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

In separate news, another Galapagos unit, Argenta, inked a deal with Boehringer Ingelheim GmbH, of Ingelheim, Germany, to apply its respiratory drug discovery services to an undisclosed target within Boehringer's respiratory disease portfolio...In other news, BioInvent said the first patient has been treated in a Phase II study of BI-505 for smoldering multiple myeloma, or asymptomatic myeloma

Covis Pharma Sarl, of Zug, Switzerland, inked a deal with affiliates of Paris-based Sanofi SA to acquire full commercial rights to Nilandron (nilutamide), Plaquenil (hydroxychloroquine), Rilutek (riluzole), Uroxatral (alfuzosin hydrochloride) and Kayexalate (sodium polystyrene sulfate) in the U.S. Sanofi will retain rights to the products outside of the U.S. Financial terms were not disclosed...In other news, Prana reported that it received a A$2.5 million (US$2.6 million) cash refund under the R&D

In other news, GSK recently agreed to a nonexclusive material transfer, patent and know-how license deal with the Health Protection Agency (HPA) for the development and manufacture of a next-generation polio vaccine...The agreement allows the HPA to contribute to global polio eradication, while securing a commitment from a major pharma firm to develop use of its technology

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

The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis' ANDA for up to 30 months from the date the plaintiffs received notice of Actavis' ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities...Actavis said it may be a first applicant to file an ANDA for the generic version of Fortesta and, should its ANDA be approved, may be entitled to 180 days of generic

The double-blind, parallel-group trials included 912 asthma patients randomized to additional tiotropium Respimat 5 mg or placebo for 48 weeks...The clinical trial is a randomized, double-blind, placebo-controlled parallel group study to evaluate the safety, clinical efficacy and pharmacokinetic profile of bertilimumab in subjects with active moderate-to-severe ulcerative colitis...Lallemand Pharma, of Lugano Switzerland, partnered with Cipla Ltd., of Mumbai, India, to market and distribute PMBL

The double-blind, parallel-group trials included 912 asthma patients randomized to additional tiotropium Respimat 5 mg or placebo for 48 weeks...With this new approval, Stivarga is intended to be used in patients whose GIST cancer cannot be removed by surgery or is metastatic and no longer responding to Gleevec (imatinib, Novartis AG) and Sutent (sunitinib, Pfizer Inc.), two other FDA-approved drugs to treat GIST...Lallemand Pharma, of Lugano Switzerland, partnered with Cipla Ltd., of Mumbai, India,

The extension will enable the company to increase the number of centers involved in the randomized, double-blind trial...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

The complaint alleges that Daiichi Sankyo pays female sales employees less than male employees for performing the same work, promotes or advances female sales employees at a slower rate than male sales employees, treats pregnant employees and working mothers of young children adversely compared to other employees and subjects women to other discriminatory terms and conditions of employment

BioAlliance Pharma SA, of Paris, said the European Independent Board of Experts held its first meeting on the ReLive Phase III trial evaluating the efficacy of Livatag (doxorubicin Transdrug) in primary liver cancer and recommended continuing the global, multicenter, randomized study without modification...Gentium expects to receive an opinion from the agency regarding the approval of defibrotide during the first quarter of 2013...The randomized, double-blind, placebo-controlled study will assess

In a flash note, she observed that, with respect to pharmacokinetics, "it's unclear whether PI3K gamma inhibition by IPI-145 has meaningful contribution to anticancer activity...OncoSec plans to use the proceeds to fund clinical trials and research and development and for other corporate purposes...The company plans to use the proceeds to fund research and development, clinical trials and for other corporate purposes.

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 Elan shareholders...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

The applications are supported by findings from Phase III study Multicenter, Randomised, Double-blind, Placebo-controlled trials of Ustekinumab, a Fully Human anti-IL-12/23p40 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Psoriatic Arthritis (PSUMMIT I and PSUMMIT II), which evaluated the efficacy and safety of subcutaneously administered Stelara 45 mg or 90 mg at weeks 0, four and then every 12 weeks...The FDA gave guidance and permission to Lipocine Inc., of Salt Lake

The primary objective of the multicenter, randomized, double-blind, placebo-controlled study is to confirm the ability of ataluren to slow disease progression as assessed by ambulatory ability based on the 6MWD in patients with nmDMD...Valeant Pharmaceuticals International Inc., of Montreal, and Galderma Pharma SA, of Lausanne, Switzerland, reached agreement on terms of a revised North American aesthetics arrangement, resolving Galderma's pending litigation related to Valeant's acquisition of

In other news, Bayer said its BAY 86-6150 is being investigated in a Phase II/III study, dubbed TRUST (TReatment with Unique recombinant rFVIIa STudy), and the recruitment of the first cohort is now complete...In other news, Viralytics is offering shareholders up to $15,000 worth of shares at 30 cents each in a new underwritten share purchase plan to fund the company's intravenous cancer trial and the continued clinical research and development of Cavatak, its lead oncolytic virus candidate

In other news, Orexo said the FDA accepted for review its new drug application for Zubsolv, a sublingual formulation of buprenorphine and naloxone, and set a PDUFA date of July l6, 2013...Tiltan Pharma Ltd., of Jerusalem, said it enrolled the first U.S

In 2008 and 2009, 20 patients suffering from moderate to severe allergies to birch pollen were enrolled in a double-blind, randomized, placebo-controlled Phase I/IIa trial and received five subcutaneous injections over two months of either AllerT (N = 15) or placebo (N = 5...Immune Pharmaceuticals Ltd., of Herzlyia-Pituach, Israel, and EpiCept Corp., of Tarrytown, N.Y., entered a merger agreement, anticipated to close in the first quarter of 2013, that will create a combined company – Immune

In addition to active involvement in the development of the monoclonal antibody, AET BioTech will provide additional investment in the biosimilar based on committed long-term financing and will oversee future commercialization of the product...IL-17 mediated signaling is known to induce the expression of cytokines and other effectors in a variety of immunological diseases such as psoriasis and chronic obstructive pulmonary disease...The FDA is not obligated to follow the advice of its advisory panels