
Pink Sheet Podcasts
Keep up with latest biopharma regulatory and policy developments with Pink Sheet podcasts.

Pink Sheet Podcast: FDA User Fees, Real-Time Oncology Review, ALS Accelerated Approval, Opioid Suit
Pink Sheet reporter looks at the biggest US FDA and pharma industry stories of the week, including the status of US FDA user fee renewal legislation, new real-time oncology review program guidance, Biogen’s ALS accelerated approval play, and Teva settling opioid litigation.

Pink Sheet Podcast: Trial Diversity, More PTAB Issues, US FDA Controlled Substance Leader Elevated
Pink Sheet reporter and editors discuss another project to improve clinical trial diversity in the US, the Patent Trial and Appeal Board director review process, and the FDA promoting its head of controlled substance policy to deputy CDER director.

Podcast Special: The Shifting Landscape For Drugs And Devices Post-Roe v. Wade
A special podcast looks at the implications for FDA-regulated sectors, from the abortion pill and OTC daily and emergency contraceptives to intrauterine devices and period-tracking apps, of the US Supreme Court’s historic overturning of Roe v. Wade.

Pink Sheet Podcast: Novavax Gets EUA, Califf Sets US FDA Departure, Hemophilia Patients Want REMS
Pink Sheet reporters and editors discuss the FDA’s latest COVID-19 vaccine emergency use authorization, activities during the FDA commissioner’s remaining time in office, and patients requesting a gene therapy risk management plan.

Pink Sheet Podcast: New Drug Pricing Bill, Second Amylyx US FDA Adcom, Skipping A Makena Vote
Pink Sheet reporters and editors discuss new changes to the Senate drug pricing bill, the FDA’s decision to call a second advisory committee meeting for Amylyx’s ALS drug, and Covis’ request to skip a vote during the hearing on Makena’s withdrawal.

New Chinese-Language Podcast: 聊聊生物制药热门话题
Join our China-based content team for this inaugural Chinese-language podcast discussing selected recent hot topics impacting the biopharma industry in China, including bispecific antibodies, antibody-drug conjugates and new regulatory policies designed to speed product approvals.

Pink Sheet Podcast Special: Assessing US FDA Commissioner Robert Califf’s First 100 Days
Reporters and editors from the Pink Sheet and sister publications covering the medical device and health, beauty and wellness sectors look at Califf’s goals, accomplishments and trials during the early days of his second term.

Pink Sheet Podcast: FDA User Fee Bill Mark-Up, Postmarket Quality Requirements, Fewer Adcom Meetings
Pink Sheet reporter and editors discuss the first mark-up of the House FDA user fee bill, the likelihood of more postmarketing quality requirements for drug manufacturers, and the significance of the shrinking number of FDA advisory committee meetings.
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