Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: did Pfizer miss out on Roivant/Roche deal?; Padcev/Keytruda combo impresses in bladder cancer at ESMO; biggest upfront ever in Daiichi/Merck deal; Rybrevant at ESMO; and subcutaneous Leqembi could open up access.
https://scrip.citeline.com/SC149266/Quick-Listen-Scrips-Five-MustKnow-Things

Scrip’s Five Must-Know Things – 30 October 2023

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Senior Editor Sue Sutter discuss the impact of the departures of several senior leaders in the US Food and Drug Administration’s facility inspection group, Office of Generic Drugs and Office of Prescription Drug Promotion (:26). They also consider Commissioner Martin Makary’s intent to combine the agency’s many adverse event databases (14:52), his idea for a new approval pathway based on a “plausible mechanism” (26:25) and the seemingly increasing influence of politics at the agency despite his declarations that the FDA is apolitical (36:16).

More On These Topics From The Pink Sheet

US FDA Retirements Continue Unabated With Drug Inspectorate Leaders, Former Chief Counsel: https://insights.citeline.com/pink-sheet/compliance/manufacturing/us-fda-retirements-continue-unabated-with-drug-inspectorate-leaders-former-chief-counsel-JRKHCHZHMBC4RLRJRBDTSIP7E4/ 

FDA Leadership Shuffle Continues: Lowell Zeta Returns As OPDP, OGD Leaders Depart: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/fda-leadership-shuffle-continues-lowell-zeta-returns-as-opdp-ogd-leaders-depart-FONMRWR37VGAFL2JJ5S27QIU2E/ 

US FDA’s Makary Floats Vague ‘Plausible Mechanism’ Approval Pathway For Rare Diseases: https://insights.citeline.com/pink-sheet/pathways-and-standards/approval-standards/us-fdas-makary-floats-vague-plausible-mechanism-approval-pathway-for-rare-diseases-RJJJCPDUDFHINMPDE5VK4OFDVQ/ 

US FDA Commissioner Makary Wants To Combine Adverse Event Reporting Systems: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-commissioner-makary-wants-to-combine-adverse-event-reporting-systems-UJ4QUEM72ZC25J7JHAC3LAKKKA/ 
Political Influence And The US FDA: A New Era?: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/political-influence-and-the-us-fda-a-new-era-SL6ZBNKHNVFEXCLQLCYTDJIETQ/ 



Drug Fix: More US FDA Departures, Makary On Combined AE Database, ‘Conditional’ Approval

Audio roundup of selected biopharma industry content from Scrip over the business week ended 25 April 2025. In this episode: 2024’s top-selling drugs; two CEOs call for higher Europe drug prices; diabetes trial win for Lilly’s orforglipron; BMS trial failure in schizophrenia; and an analysis of alliance deal-making last year.
https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-6L5MDUXZ5BGHJHLZFILGLH6ZT4/

This episode was produced with the help of AI text-to-voice and voice emulation tools.

Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Scrip's Five Must-Know Things - 28 April 2025

Aragen Life Sciences’s CEO Manni Kantipudi - also former CIO of Intel Asia - speaks with Citeline’s senior editor Vibha Ravi about the changing global supply chain dynamics as the industry watches a ticking time bomb of US tariffs on pharmaceuticals. Impacts on Indian CRDMOs of the US-China trade war, budget cuts at US NIH and lower funding for biotechs are discussed. 

Aragen CEO On Funding Cuts At NIH, Biotechs And Likely US Pharma Tariffs

 Emma Wille and Summer Colling discuss the 2025 American Academy of Neurology (AAN) conference with CNS and I&I analysts Wen-Yu Huang, Joseph Jacob and Istafa Armughan.

Highlights from AAN 2025

In this episode, we recap the key takeaways from BIO-Europe 2025, held in Milan, Italy, in March 2025, with Trajko Spasenovski, Vice President of Strategic Account Management at Evaluate, and Carolyn Hall, Senior Director of Content and Thought Leadership Marketing at Evaluate. 

After the conference, Citeline’s Managing Editor, Meredith Landry, spoke with them about their experience there and what they learned about trends in early-stage deal-making, emerging areas like cardiovascular and rare disease therapies, and the expanding role of AI in R&D. Trajko and Carolyn also shared how conferences like BIO-Europe help Norstella and its clients forge meaningful partnerships, uncover market needs, and accelerate the path to life-saving therapies through data-driven insights and strategic collaboration.

Conference Catch-Up: BIO-Europe 2025

Scrip senior writer Joseph Haas discusses the potential impact of the recent FDA staff cuts with attorneys Andrew Goodman of Paul Hastings LLP and Alan Minsk of Arnall Golden Gregory, as well as Naya Therapeutics CEO Daniel Teper

Scrip M&A Podcast: Will the FDA Staff Cuts Affect Biopharma M&A Activity?

