Even as Alkermes plc works to resolve the complete response letter (CRL) sent by the FDA regarding ALKS-3831, labeling talks are underway for the compound, an oral therapy for schizophrenia and bipolar I disorder in adults. Regulators reviewed manufacturing records and said the Dublin-based firm needs to supply documents related to making the tablet’s coating at the Wilmington, Ohio, facility. No clinical or non-clinical concerns were raised, the firm said, and shares (NASDAQ:ALKS) hardly moved, closing Nov. 17 at $18.30, up 45 cents.
The latest global regulatory news, changes and updates affecting biopharma, including CDER, CBER promise EUA transparency; FDA plasma guidance updated, again; WHO targets cervical cancer; Draft guidance to help FDA respond to 2012 citizen petition; More time to comment on instituting PTAB trials.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alkermes, Apellis, Azurrx, BMS, CNS, Cytodyn, Inovio, Istari, Kiniksa, Moderna, Plx, Praxis, Redhill, UCB, Verrica, Viiv.
If the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services has its way, one of the casualties of the COVID-19 pandemic would be the in-person speaker programs many drug and device companies sponsor. The OIG issued a special fraud alert Nov. 16 questioning the need for such events in which health care professionals are often paid a hefty honorarium or fee to provide colleagues with information that’s readily available online and in the labeling of a drug or device.
The FDA has issued Sanofi SA a complete response letter (CRL) regarding its complement pathway inhibitor sutimlimab, citing deficiencies found during a pre-license inspection of a third-party manufacturing facility.
The latest global regulatory news, changes and updates affecting biopharma, including: Lawmakers protest latest 340B scheme; Groups make case for extending sequester moratorium; More $$ needed for global vaccine effort; Russia extends COVID-19 drug, device program.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aerie, Agios, Amgen, Bayer, Biomarin, Boehringer Ingelheim, Chiesi, Heron, Innate, Menari, Moderna, Roche, Samsung, Shionogi, Sobi, UCB, Viiv.
BOGOTA, Colombia and VANCOUVER, Canada – Anvisa, Brazil’s health care surveillance agency, re-started phase III trials for Coronavac, the COVID-19 vaccine candidate developed by China-based Sinovac Biotech Ltd., after a suspension of just two days. “Anvisa understands that it has sufficient subsidies to allow the resumption of vaccination,” the regulator said on Nov. 11. Anvisa said it plans to continue monitoring “the possible relationship of causality” between an unexpected serious adverse event and the vaccine.
The latest global regulatory news, changes and updates affecting biopharma, including: WHO maps end of the road for some tropical diseases; MHRA updates import licensing guidance.
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