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Biogen Idec concurs with FDA on safety monitoring for Gilenya through REMS

Biogen Idec is committed to improving the lives of people with multiple sclerosis (MS), and no company is doing more for these patients. There has been a desire within the MS community for an oral treatment for a long time, and the approval of Gilenya has made this a reality.

23 Sep 2010

DSMB authorizes Oxygen Biotherapeutics' next cohort of Oxycyte emulsion study in severe non-penetrating TBI

Oxygen Biotherapeutics, Inc. reported today that the Data Safety Monitoring Board overseeing the company's ongoing Phase II-b trial has, based on the results of the first cohort of patients, authorized the company to move forward with the next cohort of the study. This trial is a randomized, single-dose, placebo-controlled, double-blind, dose-escalation study to evaluate the safety and tolerability of our Oxycyte® emulsion in patients with severe non-penetrating traumatic brain injury.

23 Sep 2010

Infinity Pharmaceuticals to present IPI-926 inhibitor Phase 1 data at ESMO Congress

Infinity Pharmaceuticals, Inc. today announced that Phase 1 data of its novel Hedgehog pathway inhibitor, IPI-926, will be presented during the 35th Congress of the European Society of Molecular Oncology (ESMO), in Milan, Italy.

23 Sep 2010

Weight-based taribavirin reduces anemia, increases sustained virologic response

Researchers at Cedars-Sinai Medical Center and 50 other centers found that weight-based dosing of taribavirin reduces rates of anemia while increasing sustained virologic response (SVR) in patients with chronic hepatitis C (HCV). Full details of this study are available in the October issue of Hepatology, a journal published by Wiley-Blackwell on behalf of the American Association for the Study of Liver Diseases (AASLD).

23 Sep 2010

Intarcia Therapeutics presents ITCA 650 phase 2 study results for type 2 diabetes

Intarcia Therapeutics, Inc. presented today final results of a 24-week phase 2 clinical study of ITCA 650 (DUROS continuous subcutaneous delivery of exenatide) for the treatment of type 2 diabetes at the 46th Annual Meeting of the European Association for the Study of Diabetes in Stockholm, Sweden.

23 Sep 2010

Boehringer Ingelheim to present linagliptin Phase III data at 46th EASD

New Phase III data found that investigational linagliptin therapy resulted in significant reductions in blood sugar as measured by hemoglobin A1c (HbA1c) when compared to placebo, both when added to sulfonylurea (SU) in inadequately controlled type 2 diabetes (T2D) patients, and when administered as monotherapy in T2D patients for whom metformin is inappropriate.

22 Sep 2010

Titan completes enrollment in Probuphine Phase 3 study for opioid addiction

Titan Pharmaceuticals, Inc. today announced that patient enrollment is now complete in the confirmatory, Phase 3 clinical study of Probuphine for the treatment of opioid addiction. This placebo and active controlled Phase 3 study is being conducted at 20 sites in the United States and the results are expected in the second quarter of 2011, about three months ahead of the original schedule.

22 Sep 2010

Santaris Pharma paves way to conduct clinical trial of miravirsen in patients with HVC

Santaris Pharma A/S, a clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies, today announced that it has advanced miravirsen (SPC3649), the first microRNA-targeted drug to enter clinical trials, into Phase 2 studies to assess the safety and tolerability of the drug in treatment-naive patients infected with the Hepatitis C virus.

22 Sep 2010

Results of custirsen Phase 2 trial for advanced prostate cancer published in Journal of Clinical Oncology

OncoGenex Pharmaceuticals, Inc. announced today publication of results from a randomized Phase 2 trial in the Journal of Clinical Oncology. The trial results showed a survival benefit with the investigational agent OGX-011/TV1011 (custirsen) in patients with advanced prostate cancer. The median overall survival for patients who were treated with custirsen plus first-line docetaxel/prednisone was 23.8 months compared to 16.9 months for patients treated with docetaxel/prednisone alone.

22 Sep 2010

Phase I/II DIGNITY trial abstract of ThermoDox accepted for poster session at 2010 Breast Cancer Symposium

Celsion Corporation announced today that an abstract on its Phase I/II DIGNITY trial of ThermoDox in Recurrent Chest Wall Breast Cancer has been accepted for a poster session at the 2010 Breast Cancer Symposium. The abstract will provide updated clinical results, as well as the rationale and design of the DIGNITY study, which is evaluating ThermoDox in combination with microwave hyperthermia in women with RCW Breast Cancer.

22 Sep 2010

Progenics completes methylnaltrexone bromide subcutaneous injection phase 3 study in patients with OIC

Progenics Pharmaceuticals, Inc. today announced the completion of the treatment phase of a 1,034-patient, one-year, open-label, international, phase 3 safety study of methylnaltrexone bromide subcutaneous injection in chronic, non-malignant pain patients with opioid-induced constipation (OIC).

22 Sep 2010

FDA guides Apricus Bio on RayVa's approvability for Raynaud's syndrome secondary to scleroderma

Apricus Biosciences, backed by a revenue-generating CRO business and seeking to leverage its multi-route NexACT® drug delivery technology and internal pipeline through out-licensing partnerships, announced today that the U.S. Food and Drug Administration (FDA) has provided guidance on the clinical requirements for assessing the approvability of RayVa for the treatment of Raynaud's syndrome secondary to scleroderma.

