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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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BigHat Biosciences will team up with Merck to design candidates for three drug discovery programs backed by the company’s proprietary AI technology platform.
BMS is terminating a seven-year-old gene therapy collaboration to develop potential treatments for congestive heart failure with uniQure N.V. valued at $1 billion.
With $96 million in Series A financing, Cajal Neuroscience launched Tuesday to develop drug candidates to target neurodegeneration in Alzheimer’s and Parkinson’s diseases.
As the FDA cracks down on accelerated approvals, Genentech, a Roche company, voluntarily withdrew its monoclonal antibody, Tecentriq, for metastatic bladder cancer.
AstraZeneca and Neogene have entered into a definitive acquisition agreement in which AstraZeneca will buy all outstanding equity in the smaller company.
A second patient death has been linked to the Phase III clinical trial of Eisai and Biogen’s investigational Alzheimer’s drug lecanemab, according to the journal Science.
BioMark Diagnostics Inc. (CSE: BUX) (FSE: 20B) (OTC Pink: BMKDF) (“BioMark” or the “Company”) (an advanced stage liquid biopsy company with a focus on hard to detect and treat cancers is pleased to reports that it will amend the term of the non-broker warrants (the “Warrants”) issued in relation to a private placement financing that closed on December 13, 2019 on a continuing effort to improve corporate value for its shareholders.
Spectrum Pharmaceuticals made the call Friday to slash three-fourths of its workforce on the heels of a Complete Response Letter from the FDA.
Shares of CinCor Pharma fell more than 50% in premarket trading Monday after its investigational blood pressure drug failed to meet the primary endpoint in a Phase II trial.
Many executives haven’t established their personal brands or even know that they need one. BioSpace spoke with top executives in the field to learn about the importance of a personal executive brand.