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  • FDA limits amount of acetaminophen in prescription drugs

    SILVER SPRING, Md. — The Food and Drug Administration is capping the amount of the painkiller acetaminophen in prescription drugs due to the risk of liver toxicity, the agency said Thursday.

  • Novo Nordisk develops Cornerstones4Care as diabetes resource

    PRINCETON, N.J. — Danish drug maker Novo Nordisk has created an online resource for diabetes patients that educates them about Novo Nordisk drugs and devices, recipes and nutritional values, and allows them to connect with other patients.

  • Study: Healthcare companies think REMS in need of major overhaul

    BOSTON — Various companies in the healthcare industry are uncertain about the benefits of the Food and Drug Administration’s risk evaluation and mitigation strategy program, and most think it needs a major overhaul, according to a study by the Tufts University Center for the Study of Drug Development.

    The CSDD called the study the first systematic look at REMS since the FDA introduced the program in 2008. The FDA requires drug companies to create a REMS when the agency decides it is necessary to ensure that a drug’s benefits outweigh its risks.

  • Merck to develop biosimilars with Parexel

    WHITEHOUSE STATION, N.J. — Drug maker Merck and drug industry services organization Parexel International will work together to develop biosimilars, the two said Wednesday.

    Under the agreement, Parexel will give Merck BioVentures access to clinical and regulatory services for the development of biosimilars. Financial terms of the agreement were not disclosed.

  • BI, Lilly form strategic partnership for diabetes drugs

    INDIANAPOLIS — U.S. drug maker Eli Lilly and German drug maker Boehringer Ingelheim will collaborate to develop drugs for diabetes, the companies said Tuesday.

    The agreement centers around investigative drugs currently in mid- to late-stage clinical development, including two oral drugs made by BI, BI10773 and linagliptin, and two basal insulin analogues made by Lilly, LY2605541 and LY2963016. The deal also includes options to develop and commercialize a Lilly monoclonal antibody.

  • FDA accepts application for extended-release Janumet

    WHITEHOUSE STATION, N.J. — The Food and Drug Administration has accepted a regulatory approval application for a drug to treat Type 2 diabetes made by Merck, the drug maker said Tuesday.

    Merck announced the acceptance of its application for extended-release Janumet, which combines in a single pill the active ingredient sitagliptin with extended-release metformin, a drug commonly prescribed for Type 2 diabetes.

  • Bayer: Betaseron not affected by prep pads recall

    WAYNE, N.J. — Bayer HealthCare Pharmaceuticals sought to reassure healthcare professionals and their patients that a recall of alcohol prep pads distributed with its multiple sclerosis drug did not affect the drug itself.

    The drug maker’s MS treatment Betaseron (interferon beta-1b) is distributed with prep pads made by Triad Group, which recently staged a recall of prep products due to potential contamination with Bacillus cereus bacteria, which would lead to life-threatening infections.

  • Sanofi, Genzyme get closer to deal

    CAMBRIDGE, Mass. — It appears that French drug maker Sanofi-Aventis’ efforts to acquire U.S. biotech company Genzyme are getting somewhere, according to company and media reports.

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