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Compass Pathways has completed an FDA filing for COMP360, with an expected launch in the first half of next year. The update follows a reported regulatory submission for Usona Institute’s own psilocybin candidate for depression last Monday.
A Phase 3 trial showed that Johnson & Johnson and Protagonist Therapeutics’ oral therapy Icotyde improved psoriatic arthritis symptoms but AbbVie’s injectable is likely to hold court based on higher efficacy, analysts say.
Full data from the Phase 3 HORIZON trial of Novartis’ pelacarsen failed to show any apparent benefit, leading analysts to further reduce the odds of success for Lp(a)-lowering competitors such as Amgen’s olpasiran.
Unnatural Products has risen from founder Joshua Schwochert’s garage to an acquisition deal, valued at up to $1.15 billion, to join argenx.
After Novartis confirmed the reports of tumors in patients who have been treated with the spinal muscular atrophy gene therapy, the FDA will determine if any regulatory action is needed for Zolgensma or for the pharma’s similar product Itvisma.
Follow along as BioSpace tracks job cuts and restructuring initiatives.
At the American Heart Association conference, investigators were supportive of further studying Novo’s IL-6 inhibitor ziltivekimab in patients with less severe cardiovascular and kidney disease.
After emraclidine’s schizophrenia fail and Cobenfy’s laggard launch, it’s too early to know who made the better buy: AbbVie, in its $8.7 billion Cerevel takeover in late 2023, or Bristol Myers Squibb, which spent $14 billion for Karuna just two weeks later.
Inclusion of the patient perspective is currently an “optional” part of the rare disease drug development process, CBER Director Karim Mikhail told BioSpace. Mikhail, along with his CDER counterpart Michael Davis and other agency rare disease leaders, is trying to change that.
SK pharmteco’s Tatiana Nanda, chief technical officer of SK pharmteco Viral Vector North America discusses what gene therapy sponsors must account for sooner rather than later when preparing for GMP manufacturing.