Should the U.S. government be in the business of manufacturing COVID-19 vaccines? Several prominent Democratic senators and representatives would say yes.
Two Janus kinase (JAK) inhibitors, Abbvie Inc.'s Rinvoq (upadacitinib) and Pfizer Inc.'s Cibinqo (abrocitinib), have won U.S. FDA approvals for the treatment of people with moderate to severe atopic dermatitis. Reviews of both products for the indication were delayed due to FDA concerns about class risks. Accordingly, each is labeled with a boxed warning regarding risks of serious infection, mortality, malignancy, major adverse cardiovascular events and thrombosis.
The FDA clapped a clinical hold on the IND for a clinical trial of Dyne Therapeutics Inc.’s DYNE-251 for treating Duchenne muscular dystrophy in patients amenable to skipping exon 51. The agency is asking for more clinical and non-clinical information on the therapy. A response, including data from existing and ongoing studies in the second quarter of 2022, is expected to be filed to the FDA sometime in mid-2022, Dyne said.
Not heeding earlier FDA advice has earned Levo Therapeutics Inc. a complete response letter (CRL) for its NDA seeking approval for intranasal carbetocin (LV-101) in hyperphagia associated with Prader-Willi syndrome (PWS). The CRL followed a 12-1 negative advisory committee vote in November.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algernon, Glenmark, Novartis, Numinus, Pfizer.
PARIS – The new European regulation on medical devices came into force on May 26, 2021, one year later than planned, due to the COVID-19 pandemic. This European medical device regulation (MDR) modifies the conformity assessment procedure for medical devices in the 27 countries of the European Union, repealing two council directives implemented in the early 1990s.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Imcyse.
The U.S. Center for Medicare & Medicaid Services (CMS) opened a 30-day comment window on its proposed national coverage determination (NCD) to limit Medicare access to monoclonal antibodies targeting amyloid beta in Alzheimer’s disease (AD) only in clinical trials. Biogen Inc., clearly the target, along with its AD treatment Aduhelm (aducanumab), was among the first to respond.
Robert Califf moved a step closer to his second stint as head of the U.S. FDA when the Senate Health, Education, Labor and Pensions (HELP) Committee voted 13-8 Jan. 13 to favorably send his nomination to the full Senate for a confirmation vote.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Co-Diagnostics, Cosara, G-Tech Medical, Mentor, Wavegate.
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