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  • Court rules in favor of Mylan in suit against GSK over antidepressant drug

    PITTSBURGH — A federal court has ruled that a Mylan lawsuit against GlaxoSmithKline over an antidepressant drug can go to trial, Mylan said Tuesday.

    Mylan alleges that GlaxoSmithKline breached a contract the two companies had made when it agreed to supply competing drug maker Apotex with paroxetine hydrochloride extended-release tablets, a generic version of Paxil CR. The Third Circuit Court of Appeals' ruling reversed a summary judgment dismissing Mylan's claim.

  • Legislation would exempt GDUFA payments from sequester

    WASHINGTON — A new bill would exempt user fees paid by drug companies to the Food and Drug Administration — including those of generic drug makers — from the automatic federal budget cuts that went into effect in March, commonly known as the sequester.

    The bill, the FDA Safety Over Sequestration Act, received sponsorship from Reps. Leonard Lance, R-N.J.; Anna Eshoo, D-Calif.; Doris Matsui, D-Calif.; and Mike Rogers, R-Mich. Generic drug industry trade group the Generic Pharmaceutical Association heralded the bill.

  • FDA approves Astellas drug for preventing kidney rejection

    NORTHBROOK, Ill. — The Food and Drug Administration has approved a drug made by Japanese drug maker Astellas for preventing the body from rejecting transplanted organs, the company said.

    Astellas announced through a U.S. subsidiary that the FDA had approved Astagraf XLTM (tacrolimus) extended-release capsules for preventing rejection of transplanted kidneys, for use with Genentech's CellCept (mycophenolate mofetil) and corticosteroids, with or without Simulect (basiliximab), a biotech drug made by Swiss drug maker Novartis.

  • HPV vaccination rates higher among boys when mothers receive preventive care, study finds

    PASADENA, Calif. — Boys whose mothers receive flu shots or Pap screenings are more likely to receive the human pappilomavirus vaccine, according to a new study.

    The study, conducted by Kaiser Permanente and published in the American Journal of Public Health, was based on electronic health records of more than 250,000 boys aged 9 to 17 enrolled in the Kaiser Permanente Southern California health plan.

  • Royalty Pharma hires former Morgan Stanley analyst as VP

    NEW YORK — Royalty Pharma has hired Marshall Urist as VP research and investments, the company said Friday.

    Royalty, which invests in royalty interests in drugs, hired Urist from Morgan Stanley, where he worked most recently as executive director and the senior biotechnology analyst.

    "We are excited to have Marshall join our team," Royalty founder and CEO Pablo Legorreta said. "He has had a distinguished career on Wall Street, and this experience, coupled with his deep analytical skills, make him an excellent addition to Royalty Pharma."

  • Purdue Pharma wins award for drug abuse-deterrent website

    STAMFORD, Conn. – A drug-safety website operated by drug maker Purdue Pharma has won accolades from an international awards program for marketing and communications.

  • Study finds significant increase in drug approvals for neglected diseases

    BOSTON — Almost twice as many drugs for neglected diseases have received regulatory approval around the world over the past few years compared with the beginning of the last decade, according to a new study.

  • Pain specialists more comfortable than primary care doctors with prescribing abuse-deterrent opioids, study finds

     BURLINGTON, Mass. — New, abuse-deterrent formulations of two opioid painkillers have not necessarily reduced doctors' unease with prescribing them, according to a new study.

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