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...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

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

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...The firms will aim to offer pharma and biotech companies a set of fully integrated nuclear receptor drug discovery capabilities by combining expertise in structural biology, medicinal chemistry, biology, DMPK, pharmacology and safety

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

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...Astellas Pharma Inc., of Tokyo, said the European Commission approved expanded options for pre-treatment prior to use of Qutenza (8 percent capsaicin patch...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

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...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

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

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

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...The marketing authorization applies to all 27 European Union member states

The companies will target development of drugs to treat topical ophthalmic diseases, including ocular allergy, dry eye and other inflammatory eye conditions...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