Editor's note: BioWorld has always kept a watchful eye on big pharma developments as they relate to the biotech space...In clinical studies of up to two years in duration, Zioptan, dosed once-daily in the evening lowered IOP at three months and six months by 6-8 mmHg and 5-8 mmHg, respectively, from a baseline pressure of 23-26 mmHg

Isotechnika Pharma Inc., of Edmonton, Alberta, exercised its right to terminate a development, distribution and licensing agreement with ILJIN Life Science Co...Transparency Life Sciences LLC, of New York, launched operations with the introduction of a prototype of the company's crowdsourced web platform designed to allow patients, physicians, researchers and other stakeholders to contribute to the design of clinical studies

Astellas Pharma Inc., of Tokyo, and XenoPort Inc., of Santa Clara, Calif., said Japanese regulators approved Regnite (gabapentin enacarbil) for moderate to severe primary restless legs syndrome...Pherecydes Pharma SA, of Paris, said it received €900,000 (US$1.2 million) from France's General Directorate for Armaments to partly finance the PACOBURNS project, which is set up to explore the possibility of using bacteriophages to combat bacterial infections that are resistant to antibiotics, especially

DFH Pharma Inc., of Gaithersburg, Md., is collaborating with CiVentiChem LLC, of Research Triangle Park, N.C., to develop the next generation of HIV maturation inhibitor drugs...Oncodesign SA, of Dijon, France, and Ipsen SA, of Paris, entered a research collaboration to discover and develop LRRK2 kinase inhibitors as potential treatments for Parkinson's and other diseases, using Oncodesign's Nanocyclix technology...to the firm's existing facility in Winston-Salem, part of a restructuring designed to

The ODAC will review results from clinical studies in support of the new indication, including the pivotal '147 trial, a randomized, placebo-controlled, multicenter Phase III study that compared Xgeva to placebo in prolonging bone metastasis-free survival in men with non-metastatic CRPC at high risk for bone metastases based on prostate-specific antigen criteria...Regeneron received a nonexclusive license to certain patents relating to VEGF receptor programs...Zealand Pharma A/S, of Copenhagen

In other news, AstraZeneca and Hutchison MediPharma Ltd. (HMP), of London, entered a global licensing, co-development and commercialization agreement for Volitinib (HMPL-504), a highly selective inhibitor of the c-Met receptor tyrosine kinase to treat of cancer, currently in preclinical studies...Covis Pharma Sarl, of Zug, Switzerland, agreed with GlaxoSmithKline plc, of London, to acquire commercial rights to Fortaz (ceftazidime), Zinacef (cefuroxime), Lanoxin (digoxin), Parnate (tranylcypromine

Antares Pharma Inc., of Ewing, N.J., has licensed to Pfizer Inc.'s Consumer Healthcare Business Unit one of its drug delivery technologies to develop an undisclosed product on an exclusive basis for North America...According to Hua, the newer generation of the GKA drug candidate has been further optimized for safety and efficacy and is ready to begin clinical studies

Clavis Pharma ASA, of Oslo, Norway, established the cutoff level for defining hENT1 low vs...In other news, Elan and Biogen said the FDA extended by three months the initial PDUFA date for its review of the supplemental biologics license application (sBLA) for Tysabri (natalizumab...Galderma Pharma SA, of Lausanne, Switzerland, reported top-line results from a Phase IIb trial showing that CD07805/47, a topical gel in development for moderate to severe facial erythema of rosacea, was rapidly effective

Asahi Kasei Pharma Corp. (AKP), of Tokyo, and Zosano Pharma Inc., of Fremont, Calif., entered a long-term collaboration to develop, commercialize and supply a weekly transdermal patch formulation of Teribone (teriparatide acetate), AKP's formulation of human parathyroid hormone for the treatment of osteoporosis patients with a high risk of fracture...Under the expanded agreement, the company will manufacture additional vaccine constructs for NCI, which will fund and conduct preclinical and clinical

