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Phase 2 INNOVATE PCI trial results for elinogrel presented

Phase 2 trial results for elinogrel, a novel antiplatelet agent available in both intravenous and oral formulations, were presented here today.

30 Aug 2010

Smoked cannabis relieves chronic neuropathic pain

The medicinal use of cannabis has been debated by clinicians, researchers, legislators and the public at large for many years as an alternative to standard pharmaceutical treatments for pain, which may not always be effective and may have unwanted side effects. A new study by McGill University Health Centre (MUHC) and McGill University researchers provides evidence that cannabis may offer relief to patients suffering from chronic neuropathic pain.

30 Aug 2010

BioMarin's BMN-701 receives FDA orphan drug designation for treatment of Pompe disease

BioMarin Pharmaceutical Inc. announced today that it has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for BMN-701, a novel fusion of insulin-like growth factor 2 and alpha glucosidase (IGF2-GAA) in development for the treatment of Pompe disease. An investigational new drug application (IND) for BMN-701 has been submitted, investigational material has been manufactured and a Phase I/II study is expected to start in the first quarter of 2011.

30 Aug 2010

BDSI's Phase 2 study results of BEMA Buprenorphine selected for presentation at Pain Week 2010

BioDelivery Sciences International, Inc. announced today that its abstract showing the results of a Phase 2 clinical study of BEMA Buprenorphine in the treatment of pain has been selected for oral presentation at Pain Week 2010, a national conference educating frontline clinicians who are faced with treating patients with pain. The presentation will take place on Friday, September 10, as part of the 7:00 - 9:00 AM podium presentation session.

30 Aug 2010

Trius commences oral torezolid phosphate Phase 3 clinical study for ABSSSI

Trius Therapeutics, Inc. announced that the first patient has been dosed in its Phase 3 clinical study of the oral dosage form of torezolid phosphate for the treatment of acute bacterial skin and skin structure infections (ABSSSI). The double-blind, active control, pivotal study is designed to compare the efficacy and safety of once-daily oral administration of 200 milligrams of torezolid phosphate for six days of treatment with the efficacy and safety of twice-daily oral administration of 600 milligrams of linezolid (Zyvox®) for 10 days of treatment.

30 Aug 2010

Selective lowering of heart rate reduces risk of death and hospitalization: Study

The results of a major international study presented at the European Society of Cardiology Congress in Stockholm and published simultaneously in The Lancet show, for the first time, that selectively lowering heart rate with a novel medication, ivabradine, significantly reduces risk of death and hospitalization for patients with heart failure. This also resolves a longstanding debate about whether lowering heart rate itself can actually lower the risk of heart disease progression.

30 Aug 2010

Low doses of n-3 fatty acids do not reduce overall rate of major cardiovascular events

Results from the Alpha Omega Trial, a multicentre, placebo-controlled trial in men and women following myocardial infarction (MI), suggest that low doses of n-3 fatty acids given in the form of enriched margarines do not reduce the overall rate of major cardiovascular events.

30 Aug 2010

RLY5016 potassium binder helps to regulate hyperkalemia in heart failure patients

Results from a recent phase 2b clinical trial may provide a new approach to managing excess potassium levels in patients with heart failure and heart failure with chronic kidney disease.

30 Aug 2010

Large clinical trial does not confirm benefits of erythropoieitin for first ST-elevation myocardial infarction

Results from the HEBE III study, a prospective, randomised, multicentre trial performed in seven centres in the Netherlands, suggest that the promising effects of erythropoieitin seen in previous smaller studies cannot be confirmed for the improvement of clinical outcome in patients with a first ST-elevation myocardial infarction.

30 Aug 2010

Boehringer Ingelheim announces sub-analysis result of RE-LY trial

Boehringer Ingelheim today announced results from a pre-specified, retrospective, un-blinded sub-analysis of the RE-LY trial the largest atrial fibrillation outcomes trial ever conducted were published in The Lancet.

30 Aug 2010

ATOLL study favors enoxaparin over UFH for primary Percutaneous Coronary Intervention

The international ATOLL study sponsored by the Assistance Publique - Hopitaux de Paris showed that enoxaparin reduced the composite of death, complication of myocardial infraction, procedure failure or major bleeding by 17% in comparison with standard heparin death, recurrent acute coronary syndrome or urgent revascularisation. The results of the ATOLL study were presented at the hotline session of the annual European Cardiology Congress (ESC 2010) in Stockholm, Sweden.

30 Aug 2010

Forest Laboratories reveals top-line results from cariprazine Phase II clinical trial for bipolar depression

Forest Laboratories, Inc. and Gedeon Richter Plc. today announced preliminary top-line results from an 8-week Phase II clinical trial of the novel, investigational antipsychotic agent cariprazine for the treatment of bipolar depression. Cariprazine is currently undergoing Phase III trials for separate indications of schizophrenia and bipolar mania.

