While the U.S. FDA didn’t ask for more study data or have safety or efficacy concerns, it does want modifications to Alexion, Astrazeneca Rare Disease’s sBLA for Ultomiris (ravulizumab-cwvz) to treat adults with the rare central nervous system disease neuromyelitis optica spectrum disorder. The agency has issued a complete response letter (CRL) requesting changes to Ultomiris’ Risk Evaluation and Mitigation Strategy (REMS) to better validate patients’ meningococcal vaccination status or prophylactic administration of antibiotics before being treated.

Otsuka Pharmaceutical Co. Ltd. announced plans to acquire Mindset Pharma Inc. for C$80 million (US$50.76 million) in an all-cash deal that will see Otsuka strengthen its neurology and psychiatric pipeline. Mindset, of Toronto, is developing next-generation psychedelic therapeutics to treat psychiatric and neurological disorders with high unmet needs.

Sage Therapeutics Inc. is reducing its workforce by 40% and pausing its earlier-stage programs, just a few weeks after receiving mixed news of both a U.S. FDA approval and a complete response letter for its depression drug Zurzuvae (zuranolone). The move offers the Cambridge, Mass.-based company an annualized net savings of approximately $240 million, 60% of which is related to R&D, and will extend its runway into 2026.

“I am not a fortune teller, nor am I a gambler. I will make no bets,” Lorraine Kalia told the audience at the 2023 International Congress of Parkinson’s Disease and Movement Disorders. “But I am optimistic.” At the meeting, which is being held in Copenhagen this week, Kalia, who is a scientist at Toronto Western Hospital’s Krembil Brain Institute and at the University of Toronto’s Tanz Centre for Research in Neurodegenerative Diseases, was giving an overview of “Emerging targets in the clinic” in a plenary session on “Therapeutic strategies for the future.”

The first special purpose acquisition company (SPAC) merger announced in 2023 has fallen apart. Aprinoia Therapeutics Inc. and Ross Acquisition Corp. II mutually agreed to call off the merger that had been valued at $280 million. The failed deal is part of a larger trend that has gained momentum in the past year as a struggling economy and tighter U.S. SEC restrictions dampened SPAC deals.

Scientists have discovered that a small chemokine protein released by activated platelets, platelet factor 4 (PF 4), reduced neuroinflammation, and improved cognition in aged mice. The study was published on Aug. 16 in the online edition of Nature.