In the second of two hearings before the U.S. Senate Health, Education, Labor and Pensions Committee on the next iteration of the FDA drug and device user fee agreements, the focus was supposed to be on advancing regulation and innovation. But Ranking Member Richard Burr (R-N.C.) shifted the spotlight April 26 to accountability in his opening remarks and subsequent questioning.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ardelyx, Astrazeneca, Autolus, Langsheng, Merck & Co., Obseva, Priothera, Quoin, Roche, Sol-Gel, Sorrento, Valneva.
There may be no COVID-19 vaccines authorized yet in the U.S. for the youngest children, but there’s now an approved treatment for some children who are already sick with an infection.
Links to electronic information may become a more common feature in Canadian prescription drug labeling, but electronic labeling is not expected to replace paper labels anytime soon.
Recognizing that patient views about the tradeoffs of using one drug over another may differ from those of doctors, the U.S. FDA’s Office of Prescription Drug Promotion is proposing to examine those tradeoffs in an analysis involving fictitious prescription drugs for type 2 diabetes and psoriasis.
Shares in Valneva SE fell sharply after the company said European regulators came back with further queries, including on antibody efficacy data, instead of a recommendation during a rolling review of its delayed COVID-19 vaccine. The company had expected a positive opinion on the vaccine, known as VLA-2001, following the April meeting of the European Medicines Agency’s CHMP committee.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bayer, Biogen, Direct, Incyte, Lynk, Medac, Medexus, Novartis, Revance.
After August 2021 news from the U.S. FDA of deficiencies in the NDA that Axsome Therapeutics Inc. submitted for AXS-05 in major depressive disorder (MDD), word was especially welcome April 19 that the firm has come to an agreement with the agency with regard to post-marketing requirements. Meanwhile, another player in MDD, Relmada Therapeutics Inc., is due to report phase III data with REL-1017 (esmethadone) around the middle of this year.
Biogen Inc. has given up on its attempt to get its Alzheimer’s disease drug Aduhelm (aducanumab) approved by regulators in Europe, deciding to withdraw its filing midway through a review of a previous rejection. The company had asked the European Medicines Agency’s CHMP to reconsider its negative opinion for Aduhelm in December 2021. But its subsidiary in the Netherlands wrote to the EMA this week saying that it had decided to withdraw its marketing authorization application after all.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ampio, Dragon Boat, Hansa, Moleculin, Nrx, Otsuka, Tvardi, Vertex, Zambon.
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