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Pfizer is calling upon lessons learned from one of the first drugs ever made available on the internet—Viagra—as it commercializes a new obesity drug in China.
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.
The Swiss contract development and manufacturing organization will more than double its U.S. footprint by acquiring the Merck KGaA plants.
Neurocrine Biosciences will conduct a new study for the rare disease drug Vykat to explore dosing and safety in patients with Prader-Willi syndrome who have complex health issues.
Novartis is discontinuing a neurodegeneration alliance with BioArctic in which the companies aimed to develop a drug candidate that could cross the blood-brain barrier.
Sales of assets from Seagen and Biohaven grew in the third quarter, but it wasn’t enough for Pfizer to overcome declines across the Prevnar and COVID franchises.
Debtor-in-process financing up to $55 million could keep the lights on at Karyopharm Therapeutics for its multiple myeloma and myelofibrosis programs as the biotech waits to see if its union with Ayrmid will go through.
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.
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.