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  • GDUFA reduces wait time for generics

    For all the talk about generic drugs and their potential to save piles of money for the country’s healthcare system, it’s going to be a while before many of them actually reach consumers because of the Food and Drug Administration’s huge backlog of generic drug regulatory approval applications.


  • Generics cos. turn to biosimilars as patent cliff approaches

    With the patent cliff and subsequent innovation drought moving closer, generic drug makers are looking to move up the value chain and pursue new sources of revenue, and of all the piles of pay dirt out there, biosimilars represent one of the closest things to an El Dorado, though regulations won’t take their final form for a while.


  • Gilead receives FDA approval for lower-dose HIV drug in children

    FOSTER CITY, Calif. — The Food and Drug Administration has approved a lower-dose formulation of a drug made by Gilead Sciences for treating HIV in children, the company said.

    Gilead announced the FDA approval of Viread (tenofovir disoproxil fumarate) in the 150-mg, 200-mg and 250-mg strengths combined with other antiretroviral drugs in patients ages 6 to 12 years while also approving an oral powder formulation for children ages 2 to 5 years. The agency approved the drug in the 300-mg strength for adults in 2001 and for patients ages 12 to 17 years in 2010.

  • Bristol-Myers Squibb, AstraZeneca diabetes drug hits speed bump at FDA

    PRINCETON, N.J. — The Food and Drug Administration has declined to approve a drug for Type 2 diabetes made by Bristol-Myers Squibb and AstraZeneca, saying it needs additional clinical data, the companies said Thursday.

  • Galderma Labs launches new pump design for rosacea drug

    FORT WORTH, Texas — Galderma Labs has launched a newly designed pump dispenser for a drug used to treat rosacea, the drug maker said Tuesday.

    Galderma announced the availability of the dispenser for MetroGel (metronidazole) gel in the 1% strength. The drug is used to treat bumps and blemishes in patients with rosacea. The Food and Drug Administration approved the pump in October.

  • Jazz Pharmaceuticals, Azur Pharma combine

    DUBLIN — Jazz Pharmaceuticals and Azur Pharma will become one company, the two drug makers said.

    The two said the it now will be a specialty biopharmaceutical company called Jazz Pharmaceuticals plc and will be based in Dublin.

  • Novo Nordisk partners with Paula Deen in new diabetes initiative

    PRINCETON, N.J. — Danish drug maker Novo Nordisk is partnering with cooking show host Paula Deen to launch a campaign to help adults find ways to manage challenges associated with Type 2 diabetes, the company said Tuesday.

    Deen and her sons, Bobby and Jamie, star in a series of videos as part of the Diabetes in a New Light initiative, in which Deen is sharing her personal diabetes story for the first time.

  • PCMA launches advertising campaign

    WASHINGTON — The main lobby representing pharmacy benefit managers is launching an advertising campaign amid scrutiny the industry has received lately from the public and lawmakers.

    The Pharmaceutical Care Management Association announced Tuesday the launch of its new "That's What PBMs Do" ad campaign, which includes print and video ads that focus on what the PCMA called PBMs' role in reducing pharmacy costs, Medicare Part D and mail-order pharmacy.

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