Archive for November 2022

Axsome Therapeutics’ proprietary combination of dextromethorphan and bupropion — already approved for major depressive disorder as AXS-05 — also reduced the risk of agitation related to Alzheimer’s disease (AD), the company reported. Source: Drug Industry Daily

Included in — then stripped out of — user fee legislation in September were requirements that the FDA and drug manufacturers agree on post-approval study conditions prior to a drug’s accelerated approval (AA) and require more regular study progress updates from manufacturers. The proposals also sought to permit the FDA to require studies to be…

The FDA has issued a warning letter to a Lake Forest, Calif.-based biologics company, Invitrx Therapeutics, for selling unapproved allogenic cellular-derived drugs, including a human umbilical cord-derived product. Source: Drug Industry Daily

Accelerated approval (AA) was catapulted directly into the public eye with the FDA’s controversial approval of Biogen’s Alzheimer’s drug Aduhelm (aducanumab) 18 months ago on the shaky success of its surrogate endpoints — and the pathway has stayed firmly in the limelight ever since, facing increasing scrutiny from seemingly all quarters. Source: Drug Industry Daily

CSL Behring has won FDA approval for Hemgenix (etranacogene dezaparvovec-drlb), a gene therapy with the potential to cure hemophilia B and — at $3.5 million per treatment — the most expensive drug in the world. Source: Drug Industry Daily

Three union pension funds have filed a class action antitrust suit against Bristol Myers Squibb (BMS) and several generic drugmakers claiming the companies conspired to restrict competition on blockbuster blood cancer drug Revlimid (lenalidomide) and share in the profits, thus creating a monopoly. Source: Drug Industry Daily

The FDA is proposing to add arginine hydrochloride (HCl) and lysine HCl to its 503B Bulks List of active pharmaceutical ingredients approved for compounding. Source: Drug Industry Daily

Newly proposed bipartisan legislation would require the Drug Enforcement Administration (DEA) to reclassify psilocybin and MDMA (“Ecstasy”) from Schedule I to Schedule II drugs, relaxing some of the federal laws that have so far complicated research on strictly controlled psychoactive drugs. Source: Drug Industry Daily

Two years after its blood cancer treatment Blenrep (belantamab mafodotin) won accelerated approval from the FDA, GSK has removed the drug from the market in the U.S. at the FDA’s request. Source: Drug Industry Daily

Complete document archives with self-explanatory file names are the top two — out of the top 10 — ways to be prepared for an FDA inspection, advised an FDA inspections expert at the WCG FDAnews Annual FDA Inspections Summit in Washington, D.C., Nov. 16-18. Source: Drug Industry Daily