Alnylam Pharmaceuticals Inc., of Cambridge, Mass., filed a clinical trial application with the U.K. Medicines and Healthcare Products Regulatory Agency to initiate a Phase I study of ALN-TTRsc, an RNAi therapeutic targeting transthyretin (TTR), in TTR-mediated amyloidosis...ALN-TTRsc is the first GalNAc-siRNA to enter clinical development...Cerulean Pharma Inc., of Cambridge, Mass., said it dosed the first patient in a Phase II study of lead candidate CRLX101 in advanced gastric cancer

Acura intends to complete clinical testing for a new drug submission via the 505(b)(2) pathway in the first half of 2014...BioAlliance Pharma SA, of Paris, said the European Independent Board of Experts held its first meeting on the ReLive Phase III trial evaluating the efficacy of Livatag (doxorubicin Transdrug) in primary liver cancer and recommended continuing the global, multicenter, randomized study without modification. (See BioWorld International, June 29, 2011...About 79.6 achieved clinical

that included a $30 million equity investment and a $50 million synthetic royalty agreement linked to future sales of Meningitec, a vaccine Nuron acquired earlier this month from Pfizer Inc., and its HibTiter vaccine (Haemophilus b conjugate vaccine [diphtheria CRM197 protein conjugate]), in-licensed from Wyeth LLC and subsequently out-licensed in January to Mitsubishi Tanabe Pharma Corp., of Osaka, Japan. (See BioWorld Today, Jan. 13, 2012.) In a second biotech deal on the same day, HC Royalty

Arno is conducting clinical and preclinical studies of three drug candidates to treat a variety of cancers...MEI Pharma Inc., of San Diego, completed a private placement of common stock and warrants in a financing led by new investors Vivo Ventures and New Leaf Venture Partners...NeRRe Therapeutics Ltd., of London, raised £11.5 million (US$18.4 million) to develop a portfolio of clinical and preclinical neurokinin receptor antagonists divested from GlaxoSmithKline plc, also of London. #kicker123

EyeGate Pharma Inc., of Waltham, Mass., said it enrolled the last patient in a 200-subject pivotal Phase III study of EGP-437 (dexamethasone phosphate ophthalmic solution) in patients with anterior uveitis...The company is trying to reduce the cost of clinical trials by 50 percent or more, and is partnered with Advanced Monitored Caregiving, a telehealth provider, to that end...Study patients will have in-person visits with the clinical trial staff at the beginning and end of the trial, and all other

Acasti Pharma Inc., of Laval, Quebec, said it achieved significant progress in two ongoing clinical studies with CaPre for lipid management...The registrational Phase II double-blind, placebo-controlled clinical study has completed the first of two interim analyses

Data also indicated rapid onset of activity, with clinical activity reported for 16 of 19 responders occurring within the first two cycles of treatment...OncoSec plans to use the proceeds to fund clinical trials and research and development and for other corporate purposes...The company plans to use the proceeds to fund research and development, clinical trials and for other corporate purposes.

BioAlliance Pharma SA, of Paris, said the European Independent Board of Experts held its first meeting on the ReLive Phase III trial of Livatag (doxorubicin transdrug) in primary liver cancer and recommended continuing the study without modification...Clavis Pharma ASA, of Oslo, Norway, said it reached the enrollment target for its Phase III CLAVELA study investigating elacytarabine in patients with relapsed or refractory acute myeloid leukemia (AML...with experience and expertise in stem cell

NeuroVive Pharmaceutical AB, of Lund, Sweden, said Phase I data published in Clinical Drug Investigation showed that its CicloMulsion, a Cremophor-free intravenous cyclosporine formula, was bioequivalent to Sandimmune injection and was safe and well tolerated...CicloMulsion is a cyclophilin inhibitor in clinical development to treat cardiac reperfusion injury and, under the name NeuroSTAT, in development for traumatic brain injury...Noxxon Pharma AG, of Berlin, said it treated the first patients in a

Because of the nature of the registry and vision testing variability, the company said, a clear comparison could not be drawn between registry data and clinical trial results

also participated in the financing, an unusual syndicate formed by investment funds of multiple large pharma companies...Net proceeds are expected to total about $44.7 million – or $51.5 million if underwriters exercise in full their overallotment option for 900,000 additional shares – and will be used for commercial launch activities and continued clinical development of the firm's pipeline of extended-release drugs

Accera Inc., of Broomfield, Colo., started a clinical efficacy trial examining the effects of AC-1204 in patients with mild-to-moderate Alzheimer's disease (AD...The FDA gave permission to Isotechnika Pharma Inc., of Edmonton, Alberta, to begin two Phase III trials of voclosporin, in kidney transplant

Bayer Inc., of Deerfield, Ill., and the Population Health Research Institute said they started the COMPASS trial, the largest clinical study to date of oral anticoagulant rivaroxaban

Insmed Inc., of Monmouth Junction, N.J., said the company's CLEAR-108 (CLinical Evaluation of Arikace) Phase III European and Canadian registrational study of Arikace (liposomal amikacin for inhalation) for cystic fibrosis patients with Pseudomonas aeruginosa lung infections has enrolled more than 300 patients...Opexa Therapeutics Inc., of The Woodlands, Texas, said Health Canada approved its clinical trial application, enabling the company to expand its ongoing trial in secondary progressive

The data were presented during a late-breaking clinical trials session at the 9th International Congress of the Society for Melanoma Research in Hollywood, Calif

The primary endpoint of the study is clinical benefit of AEZS-108...CellAct Pharma GmbH, of Dortmund, Germany, said its topoisomerase inhibitor CAP7...The study, conducted in 20 Asian patients at seven clinical trial sites, compared the outcome of a single intravenous dose of Zybrestat (15, 25, 35 or 45 mg/kg) with placebo

The Phase III study met its primary endpoint and demonstrated statistically significant protection against clinical and severe malaria in infants...In the trial, infants (ages 6-12 weeks at first vaccination) receiving the RTS,S vaccine candidate experienced one-third fewer episodes of both clinical and severe malaria and experienced similar reactions to the injection when compared to those who received the control meningococcal C conjugate vaccine

Sanofi Pasteur, of Swiftwater, Pa., the vaccines division of Sanofi SA, said Pediatric Infectious Disease Journal published pivotal clinical trial data used by the FDA to support the license expansion for its meningococcal conjugate vaccine, Menactra (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine), to include a two-dose schedule for infants and toddlers 9 months through 23 months of age

At least a year shy of the next milestone payment from partner Astellas Pharma Inc., Ambit Biosciences Inc...Funds will be used for working capital and general corporate purposes, including the funding of its ongoing clinical trials...The net proceeds will be used for working capital and general corporate purposes, including the continued conduct of the Abili-T clinical study, Opexa's recently initiated Phase IIb trial of personalized T-cell therapy Tcelna in patients with secondary progressive