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor in Chief Nielsen Hobbs consider the impact of FDA Commissioner Martin Makary directing one of his assistants to take over the review of Novavax’s COVID-19 vaccine (:40), as well as how states or courts could respond (19:19). They also discuss several announcements of missed user fee deadlines and whether FDA layoffs could have contributed (28:33).

More On These Topics From The Pink Sheet

Updated: Makary Backs New Novavax COVID-19 Trial, Political Officials Take Over Product Review: https://insights.citeline.com/pink-sheet/vaccines/political-official-pushing-novavax-to-conduct-covid-19-vaccine-postmarket-rct-BZTIWKSTK5G77BUQGGD3G2IOFY/ 

How States And Courts Could Insulate America From An Anti-Vaccine Executive Branch: https://insights.citeline.com/pink-sheet/vaccines/how-states-and-courts-could-insulate-america-from-an-anti-vaccine-executive-branch-DARDVWDMLVFCHM6DE75AJQHSBQ/ 

US FDA Commissioner’s Office Plans Involvement In Many Approvals In Potential Major Change: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-commissioners-office-plans-involvement-in-many-approvals-in-potential-major-change-JFPWOQ2VF5D2JAFKXKGK54REZU/ 

US FDA Miss On Stealth’s Elamipretide Boosts Signal Of Broader Delays Due To Staff Cuts: https://insights.citeline.com/pink-sheet/product-reviews/us-fda-miss-on-stealths-elamipretide-boosts-signal-of-broader-delays-due-to-staff-cuts-5ITZREGXX5H75ID6IL4Q2MHKBE/

Drug Fix: Vaccine Review Political Interference, Missed Deadlines A Harbinger Of US FDA Problems?

Anil Matai, director general, Organization of Pharmaceutical Producers of India, discusses the evolving intellectual property landscape in India post the 2024 amendments and long-standing sticking points including Section 3(d) of India’s patent regulations and regulatory data protection. Big pharma’s experience when it comes to the Bolar provision and the impact of geopolitical shifts on innovation were some of the other topics he touched on.

OPPI’s Matai On India’s IPR Regime: Progress, Pain Points, Possibilities

The potential for real world evidence (RWE) is huge, according to enthusiasts, but to the uninitiated it can seem like a complicated and forbidding subject. In this Over the Counter double episode, IQVIA Consumer Health’s vice president of global research and development and real-world evidence services, Volker Spitzer, makes understanding real world evidence easy. We start with the basics, with what it is and what companies need to know about it, and what the key difference is with randomised control trials. Many companies are already using real world evidence, Volker notes, and he extracts some key lessons for companies interested in trying it out based on his extensive experience working with industry on such projects.

Timestamps
2:00 – Introductions
4:00 – What is real world evidence?
5:00 – Can RWE and clinical trials complement each other?
10:00 – Why RWE is particularly attractive today
14:00 – Don’t reinvent the wheel
18:00 – Why is this important for consumer health companies?
25:00 – Why RWE is often a good value option, especially for SMEs
33:00 – Applications of RWE in consumer health

Guest Bio
Volker Spitzer has more than 30 years of R&D experience spanning the consumer health sector, ingredients industry, and academia. Beginning his career as a professor in pharmaceutical sciences, he ascended to global positions encompassing R&D, innovation, licensing/M&A, and medical marketing at firms like Roche, DSM Nutritional Products, and Bayer. 
Since October 2017, Volker has been affiliated with IQVIA Consumer Health, serving as the vice president for global R&D and RWE Services. His purview primarily includes clinical research, RWE, virtual trials, and the burgeoning field of digital health. He has penned over 80 scientific publications, whitepapers and textbooks centered on science and innovation.

Everything You Wanted To Know About Real World Evidence, With IQVIA’s Volker Spitzer

Audio roundup of selected biopharma industry content from Scrip over the business week ended 2 May 2025. In this episode: AstraZeneca CEO cautions Europe; Pfizer CEO optimistic on US tariffs, pricing; Merck & Co reassures on pipeline; Merck KGaA buys SpringWorks; and Akeso explains ivonescimab overall survival data.
https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-LV7ZA2GKQVHEZDZYYNZFKYQZ74/

This episode was produced with the help of AI text-to-voice and voice emulation tools.

Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Scrip's Five Must-Know Things - 7 May 2025

Citeline places biopharma and medical device professionals, and those who focus on these industries, at the forefront of knowledge and insight, by providing the perfect combination of news and information together with penetrating insight and analysis. Citeline is a leader in the field of healthcare industry information.

Scrip’s Five Must-Know Things – 30 October 2023

Citeline

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