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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

FDA approves Chelsea Therapeutics' Phase II protocol for CH-4051 antifolate in rheumatoid arthritis

Chelsea Therapeutics International, Ltd. announced confirmation by the U.S. Food and Drug Administration (FDA) that its proposed Phase II protocol for CH-4051 in rheumatoid arthritis has been approved by the agency.

26 Aug 2010

Data from PLX4032 Phase 1 clinical trial in melanoma patients with BRAF mutation published

Plexxikon today announced publication of data from the Phase 1 clinical trial of PLX4032 (RG7204), confirming that treatment of metastatic melanoma patients with the BRAF V600E mutation resulted in significant tumor shrinkage in the majority of patients. Specifically, in the melanoma extension cohort of the study, nearly all patients showed some response; 81 percent of patients had tumor shrinkage of at least 30 percent.

26 Aug 2010

Phase 1 CRLX101 clinical study paves way for promising innovations in cancer therapy: Cerulean Pharma

Cerulean Pharma Inc., a leader in designing and developing nanopharmaceuticals, today announced that results of a Phase 1 clinical study of CRLX101 (formerly IT-101), Cerulean's lead clinical development candidate, and pre-clinical data on Cerulean's development candidate, CRLX288, were presented at the American Chemical Society National Meeting & Exposition, ongoing in Boston, Massachusetts.

26 Aug 2010

FDA grants LFB's recombinant anti-CD20 monoclonal antibody orphan drug status for CLL

The recombinant anti-CD20 monoclonal antibody produced by LFB Biotechnologies received orphan drug status for the treatment of Chronic Lymphocytic Leukemia (CLL). This approval from the FDA Office of Orphan Products Development was granted on August 6th, 2010.

26 Aug 2010

Impax Pharmaceuticals completes enrollment in IPX066 Phase III trial for Parkinson’s disease

Impax Pharmaceuticals, the brand products division of Impax Laboratories, Inc., today announced that it has completed enrollment of its ADVANCE-PD trial. ADVANCE-PD is a multinational Phase III trial of its late-stage product IPX066 in advanced Parkinson's disease (PD) patients with motor fluctuations. IPX066 is an investigational extended release carbidopa-levodopa product intended to rapidly achieve and sustain effective blood concentrations of levodopa, potentially improving PD clinical symptom management.

26 Aug 2010

Nabi receives US patent for treatment and prevention of nicotine addiction with NicVAX conjugate vaccines

Nabi Biopharmaceuticals announced the receipt of a patent for treating and preventing nicotine addiction with NicVAX® and related nicotine conjugate vaccines. The United States Patent and Trademark office issued U.S. Patent No. 7,776,620 entitled "Hapten-carrier conjugates for treating and preventing nicotine addiction" for the exclusive use of methods for treating and preventing nicotine addiction with NicVAX and related nicotine vaccines. This patent runs through December 2018.

26 Aug 2010

Afferent Pharmaceuticals' P2X3 receptor antagonist reduces bladder hyperactivity

Afferent Pharmaceuticals, a clinical-stage biopharmaceutical company developing first-in-class, small molecule compounds that target P2X3 receptors, today announced preclinical in vivo results demonstrating that an investigational P2X3 receptor antagonist reduced experimentally induced bladder hyperactivity.

26 Aug 2010

CHX reports positive results from final pivotal trial of Prevora antibacterial tooth coating for cavity prevention

CHX Technologies Inc., a private Canadian pharmaceutical company that is developing new treatments for the prevention of dental diseases, today announced successful results in its final controlled pivotal trial of Prevora, its proprietary antibacterial tooth coating for the prevention of cavities. The trial surpassed objectives set by the Food and Drug Administration (FDA) protocol, clearing the way for CHX to start the process of seeking FDA approval for use in the United States.

25 Aug 2010

NIH awards University of Rochester Medical Center $15M grant for study with ImmuneRegen's Homspera

ImmuneRegen BioSciences®, a wholly owned subsidiary of IR Biosciences Holdings Inc., today announced that the National Institute of Health/National Institute of Allergy and Infectious Disease, has awarded its research partner, the University of Rochester Medical Center (URMC), a $15 million five-year, continuation grant for studies that will utilize ImmuneRegen's Homspera.

25 Aug 2010

Drug Trial News

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

FDA approves Chelsea Therapeutics' Phase II protocol for CH-4051 antifolate in rheumatoid arthritis

Data from PLX4032 Phase 1 clinical trial in melanoma patients with BRAF mutation published

Phase 1 CRLX101 clinical study paves way for promising innovations in cancer therapy: Cerulean Pharma

FDA grants LFB's recombinant anti-CD20 monoclonal antibody orphan drug status for CLL

Impax Pharmaceuticals completes enrollment in IPX066 Phase III trial for Parkinson’s disease

Nabi receives US patent for treatment and prevention of nicotine addiction with NicVAX conjugate vaccines

Afferent Pharmaceuticals' P2X3 receptor antagonist reduces bladder hyperactivity

CHX reports positive results from final pivotal trial of Prevora antibacterial tooth coating for cavity prevention

NIH awards University of Rochester Medical Center $15M grant for study with ImmuneRegen's Homspera

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