In separate news, Eisai said it filed a Type II variation application with the European Medicines Agency for Halaven (eribuln), requesting an indication extension to include treatment of earlier-line metastatic breast cancer patients

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...The goal is to validate emerging epigenetic targets for oncology indications and to demonstrate the eligibility of selected target families for drug formalations

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

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

Kengatharan declined to disclose Armetheon's financing to date but said the company is able to draw from a convertible note as it moves toward a Series A...Moving tecarfarin through an NDA filing will require about $65 million, Kengatharan estimated, which could be delivered in two tranches: $10 million to develop a pivotal Phase III plan that passes muster with the FDA and European Medicines Agency and to initiate carcinogenicity studies and CMC commercialization activities, and $55 million to

The company expects to see results from by late summer...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

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

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...In other news, SCT closed its previously announced private placement for gross proceeds of C$3.2 million (US$3.1 million

Ark has been struggling to keep itself afloat since 2010, when the European Medicines Agency rejected gene therapy candidate Cerepro for use in glioma...The studies are designed to allow PCT to evaluate the applicability of SistemQC technology in stem cell characterization employing Sistemic's miRNA profiling system and analytical approaches to product miRNA panels

The news was hardly unexpected, as the product was nodded through by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in January...Those and other questions are likely to get a further airing in Brussels Tuesday

Ark has been struggling to keep itself afloat since 2010, when the European Medicines Agency rejected gene therapy candidate Cerepro for use in glioma...Vanda said it intends to reassess its European regulatory strategy once those results become available

The news was hardly unexpected, as the product was nodded through by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in January...Those and other questions are likely to get a further airing in Brussels Tuesday

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

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 companies will expand their existing collaboration to include joint promotion of Abilify in Denmark, Finland, Germany, Italy, Spain, Sweden and the U.K. Lundbeck will promote Abilify in Austria, Belgium, Ireland, Netherlands, Poland

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

The marketing authorization applies to all 27 European Union member states...A Phase I trial is expected to start this year in primary amyloidosis patients...TikoMed's product is designed to enhance the outcome of the treatment by improving the survival of transplanted cells by inhibiting a destructive immunological reaction and through stimulation of growth factors