Janssen-Cilag International NV, of Beerse, Belgium, a unit of Johnson & Johnson, submitted a marketing authorization application to the European Medicines Agency for a fixed-dose combination of canglifozin and immediate-release metformin for Type II diabetes...The company has also submitted new drug applications to the FDA for canagliflozin and for the fixed-dose combination therapy...The companies will expand their existing collaboration to include joint promotion of Abilify in Denmark, Finland

In other news, Biotie and partner H. Lundbeck A/S, of Copenhagen, Denmark, said they received marketing authorization from the European Commission for Selincro (nalmefene), an opioid system modulator, for the reduction of alcohol consumption in adults with alcohol dependence

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...Mechlorethamine gel has orphan status in the U.S. Ceptaris said it also plans to submit a marketing authorization application in Europe in mid-2013. (See BioWorld Today, Aug. 30, 2012

The companies will target development of drugs to treat topical ophthalmic diseases, including ocular allergy, dry eye and other inflammatory eye conditions...Anika Therapeutics Inc., of Bedford, Mass., notified the European Medicines Agency that it decided to withdraw its application for centralized marketing authorization for Hyalograft C autograft (cultured autologous chondrocytes on hyaluronan-based scaffold), intended for the surgical repair of symptomatic cartilage defects of the femoral

In connection, it entered into a loan and security agreement with Biotech Investment Group LLC, relating to the funding of certain tenant improvements, relocation costs, security deposit, portions of rents related to the leased San Diego facility and certain other cash needs...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

and Europe to extend the marketing authorization for Cimzia (certolizumab pegol) for the treatment of adults with active psoriatic arthritis and for active axial spondyloarthritis

Intercell AG, of Vienna, Austria, said the pediatric indication for Ixiaro, a vaccine to protect against Japanese encephalitis (JE), was granted marketing authorization by the European Medicines Agency and the European Commission...In both studies the JE vaccine was shown to be highly immunogenic in children/adolescents age 2 months to younger than 18 years with a safety profile comparable to pediatric vaccines licensed for other diseases

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...Ipsen SA, of Paris, and Braintree Laboratories Inc., of Braintree, Mass., said that Eziclen/Izinova (BLI-800) completed the European decentralized registration procedure, giving member states 30 days

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...Ipsen SA, of Paris, and Braintree Laboratories Inc., of Braintree, Mass., said that Eziclen/Izinova (BLI-800) completed the European decentralized registration procedure, giving member states 30 days

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

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 in specific patient populations...In other news, Boehringer Ingelheim said it enrolled the first patients in its Phase III interferon-free (IFN-free) program, HCVerso, testing its IFN-free polymodal regimen combining faldaprevir (BI 201335), a next-wave once-daily protease inhibitor, and BI 207127

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

The Merck expansion grants the big pharma further access to Adimab's technology to discover and optimize fully human antibody candidates, including potentially bispecific antibody candidates, across all disease areas...Savient Pharmaceuticals Inc., of Bridgewater, N.J., said the European Commission granted marketing authorization to Krystexxa (pegloticase) for the treatment of severe debilitating chronic tophaceous gout in adults who may also have erosive joint involvement and who have failed to

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...The European Medicines Agency accepted submission of a marketing authorization application for aripiprazole depot formulation by Otsuka Pharmaceutical Co

Finox Biotech AG, of Burgdorf, Switzerland, said it submitted a marketing authorization application for its biosimilar recombinant follicle-stimulating hormone to the European Medicines Agency Oct. 30...Gentium SpA, of Villa Guardia, Italy, said it submitted responses to the second list of outstanding issues to the European Committee for Medicinal Products for Human Use in connection with the company's marketing authorization application for defibrotide to treat and prevent hepatic veno-occlusive

Algeta ASA, of Oslo, Norway, said partner Bayer AG, of Leverkusen, Germany, submitted a marketing authorization application to the European Medicines Agency for Alpharadin (radium-223 dichloride) for the treatment of castration-resistant prostate cancer patients with bone metastases...Galderma Pharma SA, of Lausanne, Switzerland, agreed to acquire Spirig Pharma AG, of Egerkingen, Switzerland

AOP Orphan Pharmaceuticals AG, of Vienna, Austria, said it plans to initiate a Phase III study to support European marketing authorization of a monopegylated interferon alpha 2b candidate (AOP2014/P1101) for the treatment of polycythemia vera...Galderma Pharma SA, of Lausanne, Switzerland, and Valeant Pharmaceuticals International Inc., of Montreal, reached agreement on terms of a revised North American aesthetics arrangement, resolving Galderma's pending litigation related to Valeant's acquisition

Alfa Wassermann SpA, of Bologna, Italy, and Norgine BV, of Amsterdam, the Netherlands, received European marketing authorization for Xifaxan 550-mg (rifaximin-alpha)/Refero/Targaxan/Tixteller for hepatic encephalopathy, a neuropsychiatric condition that can occur with cirrhosis of the liver...Reddy's Laboratories Ltd., of Hyderabad, India, acquired exclusive marketing and sales rights to Pamorelin LA (triptorelin) Depot, by Debiopharm Group, of Lausanne, Switzerland, in India for locally advanced

Preclinical treatment goals for the TNBC and IBC indications are two-pronged: as a tumor reduction agent in combination with other approved drugs in preoperative settings and as a drug to treat and control or eliminate cancer metastasis in TNBC and IBC patients...Distribution of Prothena ordinary shares in the demerger is conditioned upon, among other conditions to the demerger, a registration statement filed with the SEC, having been declared effective by the SEC and the affirmative vote of the