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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are pressing the FDA for more leeway on approaches to developing drugs for Duchenne Muscular Dystrophy, saying a June draft guidance doesn’t go far enough.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
Bristol-Myers Squibb cut short a Phase 3 study of Opdivo for the treatment of renal cell carcinoma after the immunotherapy drug met its primary endpoint versus everolimus, the current standard treatment. Read More
The FDA is calling for increased focus on the underlying biology of diseases like Alzheimer’s and diabetes, noting that the discovery of biomarkers has led to important breakthroughs for cancer and HIV/AIDS. Read More
Sponsors of new drug applications in China must submit comprehensive data showing adherence to clinical trial requirements by Aug. 25 — in a surprise move that could prompt noncompliant or unprepared companies to withdraw their applications, reducing a pending backlog of more than 1,600. Read More