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 plc

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

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 design of the trial later will be adapted, enabling it to separate into three separate personalized arms to test AZD0424 in different combinations alongside standard or other experimental treatments

Toxicity experiments conducted to date revealed best-in-class potential with a greatly improved therapeutic index compared to other armed antibodies, due to an impressive safety profile, according to the company, which has opened a manufacturing facility in Nijmegen for the production of ADCs up to Phase III trials and early launches

The drug is expected to launch in Canada in the second quarter

Beyond Pfizer, other big pharma firms also could be interested...In other financings news

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

In other news, Evotec said a compound identified and optimized in a research collaboration with Osaka, Japan-based Ono Pharmaceutical Co...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

The merger is expected to close as soon as practicable...It also licensed rights to an oral calcitonin tablet to Tarsa Therapeutics Inc., of Philadelphia, which is developing it for postmenopausal osteoporosis

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

In addition to Kim, we were joined by a long-time friend and medical consultant who's helping to vet oncology assets...In contrast to most partnering discussions in small suites, that meeting was held in a large board room with a long conference table

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