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

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

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.

Watson Pharmaceuticals Inc., of Parsippany, N.J., said that its subsidiary, Watson Laboratories Inc., filed an abbreviated new drug application with the FDA for Mesalamine delayed-release tablets 1.2 g. The product is a generic version of Lialda, by Shire Development LLC, a division of Shire plc, of Dublin, Ireland.

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

The pharma agreed to plead guilty to one misdemeanor violation of the Food, Drug and Cosmetic Act for misbranding, and agreed to certain other conditions, including maintenance of specified compliance measures and annual certification regarding its state of compliance by its CEO and board for a five-year probation period

The transaction is expected to close in the second half of the year...Fougera was spun off from Nycomed GmbH a year ago when Nycomed was sold to Osaka, Japan-based Takeda Pharmaceutical Co...Valeant Pharmaceuticals International Inc., of Montreal, agreed to pay about $64 million plus potential milestones for certain skincare assets, including OTC drug AcneFree, from University Medical Pharmaceuticals Corp., of Irvine, Calif

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

Teva Pharmaceutical Industries Ltd., of Jerusalem, said it settled its patent infringement litigation with respect to Pittsburgh-based Mylan Pharmaceuticals Inc.'s abbreviated new drug application (ANDA) for Teva's wakefulness product Nuvigil (armodafinil), which allows Mylan to begin selling generic versions of the drug under a license beginning in June 2016, or earlier under certain circumstances...A trial against subsequent ANDA filers is set to start in July

The FDA on Friday approved Levaquin (levofloxacin) to treat patients with plague...Manhattan Pharmaceuticals Inc., of New York, changed its name to TG Therapeutics Inc...Shareholders of pre-split common stock who would be entitled to receive a fractional share as a result of the reverse stock split will be entitled to round such fractional value up to the nearest whole number

Antares Pharma Inc., of Ewing, N.J., said development partner Teva Pharmaceutical Industries Ltd., of Jerusalem, entered into a settlement agreement with Pfizer Inc...Separately, Teva agreed to provide Antares with device orders of an undisclosed amount in 2013 and 2014, to make a milestone payment to Antares upon FDA approval of epinephrine auto-injector and to assume litigation costs related to the patent litigation with Meridian Medical. (See BioWorld Today, Aug. 18, 2011