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DMC recommends Emisphere Technologies' to proceed with oral calcitonin trial for OP and OA

Emisphere Technologies, Inc. today announced that an independent Data Monitoring Committee (“DMC”) informed Novartis and its partner Nordic Bioscience about their recommendation to proceed with the Osteoporosis (“OP”) Phase 3 Study 2303 and the Osteoarthritis (“OA”) Phase 3 Study 2301 exploring the safety and efficacy of an oral formulation of salmon calcitonin to treat patients with osteoporosis and osteoarthritis of the knee.

10 Dec 2009

Targacept commences TC-5619 Phase 2 study of cognitive dysfunction in schizophrenia

Targacept, Inc., a clinical-stage biopharmaceutical company developing a new class of drugs known as NNR TherapeuticsTM, today announced that it has initiated a Phase 2 clinical proof of concept trial of TC-5619 in cognitive dysfunction in schizophrenia.

10 Dec 2009

Merck commences Stimuvax Phase 3 trial in Asian patients with NSCLC

Oncothyreon Inc. today announced that Merck KGaA of Darmstadt, Germany, has initiated a Phase 3 trial of Stimuvax(R) (BLP25 liposome vaccine) in Asian patients with advanced non-small cell lung cancer (NSCLC). The trial, named INSPIRE (Stimuvax trial In Asian NSCLC Patients: Stimulating Immune Response), is anticipated to enroll approximately 420 patients in China, Hong Kong, South Korea, Singapore and Taiwan.

10 Dec 2009

Schizophrenia: Once-monthly INVEGA SUSTENNA not inferior to bi-weekly RISPERDAL CONSTA

Treatment with once-monthly INVEGA® SUSTENNA(TM) is not inferior to treatment with bi-weekly RISPERDAL® CONSTA®, according to new data from a comparative study of both treatments in patients with schizophrenia. Results of the 13-week clinical trial were released this week.

10 Dec 2009

Second-quarter fiscal 2010 results announced by Peregrine Pharmaceuticals

Peregrine Pharmaceuticals, Inc. today announced financial results for the second quarter of fiscal year (FY) 2010 ended October 31, 2009. Total revenue for the second quarter of FY 2010 increased 255% to $6,896,000, compared to $1,941,000 for the comparable prior year quarter.

10 Dec 2009

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

Drug Trial News

DMC recommends Emisphere Technologies' to proceed with oral calcitonin trial for OP and OA

Targacept commences TC-5619 Phase 2 study of cognitive dysfunction in schizophrenia

Merck commences Stimuvax Phase 3 trial in Asian patients with NSCLC

Schizophrenia: Once-monthly INVEGA SUSTENNA not inferior to bi-weekly RISPERDAL CONSTA

Second-quarter fiscal 2010 results announced by Peregrine Pharmaceuticals

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

Advancing Motor Neuron Disease Diagnosis with Non-Invasive Ultrasound and AI

How agentic AI is reshaping laboratory workflows

Fourier 80: bringing benchtop NMR systems to the laboratory

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