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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are pressing the FDA for more leeway on approaches to developing drugs for Duchenne Muscular Dystrophy, saying a June draft guidance doesn’t go far enough.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
IPEC-Americas is urging excipient makers to follow its voluntary guideline on stability testing in the wake of recent requests by foreign regulators for stability data. 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
Two FDA advisory panels will meet next month to discuss the effect of food intake on Purdue Pharma’s and Collegium Pharmaceuticals’ oxycodone drugs. Read More
Eli Lilly picked up another court win for its blockbuster antidepressant Cymbalta, when a California federal jury determined the company wasn’t liable for a woman’s severe withdrawal symptoms. Read More
Drugmakers will have to provide more benefit-risk information in common technical documents submitted to the FDA, European Medicines Agency and other regulators, under revised guidance from the International Conference on Harmonisation. Read More
The FDA’s Office of Prescription Drug Promotion warned a Valeant Pharmaceuticals subsidiary for failing to include risk information in promotional material for a cough suppressant. Read More