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Under the temporary reign of top food executive Kyle Diamantas, the FDA will sustain programs initiated by former Commissioner Marty Makary, including the Commissioner’s National Priority Voucher initiative.
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Partners Summit Therapeutics and Akeso are expected to steal the show at the American Society of Clinical Oncology’s annual conference with data from their potential Keytruda rival, alongside Revolution Medicine’s groundbreaking pancreatic cancer candidate and other assets that could reshape patient care.
The tragic tale of TIGIT is well known. However, RIPK1, myc, STING and alpha-synuclein have also left a trail of failed clinical trials, canceled partnerships and sunk investments in their wake.
Analysts homed in on Duchenne muscular dystrophy and myotonic dystrophy type 1 assets during first quarter earnings as major players like REGENXBIO and Novartis as well as Dyne, Wave, Solid and Sarepta near the regulatory finish line.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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Finch announced that it is slashing its headcount by around 37% and suspending its planned Phase I study in autism a week after Takeda withdrew from its multi-year collaboration.
The Administrative Law Judge overseeing the FTC’s challenge of Illumina’s acquisition of Grail rejected the regulator’s anti-competition argument, Illumina announced Thursday.
It’s been a busy week for research on rare diseases, with several clinical trials from AnaptysBio, Regenxbio, Sangamo and more posting results from ongoing activities.
A cell and gene therapy accelerator formed by Mayo Clinic, Hibiscus BioVentures and Innoforce is officially up and running, the partners announced this week.
Hard times are forcing biopharma companies to extend their runways as they try to eke out every cent of value from their capital.
Biopharma and life sciences companies, such as Seraxis, Verily and Vaxart, tap new members to bolster their leadership teams in roles like CMO, CTO, CCO, and more.
Shares of AnaptysBio are down more than 16% after imsidolimab failed to meet the endpoint in a Phase II trial assessing its efficacy in hidradenitis suppurativa.
Provention Bio secured a $125 million loan from Hercules Capital that will support operations and the potential launch of the company’s type 1 diabetes treatment, teplizumab.
Novo Nordisk has entered into an agreement to acquire Forma Therapeutics for $1.1 billion. Forma’s lead development candidate, etavopivat, is being developed for sickle cell disease.
On Wednesday, the FDA authorized new Omicron-specific booster shots for Pfizer-BioNTech and Moderna’s COVID-19 vaccines despite a lack of human data.