costs reflected in the ultimate price consumers must pay for these drugs?Q. PhRMA, the lobbying organization representing the industry, has published a piece on the web that claims that “due to negotiations in the market,” prices health plans paid for brand medicines increased by just 1 percent on average in 2021. They blame insurers and other middlemen for forcing many of the sickest patients to pay high out-of-pocket costs. Really? Your comment?Q. Sometimes at the end of a commercial, after all of the possible side effects are revealed, the voice/over will say that “X company may be able to help” with the cost. What are these patient assistance programs offered by biopharmaceutical companies and how do they work?Q. What are the differences between generic drugs and brand medicines? Are the generics just as good and as effective?Q. The industry always claims that the cost for prescription drugs must reflect the high cost of research and development. To many, this seems like a cop-out. Your thoughts?Q. What's your view of federal regulation of the industry? Does there need to be more? In what areas?Q. Let's talk about those individuals who would like a career in this industry. You've worked as a consultant, published research articles, taught courses for several leading industry companies. What's your advice to those who want a career in the pharmaceutical industry or move up within it? Does your book address this?Q. Where can people find your book?Become a supporter of this podcast: https://www.spreaker.com/podcast/the-lean-to-the-left-podcast--4719048/support.
The high cost of prescription drugs affects us all. But what's behind them? Is it just pharmaceutical company greed?Welcome to Lean to the Left, the podcast that explores important developments that shape our society and our world. Our guest today is Hank Laskey, PhD, a longtime adviser and consultant in the pharmaceutical industry.Hank brings a ton of knowledge and perspective about this industry and the companies that provide the life-saving drugs so important to us all. We'll tackle some of the factors that affect the prices we all pay for our prescriptions and hear his thoughts about what can, and should, be done about that.Dr. Laskey also will share with us insight that will help those who want to enter that industry, or advance within in it. That's part of the reason why he authored a book called “The Global Pharmaceutical Industry: Economic Structure, Government Regulation, and History.”The book combines the study of business and economics with medicine, science, and technology-all within a regulatory framework-and helps the reader understand the multifaceted global pharmaceutical industry.Dr. Laskey, welcome to the Lean to the Left podcast.Q. One of the major concerns that most of us have today is the high cost of prescription drugs. With insulin, for example, it got to the point where Congress capped the price at $35 per month—but only for Medicare patients. Can you walk us through what's involved here?Q. What did you think of Martin Shkreli, the Turing Pharmaceuticals owner who jacked up the price of insulin to crazy levels and who raised the cost of a decades-old drug used to treat infections in babies and people with AIDS by more than 5,000 percent?Q. Every time we turn on the TV we're bombarded with ads for pharmaceutical products for everything from HIV to cancer to skin rashes. These products are targeted to narrow segments of the population who suffer from these various diseases. Yet, those ads are within programming that is geared to a general audience. Does this make sense?Q. How does the marketing side of the industry interact with the medical side? Are these marketing costs reflected in the ultimate price consumers must pay for these drugs?Q. PhRMA, the lobbying organization representing the industry, has published a piece on the web that claims that “due to negotiations in the market,” prices health plans paid for brand medicines increased by just 1 percent on average in 2021. They blame insurers and other middlemen for forcing many of the sickest patients to pay high out-of-pocket costs. Really? Your comment?Q. Sometimes at the end of a commercial, after all of the possible side effects are revealed, the voice/over will say that “X company may be able to help” with the cost. What are these patient assistance programs offered by biopharmaceutical companies and how do they work?Q. What are the differences between generic drugs and brand medicines? Are the generics just as good and as effective?Q. The industry always claims that the cost for prescription drugs must reflect the high cost of research and development. To many, this seems like a cop-out. Your thoughts?Q. What's your view of federal regulation of the industry? Does there need to be more? In what areas?Q. Let's talk about those individuals who would like a career in this industry. You've worked as a consultant, published research articles, taught courses for several leading industry companies. What's your advice to those who want a career in the pharmaceutical industry or move up within it? Does your book address this?Q. Where can people find your book?This show is part of the Spreaker Prime Network, if you are interested in advertising on this podcast, contact us at https://www.spreaker.com/show/4719048/advertisement
STAT Washington correspondent Rachel Cohrs joins us to explain how PhRMA, the all-powerful lobbying group, lost its edge in a fight over drug-pricing negotiation. Damian gives us the inside scoop on CTAD, the big Alzheimer's disease research conference, where Eisai and Biogen presented groundbreaking data on their treatment called lecanemab. We also discuss the FDA approval of a microbiome drug for the treatment of a bowel disorder and the potential for a big acquisition of Horizon Therapeutics.
Member relations plays a huge role in helping drive member value and engagement. Don't miss this very informative podcast as Tom Morrison and Dave Will discuss the power of member relations in association engagement with Anne Pritchett, Senior VP of Policy and Research with emphasis on Member Relations with PhRMA. Dave, Tom and Anne discuss how PhRMA connects their 33 members to their value proposition and over a hundred workgroups with industry issues and advocacy.
