Pink Sheet Team
The policy and regulatory insights advantage for biopharma decision-makers around the globe.
Latest From Pink Sheet Team
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.
Pink Sheet Podcast: Drug Fix: ALS Drug Cleared, Lecanemab’s Hopeful Alzheimer’s Data, CMS’ Price Negotiation Needs
Pink Sheet reporters and editors discuss the newly approved ALS drug Relyvrio, the promising data on the Alzheimer’s drug lecanemab, and CMS’s efforts to build the drug price negotiation program.
The Citeline Awards celebrate the efforts of biopharma research and development communities, with 12 categories ranging from use of technology to quality results. Nominations are open through 20 January 2023.
Pink Sheet Podcast: RWE’s Limited Uses So Far, Learning Pandemic Lessons, COVID-19 Vaccine Reporting Changes
Pink Sheet reporters and editors discuss the role of real world evidence in US FDA product decisions, staffing and other problems that are limiting the agency’s ability to implement lessons from the pandemic, and updates to COVID-19 vaccine adverse event reporting requirements.
Pink Sheet reporters and editors discuss the positive advisory committee recommendation for Amylyx’s proposed ALS treatment, the striking drop in clinical trials conducted in Russia following the start of the war in Ukraine, and questions about Medicare price negotiations avoiding political influence.