Specialty Pharmacy

PALATINE, Ill. — The Food and Drug Administration has accepted for review an application for a pain medication designed to thwart drug abusers.

Acura Pharmaceuticals announced Monday the acceptance of King Pharmaceuticals’ application for Acurox (oxycodone hydrochloride). King developed the drug using Acura’s Aversion technology, which is designed to limit or impede the ability to abuse the drug by dissolving or crushing the pills and then injecting them.

INDIANAPOLIS — Following the exit of its oncology unit leader, drug maker Eli Lilly announced two executive changes.

Sue Mahony, currently SVP human resources and diversity, has been named SVP and president of Lilly Oncology, effective immediately. Mahony will remain a member of Lilly's executive committee. She succeeds John Johnson, who resigned from his post at Lilly last month to become CEO of Savient Pharmaceuticals.

FOSTER CITY, Calif. — Gilead Sciences has refiled an approval application with the Food and Drug Administration for an HIV drug, the drug maker said.

Gilead said it had resubmitted its application for a single-tablet combination of Truvada (emtricitabine and tenofovir disoproxil fumarate) and Johnson & Johnson subsidiary Tibotec Pharmaceuticals’ investigational drug TMC278 (rilpivirine hydrochloride) to treat HIV-1 infection in adults.

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.

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.

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.