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Advaxi to receive fund from CRUK for clinical trial of ADXS11-001

Advaxis, Inc., the live, attenuated Listeria monocytogenes (Lm) immunotherapy company, is pleased to announce that Cancer Research UK (CRUK), the UK philanthropy dedicated to cancer research, has agreed to fund the cost of a clinical trial to investigate the use of ADXS11-001, Advaxis’ lead human papilloma virus (HPV)-directed vaccine candidate, for the treatment of head and neck cancer.

10 Feb 2010

FDA expands indication for Crestor

On Feb. 8 the U.S. Food and Drug Administration approved the cholesterol-lowering medication Crestor (rosuvastatin) for some patients who are at increased risk of heart disease but have not been diagnosed with it.

10 Feb 2010

Thrombogenics announces publication of positive microplasmin Phase II trial results

ThromboGenics NV, a biopharmaceutical company focused on the discovery and development of innovative treatments for eye disease, vascular disease and cancer, announces today that the positive microplasmin Phase II trial results, evaluating the product's efficacy and safety in patients who require vitrectomy, have been published in the prestigious American Academy of Ophthalmology's Journal, Ophthalmology, the leading journal for the vitreoretinal community.

9 Feb 2010

USPTO awards NexBio patent covering sialidase pharmaceutical compositions and methods of treating influenza

NexBio, Inc. today announced the issuance by the United States Patent and Trademark Office of United States Patent No. 7,645,448 entitled "Class of Therapeutic Protein Based Molecules". This patent covers NexBio's sialidase pharmaceutical compositions, including its lead compound DAS181 (Fludase®), and methods of treating or preventing viral infection by influenza and parainfluenza with such compositions.

9 Feb 2010

Debiopharm Group signs exclusive licence agreement with Novartis for alisporivir

Debiopharm Group, a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs, today announced the signature of an exclusive licence agreement with Novartis for the development, manufacture and commercialisation of Debio 025 (alisporivir), a selective, first-in-class cyclophilin (Cyp) inhibitor with a potent anti-hepatitis C virus (HCV) effect. The product is currently in phase 2b clinical development for the treatment of hepatitis C. Debiopharm granted Novartis worldwide commercialisation rights to Debio 025 except for Japan.

9 Feb 2010

Resverlogix completes Phase 2 ASSERT trial enrollment 5 months ahead of schedule

Resverlogix Corp. announced today the completion of patient enrollment in the Phase 2 clinical study of its lead drug RVX-208. "The completion of enrollment for our Phase 2 ASSERT trial, a full 5 months ahead of our original schedule, is a very exciting achievement for our staff and our collaborators at the Cleveland Clinic.

9 Feb 2010

Denosumab exhibits superiority over Zometa in treatment of prostate cancer men with bone metastases

Amgen today announced that a pivotal, Phase 3, head-to-head trial evaluating denosumab versus Zometa® (zoledronic acid) in the treatment of bone metastases in 1,901 men with advanced prostate cancer met its primary and secondary endpoints.

9 Feb 2010

Novavax announces new data from trivalent seasonal influenza VLP vaccine study

Novavax, Inc. announced today new data from a clinical study that began in May of 2009 among healthy adults 18 to 49 years of age with Novavax's trivalent seasonal influenza Virus-like Particle (VLP) vaccine. The vaccine matched the influenza strains recommended for the 2008-2009 influenza season including H1N1 A/Brisbane/59/2007, H3N2 A/Brisbane/10/2007, and B/Florida/04/2006 strains.

9 Feb 2010

GeoVax Labs provides updates on HIV-1 vaccine trials

GeoVax Labs, Inc., an Atlanta-based, biopharmaceutical company developing human vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus) and other infectious agents, today provided an update on its vaccine trials progress.

9 Feb 2010

Positive data from Cara Therapeutics' peripherally-restricted kappa opioid agonist Phase II trial

Cara Therapeutics, Inc. today announced positive data in a Phase II proof-of-concept clinical trial of its peripherally-restricted kappa opioid agonist, CR845. The 46 patient Phase II, multi-center, double-blind, placebo-controlled study was conducted at eight hospitals in the United States and evaluated the efficacy and safety of CR845 in women following laparoscopic-assisted hysterectomy.

9 Feb 2010

Genta commences Phase 2 trial of tesetaxel on first subject

Genta Incorporated announced that the Company has initiated treatment of the first subject in a new Phase 2 trial of tesetaxel in advanced melanoma. Tesetaxel is the Company’s newest clinical-stage small molecule. As a late Phase 2 oncology product, tesetaxel is the leading oral taxane currently in clinical development. The new trial builds on more than ten years of Genta’s experience in melanoma clinical research.

9 Feb 2010

Teva Pharmaceutical Industries extends marketing rights for laquinimod, includes Nordic and Baltic regions

Teva Pharmaceutical Industries Ltd. and Active Biotech announced today that they have amended the marketing and distribution agreement for oral laquinimod, an investigational treatment for relapsing-remitting multiple sclerosis (RRMS). Under the new agreement, Teva extended its marketing and distribution rights to include the Nordic and Baltic regions, previously held by Active Biotech. Active Biotech will receive a higher royalty rate for sales in these territories compared to the royalty rate set under the original licensing agreement signed in 2004 for sales in the rest of the world.

9 Feb 2010

Inovio Biomedical announces additional immunogenicity data from therapeutic cervical cancer vaccine trial

Inovio Biomedical Corporation, a leader in DNA vaccine design, development and delivery, announced today additional interim safety and immunogenicity data from its therapeutic cervical cancer vaccine (VGX-3100) trial. VGX-3100 is a DNA vaccine targeting the E6 and E7 proteins of human papillomavirus (HPV) types 16 and 18 and is delivered via in vivo electroporation.

