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The FDA has extended until Nov. 27 its deadline for deciding whether to approve Bristol-Myers Squibb’s sBLA for Opdivo in previously untreated advanced melanoma to allow the company to present additional data from a Phase 3 clinical trial. Read More
AbbVie said it will seek FDA approval later this year for its investigational leukemia treatment venetoclax, after the drug met its primary goal in a Phase 2 trial. Read More
Proteon Therapeutics has enrolled its first patient in a second Phase 3 clinical study evaluating vonapanitase as a guard against vascular access failure in hemodialysis patients. Read More
Drugmakers in Australia are urging the Therapeutic Goods Administration to raise the number of patients required for classifying an orphan disease, saying it would bring the threshold in line with the EU, Canada and Switzerland. Read More
Drugmakers and patient groups are pressing the FDA for more leeway on approaches to developing drugs for Duchenne Muscular Dystrophy, saying a June draft guidance doesn’t go far enough. Read More
Sanofi has joined with Germany’s Evotec to develop new treatments for cancer and diabetes, marking the latest collaboration the French drugmaker has announced in recent weeks. Read More
For the third time in less than a week, AstraZeneca has entered into a deal to boost its cancer drug pipeline, this time via a $727.5 million licensing and collaboration agreement with Inovio Pharmaceuticals to develop DNA-based immunotherapies. Read More
The European Medicines Agency is declaring that six classes of diseases occur in children, forcing drugmakers to conduct pediatric tests prior to approval. Read More
Drugmakers developing treatments for diabetic and idiopathic gastroparesis should study those patient populations in separate trials, the FDA says. Read More
The Critical Path Institute has formed the Global Pediatric Clinical Trials Network Pre-Launch Consortium to facilitate treatments for infants, children and adolescents — a top FDA priority. Read More