Boehringer Ingelheim GmbH, of Ingelheim, Germany, said prescribing information for Pradaxa (dabigatran etexilate), an oral anticoagulant for reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation was updated...NextBio, of Santa Clara, Calif., said it inked a multiyear collaboration with Paris-based Sanofi SA aimed at using NextBio Clinical to incorporate patient omics and clinical data into Sanofi's drug R&D, as part of the big pharma's Translational

Novartis has worldwide rights to the drug, along with certain backup compounds in all indications, with Incyte retaining a co-development option to INC280 in the U.S...Oxford BioTherapeutics Ltd. (OBT), of Oxford, UK, and Boehringer Ingelheim GmbH, of Ingelheim, Germany, are partnering on the discovery of cancer antibody targets to be identified through OBT's OGAP discovery platform...Due to third-party manufacturing issues, distribution of Janssen Products LP's Caelyx in Europe has been

In separate news, another Galapagos unit, Argenta, inked a deal with Boehringer Ingelheim GmbH, of Ingelheim, Germany, to apply its respiratory drug discovery services to an undisclosed target within Boehringer's respiratory disease portfolio...In other news, BioInvent said the first patient has been treated in a Phase II study of BI-505 for smoldering multiple myeloma, or asymptomatic myeloma

The news also adds to the growing fear that biosimilar drug development will prove trickier – and, perhaps costlier – than previously envisioned...Among the other players include Novartis AG, Boehringer Ingelheim, Samsung Biologics and Teva Pharmaceuticals Industries Ltd

Armgo Pharma Inc., of Tarrytown, N.Y., and the Muscular Dystrophy Association (MDA) said $1 million was awarded for preclinical work in support of an investigational new drug application for AMR201, an oral, small-molecule Rycal drug that has the potential to treat Duchenne's muscular dystrophy...In separate news, another Galapagos unit, Argenta, inked a deal with Boehringer Ingelheim GmbH, of Ingelheim, Germany, to apply its respiratory drug discovery services to an undisclosed target within

Boehringer Ingelheim GmbH, of Ingelheim, Germany, is the target of a proposed national class-action lawsuit by the Toronto law firm of McPhadden Samac Tuovi LLP, relating to the blood thinner Pradax (dabigatran etexilate...Eyevensys, of Paris, received an equity investment from the Boehringer Ingelheim Venture Fund, the venture arm of Ingelheim, Germany-based Boehringer Ingelheim GmbH, and said the big pharma's head of nonclinical R&D, Michel Pairet, was appointed to its board...In other news, GSK

Boehringer Ingelheim GmbH, of Ingelheim, Germany, is the target of a proposed national class-action lawsuit by the Toronto law firm of McPhadden Samac Tuovi LLP, relating to the blood thinner Pradax (dabigatran etexilate

Boehringer Ingelheim Pharmaceuticals Inc., of Ridgefield, Conn., part of Boehringer Ingelheim GmbH, and Eli Lilly and Co., of Indianapolis, submitted a new drug application for sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin for Type II diabetes in adults

Boehringer Ingelheim Pharmaceuticals Inc., of Ridgefield, Conn., part of Boehringer Ingelheim GmbH, said a new perspective from the FDA stated the agency has not changed its recommendations regarding Pradaxa (dabigatran etexilate mesylate) capsules, following the November 2012 Mini-Sentinel evaluations

Antisense Pharma GmbH, of Regensburg, Germany, revised its business objectives related to the advancement of its next-generation TGF-beta inhibitor oligonucleotide program...BioAlliance Pharma SA, of Paris, said it inked a collaboration with an undisclosed vaccine company to develop a vaccine application of its Lauriad mucoadhesive technology...In other news, Biotie and partner H. Lundbeck A/S, of Copenhagen, Denmark, said they received marketing authorization from the European Commission for Selincro

Boehringer Ingelheim GmbH, of Ingelheim, Germany, said The New England Journal of Medicine published findings from the RE-MEDY and RE-SONATE trials investigating Pradaxa (dabigatran etexilate) in the long-term prevention of deep vein thrombosis or pulmonary embolism...Lallemand Pharma, of Lugano Switzerland, partnered with Cipla Ltd., of Mumbai, India, to market and distribute PMBL tablets in India, under the name Pulmigen, for prevention of chronic bronchopulmonary infections...ProBioGen AG, of

According to Boehringer Ingelheim GmbH, of Ingelheim, Germany, tiotropium delivered once daily by Respimat inhaler improved lung function and reduced asthma exacerbations in patients who were symptomatic after treatment with inhaled corticosteroids and long-acting beta agonists (ICS/LABA) in its UniTinA-asthma Phase III trial...Lallemand Pharma, of Lugano Switzerland, partnered with Cipla Ltd., of Mumbai, India, to market and distribute PMBL tablets in India, under the name Pulmigen, for prevention

Boehringer Ingelheim GmbH, of Ingelheim, Germany, said the FDA's Pulmonary-Allergy Drugs Advisory Committee recommended that clinical data included in a new drug application provide substantial and convincing evidence to support the approval of olodaterol as a once-daily maintenance bronchodilator treatment for airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and/or emphysema

In other news, Boehringer Ingelheim said it enrolled the first patients in its Phase III interferon-free (IFN-free) program, HCVerso, testing its IFN-free polymodal regimen combining faldaprevir (BI 201335), a next-wave once-daily protease inhibitor, and BI 207127, a non-nucleoside polymerase inhibitor, plus ribavirin in hepatitis C virus

Boehringer Ingelheim GmbH, of Ingelheim, Germany, said its new drug application for afatinib was accepted for filing and granted priority review by the FDA...Lilly acquired Avid in 2010 for $300 million up front, with another potential $500 million tied to regulatory and commercial milestones associated with Amyvid. (See BioWorld Today, Nov. 9, 2010, and April 10, 2012

Boehringer Ingelheim GmbH, of Ingelheim, Germany, inked a research service collaboration with Horizon Discovery Ltd., of Cambridge, UK, to use Horizon's Discovery Toolbox for research projects and profiling of compounds at the hit-to-lead, lead optimization and preclinical stages to elucidate their anticancer properties and help guide drug discovery programs

Boehringer Ingelheim GmbH, of Ingelheim, Germany, inked a research service collaboration with Horizon Discovery Ltd., of Cambridge, UK, to use Horizon's Discovery Toolbox for research projects and profiling of compounds at the hit-to-lead, lead optimization and preclinical stages to elucidate their anticancer properties and help guide drug discovery programs

Boehringer Ingelheim GmbH, of Ingelheim, Germany, and Eli Lilly and Co., of Indianapolis, said top-line results showed that all four Phase III studies of empagliflozin, a sodium glucose co-transporter-2 inhibitor, in Type II diabetes met their primary endpoints, defined as significant changes in HbA1c from baseline compared to placebo, with the 10-mg and 25-mg doses...In other news, Evotec said it expanded its collaboration with MedImmune, part of London-based AstraZeneca plc, after hitting a key

The companies will continue to jointly develop and commercialize the other assets stemming from the January 2011 deal...In separate news, Endo Pharmaceuticals Inc., of Chadds Ford, Pa., also agreed to pay $25 million to settle a lawsuit alleging similar price-inflating behavior