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The China State Council is calling for sweeping reforms of the country’s drug regulatory system, including accelerated approvals of novel drugs, specified timelines for deciding applications and increased public access to applications and information. Read More
Seattle Genetics has received FDA approval for its cancer drug Adcetris to treat patients with Hodgkin lymphoma who are at high risk of relapse following an autologous haematopoietic stem cell transplant to help curb the disease’s progression. Read More
Upsher-Smith Laboratories has launched its generic version of Actavis’ Alzheimer’s drug Namenda immediate release in the U.S. market, following FDA approval of an ANDA, the company said Aug. 10. 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 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
Japan’s Pharmaceuticals and Medical Devices Agency was quicker to approve more new drugs in 2014 than its U.S. and EU counterparts, according to a new study released by the Centre for Innovation in Regulatory Science. 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