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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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The U.K. drugmaker also announced plans to drop another $2 billion on expanding its R&D and manufacturing footprint in the “important” U.S. market.
Bayer reported a decline of 37% in earnings per share on Tuesday, which sent its stock down 12%. CEO Bill Anderson urged investors to be patient as the company executes on a performance-boosting strategy outlined in March.
BioSpace takes a look at the headlines across a heavy earnings week for biotechs, checking in on Allogene, Rapport and more.
With $70 million upfront and more than $1.8 billion on the line, Roche will gain access to Flare’s drug discovery engine to bolster its oncology pipeline.
In a small Phase IIa trial, Insilico’s generative AI-designed idiopathic pulmonary fibrosis drug improved lung function and was well-tolerated across all dosing groups.
In line with the restructuring initiative, 23andMe is looking for strategic opportunities for its pipeline assets, including licensing deals or outright sales.
Analysts did not seem very concerned by the treatment-related serious adverse event, noting that NGN-401 was well-tolerated at a lower dose and showed promising efficacy outcomes.
CEO Roberto Iacone admitted in an interview that the market remains tough, even for a biotech in the red-hot ADC world. But Alentis is targeting an IPO as early as 2025.
BioSpace has named 50 biopharma companies to its 2025 Best Places to Work list, including Moderna and Sutro Biopharma, whose executives share what makes their organizations special.
The shocking failure of AbbVie’s emraclidine has investors questioning the Big Pharma’s long-term neuroscience strategy, which put the drug at the center of expectations.