The FDA’s approval of Agios Therapeutics Inc.’s Pyrukynd (mitapivat) for treating hemolytic anemia marks a turnaround from nearly a year ago. That’s when Agios sold its commercial, clinical and research-stage oncology portfolio to privately held Servier Pharmaceuticals LLC to concentrate on rare diseases.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avita Medical, Medtronic, Ra Medical Systems.
As part of its ongoing effort to speed drug pricing competition in the U.S. through the development of generics, the FDA is releasing another batch of draft and revised draft product-specific guidances on the design of bioequivalence studies to support abbreviated new drug applications. Among the 30 new draft guidances is one specific to remdesivir, which was approved in October 2020 as a COVID-19 treatment.
In the latest chapter in an ongoing contract dispute between AOP Orphan Pharmaceuticals GmbH and Pharmaessentia Corp., the German Federal Court of Justice this week set aside the €143 million (US$162.8 million) in damages awarded to AOP, citing procedural flaws in quantifying the product supply and damages.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amylyx, AN2, Astrazeneca, Beigene, BMS, Cstone, Epygenix, Immune-Onc, Kato, Lupin, Moderna, Poxel, Sanofi, Valbiotis, Zai Lab.
The FDA’s device center has been eyeing an overhaul of its Quality System Regulation (QSR) for several years, and the latest development is the scheduling of a March 2 advisory committee hearing to review the proposal. The default assumption is that the agency will post the draft rule prior to the hearing, although the routine two-day window for reviewing FDA meeting materials prior to an advisory hearing might leave stakeholders with insufficient time to examine the agency’s proposal.
India’s health care industry stakeholders have been left scratching their head as authorities, who have championed self-reliance and increased supplies, provided mixed signals in recent notices.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bonalive, Evoendo, Novacyt, Oncimmune.
Drug companies won another round in their battle with the U.S. Department of Health and Human Services (HHS) over how many contract pharmacies must be given the steep discounts dictated under the 340B drug pricing program aimed at helping public clinics and hospitals provide charity care.
As the Biden administration continues to play musical chairs with key U.S. federal health leadership positions, its latest move is naming Francis Collins to serve as science adviser to the president and co-chair of the President’s Council of Advisers on Science and Technology.