"As a mostly learn-by-doing career, the experience and training of the association CEO is routinely idiosyncratic—moving up through the ranks in associations of varying sizes, types and cultures. And for the mid-career executive, thrust fresh and new into the world of associations at the CEO level, a holistic look at the association CEO position can be even more crucial." [https://www.associationceohandbook.com/] Join KiKi L'Italien as she interviews the author of The Association CEO Handbook Paul Belford about the role of the association CEO in today's environment. Outside of his client work in executive search, Paul is the author of Planning Your Career in Association Management, published in 2002 by the American Society of Association Executives, and has spoken about career-development at ASAE meetings and those of its Allied Societies. He has also served on the CEO Advisory Council of the Greater Washington Society of Association Executives, as well as on three of their compensation survey councils. He also authored The Association CEO Handbook, the second edition of which was released in 2019. Much of the content and direction of the second edition was sourced from 10 sessions of the Association CEO Masters Seminar launched in 2016 and for which he serves as Director. Prior to his career in executive search, Paul spent 11 years with PhRMA, a major Washington, D.C-based trade association, where he was responsible for international issues management. He has also worked for the U.S. government, including six years as an International Economist in the Office of the Assistant Secretary for International Affairs at the Treasury Department. An Accounting graduate of Boston College, Paul has an M.A. in Economics from Fordham University.
“What does the patient need to know? What are their knowledge gaps? What are they most in need of? Once you determine the areas you need to pinpoint, branded or nonbranded, then there's resources out there for you to use,” Chelsea Backler, MSN, APRN, AGCNS-BC, AOCNS®, VA-BC, oncology clinical specialist at ONS, told Stephanie Jardine, BSN, RN, oncology clinical specialist at ONS. Backler explained the differences between branded and nonbranded patient education resources, ways for oncology nurses to identify credible resources, and ONS's Seal of Approval Program for branded and nonbranded resources. You can earn free NCPD contact hours by completing the evaluation linked below. Music Credit: "Fireflies and Stardust" by Kevin MacLeod Licensed under Creative Commons by Attribution 3.0 Earn 0.5 contact hours of nursing continuing professional development (NCPD) by listening to the full recording and completing an evaluation at myoutcomes.ons.org by July 15, 2024. The planners and faculty for this episode have no relevant financial relationships with ineligible companies to disclose. ONS is accredited as a provider of NCPD by the American Nurses Credentialing Center's Commission on Accreditation. Episode Notes Check out these resources from today's episode: Complete this evaluation for free NCPD. ONS Seal of Approval Library Oncology Nursing Podcast Episode 43: Sharing Patient, Provider, and Caregiver Resources Episode 87: What Are the Biggest Barriers to Patient Education? Episode 179: Learn How to Educate Patients During Immunotherapy Episode 183: How Oncology Nurses Find and Use Credible Patient Education Resources Clinical Journal of Oncology Nursing article: Patient and Healthcare Provider Education Tip Sheets Oncology Nursing Forum article: The Internet as a Source of Health Information: Experiences of Cancer Survivors and Caregivers With Healthcare Providers Pharmaceutical Research and Manufacturers of America (PhRMA) codes and guidelines PhRMA's Principles on Responsible Sharing of Truthful and Non-Misleading Information To discuss the information in this episode with other oncology nurses, visit the ONS Communities. To provide feedback or otherwise reach ONS about the podcast, email pubONSVoice@ons.org.
