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

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

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

Cellceutix Corp., of Beverly, Mass., said it has recruited the first patients with advanced solid tumors for clinical studies of cancer candidate Kevetrin...TransTech Pharma Inc., of High Point, N.C., said data from a 399-patient study testing TTP488, a small-molecule drug targeting the receptor for advanced glycation endproducts, demonstrated evidence of slowing cognitive decline over 18 months in patients with mild to moderate Alzheimer's disease

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

Investigators said 47 percent of patients receiving Simponi 50 mg and 51 percent of patients receiving Simponi 100 mg maintained clinical response through week 54 compared with 31 percent of patients on placebo (p = 0.01 and p < 0.001, respectively...Investigators will report clinical response, clinical remission and mucosal healing results through one year at the American College of Gastroenterology meeting in Las Vegas

Janssen Research & Development LLC, of Spring House, Pa., a unit of Johnson & Johnson, said a Phase IIb study testing Stelara (ustekinumab) in moderate to severe Crohn's disease showed that, among patients who had previously failed or were intolerant to at least one tumor necrosis factor antagonist, a significantly greater proportion receiving intravenous Stelara achieved the primary endpoint of clinical response at week six, defined as a 100-point reduction in Crohn's Disease Activity Index

Alexion Pharmaceuticals Inc., of Cheshire, Conn., said researchers presented data from an open-label Phase II study in 14 patients with severe, relapsing neuromyelitis optica (NMO), showing that Soliris (eculizumab) met its primary endpoint with high degrees of clinical and statistical significance...AlphaCore Pharma Inc., of Ann Arbor, Mich., said its Phase I trial met the primary endpoint by demonstrating the safety and tolerability of ACP-501 (recombinant human LCAT...The positive clinical effects

Additional results from the PHOENIX-2 study showed that high levels of clinical responses were achieved and maintained with up to five years of ustekinumab treatment