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Pink Sheet Podcasts

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

Pink Sheet Podcast: US FDA Loses Gene Therapy Expert, Humira Biosimilars Launch, FDA Allows In-Person Meetings

Pink Sheet reporters and editors consider the impact of FDA Office of Tissues and Advanced Therapies Director Wilson Bryan’s retirement, the launch of Humira biosimilars and its effect on the biologic market, as well as the FDA moving to hybrid meetings with sponsors.

Pink Sheet Podcast: More US FDA Communication Problems, 2022 Novel Approval Trends, Cancer Drug Dosing Guidance

Pink Sheet reporters and editors discuss concerns related to the FDA’s announcement of a COVID-19 vaccine safety investigation, 2022 novel drug approval data, and a new guidance on cancer vaccine dose optimization.

Pink Sheet Podcast: Leqembi Approved, Medicare Price Negotiation Timeline, AAM CEO Departure

Pink Sheet reporters and editors discuss the take-aways from Leqembi’s approval as an Alzheimer’s treatment, the new timeline for information collection and comment on Medicare price negotiations, and the reasons a generic drugs trade association CEO departed.

Pink Sheet Podcast: Accelerated Approvals Drop, CMS’s Generic Tiers Reg, Cytokinetics’ Adcomm Loss

Pink Sheet reporters and editors discuss a projected decline in accelerated approvals by the US FDA, a new CMS proposed rule requiring generic drug cost sharing tiers, and the negative advisory committee recommendation for Cytokinetics’ proposed heart failure treatment.

Pink Sheet Podcast: Shouting About Innovation v. Access, AAM CEO Departs, Concerns About US FDA’s IND Regulations

Pink Sheet reporters and editor consider the line between therapeutic innovation and affordability, the Association for Accessible Medicines searching for a new CEO, and questions about IND regulations and drug repurposing.

Pink Sheet Podcast: Election Fallout, IRA Impacting Product Development, Updated US FDA Expanded Access Policy

Pink Sheet reporters and editor discuss the impact of the midterm elections, the Inflation Reduction Act’s effects on drug development, and adjustments to FDA expanded access guidance.

Pink Sheet Podcast: Makena Hearing Take-Aways, Industry’s Accelerated Approval Failings, US FDA Claims Enforcement

Pink Sheet reporters and editors discuss lessons from the public hearing on the proposed withdrawal of the preterm birth prevention drug Makena, FDA Commissioner Califf’s opinion that industry is not meeting expectations with accelerated approval confirmatory studies, and agency efforts to clarify that staff is paying attention to comparative claims in product ads.

Pink Sheet Podcast: BIO CEO Departs, Makena Withdrawal Hearing Nears, New Confirmatory Evidence Sources

Pink Sheet reporters and editors discuss Michelle McMurry-Heath’s surprising departure as head of a top biotech industry trade association, preview the FDA hearing to withdraw the preterm birth prevention drug Makena, and consider Amylyx’s Relyvrio seemingly opening a wider path to gather confirmatory evidence for approval.

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Pharma Intelligence podcasts discuss key ideas and insights affecting biopharma and medtech, brought to you by our global team of editors. Listen on-demand to our perspectives on the latest industry developments.

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