Results of a Mini-Sentinel assessment of Pradaxa (dabigatran etexilate mesylate, Boehringer Ingelheim GmbH) bleeding rate were not higher than those associated with new use of warfarin, according to the FDA...The agency investigated actual rates of gastrointestinal bleeding and intracranial hemorrhage for new users of Pradaxa compared to new users of warfarin using insurance claims and administrative data...Xarelto is the first and only oral anticoagulant approved to treat DVT and PE without the need
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
Cialis for once-daily use was approved to treat erectile dysfunction (ED) in Europe in 2007...The FDA also approved Cialis 5 mg for once-daily use to treat men who have both ED and BPH...Sunovion Pharmaceuticals Inc., of Marlborough, Mass., said the FDA accepted for review two supplemental new drug applications for use of atypical antipsychotic Latuda (lurasidone) as monotherapy and as adjunctive therapy to lithium or valproate, both to treat adult patients with depressive episodes associated with
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
Astellas Pharma Inc., of Tokyo, said the European Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of Betmiga (mirabegron) for the symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adults with overactive bladder syndrome...Sanofi Pasteur MSD, of Lyon, France, a unit of Sanofi SA, said it plans to license and commercialize a 6-in-1 pediatric vaccine in its European territories...The hexavalent
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
Bristol-Myers Squibb Co., of New York, said the European Commission granted marketing authorization for the subcutaneous formulation of Orencia (abatacept) in combination with methotrexate for the treatment of adults with moderate to severe active rheumatoid arthritis
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
Abbott Park, Ill.-based Abbott's blockbuster drug Humira (adalimumab) was approved by the FDA Friday to include treatment of moderate-to-severe ulcerative colitis in adults when immunosuppressant medicines like corticosteroids, azathioprine and 6-mercaptopurine have not worked...The FDA previously approved Humira to treat rheumatoid arthritis (2002), psoriatic arthritis (2005), ankylosing spondylitis (2006), Crohn's disease (2007), plaque psoriasis (2008) and juvenile idiopathic arthritis (2008...The
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
Results of a Mini-Sentinel assessment of Pradaxa (dabigatran etexilate mesylate, Boehringer Ingelheim GmbH) bleeding rate were not higher than those associated with new use of warfarin, according to the FDA...The agency investigated actual rates of gastrointestinal bleeding and intracranial hemorrhage for new users of Pradaxa compared to new users of warfarin using insurance claims and administrative data...Xarelto is the first and only oral anticoagulant approved to treat DVT and PE without the need