Boehringer Ingelheim GmbH, of Ingelheim, Germany, said it is conducting a nationwide recall of a single manufacturing lot of Pradaxa (dabigatran etexilate mesylate) capsules 75 mg due to a potential packaging defect that may compromise the bottle integrity...A damaged bottle could allow moisture to get into the bottle, which may impair the quality of Pradaxa

Bristol-Myers Squibb Co., of New York, said the National Institute of Health and Clinical Excellence decided to recommend Yervoy (ipilimumab), which is approved in Europe for treating advanced metastatic melanoma, within the final appraisal determination...That decision will enable eligible patients in England and Wales to routinely access treatment with Yervoy through the National Health Services

The firm anticipates peak annual sales to exceed $200 million...The 80,000-square-foot expansion is expected to be completed in March 2014 and is intended to manufacture insulin cartridges to meet the growing diabetes demand in the U.S...Health Canada had asked Novartis to suspend distribution of Agriflu and Fluad late last month as a precautionary step

Forest Laboratories Inc., of New York, said it inked a deal with moksha8, of Sao Paolo, Brazil, providing Forest with a commercial footprint in Latin America and giving moksha8 access to antidepressant drug Viibryd (vilazodone) and potentially other Forest products for the Latin American market...Terms call for Forest to provide up to $125 million in financing to moksha8 in several tranches over a two-year period, conditioned upon moksha8 achieving certain business goals

Eli Lilly and Co., of Indianapolis, said the FDA approved the label inclusion for Alimta (pemetrexed) with Phase III data demonstrating progression-free survival and overall survival advantages in the continuation maintenance setting for patients with locally advanced or metastatic nonsquamous non-small-cell lung cancer following first-line Alimta plus cisplatin. Sanofi Pasteur, of Swiftwater, Pa., the vaccines division of Sanofi SA, said it filed a supplemental biologics license application

A.P. Pharma Inc., of Redwood City, Calif., said the FDA accepted the company's resubmission of a new drug application for APF530, a long-acting formulation of granisetron in development for the prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting...Watson Pharmaceuticals Inc., of Parsippany, N.J., and Actavis Group, of Zug, Switzerland, are being required by the Federal Trade Commission to sell the rights and assets to 18 drugs to Sandoz International GmbH, a unit of

Biostar Pharmaceuticals Inc., of Xianyang, China, said it signed a one-year agreement valued at about $3 million to manufacture and supply Xijing Hospital with five additional drugs...Watson Pharmaceuticals Inc., of Parsippany, N.J., said it received approval for its abbreviated new drug application for Trospium Chloride Extended-release Capsules, the generic equivalent to Irvine, Calif.-based Allergan Inc.'s Sanctura XR...Watson said it intends to begin immediately shipping the product, which is

Roche AG, of Basel, Switzerland, lost its appeal in the federal circuit to get a preliminary injunction against generic formulations of its bisophosphonate Boniva (ibandronate) for the treatment of osteoporosis

The grant will award up to €1 million (US$1.3 million) annually to fund innovative academic research in MS...and Canada and by Merck Serono to those based elsewhere

Aeras, a vaccine development company, said it signed a deal with London-based GlaxoSmithKline plc's vaccines division to jointly develop an investigational tuberculosis vaccine containing GSK's M72 antigen and AS01E adjuvant...Versant will provide equity financing to the company, and Roche will fund the research based on a series of milestones...Roche retains an exclusive option to acquire Inception 3 upon a first lead compound reaching the filing stage of an investigational new drug application

The goal is to identify specific genomic alterations in each patient's tumor and use the results to inform patient stratification, guide drug development decisions and potentially for commercialization of new molecular diagnostics...The project-based collaboration will include both preclinical and clinical translational research to elucidate questions from proof of concept to tolerability, efficacy and effectiveness

The study's primary objective was to demonstrate that the immune response to Prevenar 13 in the 18- to 49-year-old age group is noninferior to the compound's immune response in the 60- to 64-year-old age group as measured by serotype-specific opsonophagocytic assay titers one month after vaccination...The company said the data also will be used to support planned submissions in other countries

Effective Jan. 1, 2013, BMS will relinquish rights in all markets except for rights to Plavix in the U.S...In exchange, Sanofi will make royalty payments to BMS on global sales of branded and unbranded Plavix outside the U.S...Sanofi also will make a terminal payment of $200 million to BMS in December 2018

Janssen Biotech Inc., of Horsham, Pa., said it inked a deal with Astellas Pharma Inc., of Tokyo, for the worldwide development and commercialization, except in Japan, of ASP015K, an oral, small-molecule Janus kinase inhibitor currently in Phase IIb development as a once-daily treatment for moderate to severe rheumatoid arthritis...Under the terms, Janssen, a unit of Johnson & Johnson, gains exclusive rights to ASP015K in exchange for an undisclosed up-front payment, future milestone payments and

Watson Pharmaceuticals Inc., of Parsippany, N.J., said the District Court for the Northern District of Georgia granted summary judgment in favor of Watson, and all other defendants, on all remaining claims in the pending antitrust lawsuit related to settlements of patent litigation concerning Androgel 1 percent testosterone gel

Allergan Inc., of Irvine, Calif., said its botulinum toxin Type A product, Botox, was licensed by the UK's Medicines and Healthcare Products Regulatory Agency for the management of urinary incontinence in adult patients with neurogenic detrusor overactivity due to subcervical spinal cord injury or multiple sclerosis, who are not adequately managed with anticholinergics...Bristol-Myers Squibb Co., of New York, and Pfizer Inc., also of New York, said the FDA accepted the new drug application

are soliciting consents from note holders for proposed amendments to eliminate or modify substantially all restrictive covenants, certain events of default and other provisions governing the notes...to prevent acute and delayed nausea and vomiting following highly and moderately emetogenic chemotherapy

Under the deal, the Vanderbilt Center for Neuroscience Drug Discovery will identify drug candidates from its existing program, which obtained significant support from the Michael J. Fox Foundation for Parkinson's Research, while BMS will have the right to develop and commercialize products resulting from the collaboration...In other news, BMS and partner Pfizer Inc., of New York, said the European Committee for Medicinal Products for Human Use adopted a positive opinion on Eliquis (apixaban) for

Bayer Pharma AG, of Leverkusen, Germany, successfully advanced a kinase inhibitor licensed from the Lead Discovery Center GmbH, of Dortmund, Germany, into preclinical development...Payments to LDC could aggregate to €82.5 million (US$106.8 million) in development milestones and €55 million in sales milestones, plus royalties on any net sales