Longtime Seattle Genetics COO Jumps Ship to Helm Biotech Startup Silverback Therapeutics
The COO of Seattle Genetics, Eric Dobmeier, is leaving the company to helm Silverback Therapeutics. Source: BioSpace
Gilead Commits $100M to Tackle the HIV/AIDS Epidemic in the Southern U.S.
Gilead will partner with three coordinating centers to lead the corporate giving program of the initiative. Source: BioSpace
Ultragenyx Stock Booms After Burosumab Continues to Impress in Phase III Study
Shares of Ultragenyx are sharply climbing this morning after the company announced positive results from its Phase III study of burosumab in adults with XLH. Source: BioSpace
EMA’s PRAC Revises Methods for Measuring Pharmacovigilance Impacts
The European Medicines Agency’s pharmacovigilance committee revised its methods for measuring the health outcomes of its major regulatory interventions, aiming to improve industry safety monitoring practices and find out which…
EMA Updates Brexit Guidance With Info for Generics Manufacturers
The European Medicines Agency and the European Commission broadened their guidance on Brexit to include new information for manufacturers of orphan drugs, generics and biosimilars, as well as hybrid medicines…
FDA Expects IV Saline Shortage to Improve by Year’s End, Shifts Focus to Amino Acids
The FDA remains seriously concerned about drug shortages as manufacturers in Puerto Rico continue their slow recovery from Hurricane Maria, but the shortage of IV saline product should improve by…
FDA Approves Monthly Buprenorphine MAT for Opioid Use Disorder
The FDA approved Invidior’s Sublocade, the first once-monthly buprenorphine injectable as a medication-assisted treatment for opioid use disorder. Source: Drug Industry Daily
Foundation Medicine Wins Approval From the FDA and Medicare for First-of-Its-Kind Cancer Test
Foundation Medicine's sequencing diagnostics test for solid tumors that can detect cancer-causing mutations in 324 genes was approved by the FDA Thursday. Source: BioSpace
Why This 6-Employee Biotech's Stock Jumped 2,000% in Just Three Days
The spike began after the six-person company announced it had entered into a multi-year services agreement with Merck KGaA. Source: BioSpace
Higher Death Rate Forces Bayer to Stop Xofigo/Zytiga Combo Late-Stage Study Early
An IDMC told Bayer that it should unblind its Phase III clinical trial in prostate cancer in order to further analyze an increased number of fractures and deaths. Source: BioSpace
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