The FDA granted orphan drug status to MG01Cl (sustained release metadoxine), by Alcobra Ltd., of Tel Aviv, Israel, for treatment of fragile X syndrome. Alcobra’s preclinical studies showed significant improvement in cognitive and social functioning after treatment with MG01Cl in an animal model of fragile X syndrome.

Biocon Ltd., of Bangalore, India, and Quark Pharmaceuticals Inc., of Fremont, Calif., said they inked a licensing and collaboration deal to develop a range of siRNA-based therapeutics. The collaboration will enable Biocon to co-develop, manufacture and commercialize QPI-1007, a siRNA candidate for ophthalmic conditions, for India and other key markets, and Biocon will have access to Quark’s siRNA technology platform. Financial terms were not disclosed.

Biocryst Pharmaceuticals Inc., of Research Triangle Park, N.C., said it selected two optimized plasma kallikrein inhibitors to advance into preclinical development as potential once-daily, oral treatments for the prevention of hereditary angioedema (HAE) attacks. The second-generation program’s goals include improving selectively and bioavailability compared to BCX4161, a selective kallikrein inhibitor in Phase II development for preventing HAE attacks.

Boehringer Ingelheim GmbH, of Ingelheim, Germany, and Circuit Therapeutics signed a collaboration agreement to discover therapies for psychiatric disorders. The partnership will apply Circuit’s Optogenetics platform to identify new drug targets. Under the terms of the agreement, the companies will work together for three years.

Domain Therapeutics SA, of Strasbourg, France, said it signed a licensing and partnership agreement on G protein-coupled receptor (GPCR) biosensor technology with the Universite de Montreal and its commercialization unit, with the Institute for Research in Immunology and Cancer – Commercialization of Research, as well as with McGill University. The deal gives Domain co-exclusive access to the biosensor technology, which makes it possible to discriminate the functional activation of intracellular signaling pathways associated with GPCRs.

Genmab A/S, of Copenhagen, and Glaxosmithkline plc, of London, said the FDA granted priority review designation to the supplemental biologics license application (sBLA) for the use of Arzerra (ofatumumab) in combination with an alkylator-based therapy, to be used for treatment of chronic lymphocytic leukemia patients who have not received prior treatment and are inappropriate for fludarabine-based therapy. The FDA has assigned a PDUFA date of April 19, 2014 for the sBLA.

Hutchison China Meditech Ltd. (Chi-Med), of Hong Kong, and Sinopharm Group Co. Ltd., of Beijing, said they established a joint venture to provide distribution and marketing services to both related and third party pharmaceutical companies in China. Chi-Med will invest about $9.8 million in cash into Sinopharm Holding Huyong Pharmaceutical Co. Ltd. for the subscription of 51 percent of the equity in the enlarged share capital of Huyong, so that Huyong will be consolidated as a Chi-Med subsidiary. Sinopharm will hold the balance of 49 percent of the equity in Huyong.

An administrative law judge presiding over an International Trade Commission investigation involving Neptune Technologies and Bioressources Inc., of Laval, Quebec, Acasti Pahrma Inc., a subsidiary of Neptune, Enzymotec Ltd., of Midgal Ha’emeq, Israel, and Enzymotec USA Inc. granted a joint motion by the parties to stay the proceedings for thirty days. Earlier in 2013, Neptune and Acasti filed with the ITC alleging infringement of Neptune’s krill extract composition patents by Enzymotec and other companies in the industry. The purpose of the stay was to allow a final binding written settlement agreement so that the parties can file a motion to terminate the investigation.

Ocera Therapeutics Inc., of Palo Alto, Calif., entered a technology transfer and license agreement with the Roche Group AG, of Basel, Switzerland, including the research and early development arms of member company Genentech Inc., of South San Francisco, and Roche, for rights to its Macrocyclic Template Chemistry (MATCH) discovery platform. Under the terms of the agreement, Ocera will transfer ownership of equipment and materials related to the use of the MATCH technology, and grant a license to Genentech and Roche under Ocera’s related intellectual property rights. Roche will make a one-time payment to Ocera of $4 million.

