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The utility of observational studies in clinical decision making: Lessons learned from statin trials

An article published in the May 2010 issue of Postgraduate Medicine explains the benefits observational studies have in assessing clinical practice and thereby aid in improved processes of clinical care.

16 Jun 2010

Trius Therapeutics reaches agreement with FDA under SPA for Phase 3 study of torezolid phosphate for ABSSSI

Trius Therapeutics, Inc. announced today that it has reached agreement with the United States Food and Drug Administration (FDA), under the Special Protocol Assessment (SPA) process, on the design of its planned Phase 3 study for the oral dosage form of torezolid phosphate for treatment of acute bacterial skin and skin structure infections (ABSSSI).

16 Jun 2010

Phase 3 U.S. registration study of LODOTRA shows improvement in patients with RA

Horizon Pharma, Inc., announced today that data from the Phase 3 U.S. registration study of LODOTRA, a circadian cytokine modulator and novel modified-release, low-dose prednisone tablet, showed a statistically significant improvement in American College of Rheumatology response criteria in patients with rheumatoid arthritis.

16 Jun 2010

RG7204 holds promise for metastatic melanoma with V600E BRAF mutation

Preclinical findings recently published in Cancer Research, a journal of the American Association for Cancer Research, showed RG7204 (PLX4032) inhibited proliferation of tumor cell lines that expressed V600E-BRAF, a mutation found in several human cancers, including melanoma.

16 Jun 2010

Phase IIb EMBLEM study demonstrates clinical efficacy of epratuzumab in patients with SLE

UCB and Immunomedics Inc. announced new lupus drug candidate, epratuzumab, provided a significant reduction in disease activity in patients with moderate to severe active systemic lupus erythematosus (SLE). Data presented at the European League Against Rheumatism (EULAR) meeting in Rome from the phase IIb study, EMBLEM™, showed the clinical efficacy of epratuzumab in patients with SLE.

16 Jun 2010

Nuon Therapeutics NU1618 phase 2a study in hyperuricemia meets primary endpoint

Nuon Therapeutics, Inc., a privately held, clinical stage biopharmaceutical company, announced that a phase 2a study of NU1618, the company's lead program, met its primary endpoint of reduction in serum uric acid (sUA) levels in patients with hyperuricemia.

16 Jun 2010

NexMed's NexACT-based topical psoriasis treatment bioequivalent to Talconex

NexMed, Inc., a specialty CRO with a pipeline of products based on the NexACT® technology, today announced results from a pre-clinical study showing that calcipotriene 0.005% and betamethasone dipropionate 0.064%, when formulated with NexACT®, results in a topical treatment which shows bioequivalecy in efficacy to Talconex®, one of the leading topical treatments marketed for patients with mild to moderate psoriasis.

16 Jun 2010

Nymox near completion of new NX-1207 follow-up study for BPH

Nymox Pharmaceutical Corporation announced today that the Company is nearing completion of a new multi-center U.S. long-term follow-up study of NX-1207, its investigational drug for the treatment of benign prostatic hyperplasia (BPH). Nymox expects to report final results and statistical analysis for the study in the next 1-2 weeks. The new study concerns assessment of the 48-60 month efficacy and benefits of a single treatment of NX-1207.

16 Jun 2010

New data from Phase 2a trial support further development of BMS-945429/ALD518 monoclonal antibody for RA

Bristol-Myers Squibb Company and Alder Biopharmaceuticals today announced that new data from a dose-ranging Phase 2a trial support further development of BMS-945429/ALD518, an investigational monoclonal antibody directed against interleukin-6 (IL-6), as a potential treatment for rheumatoid arthritis (RA). The Phase 2a data will be presented in a scientific session on June 18, 2010, at the Annual Congress of the European League against Rheumatism (EULAR).

16 Jun 2010

Results from ICH compliant Phase II study of MRX-4 presented at EAACI Congress

Morria Biopharmaceuticals Plc, a biopharmaceutical company focused on novel, anti-inflammatory drugs, announced today the results from its ICH compliant Phase II study of MRX-4>th EAACI Congress in London. The study's principal investigators were Drs. Eric Bateman, Mary Bateman and Paul Potter.

16 Jun 2010

Global drug distribution programs one factor in hastening drug resistance, report says

A Center for Global Development (CGD) report released Tuesday details factors leading to increased drug resistance worldwide, including drug distribution programs in developing countries, Reuters reports.

16 Jun 2010

Study aims at determining optimal dose of nab-paclitaxel with carboplatin as first-line therapy for NSCLC

The June edition of the Journal of Thoracic Oncology features a study aimed at determining the optimal dose of the chemotherapy drug nab-paclitaxel with carboplatin as a first-line therapy in patients with non-small cell lung cancer. Results will provide researchers with a data needed to guide a phase 3 trial.

16 Jun 2010

Vitamin D may help reduce incidence, severity of viral respiratory tract infections: Study

Vitamin D may help reduce the incidence and severity of viral respiratory tract infections including influenza, according to a new study conducted by investigators at Greenwich Hospital and Yale University School of Medicine.

