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The FDA has largely succeeded in expediting the review of drugs with larger health gains, but postmarket trials by companies have fallen behind in confirming some of those benefits, with many not using the gold standard of randomized controlled trials, according to two independent studies. Read More
Biocon said it plans to re-submit applications for European approval of two cancer-treatment biosimilars as soon as it corrects serious GMP deficiencies found at a Bangalore manufacturing plant. The company said it intends to fix the problems by Sept. 30. Read More
Drugmakers need to provide adequate details — and include narratives — in describing manufacturing processes in their applications, but can leave out elements such as machinery serial numbers and general GMPs, according to the European Medicines Agency. Read More
China’s high court called for severe criminal punishments for deliberately falsifying drug clinical trial reports and other related documents, issuing a judicial interpretation that takes effect Sept. 1. Read More
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
An FDA advisory panel unanimously recommended that the agency approve two biosimilars for the cancer treatments Avastin (bevacizumab) and Herceptin (trastuzumab). Read More
Biologics sponsors will only need to report minor postapproval manufacturing changes on an annual basis, said the FDA in a new draft guidance. Read More