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 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

The clinical significance of those analyses is unknown. (See BioWorld Today, March 28, 2012...TransTech Pharma Inc., of High Point, N.C., said recruitment for its recently initiated Phase III trial with TTP054 in Type II diabetics is exceeding expectations with initial top-line results to be available in early 2013

Shares of MEI Pharma Inc. (NASDAQ:MEIP) popped on Monday morning and climbed throughout the day after the company disclosed a $27.5 million private placement...The company laid groundwork for clinical trials in advance of the financing and plans to begin a "very substantial" randomized Phase II study in the U.S...Novelos plans to use the proceeds to complete an in-house clinical-stage manufacturing facility for its small-molecule, broad-spectrum, cancer-targeted imaging agent I-124-CLR1404 (LIGHT

The clinical significance of those analyses is unknown. (See BioWorld Today, March 28, 2012...TransTech Pharma Inc., of High Point, N.C., said recruitment for its recently initiated Phase III trial with TTP054 in Type II diabetics is exceeding expectations with initial top-line results to be available in early 2013

We were losing a lot of patients to these clinical trials...I'm not satisfied with this performance and not looking at clinical trials as an excuse," Johnson said...The FDA granted Xtandi (enzalutamide, Astellas Pharma Inc. and Medivation Inc.) approval in September for metastatic castration-resistant prostate cancer patients who have previously received docetaxel. (See BioWorld Today, Sept. 4, 2012.) Dendreon said it is looking for a European marketing partner, rather than just a manufacturing

Outside the U.S., Jakafi is marketed by partner Novartis AG, of Basel, Switzerland, as Jakavi, and the big pharma paid Incyte a $40 million milestone in the third quarter related to European approval...The future growth of United's PAH franchise hit a snag late last month when its oral treprostinil candidate earned a complete response letter, with the FDA citing issues in the product's clinical data package

Isotechnika Pharma Inc., of Edmonton, Alberta, completed the second tranche of its nonbrokered private placement, raising additional gross proceeds of $151,000 by the issuance of about 3.7 million units at a price of 4 cents per unit...Integra focuses on biotech firms with products mostly in clinical development

Thus, Calderon said she "would recommend requiring clinical studies to fully evaluate the abuse potential" of products submitted for review that exceed that level...Earlier this year, Zogenix Inc., of San Diego, submitted a new drug application (NDA) to the FDA for Zohydro (hydrocodone bitartrate) extended-release capsules for chronic pain developed by Alkermes Pharma Ireland Ltd., a subsidiary of Alkermes plc, of Dublin

About a year earlier, Dutch firm AM-Pharma BV banked €29.2 million (then US$39.8 million) in a Series D round, apparently the largest venture capital financing in Dutch biotechnology thus far...The company planned to switch from a bovine to a recombinant form of its AKI treatment, alkaline phosphatase. (See BioWorld Today, Sept. 14, 2011.) Bunnik, the Netherlands-based AM-Pharma had then gained only preliminary data from two small-scale clinical trials suggesting that bovine alkaline phosphatase

Noting a trend for pharma companies to engage in more collaborations and acquisitions in order to supplement their pipelines with new technology, Lammers said he could envision such an outcome for Mirna...Given the interest of big pharma in microRNA companies, including Mirna, I'm convinced if we have strong human proof-of-concept data in the clinic, most likely pharma will be interested in stepping up to the plate," Lammers said