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Drugmakers can reduce the time it takes to obtain marketing authorization from EU regulators by about two months if they seek scientific advice and make suggested changes to their clinical development plans, a new analysis shows. Read More
The FDA is advising devicemakers that plan to support a premarket submission with data from clinical studies conducted outside the U.S. to meet with the agency before finalizing their trial designs. Read More
The FDA saw an 11 percent increase in inspections carried out as part of a sweeping program to improve inspectors’ understanding of clinical practices during fiscal year 2014. Read More
Gilead Sciences is poised to enter the fledgling field of epigenetics after signing a definitive deal to purchase Denmark-based EpiTherapeutics for $65 million. Read More
Drugmakers are getting better at reporting clinical trials results in a timely manner, with only 10 percent of studies on new treatments approved by the European Medicines Agency in 2012 not disclosed within 12 months, a new study shows. Read More
Johnson & Johnson’s Janssen subsidiary has enlisted a leading bioethicist to help the company determine who should qualify for compassionate use of its experimental drugs, in what J&J is billing as a first-of-its-kind partnership. Read More
The FDA has granted breakthrough therapy designation to AbbVie’s venetoclax to treat relapsed or refractory chronic lymphocytic leukemia in people with a certain genetic abnormality — paving the way for its speedy development and review. Read More
Sponsors seeking Canadian approval of new drugs or indications based on published literature or postmarketing data need to be able to prove that their drug is comparable to its reference product, regulators says. Read More