Drug Fix: How Will US FDA Navigate Midterm Blue Wave’s Aftermath?

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter, Editor-in-Chief Nielsen Hobbs and Prevision Policy Founding Member Mike McCaughan consider the lessons learned from the US Food and Drug Administration’s Commissioner’s National Priority Voucher (CNPV) program as it officially sunsets (1:13) and its legacy (16:31). They also discuss FDA commissioner nominee Heidi Overton’s prospects for gaining support from the Senate Health, Education, Labor and Pensions Committee with a vote upcoming (19:25). More On These Topics From The Pink Sheet US FDA Winds Down Commissioner’s National Priority Voucher Pilot, Will Honor Existing Awards: https://insights.citeline.com/pink-sheet/pathways-and-standards/review-pathways/us-fda-winds-down-commissioners-national-priority-voucher-pilot-will-honor-existing-awards-ZZRIVKTLLVDN3OLZWJRSTE34UI/ Senate Committee To Vote On US FDA Commissioner Nominee Before Dem Takeover: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/senate-committee-to-vote-on-us-fda-commissioner-nominee-before-dem-takeover-IBH3IJ6RWRDRJN75J5FFYDKHPQ/

Conventional wisdom says you secure coverage first, then build demand. What if the causality runs the other way? In this special In Vivo podcast episode, senior reporter David Wild talks with Harris Kaplan (managing partner, Litmys), Sal Grouso (senior market access executive), and Roxanne Schwans (founder and CEO, OmniHealth Rx Advisors). Kaplan and Grouso recently published an article in In Vivo titled “Topspin: Why Product Demand Is What Really Matters to PBMs.” The guests argue that a preferred formulary position is rented real estate: it gives a product permission to compete, but it only stays on the shelf if prescription volume justifies it. They explain why a large rebate on a product nobody uses is worth very little, how PBMs think about net cost per member per month (PMPM), and why a product holding under 5% of category share is in a precarious spot. Drawing on real-world cases, including Vyvanse and an oral psoriasis launch, they show how demand and friction (prior authorizations, appeals, patient pull) can change the negotiating dynamic. They also walk through Litmys’s RAMP (Realistic Assessment of Market Potential) model and explain why market access should be at the table as early as Phase II.

In this episode of Strategic Intent, Maria Alfaiate, Executive Vice President for Corporate Portfolio and Product Strategy at Lundbeck, discusses neuroscience's growing resurgence in pharmaceutical investment alongside other challenges faced in central nervous system dealmaking decisions.

When a customer asks a pharmacist what to take, brand awareness only gets a product so far. A recommendation has to be earned, says pharmacist, healthcare lawyer and broadcaster Thorrun Govind. Govind, a former chair of the Royal Pharmaceutical Society’s English Pharmacy Board, joins HBW Insight’s Over the Counter podcast to talk about how manufacturers can win that trust. We discuss how pharmacists choose between products in crowded categories like pain and cough and cold, what useful educational content looks like for teams with little time to read it, and why manufacturers should be advocating for pharmacists rather than just supplying them. We also talk about how misinformation and AI chatbots are changing conversations at the counter, and where regulated AI tools could help.

世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。今回取り上げた記事はこちら Democratic Wins In Congress Will Fuel MFN, FDA Oversight, May Advance Bipartisan Legislation https://insights.citeline.com/pink-sheet/legislation/elections/democratic-wins-in-congress-will-fuel-mfn-fda-oversight-may-advance-bipartisan-legislation-KGXTFNXCYBE3XGLKI6XX47WNHI/ Another Midterm Wave Coming? US FDA Chief Counsel Announces Departure https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/another-midterm-wave-coming-us-fda-chief-counsel-announces-departure-INESSWGPL5A6NE7VGWCD6JQ3AE/ US FDA Acting Chief Of Staff Sees Stable User Fee Path Despite Democrats’ Capitol Hill Takeover https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/us-fda-acting-chief-of-staff-sees-stable-user-fee-path-despite-democrats-capitol-hill-takeover-FOLLZZTLH5CNDK2NEI5V4Z3VKI/

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the potential changes that the midterm election rout by Democrats could create for the US Food and Drug Administration in the short-term as agency officials await confirmation of a new commissioner and a new funding bill (1:02), as well as longer-term when the user fee package (14:12) and other issues like vaccines and drug pricing could emerge (25:36). More On These Topics From The Pink Sheet Democratic Wins In Congress Will Fuel MFN, FDA Oversight, May Advance Bipartisan Legislation: https://insights.citeline.com/pink-sheet/legislation/elections/democratic-wins-in-congress-will-fuel-mfn-fda-oversight-may-advance-bipartisan-legislation-KGXTFNXCYBE3XGLKI6XX47WNHI/ US FDA Acting Chief Of Staff Sees Stable User Fee Path Despite Democrats’ Capitol Hill Takeover: https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/us-fda-acting-chief-of-staff-sees-stable-user-fee-path-despite-democrats-capitol-hill-takeover-FOLLZZTLH5CNDK2NEI5V4Z3VKI/ Another Midterm Wave Coming? US FDA Chief Counsel Announces Departure: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/another-midterm-wave-coming-us-fda-chief-counsel-announces-departure-INESSWGPL5A6NE7VGWCD6JQ3AE/

