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

Gilead said it will file for regulatory approval of sofosbuvir in other territories during the second quarter, including the European Union, where the European Medicines Agency accepted the company's request for accelerated assessment

Pharming Group NV, of Leiden, the Netherlands, said it received approval from the European Medicines Agency for Sanofi Chimie to manufacture drug substance for Pharming's Ruconest (recombinant human C1 inhibitor) at its Aramon, France, site

Pharming Group NV, of Leiden, the Netherlands, said it received approval from the European Medicines Agency for Sanofi Chimie to manufacture drug substance for Pharming's Ruconest (recombinant human C1 inhibitor) at its Aramon, France, site

Ark has been struggling to keep itself afloat since 2010, when the European Medicines Agency rejected gene therapy candidate Cerepro for use in glioma

Ark has been struggling to keep itself afloat since 2010, when the European Medicines Agency rejected gene therapy candidate Cerepro for use in glioma

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

Funds will be used to advance development programs across Bionomics' pipeline, including BNC375, Bionomics' drug candidate for the treatment of Alzheimer's disease and other conditions where memory is significantly compromised and Bionomics' cancer stem cell directed drug candidate BNC101...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

plc, of Dublin, Ireland, said the European Medicines Agency granted orphan designation for its lead program, NEOD001, for the potential treatment of amyloid light-chain amyloidosis

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 condyle or trochlea caused by acute or repetitive trauma in adults

To date, 150 patients out of a total of 200 patients have already been recruited in 16 centers in Germany, Austria and Israel...The goal is to modulate the half-life of the therapy to increase efficacy of treatment...The company intends to start clinical trials in the third quarter

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

Sanofi Pasteur, of Lyon, France, the vaccines division of Sanofi SA, said the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended market approval for Sanofi Pasteur's 6-in-1 pediatric vaccine Hexyon/Hexacima, the only fully liquid, ready-to-use, 6-in-1 vaccine to protect infants against diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis and invasive infections caused by Haemophilus influenzae type b