Abbott, of Abbott Park, Ill., said the European Committee for Medicinal Products for Human Use adopted a positive opinion for anti-TNF therapy Humira (adalimumab) for the treatment of pediatric patients, ages 6 to 17, with severely active Crohn's disease who failed, are intolerant to or have contraindications to conventional therapy...Sanofi Pasteur MSD, of Lyon, France, a unit of Sanofi SA, said it plans to license and commercialize a 6-in-1 pediatric vaccine in its European territories...The

EpiCept Corp., of Tarrytown, N.Y., said MidCap Financial LLC, pursuant to the amendment to the loan and security agreement dated Aug. 7, agreed to a one-month extension of the deadline to Nov. 15 for the signing of a definitive agreement with respect to a sale of the company or a partnering transaction for topical analgesic product AmiKet...Nabi and Biota inked the deal to merge in April, and amended the terms in September

Eli Lilly and Co., of Indianapolis, said the FDA approved the label inclusion for Alimta (pemetrexed) with Phase III data demonstrating progression-free survival and overall survival advantages in the continuation maintenance setting for patients with locally advanced or metastatic nonsquamous non-small-cell lung cancer following first-line Alimta plus cisplatin. Sanofi Pasteur, of Swiftwater, Pa., the vaccines division of Sanofi SA, said it filed a supplemental biologics license application

The results included a four-fold higher in vitro activity compared to azithromycin against Neisseria gonorrhoeae, more potent anti-inflammatory activity than other macrolides and similar or greater potency compared to erythromycin, clindamycin and telithromycin against community-acquired bacterial pneumonia...In eight-week- to 10-week-old male mice, those that received Bleomycin plus PLX cells administered into the trachea showed a statistically significant improvement in oxygen saturation

Bristol-Myers Squibb Co., of New York, said the FDA approved an update to the labeling for Baraclude (entecavir) to include data on African-Americans and liver transplant patients with chronic hepatitis B infection...Watson Pharmaceuticals Inc., of Parsippany, N.J., and Actavis Group, of Zug, Switzerland, are being required by the Federal Trade Commission to sell the rights and assets to 18 drugs to Sandoz International GmbH, a unit of Basel, Switzerland-based Novartis AG, and Par Pharmaceuticals

Biostar Pharmaceuticals Inc., of Xianyang, China, said it signed a one-year agreement valued at about $3 million to manufacture and supply Xijing Hospital with five additional drugs...Watson Pharmaceuticals Inc., of Parsippany, N.J., said it received approval for its abbreviated new drug application for Trospium Chloride Extended-release Capsules, the generic equivalent to Irvine, Calif.-based Allergan Inc.'s Sanctura XR...Watson said it intends to begin immediately shipping the product, which is

Roche AG, of Basel, Switzerland, lost its appeal in the federal circuit to get a preliminary injunction against generic formulations of its bisophosphonate Boniva (ibandronate) for the treatment of osteoporosis

The Navy is working on an agreement with Epiomed to test the nasal spray, and NASA and Epiomed will collaborate on clinical trials related to FDA requirements...In separate news, Genentech received a letter from the FDA's Office of Prescription Drug Promotion stating that the visual aids included in advertisements for cancer drug Tarceva (erlotinib) are misleading because they contain "misleading efficacy claims, minimize the risks and overstate the efficacy of Tarceva

The data suggested that a subpopulation of about 45 to 50 percent of heart failure patients have responses to Gencaro that exceed other beta blockers, and a smaller subpopulation of about 10 to 15 percent where the drug was not useful...ValiRx will continue to receive royalty payments from UK sales

The grant will award up to €1 million (US$1.3 million) annually to fund innovative academic research in MS...and Canada and by Merck Serono to those based elsewhere

Aeras, a vaccine development company, said it signed a deal with London-based GlaxoSmithKline plc's vaccines division to jointly develop an investigational tuberculosis vaccine containing GSK's M72 antigen and AS01E adjuvant...Versant will provide equity financing to the company, and Roche will fund the research based on a series of milestones...Roche retains an exclusive option to acquire Inception 3 upon a first lead compound reaching the filing stage of an investigational new drug application

Patients were randomized to three dose groups of intravenously administered ALX-0061 (1mg/kg every 4 weeks, 3mg/kg every 4 weeks and 6mg/kg every 8 weeks) or to placebo...The study aims to establish the efficacy of the drug as a maintenance therapy in patients whose disease has not progressed after a first-line docetaxel-based chemotherapy...Tasquinimod is believed to have a pleiotropic mode of action that includes immunomodulatory, anti-angiogenic and antimetastatic activity

The goal is to identify specific genomic alterations in each patient's tumor and use the results to inform patient stratification, guide drug development decisions and potentially for commercialization of new molecular diagnostics...The project-based collaboration will include both preclinical and clinical translational research to elucidate questions from proof of concept to tolerability, efficacy and effectiveness

Bristol-Myers Squibb Co., of New York, said the European Commission granted marketing authorization for the subcutaneous formulation of Orencia (abatacept) in combination with methotrexate for the treatment of adults with moderate to severe active rheumatoid arthritis

The study's primary objective was to demonstrate that the immune response to Prevenar 13 in the 18- to 49-year-old age group is noninferior to the compound's immune response in the 60- to 64-year-old age group as measured by serotype-specific opsonophagocytic assay titers one month after vaccination...The company said the data also will be used to support planned submissions in other countries

Prior to the merger, BioSante will distribute contingent value rights to its stockholders providing rights related to LibiGel (female testosterone gel

Effective Jan. 1, 2013, BMS will relinquish rights in all markets except for rights to Plavix in the U.S...In exchange, Sanofi will make royalty payments to BMS on global sales of branded and unbranded Plavix outside the U.S...Sanofi also will make a terminal payment of $200 million to BMS in December 2018

If the results of the studies are sufficiently favorable, Wassermann will have the right to exercise an exclusive option for the development and commercialization of velusetrag in the European Union, Russia, China, Mexico and certain other countries...Theravance retains full rights to velusetrag in the U.S., Canada, Japan and certain other countries...Theravance is entitled to receive royalties on net sales by Alfa Wassermann ranging from the low teens to 20 percent

Under the terms, Janssen, a unit of Johnson & Johnson, gains exclusive rights to ASP015K in exchange for an undisclosed up-front payment, future milestone payments and royalties...Astellas will be responsible for completing the ongoing Phase IIb studies, and Janssen will be responsible for all other development, clinical and regulatory filing activities in its territories...Vortioxetine is thought to work through a combination of complementary mechanisms: receptor activity modulation and reuptake