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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