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Drugmakers can now make minor changes to drug safety assurance plans without waiting for FDA approval, reducing some of the burden of managing risk evaluation and mitigation strategies. Read More
The European Medicines Agency has approved a new use of Amgen’s Vectibix as first-line treatment in combination with Folfiri chemotherapy for metastatic colorectal cancer, the drugmaker said Monday.
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The FDA issued priority review vouchers to sponsors of two rare pediatric disease therapies, United Therapeutics’ cancer drug Unituxin and Asklepion Pharmaceuticals’ Cholbam for a severe metabolic disorder. Read More
Drugmakers exporting drugs from India must now include barcodes on all tertiary and secondary packaging. The policy, intended to assure the safety and effectiveness of therapies reaching patients in the U.S. and elsewhere, affects drugs made on or after April 1, 2015. Read More
The European Medicines Agency has greenlighted AbbVie’s Humira for the treatment of severe chronic plaque psoriasis in children and adolescents who have had an inadequate response to or are poor candidates for topical and photo therapies. Read More
Roche adequately warned of the risks of ingesting acne drug Accutane after April 10, 2002, a New Jersey judge ruled last week, resolving lawsuits filed by people in the state who used the product since that date. Read More
The FDA’s Office of Prescription Drug Promotion wants to know how consumers perceive drugmakers’ comparisons of pricing and efficacy information in advertisements. Read More
The Centers for Medicare & Medicaid Services has announced that it plans to begin paying for biosimilars through its Part B, Part D and state coverage policies by this summer. Read More
More new drugs are winning approval on their first FDA review than at any time in the last seven years, a review of the agency’s performance has found. Read More
Japan on Wednesday launched a new government agency to spearhead medical research and drug development through partnerships with industry and academia. Read More