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

The regulatory action does not affect the marketing authorization or continued use of Stribild, Gilead's once-daily single tablet HIV-1 regimen, which includes elvitegravir and cobicistat

The CHMP said it is of the opinion that the drug does not demonstrate a favorable risk-benefit profile and recommended against marketing authorization

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

Ipsen SA, of Paris, said Health Canada granted marketing authorization for Dysport (botulinum toxin Type A for injection) for the temporary improvement in the appearance of moderate to severe frown lines in adults younger than 65

BioAlliance Pharma SA, of Paris, said it received marketing authorization from the FDA for Sitavig (acyclovir Lauriad) in the treatment of recurring herpes labialis, marking the successful conclusion to the assessment procedure carried out by the American authorities

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

Pixuvri, an aza-anthracenedione, was granted conditional marketing authorization in Europe in May 2012

Ipsen SA, of Paris, said Health Canada granted marketing authorization for Dysport (botulinum toxin Type A for injection) for the temporary improvement in the appearance of moderate to severe frown lines in adults younger than 65

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

Pfizer Inc., of New York, said the European Commission granted conditional marketing authorization for Bosulif (bosutinib) for the treatment of adult patients with chronic phase, accelerated phase and blast phase Philadelphia chromosome-positive chronic myelogenous leukemia previously treated with one or more tyrosine kinase inhibitors and for whom Gleevec (imatinib, Novartis AG), Tasigna (nilotinib, Novartis AG) and Sprycel (dasatinib, Bristol-Myers Squibb Co.) are not considered appropriate

Based on positive data from a Phase II study in India, the firm filed a dossier for a Phase III trial in that country and, pending positive results, the study should permit Adocia to file a marketing authorization request in India and other emerging countries

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