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Generics

  • Report: FDA hearing to discuss biosimilar regulations

    WASHINGTON The Food and Drug Administration is looking for input on regulations concerning knock-off versions of biotech drugs, according to published reports.

     

    The Hill, a newspaper in Washington, reported Monday that the FDA would have a hearing on Nov. 2 and 3 concerning follow-on biologics, based on a draft document distributed to healthcare lobbyists.

     

     

    According to the report, the hearing would focus on such issues as interchangeability and definitions of such terms as “biological product.”

  • Amneal to open new distribution center

    GLASGOW, Ky. Amneal Pharmaceuticals will have a grand opening of its newly expanded distribution and sales center next week, the generic drug maker said Monday.

     

    Amneal announced the grand opening of the center in Glasgow, Ky., set to take place Monday. Representatives from the municipal and state governments, the Tennessee Valley Authority, state legislators and possibly members of Congress are expected to attend.

     

     

  • CBO: Generics saved $33 billion for Medicare Part D in 2007

    WASHINGTON Generic drugs saved Medicare Part D beneficiaries and the program as a whole $33 billion in 2007, according to a new report by the nonpartisan Congressional Budget Office. The CBO expected another $14 billion in annual savings to accrue as many new generics enter the market through 2012.

     

    The main lobby for pharmacy benefit managers said the report also showed the advantages of pharmacy benefit managers.

     

  • Caraco adds new member to board

    DETROIT Caraco Pharmaceutical Labs has appointed a new member to its board of directors.

     

    The generic drug maker announced Wednesday the appointment of former KPMG accountant Eddie Munson to its board of directors.

     

     

    Munson, who served in various positions for KPMG, will serve on Caraco’s board of directors for a term ending at the 2011 annual meeting of shareholders.

     

  • Q&A: Life after the NCPA

    After a distinguished, eight-and-a-half-year tenure as chief of the National Community Pharmacists Association, Bruce Roberts, independent pharmacy’s toughest champion, retired June 25 as NCPA’s EVP and CEO. He now is president and CEO of Benecard Services, a small pharmacy benefit manager and prescription benefit facilitator firm founded by pharmacist Richard Ullman. Roberts, a longtime former independent pharmacy owner in Leesburg, Va., brought energy and passion to his role and helped spur a resurgence, both for the organization and independent pharmacy.

  • Appeals court upholds decision to OK 'pay-for-delay' deals

    NEW YORK The federal government got a kick in the face Thursday as an appeals court ruled in favor of patent litigation settlements between branded and generic drug companies.

  • Generic versions of Copaxone hit roadblock

    NEW YORK Efforts by two generic drug makers to market a generic version of a drug for multiple sclerosis hit an obstacle this week in a U.S. District Court.

     

    The U.S. District Court for the Southern District of New York denied a motion for summary judgment filed by Sandoz and Momenta Pharmaceuticals that patents covering Teva Pharmaceutical Industries’ drug Copaxone (glatiramer acetate) are invalid due to indefiniteness.

     

     

  • Hi-Tech Pharmacal posts $3 million loss

    AMITYVILLE, N.Y. Hi-Tech Pharmacal had $40.4 million in sales during its fiscal first quarter ended July 31, the generic drug maker said Thursday. The numbers amounted to a decrease of $3 million from the same period in 2009.

     

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