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An FDA advisory committee voted to recommend that Wyeth’s Mylotarg return to the U.S. market as a treatment for CD33-positive acute myeloid leukemia in combination with daunorubicin and cytarabine. Read More
The FDA plans to expand its capabilities in high performance computing to help build disease models and simulate clinical trials, as part of an agency “innovation initiative” announced July 7 by Commissioner Scott Gottlieb. Read More
The project will focus on modernizing the agency’s regulatory processes and reducing the time, cost and uncertainty of bringing a product to market. Read More
The FDA plans to expand its capabilities in high performance computing to help build disease models and simulate clinical trials — as well as establish a new framework for regenerative medicine this fall — as part of an agency “innovation initiative” announced Friday by Commissioner Scott Gottlieb. Read More
The decision comes after a review by a data monitoring committee that found more deaths were observed in the Keytruda arms of two Phase III studies. Read More
The European Medicines Agency and the European Network for Health Technology Assessment have developed a joint platform for parallel consultations on evidence plans for marketing authorizations and health technology assessments to provide sponsors with simultaneous, coordinated advice on development strategies. Read More
The FDA and the European Medicines Agency released a draft joint plan Monday to support the development of pediatric treatments for Gaucher disease — an approach the agencies say can apply to rare diseases in general. Read More
The FDA plans to use its emerging technology program to help address key pharmaceutical quality and manufacturing challenges — and also train agency reviewers on the latest processes to keep pace with industry innovation. Read More
The FDA has released a new draft guidance that clarifies the Part 11 regulations for electronic records and signatures as they apply to clinical trials, including validation of mobile and wearable technology and the use of outsourcing and contracting. Read More