Sanofi SA, of Paris, informed the European Medicines Agency that it is withdrawing its application for marketing authorization for Mulsevo (semuloparin sodium) to prevent venous thromboembolism in certain cancer patients...In the wake of an FDA advisory committee meeting last month in which the committee voted 14-1-1 against approval of the prophylactic, the company has decided to withdraw all applications globally...Despite its thumbs down for the anticoagulant, the FDA panel encouraged Sanofi not to
Eli Lilly and Co., of Indianapolis, said it has met the FDA's requirements for pediatric exclusivity for Cymbalta (duloxetine HCl), gaining an additional six months of U.S. market exclusivity for the drug, which now will expire in December 2013. The approval does not mean that Cymbalta, a serotonin and norepinephrine reuptake inhibitor, is approved for use in pediatric patients, and, based on study results, Lilly said it will not be seeking a pediatric indication. Tianyin Pharmaceutical Co
Eisai Inc., of Woodcliff Lake, N.J., said the European Medicines Agency approved a marketing authorization application to extend the use of once-daily Zonegran (zonisamide) from adjunctive therapy to also include monotherapy for treating partial seizures in adults with newly diagnosed epilepsy...Flutiform is partnered with London-based Skyepharma plc, which saw its shares (LSE:SKP) jump 19.85 pence to close Tuesday at 97.85 pence
Astellas Pharma Inc., of Tokyo, said the FDA approved Myrbetriq (mirabegron) to treat adults with overactive bladder...The drug, an oral, selective B3-adrenoceptor agonist, also is under review in several other countries and previously gained approval in Japan
AstraZeneca will not exercise its option to acquire Merck's remaining interest in AZLP in 2012...The new agreement provides a new option to acquire Merck's partnership interest in June 2014...Merck will continue to record supply sales and equity income from the partnership for the remainder of 2012 and 2013
to treat diabetic nerve pain, post-herpetic neuralgia, fibromyalgia and partial onset seizures in adults with epilepsy who take one or more drugs for seizures
Sanofi SA, of Paris, and the Joslin Diabetes Center, of Boston, reported that they have established a collaboration that will focus on four key areas within diabetes and related metabolic disorders to identify potential new biologics or small drug candidates for the treatment of late complications of diabetes and new insulin analogues with more targeted efficacy...Sanofi has options to commercialize the results of the research...Both parties will have access to intellectual property for internal
Horizon Pharma Inc., of Deerfield, Ill., and Mallinckrodt LLC, the pharmaceuticals business of Covidien LLC, of Dublin, Ireland, signed a U.S...Horizon granted Mallinckrodt the right to co-promote Duexis to targeted physicians in the U.S
Astellas Pharma Inc., of Tokyo, and the Drugs for Neglected Diseases initiative (DNDi) agreed to collaborate on drug discovery research for leishmaniasis, Chagas disease and sleeping sickness...Boehringer Ingelheim GmbH, of Ingelheim, Germany, and Polyphor Ltd., of Allschwil, Switzerland, inked a research collaboration and license agreement to apply Polyphor's MacroFinder drug discovery technology to identify and optimize macrocyclic drug candidates addressing therapeutic targets selected by
Ferring Pharmaceuticals SA, of Saint-Prex, Switzerland, said it donated $10 million to support research at the Salk Institute for Biological Studies in La Jolla, Calif., including research on the role that TAM receptors play in immune regulation
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
Subsequently, Cytochroma regained the rights to all indications in Asia and the U.S...to lunacalcipol, the first compound in a new class of vitamin D hormone analogues...Royer Biomedical Inc., of Frederick, Md., received FDA approval to proceed with human testing of AppliGel-G (gentamicin) in the management of diabetic foot ulcers
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
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
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
Sanofi SA, of Paris, informed the European Medicines Agency that it is withdrawing its application for marketing authorization for Mulsevo (semuloparin sodium) to prevent venous thromboembolism in certain cancer patients...In the wake of an FDA advisory committee meeting last month in which the committee voted 14-1-1 against approval of the prophylactic, the company has decided to withdraw all applications globally...Despite its thumbs down for the anticoagulant, the FDA panel encouraged Sanofi not to