The Friday Five for May 27, 2022: CMS Updates Medicare.gov Ruling on Medicaid Rebate Accumulator Rule HHS Announces State Grants for Opioid Response Social Security Administration Funding AHIP 2023 Certification Dates Register for your FREE RitterIM.com account Mentioned in this episode: AHIP Medicare + Fraud, Waste, and Abuse Training Biden Administration Announces $1.5 Billion Funding Opportunity for State Opioid Response Grant Program CMS Unveils More User-Friendly Medicare Website Federal district court strikes down CMS Medicaid rebate "accumulator" rule Instagram announces visual refresh with brighter icon, new typography, no iPad app Instagram's brand refresh brings new typeface and “new energy” Instagram's Brand Refresh Interactive Instagram created custom fonts called ‘Instagram Sans,' and some of them are truly wild Instagram rolls out a new typeface, slightly tweaked logo and more in ‘visual refresh' Judge strikes down CMS' Medicaid copay rule, handing PhRMA major win Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements Official Medicare.gov Website People aren't loving Instagram's bright new app icon Social Security Official Asks House for More Customer Service Funding State Opioid Response Grants More episodes you'll like: May 20, 2022 | The Friday Five Start Selling 5-Star Medicare Advantage Plans All Year The Ideal Client for Medicare Supplement Plans Articles to Share with Your Clients: Are Medicare Part B Giveback Plans Worth It? Is It Better to Work Out Harder or Longer? Tips for Traveling with Your Pet Ritter Insurance Marketing eBooks & Guides: Agent Survival Kits: Beginners or Experts A Quick Guide to Cross-Selling Ancillary Insurance with Medicare Products Developing an Agency – Your Guide to Getting Started The Definitive Guide to Getting Leads and Prospecting for Medicare Sales The latest from Ritter's Blog: Ritter & ReminderMedia Partnership Offers Agents New Marketing Solutions The State of the ACA Market in 2022 Updates to the 2023 AHIP Certification You Should Know Connect on social: Facebook LinkedIn Twitter YouTube Instagram TikTok Sarah's LinkedIn Sarah's Instagram Subscribe & Follow: Apple Podcasts Google Podcasts Overcast Podbean Spotify Stitcher
In this episode of AHLA's monthly series on fraud and abuse issues, Matthew Wetzel, Partner, Goodwin Procter, speaks with Julie Wagner, Head of Global Ethics, Compliance & Enforcement Legal Policy, PhRMA, and Martina Rozumberkova, Principal, Control Risks, about changes made to the PhRMA (Pharmaceutical Research and Manufacturers of America) Code related to speaker programs, partly in response to 2020 guidance from HHS' Office of Inspector General. They discuss PhRMA's process for making the changes, what compliance officers need to know about the changes, and PhRMA's role in the debate about the provision of meals. From AHLA's Fraud and Abuse Practice Group. Sponsored by BRG.
Nancy Di Dia, Executive Director, Chief Diversity & Inclusion Officer & Head, US DICE at Boehringer Ingelheim USA discusses her 15 years as a D&I officer, her personal history, and how she nurtured the development of the D&I programs at a pharmaceutical industry giant. She shares her learnings on how to build sustainable change over time. Nancy Di Dia is Executive Director, Chief Diversity & Inclusion Officer & Head, US DICE at Boehringer Ingelheim USA. She brings more than 25 years of change and social experience in overall management, leadership and cultural change in the corporate world. Her experience has spanned financial services and healthcare. At Boehringer Ingelheim Nancy has responsibility for leading a culture of diversity, inclusion, engagement and belonging within BI's Animal Health, Biopharma and Human Pharma business units. In addition, Nancy is an (ICF) International credentialed and certified PCC Executive Coach with a focus on finding impactful ways to engage the brain in sustainable insights and change. She is an active member of the task force for Talent Innovation- a think tank and research group of leading global companies that leverages talent across the divides of gender, generation, geography and culture. Nancy is also on the board of the International Multicultural Institute (IMCI) a non-profit that offers service, knowledge and skills for individual and institutional change through inclusion. She was recently appointed to the Governor's council on Girls and Women in STEAM for the state of Connecticut and continues to act on the PhRMA chief diversity officer council to improve diversity in clinical studies. Nancy is fluent in Italian, an avid exerciser, rower and enjoys gardening, cooking and seeking out fine wines from around the world. #Diversity #Inclusion #SustainableChange
Frankly Speaking About Cancer with the Cancer Support Community
This episode of our special series Spotlight on Coronavirus takes a close look at the vaccines that will help combat the COVID-19 pandemic- how they work, the approval process with the FDA, and importantly, what it all means for cancer patients and their caregivers. Our guests are: Dr. Kathleen Dooling, a Chief Medical Officer for the Centers for Disease Control and Prevention (CDC); Dr. Elizabeth Robilotti, the Associate Medical Epidemiologist at Memorial Hospital for Cancer and Allied Diseases and an Attending Physician with the Infectious Disease Service at Memorial Sloan Kettering Cancer Center; and Dr. Michael Ybarra, a board-certified emergency physician and vice president of medical affairs and strategic alliances at PhRMA.
Conor is a seasoned public affairs and communications strategist adept at packaging complex issues for policy makers, the public and media. He uses his deep mix of public sector and communications experience across our government affairs accounts, real estate and health care clients, and in our issues management and crisis practice as well. He is also a talented writer, adept at penning thought leadership and public policy pieces for the C-Suite and elected officials. Before coming to Solomon McCown&, Conor served in a senior role at Liberty Square Group, working with clients to raise their profiles and achieve their public policy goals. Some of his clients included PhRMA, Horizons for Homeless Children, Morgan Stanley Wealth Management, MassMutual, and the Provider’s Council. He also served as director of communications for the campaigns of Congressman Stephen F. Lynch, Middlesex District Attorney Marian Ryan and Quincy Mayor Thomas Koch. Earlier in his career, Conor was director of communications for the Greater Boston Chamber of Commerce. He got his start at the State House, working for State Representative Thomas P. Kennedy. Conor graduated from The George Washington University and earned a Master of Science in Public Affairs from the McCormack School of Policy Studies at the University of Massachusetts Boston. He serves on the board of the Good Samaritan Medical Center and the Old Colony YMCA.
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