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Fourth-quarter and full year fiscal 2009 results announced by Biodel

Biodel Inc. today reported financial results for the fourth quarter and fiscal year ended September 30, 2009.

10 Dec 2009

Immune-based treatment promising for AD

The results of a new study on immune-based treatment of Alzheimer's disease (AD), which was conducted at 30 sites around the country, will be published in the December 15 issue of Neurology®. Lead author, Stephen P. Salloway, MD, MS, director of the Butler Hospital Memory and Aging Program and a professor of neurology and psychiatry at the Warren Alpert Medical School of Brown University, says that this 18-month phase two study on slowing the disease process in Alzheimer's patients offers promising results.

10 Dec 2009

Rituxan improves patients with previously untreated CLL, shows Phase III study CLL8

Roche announced today at the 51st Meeting of the American Society of Hematology (ASH) in New Orleans, LA (USA) that the pivotal Phase III study CLL8 showed that patients with previously-untreated chronic lymphocytic leukemia (CLL) survived their disease longer when treated with Rituxan (rituximab) compared to chemotherapy alone.

10 Dec 2009

Results from Tulip PETAL Study of elagolix announced by Neurocrine Biosciences

Neurocrine Biosciences, Inc. today announced top-line efficacy and safety results from the Tulip PETAL Study (703 Study), its fifth Phase 2 clinical trial using its proprietary, orally-active nonpeptide Gonadotropin-Releasing Hormone (GnRH) receptor antagonist, elagolix, in patients with endometriosis.

10 Dec 2009

Initiation of dose-finding study to evaluate safety and efficacy of MP4OX treatment

Sangart, Inc., a global biopharmaceutical company dedicated to developing life-saving medicines specifically designed to enhance the perfusion and oxygenation of ischemic (oxygen deprived) tissues through targeted oxygen delivery, today announced the initiation of a dose-finding study designed to evaluate the safety and efficacy of MP4OX treatment plus standard of care in severely injured trauma patients with lactic acidosis due to hemorrhagic shock.

10 Dec 2009

Second pivotal Phase 3 trial to evaluate investigational Lp-PLA2 inhibitor darapladib initiated

Attached is a press release issued earlier this morning by GlaxoSmithKline, announcing that GSK has initiated its second pivotal Phase 3 trial to evaluate the efficacy of long-term treatment with the investigational Lp-PLA2 inhibitor darapladib in men and women with acute coronary syndrome (ACS).

10 Dec 2009

Additional data from ALS patients enrolled in confirmatory Phase III STAR trial announced

AVANIR Pharmaceuticals, Inc. today announced additional data from the subset of patients with amyotrophic lateral sclerosis (ALS) enrolled in the confirmatory Phase III STAR trial.

9 Dec 2009

Roche to present data on its Herceptin, Avastin and T-DM1 studies at CTRC-AACR Symposium

Roche announced today that new 5 year follow-up data from two pivotal studies with Herceptin(R) (trastuzumab) in early breast cancer; key results from a study of Avastin(R) (bevacizumab) in the second-line treatment of advanced breast cancer and strong data on the use of trastuzumab-DM1 (T-DM1), the first antibody-drug conjugate in development for very advanced HER2-positive breast cancer, will all be presented during the CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) from 9 to 13 December 2009.

9 Dec 2009

RegeneRx Biopharmaceuticals completes Phase I trial evaluating systemic administration of RGN-352

REGENERX BIOPHARMACEUTICALS, INC. announced today that it has completed and analyzed the safety data from its double-blind, placebo controlled Phase I clinical trial evaluating the systemic administration of RGN-352. The trial included testing of a single escalating intravenous dose of the drug candidate on forty healthy volunteers in Phase IA and, subsequently, over a fourteen-day treatment period on forty volunteers in Phase IB.

9 Dec 2009

Watson Pharmaceuticals' RAPAFLO demonstrates safety and tolerability in BPH treatment

Watson Pharmaceuticals, Inc. today announced that the results of an open-label extension of two Phase 3 studies, published in the December issue of the peer-reviewed journal Urology, demonstrate long-term safety and tolerability of RAPAFLO® (silodosin) for up to 52 weeks of treatment. RAPAFLO® is an effective and uniquely selective alpha blocker for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH), the number one reason patients visit urologists.

9 Dec 2009

Osteologix to file an European Marketing Application for its NB S101 strontium therapy

Osteologix Inc. announced today that the company anticipates that it will be prepared to file a marketing application in 2011 in the European Union for its proprietary second-generation strontium therapy, NB S101 (strontium malonate). If successful, this will be Osteologix' first marketing approval of NB S101 for the treatment of postmenopausal osteoporosis.

