Other animal studies have shown inhibition and regression of tumors, and superiority to irinotecan to treat solid tumors...In other news, BioAlliance will regain full rights to the FDA-approved oropharyngeal candidiasis drug Oravig (miconazole Lauriad) from Strativa Pharmaceuticals, a subsidiary of Woodcliff Lake, N.J.-based Par Pharmaceutical Cos

It also divested a preclinical program in autoimmune diseases to DCAM Pharma Inc., and some patent interests to CharlestonPharma LLC...The facility is expected to be online in January to support the manufacturing of Pluristem's PLacental eXpanded cell product candidates for the treatment of critical limb ischemia, intermittent claudication, pulmonary hypertension and other diseases

Optimer also has filed a marketing authorization application for fidaxomicin with the European Medicines Agency and has entered an exclusive collaboration and license agreement with Astellas Pharma Europe Ltd...to develop and commercialize the drug in Europe and certain other countries. (See BioWorld Today, June 1, 2011...Ltd., of Osaka, Japan, entered an agreement to acquire all currently marketed products from Victory Pharma Inc., of San Diego, including seven treatments for pain and two for

The biotech has five clinical-stage candidates, including BL-1040, a heart attack treatment that has completed a Phase I/II study and has been out-licensed to Ikaria Inc., of Hampton, N.J. In other news, BioLineRx enrolled the first subject in a Phase I study of BL-1021, an oral small molecule aimed at treating neuropathic pain...All other shareholders in Sophion also agreed to sell their ownership shares...TcL Pharma SAS, of Nantes, France, changed its name to Effimune SAS

Subject to approval by the European Medicines Agency, initial dosing is expected to commence this fall

Endotis Pharma, of Paris, enrolled the first patients in a Phase IIa trial of anticoagulant EP217609 and its specific antidote, avidin, to manage coagulation during open-heart surgery...In other news, Medivir signed an agreement with Daewoong Pharmaceutical Co...Other studies showed Victoza (liraglutide), a once-daily GLP-1 analogue for the treatment of Type II diabetes, could safely be added to insulin treatment and helped patients reach the ADA's HbA1C target, and that Victoza helped more patients

BioAlliance Pharma SA, of Paris, said the company filed an appeal to the French Supreme Court on a procedural matter in arbitral proceedings it had initiated against SpePharm Holding BV, of Amsterdam, the Netherlands, and SpeBio BV, which the two companies formed as a joint venture to commercialize Loramyc in Europe (excluding France) under a 2007 agreement...Clavis Pharma ASA, of Oslo, Norway, was awarded a grant from The Research Council of Norway of up to $2.5 million for the development of a

BioAlliance Pharma SA, of Paris, said the company filed an appeal to the French Supreme Court on a procedural matter in arbitral proceedings it had initiated against SpePharm Holding BV, of Amsterdam, the Netherlands, and SpeBio BV, which the two companies formed as a joint venture to commercialize Loramyc in Europe (excluding France) under a 2007 agreement...Amarantus will pay a license fee of $10 million to Generex in Amarantus common stock valued at not less than $5 million and a three-year

In other news, Astellas Pharma Europe Ltd., of Staines, UK, and Theravance Inc., of South San Francisco, announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended the granting of marketing authorization for Vibativ (telavancin hydrochloride) for the treatment of adults with nosocomial pneumonia including ventilator-associated pneumonia, known or suspected to be caused by methicillin-resistant Staphylococcus aureus

Astellas Pharma Europe Ltd., of Staines, UK, and Theravance Inc., of South San Francisco, announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended the granting of marketing authorization for Vibativ (telavancin hydrochloride) for the treatment of adults with nosocomial pneumonia including ventilator-associated pneumonia, known or suspected to be caused by methicillin-resistant Staphylococcus aureus

