Search Results for: "Pharma: Other News to Note"
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Pharma: Other News To Note
GlaxoSmithKline plc, of London, said it submitted a marketing authorization application to the European Medicines Agency (EMA) for trametinib (ME) as a monotherapy and in combination with dabrafenib (BRAF) for the treatment of adults with unresectable or metastatic melanoma with a BRAFV600 mutation...Ipsen SA, of Paris, and Braintree Laboratories Inc., of Braintree, Mass., said that Eziclen/Izinova (BLI-800) completed the European decentralized registration procedure, giving member states 30 daysBioWorld Today | Friday, February 8, 2013 -
Pharma: Other News To Note
Janssen Research & Development LLC, of Titusville, N.J., a unit of Johnson & Johnson, said its San Diego-based Janssen Labs added a Concept Lab, a shared laboratory to offer entrepreneurs access to bench spaces for early stage research, and an Open Collaboration Space, an open-plan office setting designed to provide companies and individuals with desk space...Those additions allow Janssen Labs to accommodate more than double the number of companies as when it launched in late 2011 as a 30,000BioWorld Today | Wednesday, February 6, 2013 -
Pharma: Other News To Note
The transaction is subject to approval by Covidien's board, and the separation is expected to be complete at the end of the second quarter of 2013...The FDA granted orphan drug designation to the product for retinitis pigmentosaBioWorld Today | Tuesday, February 5, 2013 -
Pharma: Other News To Note
Shire plc, of Dublin, Ireland, said it reached agreement in principle to resolve the previously disclosed civil investigation into Shire's U.S...sales and marketing practices relating to Adderall XR (mixed amphetamine salts), Vyvanse (lisdexamfetamine dimesylate) and Daytrana (methylphenidate transdermal systemBioWorld Today | Monday, February 4, 2013 -
Pharma: Other News To Note
The company brought patent infringement action in April 2010 against generic firm Watson Laboratories Inc., of Parsippany, N.Y., (now known as Actavis) after Watson applied to the FDA to market a generic version of RapamuneBioWorld Today | Friday, February 1, 2013 -
Pharma: Other News To Note
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 emphysemaBioWorld Today | Thursday, January 31, 2013 -
Pharma: Other News To Note
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 antibodiesBioWorld Today | Wednesday, January 30, 2013 -
Pharma: Other News To Note
Ltd., of South Kora, for exclusive distribution rights to Hanmi's new drug application, currently under FDA review, for esomeprazole strontium delayed-release capsules...Hanmi filed the application pursuant to the 505(b)(2) pathway with data showing comparative bioequivalence of its drug to Nexium (esomeprazole magnesium delayed-release capsules, AstraZeneca plcBioWorld Today | Tuesday, January 29, 2013 -
Pharma: Other News To Note
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 commercializationBioWorld Today | Monday, January 28, 2013 -
Pharma: Other News To Note
Watson Pharmaceuticals Inc., of Parsippany, N.J., changed its name to Actavis IncBioWorld Today | Friday, January 25, 2013 -
Pharma: Other News To Note
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 andBioWorld Today | Thursday, January 24, 2013 -
Pharma: Other News To Note
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 medicationBioWorld Today | Wednesday, January 23, 2013 -
Pharma: Other News To Note
The drug is expected to launch in Canada in the second quarterBioWorld Today | Tuesday, January 22, 2013 -
Pharma: Other News To Note
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 therapyBioWorld Today | Friday, January 18, 2013 -
Pharma: Other News To Note
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. (SeeBioWorld Today | Wednesday, January 16, 2013 -
Pharma: Other News To Note
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 programsBioWorld Today | Tuesday, January 15, 2013 -
Pharma: Other News To Note
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 yearsBioWorld Today | Friday, January 11, 2013 -
Pharma: Other News To Note
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 behaviorBioWorld Today | Tuesday, January 8, 2013 -
Pharma: Other News To Note
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 NoBioWorld Today | Friday, January 4, 2013 -
Pharma: Other News To Note
Bristol-Myers Squibb Co., of New York, and Pfizer Inc., of New York, said the FDA approved Eliquis (apixaban) to reduce the risk of stroke and systemic embolism in patients with nanvalvular atrial fibrillation...It's expected to be widely available by the end of this monthBioWorld Today | Thursday, January 3, 2013
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