9 Dec 2009

Preliminary data from Phase 2 clinical trial of ZFP Therapeutic program presented

Sangamo BioSciences, Inc. announced today the presentation of preliminary data from the Phase 2 clinical trial of its ZFP Therapeutic(TM) program to develop SB-509 as a treatment for amyotrophic lateral sclerosis (ALS) at a Work in Progress session at the 20th International Symposium on ALS/MND held in Berlin, Germany.

9 Dec 2009

Clinical results from Phase 2 study of KNS-760704 presented by Knopp Neurosciences

Knopp Neurosciences Inc. (“Knopp”) announced the presentation today of encouraging clinical results in a Phase 2 safety and tolerability study of KNS-760704 in amyotrophic lateral sclerosis (“ALS”).

9 Dec 2009

Clinical trial results demonstrate greater efficacy of nilotinib over imatinib for Ph+ CML

In a large clinical trial, nilotinib demonstrated greater efficacy over the current gold standard treatment, imatinib, in adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) in the chronic phase.

9 Dec 2009

VERTICAL Phase II trial results for NHL released

The Takeda Oncology Company today reported data from a clinical trial evaluating a VELCADE based combination for patients with relapsed/refractory non-Hodgkin’s lymphoma (NHL).

9 Dec 2009

Recruitment complete in Oxagen's OC000459 IIb clinical trial for asthma

Oxagen Limited, a drug discovery and development company specializing in inflammation, today announced that the recruitment for its double blind, randomised, placebo controlled Phase IIb clinical trial in asthma with OC000459, its lead oral CRTH2 (DP2) antagonist, has now been completed.

9 Dec 2009

Memgen announces positive clinical data of ISF35 with chemotherapy

Memgen announced today that positive data evaluating its active cellular immunotherapy product, ISF35, in combination with chemotherapy in resistant chronic lymphocytic leukemia (CLL) were presented December 7 during the 51st Annual Meeting of the American Society of Hematology (Abstract #376).

9 Dec 2009

TGen and Scottsdale Healthcare test PHA-848125ac drug for thymic cancer

The Translational Genomics Research Institute (TGen) and Scottsdale Healthcare are testing a new drug specifically for thymic cancer based on early promising results at Scottsdale Healthcare.

9 Dec 2009

University of Texas launches phase II clinical trial to test stem-cell-based therapy on injured heart muscle

The second phase of a clinical trial testing a new stem-cell-based therapy on injured heart muscle has been launched by researchers at The University of Texas Medical School at Houston. It is the only study site in the Texas Medical Center.

9 Dec 2009

Data evaluating combination therapy with REVLIMID and rituximab in patients with NHL presented

Celgene International Sàrl announced that investigational data evaluating combination therapy with REVLIMID (lenalidomide) and rituximab in patients with indolent non-Hodgkin’s lymphoma (NHL) were presented during the 51st American Society of Hematology’s annual meeting in New Orleans, LA.

9 Dec 2009

Drug Trial News

Fourth-quarter and full year fiscal 2009 results announced by Biodel

Immune-based treatment promising for AD

Rituxan improves patients with previously untreated CLL, shows Phase III study CLL8

Results from Tulip PETAL Study of elagolix announced by Neurocrine Biosciences

Initiation of dose-finding study to evaluate safety and efficacy of MP4OX treatment

Second pivotal Phase 3 trial to evaluate investigational Lp-PLA2 inhibitor darapladib initiated

Additional data from ALS patients enrolled in confirmatory Phase III STAR trial announced

Roche to present data on its Herceptin, Avastin and T-DM1 studies at CTRC-AACR Symposium

RegeneRx Biopharmaceuticals completes Phase I trial evaluating systemic administration of RGN-352

Watson Pharmaceuticals' RAPAFLO demonstrates safety and tolerability in BPH treatment

Osteologix to file an European Marketing Application for its NB S101 strontium therapy

Preliminary data from Phase 2 clinical trial of ZFP Therapeutic program presented

Clinical results from Phase 2 study of KNS-760704 presented by Knopp Neurosciences

Clinical trial results demonstrate greater efficacy of nilotinib over imatinib for Ph+ CML

VERTICAL Phase II trial results for NHL released

Recruitment complete in Oxagen's OC000459 IIb clinical trial for asthma

Memgen announces positive clinical data of ISF35 with chemotherapy

TGen and Scottsdale Healthcare test PHA-848125ac drug for thymic cancer

University of Texas launches phase II clinical trial to test stem-cell-based therapy on injured heart muscle

Data evaluating combination therapy with REVLIMID and rituximab in patients with NHL presented

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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