PHARMACY

UI sues Amgen over patent infringement

BY Alaric DeArment

IOWA CITY, Iowa A major biotech company has trouble with the University of Iowa.

The university is suing Amgen, alleging that it has knowingly infringed on its patents for several years, specifically in its manufacture of drugs such as the rheumatoid arthritis and psoriasis treatment Enbrel (etanercept).

The university is demanding unspecified damages from the Thousand Oaks, Calif., company.

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Glue-like bacterial sugar could lead to vaccine

BY Alaric DeArment

LONDON A study has found that when manipulated with chemicals, a sugar that drug-resistant bacteria secrete triggered an immune response in animals.

The study, presented last week at the Dublin, Ireland, meeting of the Society for General Microbiology used a glue-like sugar that bacteria produce to protect themselves from antibiotics called PNAG.

PNAG alone does not produce an immune response in most people and animals, but the researchers, from the Harvard Medical School, hope that formulations of it do.

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FDA announces likely delay on Novo Nordisk diabetes drug

BY Alaric DeArment

WASHINGTON The Food and Drug Administration has announced that it will be unable to meet the user fee deadline for a timely approval of Novo Nordisk’s drug liragludite.

The FDA will not be able to make an approvability decision until March 23 for the drug, a treatment for Type 2 diabetes. Novo Nordisk had submitted an approval application for the drug on May 23.

The standard review period for FDA action on approval applications is 10 months. Because the agency’s advisory committee meeting will take place shortly before March 23, however, its decision will probably be delayed by a further two months, the company said.

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