Pink Sheet Team
The policy and regulatory insights advantage for biopharma decision-makers around the globe.
Latest From Pink Sheet Team
Pink Sheet Podcast: FTC Ends Amgen-Horizon Case, New Ultra-Rare Cancer Partnership, Generic Applications Lag
Pink Sheet reporter and editors discuss the US Federal Trade Commission ending its attempt to block the Amgen acquisition of Horizon Therapeutics, a proposed public-private partnership to develop ultra-rare cancer drugs, and a slow-down in ANDA submissions to the US Food and Drug Administration.
We used the US holiday weekend to upgrade our platform, so there are lots of stories to catch you up on, from Korean regulatory legislation to German exclusivity litigation.
Pink Sheet Podcast: What We Learned From The First Medicare Price Negotiation List, Pepaxto Withdrawal Update
Pink Sheet reporters and editors consider lessons and next steps after the first list of drugs subject to Medicare price negotiations was released and discuss Oncopeptides’ Pepaxto facing withdrawal under the US FDA’s new and potentially faster process.
Pink Sheet Podcast: Wegovy’s CV Benefits, Mifepristone And Water Contamination, US FDA Back To The Office?
Pink Sheet reporters and editors discuss the impact of a study showing cardiovascular benefits for the weight loss drug Wegovy, another attempt to restrict mifepristone access, and a new threat to the US FDA’s hybrid work policy.
Industry stakeholders have filed various lawsuits against the US government, attempting to slow down or block the implementation of a new Medicare drug price negotiation program. Pink Sheet's new chart tracks the developments.
Supplemental Filings: Ycanth Approved For Molluscum; CDER Counter-Terrorism Head Retires; 5 Benzodiazepines Added To Schedule I
The fourth review cycle is the charm for Verrica's cantharidin topical solution; Rosemary Roberts, head of CDER's Counter-Terrorism and Emergency Coordination Staff, retires after 35 years at the FDA; DEA deems five designer benzodiazepines with no currently accepted medical use in the US as Schedule I controlled substances.