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Specialty Pharmacy

  • Johnson & Johnson to buy Actelion for $30B

    NEW BRUNSWICK, N.J. — Johnson & Johnson will buy Switzerland-based Actelion for $30 billion, or $280 per Actelion share. As part of the transaction, Actelion will spin off its drug discovery operations and early-stage clinical development assets into a newly created company to its shareholders in the form of a dividend immediately prior to the deal closing.

  • PhRMA launches Go Boldly campaign

    WASHINGTON — The Pharmaceutical Research and Manufacturers of America on Monday launched its new multi-year advertising and public affairs initiative, Go Boldly. The campaign is aimed at highlighting those in the industry driving innovation and pointing to the opportunity that exists in tackling complex health conditions. 

  • Bristol-Myers Squibb decides against accelerated approval for Opdivo/Yervoy combo for lung cancer

    PRINCETON, N.J. — Bristol-Myers Squibb has announced that it will not seek an accelerated regulatory approval for a combination of its Opdivo (nivolumab) and Yervoy (ipilimumab) as a first-line treatment for lung cancer. 
     
    The company said the announcement was “based on a review of data available at this time,” and noted that they would not provide additional details to “protect the integrity of ongoing registrational studies.”
     

  • FDA issues draft guidance on biosimilar interchangeability

    SILVER SPRING, Md. — The Food and Drug Administration recently shared the first draft guidance addressing the interchangeability of biosimilar drugs and their reference products. 
     

  • Mayne Pharma launches Fabior, Sorilux

    GREENVILLE, N.C. — Mayne Pharma on Wednesday announced the launch of Fabior (tazarotene, 0.1%) Foam and Sorilux (calcipotiene, 0.005%) Foam. Mayne Pharma acquired the products from GSK in August 2016, and they complement the company’s Doryx, the first branded product in its specialty brands division that it launched in 2015. 
     

  • Sanofi, ImmuNext enter specialty drug development agreement

    BRIDGEWATER, N.J. and LEBANON, N.H. — Sanofi and ImmNext on Monday announced a new agreement surrounding the development of a novel antibody that could treat such autoimmune diseases as lupus and multiple sclerosis. 
     

  • FDA approved 22 new drugs in lower-than-average 2016

    SILVER SPRING, Md. — The Food and Drug Administration’s Center for Drug Evaluation and Research’s number of new drug approvals came in low in 2016, according to the agency’s year-end review of the new therapies that passed regulatory muster. The number of drugs the FDA approved last year, 22, is less than half of the 45 approved in 2015 and lower than the average of the last 10 years of approvals, which is 29. 
     

  • FDA approves new indication for Genentech’s Lucentis

    SILVER SPRING, Md. — The Food and Drug Administration has approved a new indication for Genentech’s Lucentis (ranibizumab injection). The drug has been approved to treat patients with myopic choroidal neovascularization, which is a complication of severe near-sightedness that can lead to blindness. 
     
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