30 Aug 2010

TEMSO Phase III Trial shows ARR reduction in multiple sclerosis patients

Sanofi-aventis announced today that the investigational once-daily oral drug teriflunomide significantly reduced annualized relapse rate (ARR) at 2 years versus placebo in patients with relapsing multiple sclerosis (RMS), thus achieving the primary endpoint in the TEMSO phase III trial.

30 Aug 2010

Merck's initiation of IMO-2055 Phase 1b clinical trial in SCCHN triggers €3.0M milestone payment to Idera

Idera Pharmaceuticals, Inc., today announced that it has achieved a milestone under its worldwide licensing and collaboration agreement with Merck KGaA, Darmstadt, Germany. The milestone was achieved upon Merck KGaA's initiation of a Phase 1b clinical trial of IMO-2055 (EMD 1201081), an agonist of Toll-like Receptor 9 (TLR9), in combination with cisplatin, fluorouracil and cetuximab (Erbitux®) in first-line treatment of patients with squamous cell carcinoma of the head and neck (SCCHN).

27 Aug 2010

Experimental drug PLX4032 holds promise against cancers with faulty BRAF gene

An experimental drug designed to treat cancers with a particular genetic fault has shown promising results in a small clinical trial.

27 Aug 2010

FDA denies accelerated approval of Genentech's trastuzumab-DM1 (T-DM1) BLA for metastatic breast cancer

In its review of the BLA, the FDA stated the T-DM1 trials did not meet the standard for accelerated approval because all available treatment choices approved for metastatic breast cancer, regardless of HER2 status, had not been exhausted in the study population.

27 Aug 2010

Vanda Pharmaceuticals initiates tasimelteon Phase III clinical trial for Non-24-Hour Sleep Wake Disorder

Vanda Pharmaceuticals Inc., today announced it has initiated a Phase III clinical trial to evaluate tasimelteon in patients with Non-24-Hour Sleep Wake Disorder (N24HSWD), a condition experienced primarily by totally blind individuals that results in abnormal night sleep patterns and chronic daytime sleepiness.

26 Aug 2010

Lotus Pharmaceuticals initiates R-Bambuterol Clinical Trial I on-schedule

Lotus Pharmaceuticals, Inc., a growing developer, manufacturer and seller of medicine and drugs in the People's Republic of China, announced today that it has entered R-Bambuterol Clinical Trial I on-schedule and is on-track to complete in six months. The studies will evaluate the safety and tolerability of the new drug as well as the biological activity by measuring responses in healthy volunteers.

26 Aug 2010

NeoPharm second-quarter net loss decreases to $0.8 million

NeoPharm, Inc., a publicly traded biopharmaceutical company dedicated to the research, development and commercialization of new and innovative therapeutic applications of drugs for various forms of cancer and other diseases, today announced its second quarter 2010 financial results.

26 Aug 2010

Dose-defining Phase IIa trial of CXL-1020 initiated for treating patients with ADHF

Cardioxyl Pharmaceuticals, Inc., a clinical-stage pharmaceutical company developing therapeutic agents for the treatment of cardiovascular disease, today announced that it has initiated a dose-defining Phase IIa trial of its lead drug candidate, CXL-1020, for the treatment of patients with acute decompensated heart failure.

26 Aug 2010

Drug Trial News

Phase 2 INNOVATE PCI trial results for elinogrel presented

Smoked cannabis relieves chronic neuropathic pain

BioMarin's BMN-701 receives FDA orphan drug designation for treatment of Pompe disease

BDSI's Phase 2 study results of BEMA Buprenorphine selected for presentation at Pain Week 2010

Trius commences oral torezolid phosphate Phase 3 clinical study for ABSSSI

Selective lowering of heart rate reduces risk of death and hospitalization: Study

Low doses of n-3 fatty acids do not reduce overall rate of major cardiovascular events

RLY5016 potassium binder helps to regulate hyperkalemia in heart failure patients

Large clinical trial does not confirm benefits of erythropoieitin for first ST-elevation myocardial infarction

Boehringer Ingelheim announces sub-analysis result of RE-LY trial

ATOLL study favors enoxaparin over UFH for primary Percutaneous Coronary Intervention

Forest Laboratories reveals top-line results from cariprazine Phase II clinical trial for bipolar depression

TEMSO Phase III Trial shows ARR reduction in multiple sclerosis patients

Merck's initiation of IMO-2055 Phase 1b clinical trial in SCCHN triggers €3.0M milestone payment to Idera

Experimental drug PLX4032 holds promise against cancers with faulty BRAF gene

FDA denies accelerated approval of Genentech's trastuzumab-DM1 (T-DM1) BLA for metastatic breast cancer

Vanda Pharmaceuticals initiates tasimelteon Phase III clinical trial for Non-24-Hour Sleep Wake Disorder

Lotus Pharmaceuticals initiates R-Bambuterol Clinical Trial I on-schedule

NeoPharm second-quarter net loss decreases to $0.8 million

Dose-defining Phase IIa trial of CXL-1020 initiated for treating patients with ADHF

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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