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The UK’s healthcare cost watchdog issued a mixed bag of recommendations Wednesday, supporting Pfizer’s Inlyta as a second-line treatment for advanced kidney cancer while nixing Dendreon’s Provenge for asymptomatic or minimally symptomatic metastatic hormone-relapsed prostate cancer. Read More
The FDA has laid out a regulatory research agenda for the year that includes identifying better methods for assessing generics, improving drug safety, biosimilars development and finding ways to assess advanced, new drugs as areas where the agency would like to sponsor research. Read More
Quality problems at an India contract manufacturer are prompting Sagent Pharmaceuticals to recall its injectable atracurium besylate and shift manufacturing of the drug to its U.S. facility, leading to a likely shortage of the product. Read More
Merck signed an agreement with the Medicines Patent Pool opening the door to lower-cost pediatric versions of its HIV drug Isentress in 92 countries with high rates of HIV infection. Read More
South Korea-based Celltrion launched its biosimilar of Janssen’s autoimmune disease therapy Remicade in another 12 European markets, bringing the product’s total presence to 31 countries. Read More
Santarus and Cosmo Technologies have sued Actavis charging its Paragraph IV ANDA against Santarus’ ulcerative colitis therapy Uceris infringes the drug’s patents. Read More
Mexican regulators laid out rules for older biosimilars registered prior to Oct. 19, 2011, when the country’s biosimilarity rules were first established, mandating that companies conduct clinical trials to prove biosimilarity. Read More
The FDA on Monday granted accelerated approval to Novartis’ Farydak, the first histone deacetylases inhibitor for use in treating multiple myeloma. Read More
Drugmakers will be able to make major changes to their products faster under a new European Medicines Agency policy of scheduling new variations reviews weekly rather than monthly. Read More