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 cells were grown in culture and demonstrated to have the correct CD antibody markers for mesenchymal stem cells and other cells consistent with stromal vascular fraction cells...The company plans to cut its work force by 50 percent...reduce expenses related to commercialization activities for NP101, its transdermal patch for acute migraine, and earlier stage candidates

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

The companies plan to initiate a Phase II study in 2013 and, upon successful completion, introduce NuroPro as a laboratory-developed test in a clinical laboratory improvement amendment-certified laboratory before seeking FDA approval...The sale is expected to result in gross proceeds to Optimer of $60 million and will be used to support the commercialization of Dificid (fidaxomicin) tablets and for other corporate purposes...The company expects one-time severance and other charges to total about $1.5

The milestones are tied to certain regulatory and sales achievements...Veloxis will supply the product to Chiesi for sale, and Chiesi committed to certain minimum purchases during the term of the deal

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

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

On Tuesday, CTI's shares (NASDAQ:CTIC) opened 20 percent higher on the news before edging lower to close at $2.52, a gain of 29 cents, or 13 percent, on the day...Prior to conversion, those sales reps were employees of Ventiv Commercial Services LLC, and were provided to Depomed pursuant to a service agreement...GenVec retains the right to commercialize the technology, which uses an adenovector delivery system that is capable of generating strong immune responses while avoiding the problems of vector

The NDS is expected to be filed in the fourth quarter of 2013, once the accelerated stability is completed at its new manufacturer...The product is expected to become available in pharmacies in January 2013...commercial rights to Fareston (toremifene citrate) for the treatment of metastatic breast cancer in postmenopausal women from Memphis, Tenn-based GTx Inc

Watson Pharmaceuticals Inc., of Parsippany, N.J., said the District Court for the Northern District of Georgia granted summary judgment in favor of Watson, and all other defendants, on all remaining claims in the pending antitrust lawsuit related to settlements of patent litigation concerning Androgel 1 percent testosterone gel

Both parties agreed to the conclusion, with no further financial responsibilities for either party...Chondrogen, a similar product to Prochymal, is in development for osteoarthritis of the knee...The product is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (beta lactam-resistant) staphylococci and for the infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs

Abbott Park, Ill.-based Abbott's blockbuster drug Humira (adalimumab) was approved by the FDA Friday to include treatment of moderate-to-severe ulcerative colitis in adults when immunosuppressant medicines like corticosteroids, azathioprine and 6-mercaptopurine have not worked...The FDA previously approved Humira to treat rheumatoid arthritis (2002), psoriatic arthritis (2005), ankylosing spondylitis (2006), Crohn's disease (2007), plaque psoriasis (2008) and juvenile idiopathic arthritis (2008...The