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  • FDA approves 72 mcg dose of Linzess for chronic idiopathic constipation

    CAMBRIDGE, Mass., and DUBLIN — The U.S. Food and Drug Administration approved Allergan and Ironwood Pharmaceutical’s Linzess (linaclotide) 72 mcg dose for the treatment of chronic idiopathic constipation in adult patients. The newly approved does is expected to available in the first quarter of this year.

    Linzess is now FDA-approved in three dosage strengths: 290 mcg for adult patients with irritable bowel syndrome with constipation (IBS-C), and 145 mcg and a new 72 mcg for the treatment of adults with CIC.

  • Trump meets with pharma execs at White House

    WASHINGTON — Executives from several pharmaceutical companies and the Pharmaceutical Research and Manufacturers of America convened at the White House Tuesday for a meeting with President Donald Trump, Vice President Mike Pence and House Energy and Commerce Committee chairman Rep. Greg Walden, R-Ore. The president kicked off the meeting by mentioning the price of drugs and the need for competition in the marketplace. 
     

  • Adapt Pharma gets FDA approval for 2-mg Narcan Nasal Spray

    SILVER SPRING, Md. — The Food and Drug Administration has approved a 2-mg formulation of Adapt Pharma’s Narcan Nasal Spray, the company announced Wednesday. 
     
    The 2-mg dose is approved for use in patients who are opioid dependent and expected to be at risk for severe opioid withdrawal in situations where there is a low risk for accidental or intentional opioid exposure by household contacts. 
     

  • FamilyWize introduces Medicine Cabinet

    BETHLEHEM, Pa. — FamilyWize on Monday announced a new feature for patients looking for the best price on their prescription medications. The FamilyWize Medicine Cabinet, which the company says is the next evolution of its Drug Price Lookup Tool. The Medicine Cabinet allows users to create a personal profile and easily find the lowest price for their prescriptions through FamilyWize’s website and mobile app. 
     

  • 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 approves Trulance from Synergy Pharmaceuticals

    The Food and Drug Administration has approved Synergy Pharmaceuticals’s Trulance (plecanatide), the company and agency announced Thursday. The drug is indicated to treat adults with chronic idiopathic constipation. It’s the first drug designed to replicate the function of the gastrointestinal peptide uroguanylin.
     

  • Kaléo announces Auvi-Q availability

    RICHMOND, Va. — Kaléo on Thursday announced that its Auvi-Q epinephrine auto-injector would be available by prescription starting Feb. 14. Kaléo announced in October that it would be bringing back the auto-injector, which features voice instructions and automatically retracting needle. 
     
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