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Pharma, biotech and life science companies from across the globe share data and progress on pipelines and other company events.
The Christiana Care Health System’s Gene Editing Institute, based in Wilmington, Del., is pulling together a preliminary investigational new drug application (IND) for the U.S. Food and Drug Administration (FDA).
The CRL called for additional CMC and non-clinical information for the post-operative pain treatment. It did not specify any safety or efficacy concerns.
The FDA gave the nod to AbbVie’s Mavyret for all six strains of hepatitis C in children ages 12 to 17 years. The drug was approved for adults 18 years or older in 2017.
The company disclosed the data breach in a filing with the U.S. Securities and Exchange Commission on Tuesday. The hacking occurred in March and the company said the data of about 1 percent of its total number of clients was compromised.
Nabriva Therapeutics announced that the Food and Drug Administration (FDA) had issued a Complete Response Letter (CRL) for its New Drug Application (NDA) for Contepo (Fosfomycin) to treat complicated urinary tract infections (cUTI), including acute pyelonephritis.
Teva Pharmaceuticals recalled 35 lots of bulk Losartan Potassium after a known carcinogen was discovered in the active pharmaceutical ingredient.
NHS England will acquire hepatitis C drugs from the companies at competitive prices and work to identify patients around the country.
The U.S. Department of Health and Human Services Office of the Chief Technology Officer and the American Society of Nephrology have selected 15 winning teams for Phase 1 of the KidneyX Redesign Dialysis prize competition.
uBiome said it “does not have any control over physician billing. Any improper billing by physicians, if it occurred, is not related to uBiome’s billing practices,”
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