BioAlliance Pharma SA, of Paris, licensed Japanese development and commercialization rights for its antifungal agent Loramyc (miconazole Lauriad) to Tokyo-based Sosei Group Corp...Phylogica will also have an option to expand the collaboration to include an undisclosed number of other disease-associated targets...Santaris Pharma A/S, of Hoersholm, Denmark, advanced its cardiometabolic candidate, SPC4955, to Phase I trials

Tibotec has been leading the development and commercialization of telaprevir for Janssen Pharmaceutica NV, another J&J company, which has rights to the drug in Europe, the Middle East, South America and other regions. (See BioWorld Today, April 29, 2011.) Osaka, Japan-based Mitsubishi Tanabe Pharma Corp., which has rights to telaprevir in Japan and China, filed a new drug application in Japan in January...However, the two drugs won't have the market to themselves for long as several other

In other news, Sanofi-Aventis said that the company terminated its potential $375 million, July 2010 license agreement with Metabolex Inc., of Hayward, Calif., for diabetes drug SAR260093/MBX-2982, a GPR119 receptor agonist...Santaris Pharma AS, of Hoersholm, Denmark, and San Diego, advanced SPC5001 into Phase I trials for the treatment of high cholesterol...Swedish Orphan Biovitrum AB, of Stockholm, Sweden, and Biogen Idec Inc., of Weston, Mass., said the European Medicines Agency's (EMA) Pediatric

Acceleron Pharma Inc., of Cambridge, Mass., presented preclinical data showing RAP-661 increased bone mineral density, increased osteoblast activity and decreased osteoclast activity in a mouse model of bone loss...Biogen Idec Inc., of Weston, Mass., and Swedish Orphan Biovitrum AB, of Stockholm, Sweden, said the European Medicines Agency's (EMA) Pediatric Committee agreed to a pediatric investigational plan for their long-lasting, fully recombinant Factor IX Fc fusion protein, paving the way for a

BioAlliance Pharma SA, of Paris, extended its ongoing clonidine Lauriad Phase II trial in chemoradiation therapy-induced oral mucositis in patients with head and neck cancer to Germany and Spain, a move intended to accelerate patient recruitment

patients for the treatment of medullary thyroid cancer that cannot be removed by surgery or that has spread to other parts of the body...Medigene AG, of Martinsreid, Germany, and Triton Pharma AG, of Concord, Ontario, partnered to commercialize Veregen in Canada for the treatment of genital warts...Medgenics said it intends to use the proceeds for product development activities, including clinical trials of its product candidates Epodure to treat anemia in chronic kidney disease, Infradure to treat

The European Medicines Agency's Committee for Medicinal Products for Human Use recommended the approval of Weston, Mass.-based Biogen Idec Inc.'s Avonex (interferon beta-1a) Pen for patients with relapsing multiple sclerosis or a single demyelinating event...Medigene AG, of Martinsreid, Germany, and Triton Pharma AG, of Concord, Ontario, partnered to commercialize Veregen in Canada for the treatment of genital warts

The European Medicines Agency granted orphan drug designation to Formac Pharmaceuticals NV, of Leuven, Belgium, for FP110, a Phase IIa candidate for pouchitis...MorphoSys AG, of Martinsried, Germany, signed a manufacturing agreement with Boehringer Ingelheim GmbH, of Ingelheim, Germany, to cover the process of developing and manufacturing additional clinical material for MorphoSys' anti-CD19 antibody MOR208 and other drug candidates...In other news, the FDA has approved Oxford BioMedica plc's

The European Medicines Agency granted orphan drug designation to Formac Pharmaceuticals NV, of Leuven, Belgium, for FP110, a Phase IIa candidate for pouchitis...According to a new study in Nature Genetics, Hoersholm, Denmark-based Santaris Pharma A/S's locked nucleic acid-based compounds can inhibit disease-associated microRNA families...Results from Shire's Replagal study 059 in 70 patients showed that switching from Fabrazyme to Replagal 0.2 mg/kg every other week was well tolerated