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  • Brand medicines at retail pharmacy to no longer be covered by Tricare for Life

    FALLS CHURCH, Va. — Tricare for Life beneficiaries soon will receive letters guiding them to Tricare Pharmacy Home Delivery or a military pharmacy for some prescriptions as part of a congressionally mandated pilot program, officials of the military healthcare plan reported Tuesday.

    Tricare for Life is secondary coverage for Tricare beneficiaries who have both Medicare Parts A and B in the United States and U.S. territories.

  • FDA initiates Secure Supply Chain Pilot Program with 13 prequalified pharmaceutical distributors

    SILVER SPRING, Md. — The Food and Drug Administration on Tuesday announced the initiation of the Secure Supply Chain Pilot Program to enhance the security of imported drugs. 

    In August 2013, the FDA published a notice in the Federal Register (78 FR 51192) to solicit companies to voluntarily submit applications for participation in this two-year program. Thirteen prequalified companies have now been designated to take part, and will receive expedited entry for the importation of up to five selected drug products into the United States.

  • Adherence gets some stickiness

    “No one gets paid unless patients improve adherence.”

    That’s what Aaron McKethan, SVP of strategy and business development for RxAnte, had to say in a Jan. 13 article on Forbes.com, “A digital health acquisition to watch.” The story focused largely on RxAnte’s recent acquisition by Millennium Laboratories in December — which the author described as a “little-known, private equity-backed urine drug testing company” — and the technology it uses to improve patient adherence.

  • FDA commissioner blogs regarding challenges facing Indian drug manufacturers

    SILVER SPRING, Md. — In a blog post updated Friday, Food and Drug Administration commissioner Margaret Hamburg addressed two challenges facing Indian drug manufacturers — approval times for abbreviated new drug applications and quality inspections. 

  • CDC: Flu rates on the decline but still prevalent across 13 states

    ATLANTA — While flu activity declined slightly from the week prior, incidence of influenza-like illness rates remained above the national baseline for the week ended Feb. 8, the Centers for Disease Control and Prevention reported Friday. 

    Six states were still experiencing high ILI activity, including Arkansas, Connecticut, Kansas, New York, Oklahoma and Texas.

  • Actavis to acquire Forest Labs. for approximately $25 billion

    DUBLIN — Actavis and Forest Labs. on Tuesday announced that they have entered into a definitive agreement under which Actavis will acquire Forest for a combination of cash and equity valued at approximately $25 billion, or $89.48 per Forest share ($26.04 in cash and 0.3306 Actavis shares for each share of Forest common stock). The per share consideration represents a premium of approximately 25% per share over Forest’s stock price, and a premium of approximately 31% over Forest’s 10-day volume weighted average stock price, as of the close of trading on Feb.

  • FDA advisory committees vote against changing naproxen label to highlight a lower CVD profile

    SILVER SPRING, Md. — After meeting for two days earlier this week, the Food and Drug Administration's Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 16-9 against changing the label of naproxen to highlight a lower cardiovascular risk profile as compared to other NSAIDs, according to published reports. 

    Those advisory panels who voted against the change felt the data were insufficient to say naproxen was safer than other NSAIDs.

  • Teva's Synribo gets FDA approval

    JERUSALEM — Teva Pharmaceutical Industries on Thursday announced that the Food and Drug Administration has granted full approval of Synribo (omacetaxine mepesuccinate) for injection.

    The drug is indicated for adult patients with chronic phase or accelerated phase chronic myeloid leukemia with resistance and/or intolerance to two or more tyrosine kinase inhibitors.

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