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

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

In other news, Evotec said it expanded its collaboration with MedImmune, part of London-based AstraZeneca plc, after hitting a key milestone...Under the agreement, Pepscan will use its CLIPS platform and other protein mimicry technologies to help discover new antibodies

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 agreement, Pepscan will use its CLIPS platform and other protein mimicry technologies to help discover new antibodies...to purchase up to 1 million shares, or about 1.06 percent of the company's outstanding stock, at a price of $161.25 per share, marking a 4.46 percent discount to the Dec. 27 closing price

PharmaIN Corp., of Bothell, Wash., and LAT Pharma LLC, of Chicago, said the FDA granted orphan designation for terlipressin for the treatment of ascites due to all etiologies except for cancer...Terlipressin is designed to reduce portal vein pressure and increase mean arterial pressure in cirrhotic patients with splanchnic vasodilation...Tranzyme Pharma Inc., of Research Triangle Park, N.C., reported the successful completion of its chemistry-based drug discovery collaboration with New York-based

Public biopharmaceutical companies, which had a great year, by and large were not able to fully leverage their increased stock valuations, successful clinical results and product approvals into follow-on and other financings...The company paid $350 million in cash, with the remainder made up of milestones: $195 million related to the development and regulatory approval of Bruton's tyrosine kinase (Btk) inhibitor AVL-292, and up to $380 million in potential payments contingent upon the development

The company paid $350 million in cash, with the remainder made up of milestones: $195 million related to the development and regulatory approval of Bruton's tyrosine kinase (Btk) inhibitor AVL-292, and up to $380 million in potential payments contingent upon the development and approval of candidates generated from Avila's Avilomics platform. (See BioWorld Today, Jan. 27, 2012.) On the other side of the coin, Medicis was acquired by Canada's largest specialty pharma Valeant Pharmaceuticals