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Amgen and Novartis have launched a neuroscience drug collaboration to develop and commercialize new inhibitors to fight Alzheimer’s disease and treat migraines. Read More
The FDA has approved Merck’s anti-nausea and vomiting drug Emend for children undergoing chemotherapy, making the drug the first and only NK1 receptor antagonist for this indication. Read More
Leaders of the House Energy & Commerce Committee are asking FDA Acting Commissioner Stephen Ostroff to explain what steps the agency is taking to address safety concerns around the blood thinner Coumadin and its generic version, warfarin. Read More
HHS Wednesday proposed an overhaul of human research subject protections, including simpler informed consent forms, informed consent for secondary research using biospecimens and using a single IRB for all domestic sites in multisite clinical trials. Read More
Allergan said Wednesday that results from two Phase 3 studies evaluating Avycaz in hospitalized adults with complicated urinary tract infections, including pyelonephritis, affirm the drug’s safety and efficacy. Read More
By a two to one vote, a Federal Circuit Court of Appeals panel cleared the way for Sandoz’s launch of Zarxio, the first FDA-approved biosimilar, as early as today. Read More
Requiring drug compounders to provide information on all products taken by a patient that may be “suspect” in an adverse reaction would be unduly burdensome, necessitating full access to a patient’s medical records, the International Academy of Compounding Pharmacists says. Read More