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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.
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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.
Also lined up are target action dates for Sanofi’s Gaucher disease therapy, GSK’s lung cancer medicine and BridgeBio’s muscular dystrophy drug.
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Watching the baseball playoffs this week, I was struck by the parallels between the Los Angeles Dodgers and Eli Lilly. Both franchises spend a lot of money and always appear to come out on top.
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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.
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.
While Moderna preps an entry to the oncology market next year with a personalized cancer vaccine, COVID sales are holding steady with several other vaccine launches underway around the world.
The BioSpace 40 Under 40 honoree helped steer Forge’s sale to Ajinomoto. Now, Samantha Piteri-Molina sees opportunities in AI-driven analytics and Ohio’s gene therapy ecosystem—with a responsibility to patients worldwide.
Sarepta Therapeutics’ newly minted CEO Michael Severino laid out his path to returning the muscular dystrophy therapy maker to the forefront of the rapidly expanding market.
Personalized cancer vaccines are getting closer to market. Merck and Moderna just showed successful manufacturing in a large Phase 3 trial, proving they can deliver the goods.
Pent-up demand for the new pancreatic cancer therapy Rasonque helped RevMed soar past analysts’ sales expectations and reach 5,000 patients in the third quarter.
With backing from three Big Pharma investment arms, British biotech T-Therapeutics is brewing up a clinical launch for its cancer and autoimmune T cell engagers.
Evommune is commiting $30 million upfront for Hinova Pharmaceuticals’ oral molecular glue degrader—a low-cost bet with a high probability of success, according to analysts, after clinical failures roiled the biotech’s internal pipeline earlier this year.
AstraZeneca has apparently made a $10 billion bid to acquire Rhythm Pharmaceuticals, an offer William Blair suspects will not be the last for the hot ticket metabolic biotech.