Clinigen Group plc, of Burton-on-Trent, UK, and Theravance Inc., of South San Francisco, entered an exclusive commercialization agreement in the European Union and certain other countries located in Europe for Vibativ (telavancin) in nosocomial pneumonia, including ventilator-associated pneumonia, known or suspected to be caused by methicillin-resistant Staphylococcus aureus, when other alternatives are not suitable...In other news, Elan said its Tysabri (natalizumab) restructuring transaction is

Clinigen Group plc, of Burton-on-Trent, UK, and Theravance Inc., of South San Francisco, entered an exclusive commercialization agreement in the European Union and certain other countries located in Europe for Vibativ (telavancin) in nosocomial pneumonia, including ventilator-associated pneumonia, known or suspected to be caused by methicillin-resistant Staphylococcus aureus, when other alternatives are not suitable...Cubist Pharmaceuticals Inc., of Lexington, Mass., and Astellas Pharma Inc., of

The companies will expand their existing collaboration to include joint promotion of Abilify in Denmark, Finland, Germany, Italy, Spain, Sweden and the U.K. Lundbeck will promote Abilify in Austria, Belgium, Ireland, Netherlands, Poland, Portugal and Romania...Under the agreement, Lundbeck will have the right to promote all formulations of Abilify currently marketed, sold or distributed by Otsuka in the European Union

Antisense Pharma GmbH, of Regensburg, Germany, revised its business objectives related to the advancement of its next-generation TGF-beta inhibitor oligonucleotide program...BioAlliance Pharma SA, of Paris, said it inked a collaboration with an undisclosed vaccine company to develop a vaccine application of its Lauriad mucoadhesive technology...In other news, Biotie and partner H. Lundbeck A/S, of Copenhagen, Denmark, said they received marketing authorization from the European Commission for Selincro

BioAlliance Pharma SA, of Paris, said it inked a collaboration with an undisclosed vaccine company to develop a vaccine application of its Lauriad mucoadhesive technology...The marketing authorization applies to all 27 European Union member states

Exelixis Inc., of South San Francisco, partnered with Swedish Orphan Biovitrum AB (Sobi), of Stockholm, Sweden, to distribute and commercialize Cometriq (cabozantinib) for metastatic medullary thyroid cancer in the European Union and potentially other countries

OSE Pharma SA, of Paris, said the FDA granted orphan drug status to its lead candidate, OSE 2101, to treat non-small-cell lung cancer (NSCLC) in patients expressing HLA-A2

Pursuant to the terms, each of the company's ordinary shares, including shares represented by American depositary shares (ADS), will be cancelled in exchange for the right to receive $2.20 in each per share, or $15.40 per ADS...Due to the oversubscription, the closing unit price was set at NIS3.544 per unit

GlaxoSmithKline plc, of London, said it submitted a marketing authorization application to the European Medicines Agency (EMA) for trametinib (ME) as a monotherapy and in combination with dabrafenib (BRAF) for the treatment of adults with unresectable or metastatic melanoma with a BRAFV600 mutation...The sulphate-based formulation (sodium, magnesium and potassium sulphates) will be indicated in adults for bowel cleansing prior to colonoscopy and similar procedures...Ipsen holds exclusive manufacturing

Isotechnika Pharma Inc., of Edmonton, Alberta, and privately held Aurinia Pharmaceuticals Inc., of Victoria, British Columbia, said they signed a binding term sheet for a merger to create a clinical-stage firm focused on the global nephrology market...Under the terms, Bio-Link will work with Phylogica to monetize those assets through out-licensing or disposal of the Phylomer peptides to a pharma or biotech company...Protalix BioTherapeutics Inc., of Carmiel, Israel, said it engaged Citigroup to assist

BioCryst's chimpanzee study had been designed to determine if nontoxic doses of BCX5191 would have a potent antiviral effect...Cerulean Pharma Inc., of Cambridge, Mass., said preclinical data showed that CRLX101 in combination with Avastin (bevacizumab, Roche AG) inhibited tumor growth and improved survival vs...Lee's will have an option to negotiate for commercial rights in China

The drug is expected to launch in Canada in the second quarter...Pfizer Inc., of New York, said the Committee for Medicinal Products for Human Use of the European Medicines Agency offered a positive opinion on the conditional marketing authorization of bosutinib in the European Union (EU) in chronic phase, accelerated phase and blast phase Philadelphia chromosome positive chronic myelogenous leukemia patients previously treated with one or more tyrosine kinase inhibitors and for whom imatinib

and European Union and fast-track status by the FDA...Synageva's relative silence on the Phase III study – including lack of public confirmation the trial has begun to enroll – prompted M. Ian Somaiya, senior research analyst at Piper Jaffray & Co., to sound a cautious note on the company's outlook...In other financings news

Eliquis is an oral Factor Xa inhibitor that has been approved for the same indication already in the European Union and Canada...The FDA acknowledged receipt of a new drug application for Eliquis in September and deemed it a complete response to its June 22 complete response letter requesting additional information on data management and verification from the ARISTOTLE trial

Brinavess has received approval in the European Union for the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults but has not received FDA approval...Shares of Somaxon (NASDAQ:SOMX) soared on the buyout news, gaining 80.3 percent, or $1.18, to close Tuesday at $2.65. (See BioWorld Today, March 19, 2010, July 16, 2010, Aug. 26, 2010, and June 9, 2011...Ltd., pursuant to the existing license, commercialization and supply agreement between Sucampo Pharma Ltd., SPI's subsidiary

Alimera and partner pSivida Corp., of Watertown, Mass., turned to the European Union's decentralized regulatory procedure after Iluvien, an intravitreal implant that delivers fluocinolone acetonide, received two complete response letters from the FDA. (See BioWorld Today, Dec. 28, 2010, and Nov. 14, 2011...Apexigen Inc., of Burlingame, Calif., signed a manufacturing supply agreement with Boehringer Ingelheim GmbH, of Ingelheim, Germany, under which the big pharma firm will provide cell line

Those and other data are set to be presented at the American Society for Hematology meeting in Atlanta next month...Should the trial hit the predefined overall survival endpoint, the company said it expects those data to support marketing applications for AlloStim in the U.S., European Union and other jurisdictions...Under the terms, Nordic Pharma will commercialize the product in those areas, with Medigene receiving milestone payments and double-digit royalties on sales, as well as certain payments

The contract, issued under the Russian Federation's "Pharma 2020" development initiative, provides matching funding over a period of about three years, which will be used to support preclinical and clinical studies...Early this year, Theravance's partner for Vibativ, Astellas Pharma Inc., of Tokyo, handed back full rights to the program. (See BioWorld Today, Dec. 1, 2009...The company plans to disclose a new ticker symbol in January

Erytech Pharma, of Lyon, France, said it entered a definitive agreement granting Orphan Europe, part of the Recordati Group, of Milano, Italy, exclusive rights for the commercialization and distribution of Graspa in acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML) in Europe...Sarepta Therapeutics Inc., of Cambridge, Mass., said it inked a collaboration for the development of an additional exon-skipping drug, targeting exon 53, with the University College London's scientist