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

SOHO Industri Pharmasi for the registration and commercialization of Caldolor (ibuprofen) injection, which is used to treat pain and fever in the hospital setting...Merck Serono, of Geneva, a division of Merck KGaA, and the Feinstein Institute for Medical Research, the research division of the North Shore-Long Island Jewish Health System in New York, said they will collaborate to develop antibodies for the treatment of systemic lupus erythematosus (SLE...The program will focus on the use of antibodies

Through a two-year collaboration, AstraZeneca will add 250,000 high-quality compounds to LDC's internal screening collection to pursue projects in the areas of oncology, neuroscience, respiratory and inflammation, cardiovascular, gastrointestinal and infection research...AstraZeneca then will have a preferred right to obtain a license for preclinical and clinical development and commercialization

Watson Pharmaceuticals Inc., of Parsippany, N.J., changed its name to Actavis Inc

Novartis AG, of Basel, Switzerland, said the FDA expanded the approved use of Exjade (deferasirox) to treat patients ages 10 and older who have chronic iron overload resulting from nontransfusion-dependent thalassemia, a genetic blood disorder...The FDA also is authorizing the marketing of FerriScan as an imaging companion diagnostic for Exjade to select patients for therapy and to manage therapy...Exjade previously gained approval for chronic iron overload due to blood transfusions in patients 2 and

Allergan Inc., of Irvine, Calif., said the FDA approved Botox (onabotulinumtoxinA) for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency in adults who have had an inadequate response to or are intolerant of an anticholinergic medication

Ltd., of Osaka, Japan, inked a licensing deal to develop and market in Japan an oral formulation of a pediatric beta-blocker for the treatment of infantile hemangioma requiring a systemic therapy

Astellas Pharma Inc., of Tokyo, said the FDA accepted for filing a supplemental new drug application for Tarceva (erlotinib) for first-line use in patients with locally advanced or metastatic non-small-cell lung cancer whose tumors have epidermal growth factor receptor (EGFR)-activating mutations...The drug is indicated in combination with other antiretrovirals in HIV-1-infected patients with no darunavir resistance-associated mutations

said Amyvid (florbetapir F 18 injection) was approved in Europe as a diagnostic radiopharmaceutical indicated for positron emission tomography imaging of beta-amyloid neuritic plaque density in the brains of adults with cognitive impairment who are being evaluated for Alzheimer's disease and other causes of cognitive impairment...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

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

Astellas Pharma Inc., of Tokyo, said it received European approval for Betmiga (mirabegron) for treating overactive bladder symptoms in adults...In separate news, Janssen reported that the FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 10-5 late Thursday to recommend approval of canaglifozin, a selective sodium glucose co-transporter 2 inhibitor, to treat Type II diabetes in adults

Bayer HealthCare Pharmaceuticals Inc., of Wayne, N.J., said the FDA approved Skyla (levonorgestrel-releasing intrauterine system) 13.5 mg for the prevention of pregnancy for up to three years

Under the terms, Forest agreed to provide a license permitting Glenmark to launch its generic versions of Bystolic as of the date of either the later of three calendar months prior to the expiration of U.S. Patent No

Perrigo Co., of Allegan, Mich., signed a merger agreement for the acquisition of Cobrek Pharmaceuticals Inc., of Chicago, for $45 million. Perrigo acquired an 18.5 percent minority stake in Cobrek in 2008, in connection with a product development partnership agreement around foam dosage form generic products. As part of the merger agreement, Cobrek will forgo profit share payments from Perrigo in the second quarter of 2013.

Without admitting or denying allegations, Lilly consented to pay a civil settlement of $29.4 million and agreed to have an independent compliance consultant conduct a 60-day review of the company's internal controls and compliance program related to the FCPA...As part of the settlement, Sanofi agreed to pay $109 million to the settling parties and expects to enter a corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services

Allergan Inc., of Irvine, Calif., said it completed the acquisition of SkinMedica Inc., of Carlsbad, Calif., for about $350 million.

Flutemetamol, an investigational positron emission tomography imaging agent, to support Merck's development of MK-8931, an oral, beta-amyloid precursor protein site cleaving enzyme inhibitor in development for Alzheimer's disease...Shire plc, of Dublin, Ireland, reported a positive outcome from the European Decentralised Procedure for Elvanse (to be known as Tyvense in Ireland), indicated as part of a comprehensive treatment program for attention-deficit hyperactivity disorder in children, ages 6

Takeda acquired URL Pharma earlier this year for gout therapy Colcrys...and Canada to Probuphine, a subdermal implant and a long-acting product designed to deliver six months of buprenorphine hydrochloride following a single treatment

The cornerstone of the initiative is the MMRF CoMMpass study, which is designed to follow 1,000 newly diagnosed multiple myeloma patients over five years to understand the molecular changes underpinning the progress of the disease...Vanda said it intends to appeal the opinion and request a re-examination of the CHMP decision