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22 thg 6
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Hai tháng một lần
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Series cập nhật hằng tháng

2 ngày trước

Drug Fix: Understanding The PDUFA VIII Revenue Cut And GDUFA IV Name Change

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. More On These Topics From The Pink Sheet 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/
4 ngày trước

The State of Play in Biotech and the Decisions Shaping the Industry

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
7 thg 8

Drug Fix: Regulatory Nationalism And US FDA’s IND Reforms

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). More On These Topics From The Pink Sheet 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/
6 ngày trước

Strategic Intent: First-in-class, two markets: Annexon’s GBS and GA Strategies

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.
6 thg 8

Proof of Concept - AI in Drug Discovery

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.
4 thg 8

Podcast: China's Evolving Role in Global Clinical Development

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

Strategic Intent: First-in-class, two markets: Annexon’s GBS and GA Strategies

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.
22 thg 7

European Biotech At A Crossroads: How Can It Stay Competitive? Video Podcast

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.
2 ngày trước

Drug Fix: Understanding The PDUFA VIII Revenue Cut And GDUFA IV Name Change

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. More On These Topics From The Pink Sheet 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/
22 thg 6

The Yescarta Launch Examined

This debut video episode of the In Vivo podcast examines the successes and pitfalls of the commercial launch of Yescarta (axicabtagene ciloleucel), Kite Pharma’s CAR-T therapy for relapsed/refractory large B-cell lymphoma. David Wild, senior reporter at In Vivo, is joined by Harris Kaplan, who consulted on the launch and conducted interviews with physicians, nurses, and hospital administrators before and after it, and is managing partner of Litmys, a life sciences commercial strategy consulting firm; Diane Parks, who led the Yescarta launch for Kite; and Jim Haag, a patient who received CAR-T therapy. It's a candid, unfiltered look at the gap between what innovation promises and what the healthcare system actually delivers. Here are some of Harris Kaplan’s contributed articles for In Vivo: Commercialization 3.0: Achieving New Product Success In Health Care’s New Era Commercialization 3.0: Recognizing And Managing The Human Side Of Change Physician Behavioral Inertia: Innovation’s Greatest Enemy

A home for specialist reporting, sharp analysis and industry intelligence across the biopharma, regulation, medtech, generics and the consumer health landscape. Norstella brings together the life sciences industry’s most authoritative news and insights brands - Scrip, Pink Sheet, In Vivo, Medtech Insight, HBW Insight and Generics Bulletin.