8 Feb 2010

Anthera Pharmaceuticals reaches agreement with the FDA on SPA for VISTA-16 clinical study

Anthera Pharmaceuticals, Inc., a privately held biopharmaceutical company developing drugs to treat serious diseases associated with inflammation, announced today that it reached an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the Phase 3 clinical study named VISTA-16 (Vascular Inflammation Suppression to Treat Acute Coronary Syndrome - 16 Weeks) for its lead product candidate, A-002, an oral sPLA2 inhibitor, in combination with HMG-CoA reductase inhibitor, or statin, therapy for short-term (16-week) treatment of patients experiencing an acute coronary syndrome.

8 Feb 2010

CREON effective in improving CFA and CNA in pediatric patients with EPI due to CF

Solvay Pharmaceuticals, Inc. announced that Phase IIIb data published in the January issue of Clinical Therapeutics confirm that CREON® (pancrelipase) Delayed-Release Capsules significantly improves a key measure of fat absorption in children aged 7-11 years who have exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF), EPI is a condition resulting from a deficiency in the production and/or secretion of pancreatic enzymes that are necessary to digest nutrients in food.

5 Feb 2010

EBMT honours abstract on Defibrotide in Hepatic VOD prevention with the Van Bekkum Award

Gentium S.p.A. today announced that the abstract titled, "Defibrotide prevents hepatic VOD and reduces significantly VOD-associated complications in children at high risk: final results of a prospective phase II/III multicentre study," has been awarded the Van Bekkum Award for the best abstract submitted to the physician's program for the European Group for Blood and Marrow Transplantation's (EBMT) 36th Annual Meeting, to be held in Vienna, March 21-24, 2010.

5 Feb 2010

BioTime announces results of independent Hextend study in hemodynamically unstable trauma patients

BioTime, Inc. today reported recently-released results from an independent study evaluating the use of Hextend® in hemodynamically unstable trauma patients. Hextend (6% Hetastarch in Lactated Electrolyte Injection) is BioTime’s commercially-available blood plasma volume expander used to treat hypovolemia (low blood volume). The study, conducted at the University of Miami Ryder Trauma Center, reported that initial resuscitation with Hextend was associated with no obvious coagulopathy and reduced mortality compared to fluid resuscitation without Hextend.

5 Feb 2010

Top-line results from Optimer Pharmaceuticals' second fidaxomicin Phase 3 trial in CDI patients

Optimer Pharmaceuticals, Inc. today announced positive top-line results from the second of two pivotal Phase 3 trials evaluating the safety and efficacy of fidaxomicin (OPT-80) in patients with Clostridium difficile Infection (CDI). This study was conducted in approximately 100 clinical sites throughout North America and Europe. The Company plans to use data from this study to support submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2010.

5 Feb 2010

BioMarin announces update on BMN 110 Phase I/II trial for Morquio A Syndrome

BioMarin Pharmaceutical Inc. today announced an update on the Phase I/II trial for BMN 110 or N-acetylgalactosamine 6-sulfatase (GALNS), intended for the treatment of the lysosomal storage disorder Mucopolysaccharidosis Type IVA (MPS IVA), or Morquio A Syndrome. Preliminary clinical data from the first 24 weeks of the study (12 weeks at 0.1mg/kg and 12 weeks at 1.0 mg/kg) have been evaluated, and BioMarin plans to announce top-line results for the full 36-week study after completion of dosing at 2.0 mg/kg in the second quarter of 2010.

5 Feb 2010

WORLD Symposium: Protalix Biotherapeutics to present data on taliglucerase alfa Phase III Gaucher disease trial

Protalix Biotherapeutics, Inc. today announced that data from its pivotal Phase III trial of taliglucerase alfa in patients with Gaucher disease will be presented at the Annual Meeting of the Lysosomal Disease Network: WORLD Symposium 2010, February 10-12, 2010 in Miami, Florida.

5 Feb 2010

Drug Trial News

Advaxi to receive fund from CRUK for clinical trial of ADXS11-001

FDA expands indication for Crestor

Thrombogenics announces publication of positive microplasmin Phase II trial results

USPTO awards NexBio patent covering sialidase pharmaceutical compositions and methods of treating influenza

Debiopharm Group signs exclusive licence agreement with Novartis for alisporivir

Resverlogix completes Phase 2 ASSERT trial enrollment 5 months ahead of schedule

Denosumab exhibits superiority over Zometa in treatment of prostate cancer men with bone metastases

Novavax announces new data from trivalent seasonal influenza VLP vaccine study

GeoVax Labs provides updates on HIV-1 vaccine trials

Positive data from Cara Therapeutics' peripherally-restricted kappa opioid agonist Phase II trial

Genta commences Phase 2 trial of tesetaxel on first subject

Teva Pharmaceutical Industries extends marketing rights for laquinimod, includes Nordic and Baltic regions

Inovio Biomedical announces additional immunogenicity data from therapeutic cervical cancer vaccine trial

Anthera Pharmaceuticals reaches agreement with the FDA on SPA for VISTA-16 clinical study

CREON effective in improving CFA and CNA in pediatric patients with EPI due to CF

EBMT honours abstract on Defibrotide in Hepatic VOD prevention with the Van Bekkum Award

BioTime announces results of independent Hextend study in hemodynamically unstable trauma patients

Top-line results from Optimer Pharmaceuticals' second fidaxomicin Phase 3 trial in CDI patients

BioMarin announces update on BMN 110 Phase I/II trial for Morquio A Syndrome

WORLD Symposium: Protalix Biotherapeutics to present data on taliglucerase alfa Phase III Gaucher disease trial

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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