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Compass Pathways revealed that an FDA filing for COMP360 will be complete “in the next two weeks,” with an expected drug launch in the first half of next year. The update follows a reported regulatory submission for Usona Institute’s own psilocybin candidate for depression on Monday.
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By allowing compounding pharmacies to produce certain unapproved peptides, the Department of Health and Human Services could, in the short term, put patients in harm’s way. Longer term, the policy shift threatens the industry that brings new medicines to market.
A fresh FDA review for Biohaven’s embattled ataxia drug lifted the biotech’s shares, while a late-stage lung cancer miss battered ArriVent, which failed to rebound even after encouraging early ADC data.
With companies including AstraZeneca, Pfizer and Revolution Medicines clamoring to get in on Summit Therapeutics’ Akeso-partnered PD-1xVEGF antibody, one analyst calls the asset “the next major backbone” of cancer treatment.
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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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The cessation of manufacturing activities follows a Sun Pharma recall and reports that regulators found fault with the company’s quality system.
In a mid-stage trial, the lower dose of Tiziana’s intranasal monoclonal antibody reduced microglial activation in a specific type of multiple sclerosis. But the path forward remains unclear after the higher dose failed to deliver the same benefit.
Sail Biomedicine’s $925 million deal with Johnson & Johnson helped boost the cell and gene therapy sector over biologics in terms of venture capital fundraising in the third quarter.
After a year of controversial regulatory reversals, the FDA has accepted uniQure’s application for ifezuntirgene inilparvovec for priority review, with a May 1 action date. If approved, the therapy—also called AMT-130—would be the first disease-modifying treatment for Huntington’s disease.
Former biologics boss Peter Marks had a vision. With the FDA’s latest draft guidance, it’s coming to fruition. Speaking with BioSpace, current CBER leader Karim Mikhail said the “adapted pathway” is designed to develop personalized gene therapies more quickly.
Saudi Arabia is building the regulatory framework, partnerships infrastructure and IP landscape needed to support a biotech ecosystem, despite regional political instability. Whether it can produce sustainable biotech companies and a resilient manufacturing base for global production remains an open question, but the future looks bright.
If approved, BridgeBio Pharma’s BBP-418—which, according to one Jefferies analyst, boasts “pretty darn compelling” data—would be the first therapy for limb-girdle muscular dystrophy. The FDA has an action date of Nov. 27.
Strong immunology and neuroscience sales fueled AbbVie’s latest quarterly beat as the pharma’s stock continues to hit all-time highs.
“You don’t spend one and a half billion dollars without creating jobs,” AstraZeneca CEO Pascal Soriot said as the pharma announced a new cost savings program alongside third quarter earnings.
Regeneron executives struck an upbeat tone on an investor call Friday as the biotech posted a consensus-beating $5.1 billion in third quarter earnings and CEO Leonard Schleifer touted the company’s ‘disease agnostic’ pipeline and approach to business development.