"The money is back in RNA. In recent weeks, Merck KGaA agreed to pay about $1.1 billion for Silence Therapeutics, Novartis signed a deal worth up to $7.8 billion with Abogen Biosciences, and Roche paid more than $1 billion for an RNAi obesity drug from Rona Therapeutics. Meanwhile, Merck and Moderna’s personalized melanoma vaccine cut the risk of recurrence or death by 42% in a Phase 3 trial. So, is RNA now a durable drug modality, and what still separates today’s headlines from routine medicine?   In this episode of Proof of Concept, In Vivo's David Wild speaks with Dr. John Cooke, cardiologist, founder and president of the Society for RNA Therapeutics, and founding director of the Center for RNA Therapeutics at Houston Methodist. Cooke discusses his team’s first-in-human personalized mRNA vaccine for osteosarcoma relapse, the vision of 'RNA in a box' deployable manufacturing units at hospitals, the misconceptions that still dog RNA therapeutics, and why delivery remains the field’s biggest hurdle. He also compares mRNA, circular RNA, self-amplifying RNA, and RNAi, and looks at in vivo CAR-T and extrahepatic targets."  Proof of Concept is the monthly innovation-focused podcast from the teams at In Vivo, Scrip, and MedTech Insight.

For emerging biotech companies, development success is often measured by clinical milestones, safety, and efficacy. However, demonstrating an asset’s value extends beyond regulatory approval. Understanding patient needs and treatment experiences, as well as evolving stakeholder expectations, early in development plays an important role in shaping a more informed evidence strategy. In this podcast, Ashwin Rai, Director of Data Science and Advanced Analytics, and Gale Harding, Senior Research Leader, from the PPD clinical research business of Thermo Fisher Scientific, discuss how integrating real-world data and patient-centered insights earlier in development can help developers address evidence gaps, inform critical decisions, and build a stronger foundation for demonstrating treatment value. What the Podcast Explores • Why evidence planning should begin early in asset development, rather than closer to commercialization • How real-world data can help identify unmet needs, understand patient journeys, and inform development decisions, and why more data doesn’t necessarily mean better data • The importance of capturing patient experiences and outcomes beyond traditional clinical endpoints • How patient-centered research can help address evidence gaps and strengthen an asset’s value story • Why evidence strategies must evolve alongside changing stakeholder expectations and development priorities

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter, Senior Reporter Maaisha Osman and Editor-in-Chief Nielsen Hobbs consider the impact of the Health and Human Services Department’s temporary order allowing compounding of unapproved peptides on the drug industry (1:58), including whether stakeholder could use the precedent to gain access to other products (4:05). They also analyze HHS’ dismissal of US Food and Drug Administration safety concerns (11:28). In addition, the group discusses the Pharmaceutical Research and Manufacturers of America’s opposition to releasing complete response letters and the future of legislative efforts to codify the practice (19:52). More On These Topics From The Pink Sheet HHS Peptide Policy Brushes Off US FDA Safety Concerns As Hypothetical: https://insights.citeline.com/pink-sheet/compliance/manufacturing/hhs-allows-compounding-of-six-unapproved-peptides-UEKWZWETHFG4XJXTVA4VUNE3PU/ Peptides Compounding Would ‘Undermine’ US FDA Drug Approval Process, Ex-Agency Official Argues: https://insights.citeline.com/pink-sheet/pathways-and-standards/approval-standards/peptides-compounding-would-undermine-us-fda-drug-approval-process-ex-agency-official-argues-7RZQLE3HJ5B4FMB3AUREB5LUZU/ US FDA’s Complete Response Letter Postings A Gift To Chinese Competitors, PhRMA Says: https://insights.citeline.com/pink-sheet/product-reviews/complete-response-letters/us-fdas-complete-response-letter-postings-a-gift-to-chinese-competitors-phrma-says-IJ2VETAAGND5NH6CXWADH3R6TU/

In this episode of Strategic Intent, Partner at Sofinnova Partners, David Evans discusses his transition from Roche Venture Fund, different investments strategies, general market analysis across Europe and US, as well as growing therapeutics area trends within biotech.