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  • FDA approves Gilead’s hepatitis C drug Epclusa
    SILVER SPRING, Md. — The Food and Drug Administration has approved Gilead Sciences’ Epclusa (sofosbuvir 400 mg/velpatasvir 100 mg), the company announced earlier this week. Epclusa is a single tablet treatment for adults with genotype 1-6 chronic hepatitis and for patients with hepatitis C genotype 2 and 4 without the need for ribavirin. The drug for 12 weeks was approved for use in patients without cirrhosis or with compensated cirrhosis and in combination with ribavirin. 
     

  • PhRMA taps Brian Toohey to head international advocacy
    WASHINGTON — The Pharmaceutical Research and Manufacturers of America on Thursday announced the addition of Brian Toohey as SVP international advocacy, effective July 11. 
     
    Toohey is the former president and CEO of the Semiconductor Industry Association, where he oversaw that industry’s federal advocacy, international trade and technology programs. Before joining the SIA, Toohey had been at PhRMA, first as a lead international lobbyist and then as the leader of its international advocacy team. 
     

  • CHPA case study explores teen abuse of dextromethorphan

    WASHINGTON -- The Consumer Healthcare Products Association has published a case study regarding efforts to curb teen abuse of over-the-counter cough medicine containing dextromethorphan. 

    The paper, “Dextromethorphan: a case study on addressing abuse of a safe and effective drug,” was published in Substance Abuse Treatment, Prevention, and Policy, an open access, peer-reviewed journal that encompasses research concerning substance abuse, with a focus on policy issues.

  • Pharmasave pharmacists trained in medication therapy management

    VANCOUVER, B.C. -- Pharmasave announced that its pharmacists have been trained to be leaders in providing medication therapy management programs.

    This includes reviewing medications for appropriateness, identifying potential problems such as drug interactions, alternative therapies and contraindications and patient counselling on appropriate use. 

  • Senators, U.S. Rep introduce bill to shorten length of biologics exclusivity
    WASHINGTON — U.S. Rep. Jan Schakowsky and Sens. Sherrod Brown and John McCain on Thursday introduced a piece of legislation aimed at shortening the period of exclusivity for brand-name biologics products. The Price Relief, Innovation and Competition for Essential Drugs (PRICED) Act would amend the Public Health Service act to change the exclusivity period from 12 years to seven years. 
     

  • FDA extends shelf life of Flublok influenza vaccine

    MERIDEN, Conn. - Protein Sciences announced Thursday that FDA has extended the shelf life for Flublok, its seasonal influenza vaccine, to nine months from the date of manufacture. That increases the previous shelf life by three months.  The longer shelf life will make it easier for healthcare providers and pharmacies to stock Flublok and vaccinate people throughout the influenza season, which in some years can last as long as April or May.

  • Congress calls on CMS to finalize DIR guidance

    ALEXANDRIA, Va. - As many as 16 United States Senators and 30 members of the House of Representatives recently wrote to the Centers for Medicare & Medicaid Services, urging the agency to finalize its proposed guidance on how Medicare prescription drug plan sponsors report pharmacy price concessions, often referred to as direct and indirect remuneration (DIR) fees, to provide more accurate information to beneficiaries, pharmacies and the federal government.

  • Biogen names McKenzie EVP pharmaceutical operations, technology
    CAMBRIDGE, Mass. — Biogen on Thursday announced named Paul McKenzie as its EVP pharmaceutical operations and technology, effective July 1.  McKenzie, who was previously the company’s SVP global biologics manufacturing and technical operations, will head the company’s asset management, technical development, supply chain operations, global manufacturing, quality and engineering. 
     
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