Alk-Abello A/S, of Copenhagen, Denmark, said authorities in France have issued a marketing authorization for its new house dust mite sublingual allergy immunotherapy tablet (SLIT-tablet), Acarizax.

Cardiome Pharma Corp., of Vancouver, British Columbia, said it has filed a request for orphan drug designation with the FDA's Office of Orphan Products Development (OOPD) for an oral formulation of vernakalant hydrochloride. The indication listed within the application is the prevention of postoperative atrial fibrillation in patients undergoing coronary artery bypass graft surgery.

Cancer Research Technology (CRT), the development and commercialization arm of Cancer Research UK, said it has entered into a license agreement with MSD, known as Kenilworth, N.J.-based Merck & Co Inc. in the U.S. and Canada, to develop inhibitors of protein arginine methyltransferase 5 (PRMT5). These promising new drugs, which potentially have clinical applications in both cancer and non-cancer blood disorders, have been developed by the Australian Cooperative Research Centre (CRC) for Cancer Therapeutics (CT) with support from the Wellcome Trust and CRT, which has licensed rights to MSD on behalf of CT, a Melbourne based company. The PRMT5 protein is involved in many cellular processes including the epigenetic control of genes such as p53. High levels of PRMT5 protein are found in mantle cell lymphoma, chronic lymphocytic leukemia, melanoma, lung and breast cancers and are linked to poor survival. Under terms of the license, MSD will be responsible for R&D, including clinical development, and for worldwide commercialization of products. As part of the research and development activities, MSD has entered into a research collaboration with CT focusing on blood disorders, which MSD will fund. CRT will receive an up-front payment of $15 million and is eligible to receive potential payments of up to $500 million for achievement of development, regulatory and commercialization milestones. In addition, the agreement provides for royalties on sales. All payments will be shared between CRT, CT and the Wellcome Trust with the majority being returned to CT and its Australian research partners.

Eli Lilly and Co., of Indianapolis, and Roche Diagnostics, a unit of Basel, Switzerland-based Roche AG, said they partnered for ongoing development of a commercially scalable cerebrospinal fluid assay for amyloid-beta 1-42. The goal is to improve detection of amyloid, which, together with tau tangles, is a key marker of Alzheimer's disease. Under the nonexclusive agreement, Lilly is responsible for certain milestone payments upon successful completion of key development objectives. Roche is responsible for the development, registration and commercialization of the new test. Financial terms were not disclosed.

Ferring Pharmaceuticals SA, of Saint-Prex, Switzerland, and Karolinska Institutet, of Solna, Sweden, said they entered a collaboration and will establish a research center to focus on the human microbiome. The project, to be fully funded by Ferring and overseen by a joint governance committee, will be led by Lars Engstrand, of the Karolinska Institutet, who will serve as the center's director. One of the goals of the program is to futher understanding of the human microbiome to physiology and pathophysiology and develop new therapies.

Immunocellular Therapeutics Ltd., of Los Angeles, said it entered a research agreement with Eduardo Davila, an associate professor of microbiology and immunology at the University of Maryland School of Medicine, and the University of Maryland, Baltimore. The research will entail three projects: The first project will evaluate certain small-molecule immune modulators with the potential to enhance T-cell killing of tumor cells. The second project involves combining engineered killer T-cells and dendritic cell immunotherapies for tumor killing. The third project will study peptide configurations to use with dendritic cell immunotherapies with the goal of inducing enhanced T-cell responses. Financial details were not disclosed.

Leo Pharma AS, of Ballerup, Denmark, said it launched its first innovation lab in North America, in Markham, Ontario. The goal of the lab is to find new, nonpharmaceutical treatments for psoriasis and attract partners to develop apps, web platforms, wearable products, virtual reality, artificial intelligence, telemedicine, and other technologies. The lab will receive C100 million (US$70.8 million) in funding.

Merck & Co. Inc., of Kenilworth, N.J., said the FDA accepted for review the biologics license application for bezlotoxumab, an investigational antitoxin for prevention of Clostridium difficile infection recurrence. The FDA granted priority review, with a PDUFA date of July 23, 2016. The company also filed a marketing authorization application for bezlotoxumab with the EMA that is currently under review.

Meridian Laboratories Inc., of Buffalo Grove, Ill., said the FDA agreed during a pre-new drug application (NDA) meeting to the company's proposal to use the 505(b)(2) regulatory pathway for ML141, Meridian's liquid formulation of docetaxel injection for the treatment of multiple forms of cancer. The company said it is moving forward with the manufacture of the submission batches and completion of the NDA submission.

Ono Pharmaceutical Co. Ltd., of Osaka, Japan, said it expanded its adoption of the Medidata Clinical Cloud electronic data capture and management technology to include all clinical trials testing the use of immunotherapy drug Opdivo (nivolumab) against a broad range of cancers. Terms were not disclosed.

Psychogenics Inc., of Tarrytown, N.Y., said it obtained a license from the University of California, San Diego, to its Line-41 mouse model of Alzheimer's disease, expressing human APP with the Swedish (K670N/M671L) and London (V717I) mutations under the control of the murine-Thy-1 promoter. Terms were not disclosed.

Regenerx Biopharmaceuticals Inc., of Rockville, Md., disclosed publication of a new scientific study demonstrating how the hormone thymosin beta 4 initiates remyelination by promoting the differentiation of oligodendrocyte progenitor cells (OPCs) in two separate demyelination animal models, including the experimental autoimmune encephalomyelitis (EAE) model and the cuprizone diet model, both commonly used for studying different aspects of MS-related pathology. The research was published in the Journal of Neurobiology of Disease. Regenerx is developing the peptide for tissue and organ protection, repair and regeneration.

Replikins Ltd., of Boston, said it completed discovery on a synthetic genomic-based peptide vaccine-blocker for Zika virus based on the conserved Replikin sequences in the Zika genome and will soon begin testing the efficacy of the Zika synthetic vaccine.

Vertex Pharmaceuticals Inc., of Boston, said Health Canada approved Prorkambi (lumacaftor/ivacaftor), to treat cystic fibrosis (CF) in those 12 and older who have two copies of the F508del mutation. Eligibility for the drug will be determined via genetic testing. The approval was based on data from two phase III trials (TRAFFIC and TRANSPORT) that studied more than 1,100 eligible participants with CF.