16 Jun 2010

Immunomedics initiates dosing in milatuzumab-doxorubicin conjugate Phase I/II trial for relapsed multiple myeloma

Immunomedics, Inc., a biopharmaceutical company focused on developing monoclonal antibodies to treat cancer and other serious diseases, today announced the dosing of the first patient in a Phase I/II clinical trial of the doxorubicin conjugate of milatuzumab for the treatment of patients with relapsed multiple myeloma.

16 Jun 2010

Galera Therapeutics completes Series 1 financing

Galera Therapeutics, a drug development company focused on novel therapeutics to protect against the side effects and increase the effectiveness of cancer treatment, today announced it has completed a Series 1 financing led by BioGenerator. Also participating in the round is Galera Angels, LLC, an angel investment group, and Analytical Bio-Chemistry Laboratories, Inc., of Columbia Missouri.

16 Jun 2010

Cytokine PharmaSciences completes misoprostol vaginal insert Phase II study

Cytokine PharmaSciences, Inc. today announced the completion of a Phase II study of the misoprostol vaginal insert (MVI), a proprietary, controlled-release and retrievable polymer chip containing prostaglandin E(1) (PGE1). Results of the dose-finding study in pregnant women at term gestation confirm the efficacy and safety of this investigational product and suggest that the MVI may reduce time to delivery after induction, support more natural labor, and reduce the rate of cesarean delivery.

16 Jun 2010

Biogen Idec initiates enrollment in Phase II BG-12 combination trial for relapsing-remitting multiple sclerosis

Biogen Idec today announced enrollment of the first patient in a multicenter Phase II clinical trial designed to evaluate its investigational oral therapy BG-12 (dimethyl fumarate) in combination with commonly used first-line treatments in patients with relapsing-remitting multiple sclerosis (RRMS).

15 Jun 2010

Positive clinical trial results for Anacor Pharmaceuticals' AN2728 announced

Anacor Pharmaceuticals today announced positive clinical trial results for its lead phosphodiesterase-4 inhibitor, AN2728, a novel topical anti-inflammatory compound derived from Anacor's boron chemistry platform. These results were obtained from a multi-center, Phase 2b, randomized, double-blind, dose-ranging, bilateral trial comparing AN2728 ointment, 0.5% and 2.0%, applied once or twice daily, to vehicle in 145 patients with mild-to-moderate plaque-type psoriasis.

15 Jun 2010

Endosense launches ProForce Registry Study of TactiCath force-sensing ablation catheter

Endosense, a medical technology company focused on improving the efficacy, safety and reproducibility of catheter ablation for the treatment of cardiac arrhythmias, has announced enrollment of the first patients in its ProForce Registry. The news marks the launch of the ProForce Registry Study, an international, single arm, multi-center, post-market trial of Endosense's TactiCath force-sensing ablation catheter.

15 Jun 2010

Alexion's Soliris may benefit patients with thrombotic microangiopathy from uncontrolled complement activation

Researchers reported today that Soliris® (eculizumab), a first-in-class terminal complement inhibitor developed by Alexion Pharmaceuticals, Inc., may provide clinical benefits to patients with thrombotic microangiopathy (TMA) resulting from uncontrolled complement activation. TMA, the formation of blood clots in capillaries and small arteries, can lead to life-threatening damage in multiple organs including kidney failure, thrombocytopenia (abnormally low platelet count) and anemia.

15 Jun 2010

Efficacy News and Research

The utility of observational studies in clinical decision making: Lessons learned from statin trials

Trius Therapeutics reaches agreement with FDA under SPA for Phase 3 study of torezolid phosphate for ABSSSI

Phase 3 U.S. registration study of LODOTRA shows improvement in patients with RA

RG7204 holds promise for metastatic melanoma with V600E BRAF mutation

Phase IIb EMBLEM study demonstrates clinical efficacy of epratuzumab in patients with SLE

Nuon Therapeutics NU1618 phase 2a study in hyperuricemia meets primary endpoint

NexMed's NexACT-based topical psoriasis treatment bioequivalent to Talconex

Nymox near completion of new NX-1207 follow-up study for BPH

New data from Phase 2a trial support further development of BMS-945429/ALD518 monoclonal antibody for RA

Results from ICH compliant Phase II study of MRX-4 presented at EAACI Congress

Global drug distribution programs one factor in hastening drug resistance, report says

Study aims at determining optimal dose of nab-paclitaxel with carboplatin as first-line therapy for NSCLC

Vitamin D may help reduce incidence, severity of viral respiratory tract infections: Study

Immunomedics initiates dosing in milatuzumab-doxorubicin conjugate Phase I/II trial for relapsed multiple myeloma

Galera Therapeutics completes Series 1 financing

Cytokine PharmaSciences completes misoprostol vaginal insert Phase II study

Biogen Idec initiates enrollment in Phase II BG-12 combination trial for relapsing-remitting multiple sclerosis

Positive clinical trial results for Anacor Pharmaceuticals' AN2728 announced

Endosense launches ProForce Registry Study of TactiCath force-sensing ablation catheter

Alexion's Soliris may benefit patients with thrombotic microangiopathy from uncontrolled complement activation

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

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