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
Pfizer Inc., of New York, said the European Commission approved expanding the use of pneumococcal conjugate vaccine Prevener 13 (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) to older children and adolescents, ages 6 to 17, for active immunization for the prevention of invasive disease, pneumonia and acute otitis media caused by vaccine-type Streptococcus pneumoniae
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
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
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 alliance will involve researchers from both organizations working together to investigate new ways of treating neurological diseases such as Alzheimer's, Parkinson's and other related disorders...The goal will be to identify and validate drug targets, develop new therapeutics and evaluate them in proof-of-concept trials
Eisai has a pending new drug application for Aciphex delayed-release sprinkle capsules 5 mg and 10 mg for the proposed indication of gastroesophageal reflux disease (GERD), maintenance of healing of GERD and improvement of symptoms of GERD in children, ages 1 to 11
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