Specialty Pharmacy

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug for preventing preterm births.

The agency announced Friday the approval of Baxter Pharmaceutical Solutions’ Makena (hydroxyprogesterone caproate) injection, for reducing the risk of preterm delivery before 37 weeks of pregnancy in pregnant women with a history of at least one spontaneous preterm birth.

SILVER SPRING, Md. —The Food and Drug Administration announced Friday the approval of Waltham, Mass.-based Thermo Fisher’s QMS Everolimus Immunoassay, a test that monitors the blood for levels of Novartis’ drug Zortress (everolimus).

Zortress is a drug used to prevent rejection of transplanted kidneys.

“QMS Everolimus is the first FDA-cleared test physicians can use to maintain appropriate levels of the immunosuppressant everolimus,” FDA Center for Devices and Radiological Health director Jeffrey Shuren said.

DUBLIN — Irish biotech company Elan and German drug maker Boehringer Ingelheim will collaborate to develop and manufacture antibody-based medicines.

The two companies said BI would perform technical development, clinical manufacturing and regulatory filing support, while Elan would lead discovery, preclinical testing, clinical development and commercialization of the drugs. Financial terms of the deal were not disclosed.

ST. LOUIS — The Food and Drug Administration has approved a painkiller delivered through a skin patch made by Mallinckrodt, the generic drug maker said Friday.

Mallinckrodt, part of Covidien, said the FDA approved its fentanyl transdermal system patch.

The patch is a generic version of Johnson & Johnson’s Duragesic. The drug, an opioid and Class II controlled substance, is used for managing persistent, moderate-to-severe pain that requires continuous opioid administration.

SOUTH SAN FRANCISCO, Calif. — Women with ovarian cancer who received a drug made by Genentech lived longer without their disease becoming worse, according to a late-stage clinical trial.

Genentech, part of Swiss drug maker Roche, announced results from its phase-3 “OCEANS” study, in which women with recurring ovarian cancer received Avastin (bevacizumab) with gemcitabine and carboplatin, both chemotherapy drugs, followed by use of Avastin alone.

NEW YORK — Sandoz is developing as many as 10 new follow-on biologics, according to published reports.

Reuters, citing an interview with Sandoz head Jeff George in the German newspaper Handelsblatt, said the generics arm of Swiss drug maker Novartis had eight to 10 new biosimilar molecules in development.

CAMBRIDGE, Mass. — The Food and Drug Administration has given expedited review to a drug for preventing hemodialysis failure in patients with end-stage kidney disease.

The FDA granted fast-track review status to the cell-based therapy Vascugel, made by Pervasis Therapeutics. The FDA grants the status to accelerate review of treatments for serious and life-threatening conditions, particularly those that address serious, unmet medical conditions.

LAKE FOREST, Ill. — The Food and Drug Administration has approved a generic cancer drug from Hospira.

The drug maker announced the approval of topotecan injection for treating small-cell lung cancer sensitive disease after first-line chemotherapy has failed.

The drug is a generic version of GlaxoSmithKline’s Hycamtin, which had sales of more than $140 million in 2010, according to Hospira.