Addex Therapeutics SA, of Geneva, said regulatory authorities in the Netherlands gave approval to start in the first half of this year a Phase I study of ADX71441, a GABA-B receptor positive allosteric modulator, for Charcot-Marie-Tooth1A (CMT1A) neuropathy and other disease indications...for the Brisbane, Australia-based company's Diversity Scanning Array (DSA) and Versatile Assembly on Stable Templates (VAST) technologies in a deal worth up to $240 million in milestones, plus other payments

Omeros Corp., of Seattle, said the European Medicines Agency granted eligibility for centralized review of the company's planned marketing authorization application (MAA) for ophthalmology candidate OMS302 (ketorolac and phenylephrine

Novartis has worldwide rights to the drug, along with certain backup compounds in all indications, with Incyte retaining a co-development option to INC280 in the U.S...Due to third-party manufacturing issues, distribution of Janssen Products LP's Caelyx in Europe has been intermittently disrupted since 2011

BioMarin Pharmaceutical Inc., of San Rafael, Calif., said it submitted a marketing authorization application to the European Medicines Agency for Vimizim (BMN-110, elosulfase alfa), an enzyme replacement therapy for patients with rare lysosomal storage disorder mucopolysaccharidosis Type IVA, also called Morquio A syndrome

Medivir AB, of Stockholm, Sweden, said Janssen-Cilag International NV, of Beerse, Belgium, part of Johnson & Johnson, submitted a marketing authorization application to the European Medicines Agency seeking approval for the protease inhibitor simeprevir (TMC435) for hepatitis C virus patients

Addex Therapeutics SA, of Geneva, reported preclinical data showing that its mGlu5 negative allosteric modulator oral small molecule, dipraglurant, dose-dependently prevented the abnormal excitatory effect observed on brain slices of transgenic primary generalized torsion dystonia 1 (DYT1) mice overexpressing the human mutant TOR1A gene by decreasing the paradoxical neuronal activity induced by the dopamine D2 receptor agonist quinpirole. DYT1 is a common and severe genetic form of dystonia

Gentium SpA, of Villa Guardia, Italy, said it requested a re-examination of the negative opinion adopted by the European Committee for Medicinal Products for Human Use (CHMP) March 22, regarding the marketing authorization application (MAA) submitted for defibrotide to treat and prevent hepatic veno-occlusive disease in adults and children undergoing hematopoietic stem cell transplantation therapy

to begin a Phase IIa trial of BL-8040, a selective antagonist of chemokine receptor CXCR4, in acute myeloid leukemia (AML...According to the terms, Shasun will be able to use the Debiopharm technology to manufacture synthetic Huperzine-A under GMP quality conditions and commercialize it in pharmaceutical and nutraceutical markets...In other news, GSK experienced manufacturing delays for manufacture and supply of Horizant (gabapentin enacarbil), partnered with XenoPort Inc., of Santa Clara, Calif

Sanofi Pasteur Ltd., of Lyon, France, the vaccines division of Sanofi SA, said a decentralized marketing authorization application has been accepted for review in the European Union (EU) countries for a quadrivalent formulation of Vaxigrip, Sanofi Pasteur's seasonal inactivated split-virion influenza vaccine produced at its facility in Val de Reuil, France

Arena Pharmaceuticals Inc., of San Diego, said partner Eisai Inc., of Woodcliff Lake, N.J., submitted a marketing authorization application for Belviq (lorcaserin HCl) in Mexico for use as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index of 30 kg/m2 or greater, or 27 kg/m2 or greater in the presence of at least one weight-related co-morbid condition

In separate news, Astellas signed a deal to access the TSUBAME2.0 supercomputer at the Tokyo Institute of Technology to discover candidates for NTDs caused by dengue virus...In other news, The Nasdaq OMX Stockholm's listing committee approved the listing of NeuroVive's shares

The company said it intends to submit a marketing authorization application in Europe with Denmark as the reference member state and contended, based on the positive response in the official minutes of the meeting with the DKMA, that no further clinical studies will be required prior to the submission

Vanda Pharmaceuticals Inc., of Washington, said it withdrew its marketing authorization application in Europe for Fanaptum (oral iloperidone tablets) for the treatment of adults with schizophrenia

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

Ltd., of Osaka, Japan, said it submitted a marketing authorization application to the European Medicines Agency for vedolizumab, a gut-selective humanized monoclonal antibody, for the treatment of adults with moderately to severely active ulcerative colitis and Crohn's disease

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

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 European Medicines Agency has accepted the marketing authorization application for Cometriq...Vivus Inc., of Mountain View, Calif., said that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) confirmed its Oct. 18, 2012, decision to decline the Marketing Authorization Application (MAA) for Qsiva (phentermine/topiramate ER) for the treatment of obesity in the European Union

Gentium SpA, of Villa Guardia, Italy, made an oral presentation for the European Medicines Agency's Committee for Medicinal Products for Human Use supporting its marketing authorization application for Defibrotide in hepatic veno-occlusive disease in adults and children receiving hematopoietic stem cell transplantation therapy