Somaxon Pharmaceuticals Inc., of San Diego, said the FDA provided clinical and regulatory guidance to move an OTC version of Silenor forward, including the development of an OTC label tailored to Silenor's clinical profile and differentiated from other OTC sleep products that could potentially enable Silenor to become the first prescription insomnia agent converted to an OTC product

Action Pharma A/S, of Aarhus, Denmark, released top-line results for its Phase IIb AP214 trial in patients undergoing major cardiac surgery, indicating that AP214 is safe, reduces kidney injury and improves 90-day outcomes on a composite end point (death, dialysis and kidney function) in patients undergoing cardiac surgery with cardiopulmonary bypass who are at increased risk of developing acute kidney injury...Amarin plans to separately seek approval for the treatment of high triglycerides in

Ascendis Pharma A/S, of Copenhagen, Denmark, said a Phase II study of ACP-001 in growth hormone-deficient adults met all primary and secondary endpoints, the primary endpoint being the change in IGF-I levels from baseline compared to daily growth hormone...Prana is preparing to start clinical studies of PBT2 in AD and

In separate news, Aestus said it expanded its research collaboration with the ALS Therapy Development Institute to test additional small-molecule compounds for the ability to slow or stop the progression of amyotrophic lateral sclerosis...Prana is preparing to start clinical studies of PBT2 in AD and Huntington's disease

Action Pharma A/S, of Arhus, Denmark, said that it has completed the last visit of its last patient in a Phase IIb study of AP214 for prevention of kidney injury in patients undergoing cardiac surgery...Astellas Pharma Inc., of Tokyo, and Medivation Inc., of San Francisco, reported results from a preclinical study that the companies said provided evidence that MDV3100, an oral androgen receptor antagonist in clinical development to treat advanced prostate cancer patients, inhibits proliferation of

It also divested a preclinical program in autoimmune diseases to DCAM Pharma Inc., and some patent interests to CharlestonPharma LLC...The facility is expected to be online in January to support the manufacturing of Pluristem's PLacental eXpanded cell product candidates for the treatment of critical limb ischemia, intermittent claudication, pulmonary hypertension and other diseases

In other news, the FDA approved AstraZeneca's Brilinta (ticagrelor), an oral antiplatelet treatment for acute coronary syndromes...According to the trial protocol, the board is to review safety data once 100 patients complete the study's follow-up period...Galapagos NV, of Mechelen, Belgium, initiated a Phase I trial for GLPG0492, a small-molecule candidate to treat cachexia (loss of weight and muscle mass) and other potential indications, such as Duchenne's muscular dystrophy

Endotis Pharma, of Paris, enrolled the first patients in a Phase IIa trial of anticoagulant EP217609 and its specific antidote, avidin, to manage coagulation during open-heart surgery...In other news, Medivir signed an agreement with Daewoong Pharmaceutical Co...Other studies showed Victoza (liraglutide), a once-daily GLP-1 analogue for the treatment of Type II diabetes, could safely be added to insulin treatment and helped patients reach the ADA's HbA1C target, and that Victoza helped more patients

The plant will be used to produce enzyme replacement therapy GALNS (N-acetylgalactosamine 6-sulfatase), which is in Phase III for mucopolysaccharidosis Type IVA, as well as other products...LLS will provide up to $7.5 million in milestone funding to Epizyme to support the early development of the personalized epigenetic therapy...Daewoong will carry out clinical studies and obtain regulatory approval for marketing and sales of the product in those territories

Acceleron Pharma Inc., of Cambridge, Mass., presented preclinical data showing RAP-661 increased bone mineral density, increased osteoblast activity and decreased osteoclast activity in a mouse model of bone loss...Angion Biomedica Corp., of New York, announced the establishment of an alliance with Duke University and Massachusetts General Hospital to pursue development and clinical studies of its lead therapeutics for treatment of ischemic stroke, which target protective and regenerative systems