Pink Sheet Editor-in-Chief Nielsen Hobbs, executive editor Derrick Gingery, and senior reporter Maaisha Osman discuss new FDA commissioner nominee Heidi Overton, her prospects for confirmation, and what her pick means for the agency.

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FDA Commissioner Nominee Has The White House’s Trust. Winning Over Career Staff Is Another Matter: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/fda-commissioner-nominee-has-the-white-houses-trust-winning-over-career-staff-is-another-matter-IIZWK46CFVHMBIZF5XM7L4PQ6U/

Trump To Nominate White House Advisor Overton As FDA Commissioner: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/outgoing-georgia-congressman-buddy-carter-eyed-for-fda-commissioner-RHIYQUYTIVGRTFEXYCHCWPG54Y/

One in ten women has endometriosis, yet treatment options remain largely unchanged for decades. Tanya Petrossian, CEO of EndoCyclic Therapeutics, explains how her company's non-hormonal peptide platform - now FDA-cleared for human trials - could finally change that.

Biopharma’s small-to-mid-cap players are stepping up as serious acquirers. David Wild and Scrip’s Jessica Merrill unpack how companies like argenx, Insmed, Jazz, Genmab, UCB, and BioMarin are using M&A to extend growth beyond their first commercial successes and what that shift means for investors, dealmaking, and the next generation of big biotechs.

Everyone in consumer health is talking about GLP-1s. While this new generation of weight loss drugs is firmly on the prescription-only side, industry is now thinking about how it can meet users’ needs for products that address side effects and the nutritional gaps that come with rapid weight loss. In this episode of HBW Insight’s Over the Counter, ALL Creative founder Beverley Law and consultant Martina Gripp – who has 25 years’ experience in industry including at Boehringer Ingelheim and Perrigo – unpick what a companion products category actually requires. We talk claims and the grey area around referencing a prescription brand, the difference between a product marketed for GLP-1 users and one that ends up being used by them, what a real evidence investment looks like from bibliographic data through to a clinical trial, and what OTC companies should be doing right now.

A quick update for our listeners: HBW Insight now has its own dedicated podcast channel. To stay up to date on the latest, follow HBW Insight’s Over The Counter podcast on Spotify and Apple Podcast. You'll find the link in this episode's description.

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Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss the important provisions of the new prescription drug and generic drug user fee commitment letters (:53), including the revenue cut coming in PDUFA VIII (7:16), as well as the new formal meeting names (13:53) and “America First” incentives (23:47) in GDUFA IV.

US FDA Will Start PDUFA VIII Collecting Less Revenue, But Will Fees Drop?: https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/us-fda-will-start-pdufa-viii-collecting-less-revenue-but-will-fees-drop-3VJC34BDRZFHHMY5N5YIODQRZ4/

Generic Drug User Fee Deal Creates Domestic-Focused Incentives, Could Lower Application Fees: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/generics/generic-user-fee-deals-creates-domestic-focused-incentives-could-lower-application-fees-UOG7BGF2YNA3NMWHLFMM2C2BFU/

Generic Drug User Fee Agreement Streamlines Meetings, Creates ‘Complex Issue’ Goal Extension: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/generics/generic-drug-user-fee-agreement-streamlines-meetings-creates-complex-issue-goal-extension-TZFGYWV2VNCF3M7GJWPOJZ66SI/

Biotech leaders are navigating disciplined growth, shifting global dynamics, and rising expectations across boards, partners, and clinical teams. In this opening episode, a panel of experienced biotech executives step back to discuss where the industry truly stands, the forces shaping decision‑making, and how leaders are approaching strategy, execution, and collaboration in today’s biotech landscape.

Featuring:

- Claire Riches, VP, Clinical Solutions, Citeline

- Ross Pettit, Chief Development Officer, Kestrel Therapeutics

- Carrie Melvin, Head of Clinical Operations and Data Management, Lantheus

- Marrissa Volpe, SVP, Clinical Development, NervGen

- Jennifer Burg, SVP, Clinical Development Operations, Axonis Therapeutics

View the video series and find out more information here: https://www.citeline.com/biotech

On this episode of Strategic Intent, In Vivo’s David Wild sits down with Doug Love, President and CEO of Annexon Inc., to discuss how the company is transitioning from a platform-centric biotech into a commercial organization. Love walks through the distinct go-to-market strategies for an acute rare disease treated in hospitals versus a large chronic ophthalmology market served by retina practices, and explains how Annexon is building two dedicated commercial teams to support both launches. The conversation also covers Annexon’s oral complement inhibitor ANX1502, capital allocation priorities across late-stage and platform programs, and how most-favored-nation (MFN) pricing dynamics are influencing launch sequencing and ex‑US partnering plans.

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss the impact of nationalism on the regulatory process, which entered the fray once again when news of a potential AstraZeneca-Bristol Myers Squibb merger broke (:58), as well as the US Food and Drug Administration’s IND reform pilot program (11:22), including the potentially influential role of external qualified research institutions (16:20) and the resources the pilot will require (20:29).

Oncology Overlap, Nationalism Cast Doubts On Potential AstraZeneca/BMS Merger: https://insights.citeline.com/pink-sheet/policy-regulation/oncology-overlap-nationalism-cast-doubts-on-potential-astrazenecabms-merger-NL65J53QYNF57GBW53AZGSYD54/

Merged AstraZeneca, BMS Would Have Deep Solid Tumor And Blood Cancer Portfolio: https://insights.citeline.com/pink-sheet/r-and-d/merged-astrazeneca-bms-would-have-deep-solid-tumor-and-blood-cancer-portfolio-IF4Z7IRHEFDIRDUAZTZP2PHEDM/

US FDA’s IND Reform Pilot Could Use External Partners To Speed Trial Set-Up: https://insights.citeline.com/pink-sheet/r-and-d/clinical-trials/us-fdas-ind-reform-pilot-could-use-external-partners-to-speed-trial-set-up-7QU7Y7US4FCJRLRWZWV4CLCQBA/

In this episode of Proof of Concept, Krishna Bulusu joins us for an honest, industry-wide look at what AI and simulation can and can't do. Having spent years in oncology data science at AstraZeneca before becoming VP of Product Innovation & Strategy at Turbine, he's seen the problem from both sides — as the big-pharma adopter deciding whether to trust these tools, and as the builder creating them.

We cover how simulation is used to find and de-risk drug targets, why some AI tools get adopted while others stall, the translational gap between lab results and real patients, and the honest question of where the field is overhyped — and what would count as real proof.

Science Corp.'s PRIMA brain-computer interface receives CE mark for restoring central vision in AMD patients. Viz.ai partners with Cortechs.ai on MS tracking. AMA urges Congress to regulate mental health AI chatbots. MedLink earns Mayo Clinic Platform qualification.