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

to formulate CytoDyn's PRO 140 bulk drug substance through a fill-and-finish process for clinical-ready vials to advance two National Institutes of Health (NIH)-funded Phase IIb studies...Pfenex Inc., of San Diego, awarded Glide Pharma, of Oxford, UK, a subcontract to develop a solid formulation containing the recombinant protective antigen (rPA) from Bacillus anthracis expressed in Pfenex Expression Technology, suitable for delivery with the Glide SDI (solid dose injector

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

The CHMP said it is of the opinion that the drug does not demonstrate a favorable risk-benefit profile and recommended against marketing authorization...Pfizer intends to appeal the opinion and seek a re-examination by CHMP

Addex Therapeutics, 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...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

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

The news also adds to the growing fear that biosimilar drug development will prove trickier – and, perhaps costlier – than previously envisioned...That alliance led to the approval of Remsima in Korea last year, and a marketing authorization application is under review for the Remicade biosimilar in Europe, where it is expected to be launched as Infectra, according to GlobalData. (See BioWorld Today, Aug. 9, 2012.) Applications have yet to be filed in the U.S., where biosimilar development is

Avilex Pharma ApS, of Copenhagen, Denmark, said it has received seed funding from Novo Seeds, the early stage financing arm of Novo A/S, which will be used to support the development of dimeric ligands targeting PDZ domains...In other news, GSK experienced manufacturing delays for manufacture and supply of Horizant (gabapentin enacarbil), partnered with XenoPort Inc., of Santa Clara, Calif., resulting in a stockout of the drug...The firms will aim to offer pharma and biotech companies a set of fully

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

Pradax is used to prevent clotting in patients who suffer from atrial fibrillation...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

As a result of the amendment, Takeda assumes full responsibility for Omontys and, should the big pharma opt to re-introduce the drug to the market, Affymax would be eligible to receive royalties and potential commercial milestone payments totaling up to $180 million

The drug is expected to be available by the end of May...EBFs are medicines reformulated to provide additional patient benefit...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

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...Terms include certain milestones and tiered royalty payments to the HPA in return for technology transfer and other licensing rights

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...Astellas Pharma Inc., of Tokyo, and Nagasaki University signed a collaborative research agreement to discover new drugs for the treatment of neglected tropical diseases (NTDs) caused by dengue virus...In other news, The Nasdaq OMX Stockholm's

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...TransTech Pharma Inc., of High Point, N.C., said the FDA granted fast-track designation for TTP488, a small-molecule chemical compound in development to treat Alzheimer's disease (AD

Ark has been struggling to keep itself afloat since 2010, when the European Medicines Agency rejected gene therapy candidate Cerepro for use in glioma...Medigene's partner, Nordic Pharma Group, of Paris, is planning to launch Veregen in the Czech Republic, Poland, Hungary and Slovakia this year, upon conclusion of the reimbursable price-fixing procedure by the responsible authority...Vanda said it intends to reassess its European regulatory strategy once those results become available

In other news, Elan said its Tysabri (natalizumab) restructuring transaction is set to close with Weston, Mass.-based Biogen Idec Inc...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

Eisai Inc., of Woodcliff Lake, N.J., reported that the German Federal Joint Committee said it considers the additional benefit of Fycompa (perampanel) unproven when compared to two other treatments...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...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