More than a year into U.S. President Joe Biden’s four-year term, the FDA commissioner seat remains open. While Robert Califf secured a critical endorsement Jan. 31 in his quest for a second term in the post, his hope for a sequel may still be up in the air.
As part of a settlement in a class action suit, Vyera Pharmaceuticals LLC and its parent company, Phoenixus AG, of Baar, Switzerland, agreed last week to pay up to $28 million to a proposed class of third-party payers that covered Daraprim (pyrimethamine).
Last week, Incyte Corp. said it was pulling its NDA seeking accelerated approval for the PI3K-delta inhibitor parsaclisib in three non-Hodgkin lymphoma subtypes, a move that followed recent decisions by Gilead Sciences Inc. and Secura Bio Inc. to withdraw from U.S. commercialization their respective PI3K-delta inhibitors in indications for which they’d received accelerated approval. But the recent spate of headlines is hardly “a condemnation” on the entire class of drugs, said Dan Gold, CEO of MEI Pharma Inc., which is aiming for a potential accelerated approval filing of its own PI3K-delta drug, zandelisib, this year.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akeso, Altimmune, Celltrion, Cybin, Eagle, Filament, Genentech, Immunoprecise, Janssen, Kite, Nordic, Novelmed, Reata, Regeneron, Sanofi, Veru, Viridian.
U.S. FDA regulation of combination products has always been complicated, and a new final guidance takes up the long-standing controversy over FDA review of these applications. The final guidance makes explicit the possibility that the individual components of a cross-labeled combination product will be reviewed separately, a concession that industry saw as critical to ensure that these applications can make it through the FDA gauntlet without undue delay.
The quinquennial user fee process for medical devices has always proven controversial, but the FDA and industry have missed a Jan. 15 deadline for an agreement to be presented to Congress. Recently, several members of the House and Senate inked a letter to the FDA about the missed deadline, a signal that the agency’s aspirations for a $2.5 billion user fee deal are in jeopardy.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Applaud Medical, Orasure Technologies.
Blueprint Medicines Corp.’s cancer drug Ayvakyt (avapritinib) looks set to gain an expanded label in Europe, amid a flurry of decisions from the European Medicines Agency’s CHMP scientific committee. Late last week the CHMP gave a positive opinion for Ayvakyt for treatment of adults with advanced systemic mastocytosis, meaning the drug is likely to gain a further European indication in the coming weeks.
PERTH, Australia – A new parliamentary report, The New Frontier: Delivering better health for all Australians, is recommending significant reforms to the nation’s health care system to ensure Australians have faster access to new drugs and devices. The House of Representatives Standing Committee on Health, Aged Care and Sport examined the range of new drugs and emerging medical technologies that are in development and progressing through the regulatory system in Australia and in other countries.
While comments continue to pour in, both in opposition and support, regarding the U.S. Centers for Medicare & Medicaid Services’ (CMS) proposed national coverage decision that would restrict Medicare coverage of monoclonal antibodies intended to treat Alzheimer’s to those used in CMS- or NIH-approved clinical trials, some groups also are appealing to Health and Human Services (HHS) Secretary Xavier Becerra to step into an HHS agency turf war.
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