In other news, Addex said dipraglurant demonstrated dose-dependent mGlu5 receptor occupancy in a nonhuman primate positron emission tomography study, showing the correlation between the plasma concentration of dipraglurant and occupancy of dipraglurant on mGlu5 receptors in the brain...Formed in 2011, Ascletis also has added late-stage candidates ASC-06 (ALN-VSP), a first-in-class, systemically delivered RNAi therapeutic for liver cancers, and ASC-08 (danoprevir), a hepatitis C protease inhibitor,

Allergan licensed rights to the Darpin technology from Molecular Partners AG for development in AMD and other eye diseases. (See BioWorld Today, Aug. 22, 2012.) And Eylea has fared well so far against Roche AG's Lucentis (ranibizumab), due to its lower cost and a label that calls for less frequent dosing, and even to cancer drug Avastin (bevacizumab), a cheaper, off-label alternative

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

Formed in 2011, Ascletis also has added late-stage candidates ASC-06 (ALN-VSP), a first-in-class, systemically delivered RNAi therapeutic for liver cancers, and ASC-08 (danoprevir), a hepatitis C protease inhibitor, to its portfolio. (See BioWorld Today, April 7, 2011...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

Celgene Corp., of Summit, N.J., said the European Committee for Medicinal Products for Human Use adopted a positive opinion for Revlimid (lenalidomide) for the treatment of patients with transfusion-dependent anemia due to low or intermediate-1 risk myelodsyplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate...Ligand Pharmaceuticals Inc., of San Diego, reported preclinical data showing highly targeted liver

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

Inc., of Whitehouse Station, N.J., entered into a nonexclusive deal with Bristol-Myers Squibb Co., of New York, to conduct a Phase II trial of a once-daily oral combination regimen consisting of BMS' NS5A replication complex inhibitor daclatasvir and Merck's NS3/4A protease inhibitor MK-5172 to treat chronic hepatitis C virus infection genotype 1

Armgo Pharma Inc., of Tarrytown, N.Y., and the Muscular Dystrophy Association (MDA) said $1 million was awarded for preclinical work in support of an investigational new drug application for AMR201, an oral, small-molecule Rycal drug that has the potential to treat Duchenne's muscular dystrophy...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

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...Roche AG and Ascletis Inc., of Hangzhou, China, have entered into a collaboration to develop and commercialize Roche's investigational protease inhibitor danoprevir in China for the treatment of hepatitis-C virus

Gilead Sciences Inc., of Foster City, Calif., submitted a new drug application (NDA) to the FDA for sofosbuvir, its once-daily oral nucleotide analogue to treat chronic hepatitis C virus (HCV) infection...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...Santaris Pharma A/S, of Hoersholm, Denmark, said the New England Journal of Medicine published online the final Phase IIa hepatitis C virus (HCV) data

Janssen Research & Development LLC, of Titusville, N.J., a division of Johnson & Johnson, submitted a new drug application to the FDA seeking approval for simeprevir (TMC435), an NS3/4A protease inhibitor, administered as a 150-mg capsule once daily with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C virus in adult patients. (See BioWorld Today, Dec. 26, 2012...RIJ said it aims to commercialize the world's first pharmaceutical iPS cell-derived retinal pigment

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 separate news, Astellas signed a deal to access the TSUBAME2.0 supercomputer at the Tokyo Institute of Technology to discover candidates for NTDs caused by dengue virus...In other news, The Nasdaq OMX Stockholm's listing committee approved the listing of NeuroVive's shares

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 procedure by the responsible authority...The IMODI project, which brings together big pharma firms including Paris-based Sanofi SA and Ipsen SA, along with

Lallemand Pharma, of Lugano Switzerland, partnered with Cipla Ltd., of Mumbai, India, to market and distribute PMBL tablets in India, under the name Pulmigen, for prevention of chronic bronchopulmonary infections...Medivir AB, of Huddinge, Sweden, said that its partner Janssen Pharmaceuticals Inc., part of Johnson & Johnson, of New Brunswick, N.J., submitted a regulatory application to the Japanese Ministry of Health and Welfare for simeprevir in genotype 1 chronic hepatitis C. The drug is an NS3

In connection, it entered into a loan and security agreement with Biotech Investment Group LLC, relating to the funding of certain tenant improvements, relocation costs, security deposit, portions of rents related to the leased San Diego facility and certain other cash needs...Exelixis Inc., of South San Francisco, partnered with Swedish Orphan Biovitrum AB (Sobi), of Stockholm, Sweden, to distribute and commercialize Cometriq (cabozantinib) for metastatic medullary thyroid cancer in the European

Isotechnika Pharma Inc., of Edmonton, Alberta, and privately held Aurinia Pharmaceuticals Inc., of Victoria, British Columbia, said they signed a binding term sheet for a merger to create a clinical-stage firm focused on the global nephrology market...Under the terms, Bio-Link will work with Phylogica to monetize those assets through out-licensing or disposal of the Phylomer peptides to a pharma or biotech company...Protalix BioTherapeutics Inc., of Carmiel, Israel, said it engaged Citigroup to assist