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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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Sonoma Bio announced its plans to erect an 83,000-square-foot operations facility in Seattle, while Thermo Fisher opened a new viral vector manufacturing plant in Massachusetts.
Anthony Quinn has stepped down from his role as chief executive officer and transitioned to an advisory role. Jim Kastenmayer, general counsel, will assume the post on an interim basis.
In an interview with Reuters, AstraZeneca CEO Pascal Soriot said Tuesday that he isn’t sure if the company will continue developing vaccines. He also hinted at potential M&A action.
Layoffs at Atara have begun weeks after the Bay Area company announced plans to terminate 20% of its staff under a new corporate strategy focused on the innovation within the company’s pipeline.
Money is now flowing into promising platforms for prostate cancer from AdvanCell, mRNA therapeutics from eTheRNA, hepatitis from Bluejay and more.
Of the 1,400 jobs Novartis plans to eliminate in Switzerland, about half will include leadership and management positions, the company reported Monday.
BrainVectis will begin assessing a gene therapy for Huntington’s disease in France after receiving clearance from health authorities there to conduct a Phase I/II study.
A day after Pfizer and partner BioNTech submitted an EUA request to the FDA for their booster shot targeting Omicron variants BA.4 and BA.5, the regulator appears close to approving it.
Alcon announced it is buying out Aerie Pharmaceuticals for about $770 million to gain access to the ophthalmic pharma firm’s open-angle glaucoma and ocular hypertension treatments.
Shares of Foghorn are tumbling after the FDA placed a full clinical hold on a Phase I dose escalation study that had already been subject to a partial hold following a patient death.