762,888, which covered multiple sclerosis drug Copaxone (glatiramer acetate injection), expiring May 23, 2015, and hoped to obtain a declaration that its proposed generic version would not infringe the '888 patent

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

K-V Pharmaceutical Co., of St. Louis, said the FDA provided further guidance to health care providers and pregnant women at high risk for recurrent preterm birth, recommending the use of its Makena rather than the compounded formulations of hydroxyprogesterone caproate...Janssen Research & Development LLC, of Raritan, N.J., a unit of Johnson & Johnson, said it submitted a new drug application seeking accelerated approval of bedaquiline (TMC207) as an oral treatment, to be used as part of

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

Janssen is evaluating the letter and said it will respond to the agency's questions

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

The companies said the FDA approved their abbreviated new drug application (ANDA) in mild to moderate Alzheimer's disease and mild to moderate dementia associated with Parkinson's disease, and they plan to launch immediately...Under terms of the settlement agreement, Novartis granted the companies a license to market a generic version of Exelon before the expiration of its patent in February 2014...Pfizer Inc., of New York, and Cold Spring Harbor Laboratory established a research collaboration to

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

Mylan Pharmaceuticals Inc., of Pittsburgh, settled a dispute with Teva Pharmaceuticals USA Inc., part of Teva Pharmaceutical Industries Ltd., of Jerusalem, over litigation brought by Mylan against the FDA related to Mylan's abbreviated new drug application for Modafinil tablets, 100 mg and 200 mg...The agreement with Teva stipulates that Mylan may launch its Modafinil tablets on Aug. 10, prior to the expiration of the 180-day marketing exclusivity period granted to Teva

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

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

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