Omeros Corp., of Seattle, said OMS721, its lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2, received orphan designation from the FDA for prevention of complement-mediated thrombotic microangiopathies. Omeros is completing a Phase I study of OMS721, with a Phase II program slated to start in the first quarter of 2014.

Open Monoclonal Technology Inc. (OMT), of Palo Alto, Calif., said Genentech Inc., of South San Francisco, a member of the Roche Group, and Roche will acquire unlimited access to the Omnirat antibody platform through the purchase of one of OMT’s spinout companies. Following the acquisition, Genentech and Roche will be able to use the platform to generate human therapeutic antibodies for any target and indication. Genentech and Roche also gained the right to further engineer the platform. Terms were not disclosed.

Oxford Biomedica plc, of Oxford, UK, signed an option agreement with Glaxosmithkline plc (GSK), of London, granting GSK an option to a non-exclusive license under Oxford Biomedica’s Lentivector platform technology patents for the development and commercialization of up to six product candidates targeting rare orphan diseases. Financial terms were not disclosed.

Provectus Pharmaceuticals Inc., of Knoxville, Tenn., held a Type C meeting with the FDA’s Division of Oncology Products on Dec. 16, 2013, to determine which of the available paths that Provectus’ oncology drug PV-10 will take in pursuit of FDA approval and commercialization. Under FDA rules, the agency should issue official minutes to the company within 30 days after such a meeting, in this case by Jan. 15, 2014. The minutes will clarify the available regulatory paths and, therefore, allow the company to better estimate a timeline to commercialization of PV-10, Provectus said.

Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., said the FDA accepted for standard review the company’s supplemental biologics license application (sBLA) for Eylea (aflibercept) Injection for the treatment of diabetic macular edema. The target action date is Aug. 18, 2014.

Respira Therapeutics Inc., of Albuquerque, N.M., closed on an investment from Santa Fe, N.M.-based venture capital funds Sun Mountain Capital and Cottonwood Technology Fund, as well as private individuals. Brian Birk, managing partner of Sun Mountain Capital, was elected to the Respira board as part of the deal. The funds raised in this round will be used to transition Respira from an inhaler technology-based company into a pharmaceutical development company targeting drug / inhaler products used for the treatment of important diseases, the company said. Headquarters have moved from Santa Fe, N.M., and the technical laboratory from Austin, Texas, both to Albuquerque, N.M.

Retrophin Inc., of New York, unveiled its latest clinical development candidate RE-034 (cosyntropin), a long-acting synthetic analog (amino acids 1-24) of the naturally occurring adrenocorticotropic hormone, formulated with zinc. Cosyntropin is also known outside the U.S. as tetracosactide. Retrophin plans to file an investigational new drug application and initiate a Phase I pharmacokinetic trial of RE-034 in the first half of 2014. Shortly thereafter, the company plans to initiate Phase III pivotal clinical trials of RE-034 for the treatment of infantile spasms, or West Syndrome, a catastrophic form of epilepsy, and nephrotic syndrome.

Taiwan Liposome Co. Ltd. (TLC), of Taipei, Taiwan, signed a collaboration agreement with Sandoz AG, an affiliate in the generics division of Novartis AG, of Basel, Switzerland, giving Sandoz responsibility for commercialization of Liposomal Amphotericin B in the European Union and the U.S.

Teva Pharmaceuticals USA Inc., a subsidiary of Teva Pharmaceutical Industries, Ltd., of Jerusalem, signed an agreement with Pfizer Inc. to settle patent litigation related to its sildenafil citrate tablets, a generic equivalent of Viagra. Under the agreement, Teva will launch its abbreviated new drug application products pursuant to a royalty bearing license on Dec. 11, 2017, or earlier. The FDA has given tentative approval to Teva’s sildenafil citrate tablets 25, 50, and 100 mg.

Uluru Inc., of Addison, Texas, further expanded its international marketing and distribution network, assigning exclusive marketing and distribution rights for Altrazeal in India. Altrazeal is a wound dressing designed for chronic and acute wounds such as diabetic foot ulcers, venous leg ulcers and geriatric wounds.

Versartis Inc., of Redwood City, Calif., received FDA orphan drug designation for VRS-317 to treat growth hormone deficiency with once-monthly dosing. The company previously orphan designation from the European Commission for the drug candidate.