Specialty Pharmacy

SILVER SPRING, Md. — Fake versions of a cancer drug made by Roche's U.S. unit have entered the United States, the Food and Drug Administration warned Wednesday.

The FDA advised healthcare professionals and patients that a counterfeit version of Genentech's Avastin (bevacizumab) had been distributed in the United States. The agency said the counterfeit versions carried Roche's logo instead of Genentech's and displayed batch numbers starting with B6010, B6011 or B86017.

FOSTER CITY, Calif. — The Food and Drug Administration is giving priority review to a drug made by Gilead Sciences that the company is investigating for the prevention of HIV.

Gilead said the FDA gave the special designation to its application for Truvada (emtricitabine and tenofovir disoproxil fumarate) for pre-exposure prophylaxis, or PrEP, to reduce the risk of HIV infection. The FDA originally approved Truvada for treating HIV infection in 2004, and it is currently the most prescribed antiretroviral drug in the United States.

NEW YORK — Bristol-Myers Squibb has completed its acquisition of a developer of hepatitis C treatments.

Bristol said it successfully completed its tender offer for all of the outstanding shares of common stock of Alpharetta, Ga.-based Inhibitex, at a purchase price of $26 per share via a “short form merger” in which all such shares were converted into the right to receive the aforementioned share price in cash and without interest, less any applicable withholding taxes.

MISSISSAUGA, Ontario — Valeant Pharmaceuticals is set to acquire a privately owned ophthalmic biotechnology company, the drug maker said Monday.

Valeant said it will acquire Eyetech upfront payment and potential future milestones. The transaction, which is subject to customary closing conditions, is expected to close this week. Additional details were not disclosed.

DUBLIN, Calif. — An expert panel at the Food and Drug Administration has given a thumbs-down to a drug made by Astex Pharmaceuticals and Eisai for which the two had sought approval as a treatment for leukemia.

The FDA's Oncologic Drugs Advisory Committee voted 10-3 with one abstention not to support the risk-benefit profile of Dacogen (decitabine) in certain elderly patients with acute myeloid leukemia. The FDA is not bound by advisory committee votes when deciding whether or not to approve a drug, but usually follows them.

SILVER SPRING, Md. — The Food and Drug Administration reached a major milestone on the path to a regulatory regime for follow-on biologics on Thursday with the release of draft guidance on biosimilar product development.

PHOENIX — Specialty pharmacy provider The Apothecary Shops has inked a deal with Pfizer to distribute a new drug for treating kidney cancer.

The specialty provider announced Wednesday that Pfizer had granted it distribution rights for Inlyta (axitinib), which the Food and Drug Administration approved on Jan. 27 for advanced renal cell carcinoma in patients who have failed one systemic therapy.

FLORHAM PARK, N.J. — Specialty pharmacy company Amber Pharmacy has implemented a prior authorization system provided by Armada Health Care, Amber said.

Amber announced that it had incorporated Armada's Web-based ApproveRx system into its daily pharmacy operations, saying that it would help simplify the prior authorization process for prescribers and pharmacies. Prior authorizations have traditionally required extra staffing time and resources to locate the correct form from thousands of different insurance forms varying by drug, payer and plan.