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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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Backed by biopharma royalty, Areteia Therapeutics will focus on developing an old molecule for a very prevalent disease - asthma.
Genentech has exercised the second option in its potentially $1.7 billion agreement with Bicycle Therapeutics, triggering a $10 million payment.
Nanoscope Therapeutics will make two presentations at the 2022 ASRS meeting on their gene therapy programs to treat degenerative retinal diseases, retinitis pigmentosa and Stargardt disease.
Verve Therapeutics dosed its first patient with VERVE-101, a one-time treatment that aims to permanently lower low-density lipoprotein (LDL) cholesterol in patients and prevent heart disease.
Flagship Pioneering has launched Apriori Bio, which utilizes artificial intelligence to predict virus activity and variant formation, including COVID-19.
uniQure gave a 12-month update on AMT-130, the first-ever AAV gene therapy for HD to enter clinical trials. BioSpace spoke with the company’s president of R&D, Dr. Ricardo Dolmetsch.
Exelixis’ Cabometyx, in combination with two BMS-owned drugs, hit the primary endpoint of progression-free survival but missed the secondary endpoint of overall survival in renal cell carcinoma.
Vertex Pharmaceuticals plans to acquire ViaCyte for $320 million in cash. ViaCyte focuses on stem cell-derived cell replacement therapies that they hope will cure type 1 diabetes (T1D).
Tonix Pharmaceuticals announced a mid-stage study for major depressive disorder, which followed the June disclosure of a Phase II study for a cocaine intoxication therapy.
Innoviva Inc. and La Jolla Pharmaceutical Company announced Monday that they had entered into a $149-million merger agreement.