22 Sep 2010

Aeras and Crucell commence Phase II study of TB vaccine candidate in infants

Dutch biopharmaceutical company Crucell N.V. and the Aeras Global TB Vaccine Foundation today announced the start of a Phase II clinical trial in infants of the jointly developed tuberculosis (TB) vaccine candidate, AERAS-402/Crucell Ad35.

22 Sep 2010

Novartis' SOM230 reduces cortisol levels in Cushing's disease patients

Novartis Pharmaceuticals Corporation announced today that the results of a Phase III study of SOM230 (pasireotide) showed a reduction in cortisol levels in patients with Cushing's disease, a condition in which a benign (non-cancerous) pituitary tumor causes the adrenal glands to produce excess cortisol and can be fatal. Results will be presented at the 14th Congress of the European Neuroendocrine Association (ENEA).

22 Sep 2010

ChemoCentryx presents CCX140 clinical data at EASD

ChemoCentryx, Inc., today announced that it reported positive preclinical and Phase I study results at the European Association for the Study of Diabetes (EASD). CCX140, a novel, orally bioavailable small molecule antagonist of the chemokine receptor CCR2, improved metabolic function while significantly reducing inflammatory macrophages found in adipose tissue in an animal model, and was well tolerated in Phase I clinical trials.

21 Sep 2010

NIDA awards 5-year, $3.7M research grant for development of drug to treat cocaine addiction

The University of Maryland School of Pharmacy has received a prestigious $3.7 million grant to develop a drug to treat cocaine addiction based on an active ingredient found in some Chinese prescription medicines.

21 Sep 2010

VIVUS announces QNEXA study results for obesity treatment

VIVUS, Inc. today announced positive top-line results from a two-year study of QNEXA(phentermine/topiramate) Controlled Release Capsules, an investigational therapy for treatment of obesity, a condition that affects approximately one-third of adult Americans.

21 Sep 2010

Cytheris commences enrollment in CYT107 recombinant human Interleukin-7 clinical trial for HIV

Cytheris SA, a clinical stage biopharmaceutical company focused on research and development of new therapies for immune modulation, today announced that it has begun enrolling patients in INSPIRE 3, a Phase II clinical program evaluating the effect of repeated cycles of the company's investigative immune-modulator, recombinant human Interleukin-7 (CYT107), in the treatment of chronically HIV-1 infected patients classified as Immunological Non-Responders (INR) after at least 24 months of highly active anti-retroviral therapy (HAART).

21 Sep 2010

ImmunoGen commences clinical testing with SAR566658 anticancer compound

ImmunoGen, Inc., a biotechnology company that develops targeted antibody-based anticancer products, today announced the start of clinical testing with SAR566658. Eight compounds are now in the clinic through ImmunoGen's product programs and those of its partners, consistent with Company expectations of as many as 12 such compounds being in the clinic by late 2011 and marked, sustained pipeline growth thereafter.

21 Sep 2010

Annals of Internal Medicine publishes GRACE study data on HIV therapy

Data from the GRACE study will be published in the September 21st issue of the Annals of Internal Medicine. GRACE is the largest-ever study of treatment experienced adult women with HIV-1 to examine gender differences in response to HIV therapy. Sponsored by Tibotec Therapeutics Clinical Affairs, a division of Centocor Ortho Biotech Services, LLC, the GRACE study enrolled 67 percent women, demonstrating that it is possible to recruit large numbers of women into U.S.-based HIV treatment studies.

21 Sep 2010

Drug Trial News

Biogen Idec concurs with FDA on safety monitoring for Gilenya through REMS

DSMB authorizes Oxygen Biotherapeutics' next cohort of Oxycyte emulsion study in severe non-penetrating TBI

Infinity Pharmaceuticals to present IPI-926 inhibitor Phase 1 data at ESMO Congress

Weight-based taribavirin reduces anemia, increases sustained virologic response

Intarcia Therapeutics presents ITCA 650 phase 2 study results for type 2 diabetes

Boehringer Ingelheim to present linagliptin Phase III data at 46th EASD

Titan completes enrollment in Probuphine Phase 3 study for opioid addiction

Santaris Pharma paves way to conduct clinical trial of miravirsen in patients with HVC

Results of custirsen Phase 2 trial for advanced prostate cancer published in Journal of Clinical Oncology

Phase I/II DIGNITY trial abstract of ThermoDox accepted for poster session at 2010 Breast Cancer Symposium

Progenics completes methylnaltrexone bromide subcutaneous injection phase 3 study in patients with OIC

FDA guides Apricus Bio on RayVa's approvability for Raynaud's syndrome secondary to scleroderma

Aeras and Crucell commence Phase II study of TB vaccine candidate in infants

Novartis' SOM230 reduces cortisol levels in Cushing's disease patients

ChemoCentryx presents CCX140 clinical data at EASD

NIDA awards 5-year, $3.7M research grant for development of drug to treat cocaine addiction

VIVUS announces QNEXA study results for obesity treatment

Cytheris commences enrollment in CYT107 recombinant human Interleukin-7 clinical trial for HIV

ImmunoGen commences clinical testing with SAR566658 anticancer compound

Annals of Internal Medicine publishes GRACE study data on HIV therapy

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