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Enrollment complete in Ceregene's CERE-120 Phase 2b trial for Parkinson's

Ceregene, Inc. reported today that it has completed enrollment in its Phase 2b trial of CERE-120, a gene therapy product expressing the neurturin (NRTN) gene for the treatment of Parkinson's disease.

1 Dec 2011

Auxilium initiates XIAFLEX phase IIa trial in Frozen Shoulder syndrome

Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, today announced that the first patient has been dosed in its open-label phase IIa trial of XIAFLEX (collagenase clostridium histolyticum) for the treatment of idiopathic adhesive capsulitis of the shoulder, also known as Frozen Shoulder syndrome.

1 Dec 2011

Celldex launches rindopepimut Phase 3 trial in EGFRvIII-positive glioblastoma

Celldex Therapeutics, Inc. today announced that it has launched a pivotal, randomized, double-blind, controlled Phase 3 trial of rindopepimut in patients with surgically resected epidermal growth factor variant III (EGFRvIII)-positive glioblastoma, the "ACT IV Study."

1 Dec 2011

Statens Serum Institut, Aeras initiate new candidate TB vaccine Phase I trial

Statens Serum Institut and Aeras today announce the initiation of the first Phase I clinical trial of a new candidate TB vaccine designed to protect people latently infected with TB from developing active TB disease.

1 Dec 2011

Idera regains global rights to IMO-2055 from Merck KGaA for treatment of cancer

Idera Pharmaceuticals, Inc. today announced that it has regained global rights to IMO-2055, an agonist of Toll-like Receptor (TLR) 9, as part of an agreed-upon termination of its oncology collaboration with Merck KGaA, Darmstadt, Germany.

1 Dec 2011

Combination treatment improves progression-free survival in pancreatic neuroendocrine tumors

Combination treatment with everolimus, an inhibitor of the mammalian target rapamycin (mTOR), and octreotide has shown to improve progression-free survival for patients with advanced neuroendocrine tumors and a history of carcinoid syndrome, according to researchers at The University of Texas MD Anderson Cancer Center.

30 Nov 2011

Neogenix novel antibody selected as one of Windhover's 2011 Top 10 Projects to Watch

Neogenix Oncology, Inc. has announced that the company's novel antibody NEO-101, which targets pancreatic and colorectal cancer cells, has been selected as one of Windhover's 2011 Top 10 Projects to Watch.

30 Nov 2011

Genentech announces results from pertuzumab studies on HER2-positive breast cancer

Genentech, a member of the Roche Group, today announced the company will present results from studies of its investigational medicine pertuzumab in HER2-positive breast cancer at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium December 6-10.

30 Nov 2011

BioMarin commences GALNS Phase 2 study in mucopolysaccharidosis IVA

BioMarin Pharmaceutical Inc. today announced the initiation of a Phase 2 study for GALNS (N-acetylgalactosamine 6-sulfatase) in patients under five years of age with mucopolysaccharidosis IVA.

30 Nov 2011

Enrollment complete in Alnylam's ALN-RSV01 Phase IIb study for RSV infection

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today that it has completed patient enrollment in its Phase IIb study with ALN-RSV01, an RNAi therapeutic for the treatment of respiratory syncytial virus (RSV) infection.

29 Nov 2011

FDA assigns priority-review designation for ELIQUIS NDA for stroke prevention in atrial fibrillation

Bristol-Myers Squibb Company and Pfizer Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for ELIQUIS® (apixaban), an investigational compound for the prevention of stroke and systemic embolism in patients with atrial fibrillation.

29 Nov 2011

Testing of vaginal gel for HIV prevention halted after interim results showed no difference from placebo

Researchers involved with a multi-armed clinical trial designed to evaluate different antiretroviral (ARV) interventions for HIV prevention on Friday announced the arm testing a vaginal gel had been stopped because it was not working, the New York Times reports.

29 Nov 2011

Selcia completes 14C radiolabelled API projects for clients

Selcia has successfully completed 14C radiolabelled API projects on behalf of a diverse range of clients for phase 1 human trials, following MHRA GMP Certification in September 2010. In response to a sharp increase in demand for this specialist service, Selcia has invested to double its capacity for handling GMP radiolabelling projects.

29 Nov 2011

VOICE continues testing daily use of ARV Truvada among women in sub-Saharan Africa

VOICE, an HIV prevention trial that has been evaluating two antiretroviral (ARV)-based approaches for preventing the sexual transmission of HIV in women - daily use of one of two different ARV tablets or of a vaginal gel - has stopped testing the gel.

29 Nov 2011

Tenofovir gel no more effective than placebo gel in preventing HIV

An independent review of the VOICE study, funded by the National Institute of Allergy and Infectious Diseases (NIAID) and conducted by the Microbicide Trials Network, determined that tenofovir gel was no more effective than placebo gel in preventing HIV.

28 Nov 2011

FDA grants IND for AEZS-130 Phase 2A trial in cancer cachexia

Aeterna Zentaris Inc. today announced that the U.S. Food and Drug Administration has granted Jose M. Garcia, MD, PhD, Assistant Professor, Division of Diabetes Endocrinology and Metabolism, Departments of Medicine and Molecular and Cell Biology, Baylor College of Medicine and Michael I. DeBakey Veterans Administration Medical Center, in Houston Texas, an Investigational New Drug approval for the initiation of a Phase 2A trial to assess the safety and efficacy of repeated doses of the Company's ghrelin agonist, AEZS-130, in patients with cancer cachexia.

28 Nov 2011

Inviragen commences DENVax Phase 2 trial for dengue

Inviragen, Inc. today announced the initiation of a Phase 2, randomized, double-blind, placebo-controlled study of DENVax, the Company's investigational dengue vaccine.

28 Nov 2011

Enrollment complete in SUSTAIN Phase 2b clinical trial for atherosclerotic CVD

Resverlogix Corp. today announced that SUSTAIN, a Phase 2b clinical trial comprised of 176 subjects, is fully enrolled.

28 Nov 2011

Inspiration commences enrollment in second OBI-1 Accur8 clinical trial program for congenital hemophilia A

Inspiration Biopharmaceuticals, Inc. today announced the initiation of patient enrollment in the second of two pivotal studies in the Company's OBI-1 Accur8 clinical trial program.

28 Nov 2011

Bayer, Regeneron commence EYLEA Phase 3 clinical trial for wet AMD in China

Regeneron Pharmaceuticals, Inc. and Bayer HealthCare today announced that they have initiated a Phase 3 clinical trial evaluating the efficacy and safety of EYLEA (aflibercept) Injection in the neovascular form of age-related macular degeneration (wet AMD) in China.

28 Nov 2011