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.

How shifting perceptions and new opportunities are changing the way sponsors approach China

Generics Bulletin’s senior reporter Urtė Fultinavičiūtė launches a new interview podcast series “Off-Patent, On Record.” In the inaugural episode, Urtė is joined by Dave Wallace, executive editor at Generics Bulletin, who has been covering the off-patent drug industry as a journalist and editor for 16 years.

Consumers are turning to AI at the start of the self-care journey in growing numbers, but they do not yet trust it, the latest Better Health Report from Simon-Kucher & Partners shows.

They do trust pharmacists, who can convert that trust into sales, providing crucial sales volume growth for their consumer healthcare industry partners.

However, as Simon-Kucher’s Christian Danelund and Chris Rebholz explain in the latest episode of HBW Insight’s Over the Counter podcast – now also in video – pharmacists feels that support from industry has declined over recent years.

This Scrip video podcast brings together three European biotech leaders to discuss the challenges facing the sector, and what measures are needed to stop it falling behind the US and China and to create the next generation of European biotech champions.