What was billed as a U.S. Senate Health, Education, Labor and Pensions Committee hearing June 16 to get an update from top government health officials on the nation’s response to COVID-19 was, in reality, a concerted effort to get Republicans in the U.S. Senate to open the checkbook so the Biden administration could fill in the amount for more COVID-19 spending, Ranking Member Richard Burr (R-N.C.) charged as he concluded the hearing.
In keeping with the 21st Century Cures Act, the U.S. FDA issued a draft guidance describing a standards recognition program for regenerative medicine therapies at the Center for Biologics Evaluation and Research that’s intended to facilitate the development of the therapies and reduce the regulatory burden.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 180, Biontech, Covis, Horizon, Jazz, Kintara, Moderna, Omega, Pfizer, Phanes, Redx.
After a two-day session of the FDA’s Vaccines and Related Biologic Products Advisory Committee, the U.S. is within days of a long-awaited milestone of having not just one but at least two vaccines available for nearly every American. The VRBPAC voted unanimously, 21-0, June 15 to support amending the emergency use authorizations for both the Moderna Inc. and Pfizer Inc.-Biontech SE COVID-19 mRNA vaccines to allow their use in children 6 months and older.
The FDA’s Psychopharmacologic Drugs Advisory Committee posted briefing documents related to the June 17 meeting, set to consider Acadia Pharmaceuticals Inc.’s sNDA for Nuplazid (pimavanserin) to treat hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP). Although shares of the San Diego-based firm (NASDAQ:ACAD) stayed in the black, closing at $18.77, up $2.52, or 15.5%, the briefing docs did not bring uniformly good news, echoing some of the concerns spelled out in an earlier complete response letter.
The U.S. Supreme Court shot down a rule June 15 that allowed the Department of Health and Human Services (HHS) to sharply reduce Medicare reimbursement for Part B drugs to hospitals participating in the 340B prescription drug discount program.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alnylam, Attgeno, Cellenkos, Eli Lilly, Incyte, Innovent, Moderna, Nammi, Outlook, Stealth, Tremeau.
U.S. FDA Commissioner Robert Califf offered the keynote address at this year’s annual meeting of the Food and Drug Law Institute (FDLI), revisiting recent events that have roiled the agency’s staff and reputation. Califf made a point of emphasizing the need for new statutory authorities in connection with the supply chains for FDA-regulated products, and remarked that his return to the agency will not be a reversion to the norm in this context.
The European Commission and the U.S. Department of Health and Human Services (HHS) recently signed an arrangement to strengthen their cooperation on preparedness and response to public health threats.
Eli Lilly and Co. crossed the line in front of three strong competitors with the U.S. FDA’s approval of Olumiant (baricitinib) as a first-in-disease systemic treatment for severe alopecia areata. Two of those three are, like Olumiant, JAK inhibitors and have recent phase III data to run by the FDA.
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