Boehringer Ingelheim GmbH, of Ingelheim, Germany, said the labeling of Pradaxa (dabigatran etexilate mesylate) 150-mg capsules was updated to affirm that twice-daily use of the drug was superior to warfarin in reducing ischemic and hemorrhagic strokes, based on the results of the pivotal RE-LY trial conducted in 18,000 patients with nonvalvular atrial fibrillation (NVAF...Additionally, Boehringer recently launched a Phase II trial of the GLORIA-AF patient registry, designed to better characterize

Forest Laboratories Inc., of New York, issued a statement in response to a Form 13D filing from entities affiliated with activist shareholder Carl Icahn stating an intention to nominate a minority slate of candidates to the company's board

Boehringer Ingelheim GmbH, of Ingelheim, Germany, and Eli Lilly and Co., of Indianapolis, said they received a positive opinion from the European Medicine's Agency medicinal committee recommending approval of Jentadueto, a product containing DPP-4 inhibitor linagliptin and metformin in a single tablet for twice-daily dosing, to improve glycemic control in adults with Type II diabetes who are inadequately controlled on maximally tolerated metformin alone or are already being treated with the

Almirall recently signed a deal granting Menarini Group, of Florence, Italy, rights across a majority of European Union member states, as well as Russia, Turkey and other CIS countries, where it will market the drug as Bretaris Genuair...In addition to BMS, the collaboration comprises 10 cancer-research institutions, including the Dana-Farber Cancer Institute, Johns Hopkins Kimmel Cancer Center and Memorial Sloan-Kettering Cancer Center...The company said it will respond to the agency as quickly as

If approved by the European Commission, the drug would offer a single-tablet treatment option, taken twice-daily, for adults with Type II diabetes who need to improve control of their blood glucose

to reduce the risk of blood clots in the legs and lungs of people who have just had knee or hip replacement surgery and to reduce the risk of hemorrhagic and thrombotic strokes as well as other blood clots in individuals with atrial fibrillation not caused by a heart valve problem

The submission is supported by clinical trials involving more than 11,000 patients treated for up to four years and several ongoing studies, including the EXAMINE (EXamination of CArdiovascular OutcoMes: AlogliptIN vs. Standard of CarE in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome) trial, which will evaluate cardiovascular endpoints following treatment with alogliptin to comply with the FDA's cardiovascular safety guideline

Novo Nordisk A/S, of Bagsvaerd, Denmark, said the FDA approved Levemir (insulin detemir [rDNA origin] injection) for use in children, ages 2 to 5, with Type I diabetes

H. Lundbeck A/S, of Copenhagen, Denmark, and not-for-profit research organization CHDI Foundation Inc., of Deerfield, Ill., said they are collaborating to investigate a targeted therapy for Huntington's disease...Inc., of Whitehouse Station, N.J., said the FDA approved a labeling update for HIV-1 drug Isentress (raltegravir) film-coated tablets to include 156-week data from the STARTMRK study showing that the integrase inhibitor in combination therapy demonstrated long-term viral suppression, a

In an additional fMRI analysis, Lyrica was found to affect grey matter density in parts of the brain known to process pain

Pfizer Canada Inc., of Kirkland, Quebec, part of Pfizer Inc., launched Xyntha Solofuse in Canada to prevent and control hemorrhagic episodes in patients with hemophilia A. The preloaded device delivers Xyntha (recombinant Factor VIII) by intravenous infusion after reconstitution of a freeze-dried powder...Available in three strengths, Xyntha Solofuse can be connected to an adapter to provide intermediate doses and allow the combination of multiple dosage strengths

Under the agreement, BMS will fund research efforts at the university's School of Life Sciences to identify and validate targets in oncology and immunoscience...In separate news, BMS said the FDA approved its biologics manufacturing facility in Devens, Mass., for commercial production of arthritis drug Orencia (abatacept

Stiefel, of Research Triangle Park, N.C., part of GlaxoSmithKline plc, said the FDA approved a new drug application for Fabior (tazarotene) foam 0.1 percent, a topical formulation of a retinoid to treat acne vulgaris in patients 12 years and older

Mylan Inc., of Pittsburgh, said it launched generic atorvastatin in France, Belgium, the UK, the Netherlands and Ireland. Atorvastatin is a generic version of New York-based Pfizer Inc.'s top-selling cholesterol-lowering drug Lipitor.

to reduce the risk of blood clots in the legs and lungs of people who have just had knee or hip replacement surgery, and to reduce the risk of both hemorrhagic and thrombotic strokes as well as other blood clots in people with atrial fibrillation not caused by a heart valve problem

Clinigen partnered with Hospira Inc., of Lake Forest, Ill., to distribute the drug to U.S...patients on an emergency supply basis in September 2011, and Hospira retains exclusive rights to market, promote and distribute Foscavir in the U.S. Clinigen acquired the Foscavir brand from London-based AstraZeneca plc in 2010

Janssen Research & Development LLC, of Raritan, N.J., said it submitted a supplemental new drug application seeking approval of Xarelto (rivaroxaban), an oral anticoagulant, to treat patients with deep-vein thrombosis or pulmonary embolism and to prevent recurrent venous thromboembolism...The drug is expected to be available in the second half of this year

Ipsen SA, of Paris, said it opened its new commercial headquarters in Basking Ridge, N.J., as part of its efforts to expand the firm's capabilities and capacity in the U.S...Relocation of the firm's headquarters is expected to create more than 100 full-time jobs in New Jersey

Baxter International Inc., of Deerfield, Ill., said it will build a manufacturing facility in Covington, Ga., to support its plasma-based treatments, including therapies for immune disorders, trauma and other critical conditions...The firm expects capital investments for the site to exceed $1 billion over the next five years and to create more than 2,000 jobs in total