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Northwestern University awarded NIH grant to conduct phase III Parkinson's neuroprotective study

Tanya Simuni, M.D., medical director of Northwestern University's Parkinson's Disease and Movement Disorders Center, was awarded a grant from the National Institutes of Health to conduct a $16 million phase III study of the safety and efficacy of the drug isradipine as a potential neuroprotective agent in Parkinson's disease.

2 Apr 2014

Study demonstrates efficacy, tolerability of vemurafenib in aggressive form of metastatic melanoma

The Lancet Oncology has published results from the largest ever trial of a single melanoma treatment. The open label safety study was conducted to assess the tolerability of Zelboraf (vemurafenib), and featured 3,222 patients from across 44 countries.1 246 of these patients were from the UK.

2 Apr 2014

Teva granted certiorari petition related to Mylan's ANDA for Copaxone

Mylan Inc. announced that today the Supreme Court of the United States granted certiorari in Mylan's patent litigation against Teva relating to Mylan's Abbreviated New Drug Application (ANDA) for glatiramer acetate (Copaxone).

1 Apr 2014

rEVO Biologics commences ATryn Phase 3 clinical program for treatment of preeclampsia in pregnant women

rEVO Biologics Inc., a subsidiary of LFB SA, today announced the initiation of the Phase 3 clinical program for ATryn for the treatment of preeclampsia in pregnant women during the 24th to 28th week of pregnancy.

31 Mar 2014

Halozyme meets primary endpoint in Hylenex CONSISTENT 1 trial

Halozyme Therapeutics, Inc. today announced that the primary endpoint of non-inferiority of A1C levels at six months was met for the CONSISTENT 1 trial. The trial is evaluating Hylenex® recombinant and a new formulation of Hylenex currently under U.S Food and Drug Administration (FDA) review, when used as pretreatment of the insulin infusion site in patients with type 1 diabetes receiving continuous subcutaneous insulin infusion (CSII) in comparison to no pre-treatment.

31 Mar 2014

Heron initiates SUSTOL Phase 3 clinical trial for CINV prevention associated with emetogenic chemotherapy

Heron Therapeutics, Inc., a specialty pharmaceutical company, today announced the initiation of a Phase 3 clinical trial of SUSTOL™ (APF530), the Company's lead product candidate for the prevention of chemotherapy-induced nausea and vomiting (CINV) associated with moderately and highly emetogenic chemotherapy.

31 Mar 2014

BioLight seeks FDA IND approval for subconjunctival Latanoprost controlled release insert Phase I/IIa study

BioLight Israeli Life Sciences Investments Ltd., a firm that invests in, manages and commercializes biomedical innovations grouped into clusters around defined medical conditions, announces that ViSci, its wholly owned subsidiary, has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to conduct a Phase I/IIa clinical study with its subconjunctival Latanoprost controlled release insert for the treatment of glaucoma.

31 Mar 2014

CytRx’s aldoxorubicin receives European orphan medicinal product designation for treatment of advanced soft tissue sarcomas

CytRx Corporation, a biopharmaceutical research and development company specializing in oncology, today announced that aldoxorubicin has received orphan medicinal product designation from the European Commission for the treatment of advanced soft tissue sarcomas. The designation is to encourage the development of drugs which may provide significant benefit to patients suffering from rare diseases.

31 Mar 2014

Prana Biotechnology releases top-line results of PBT2 Phase II Imaging trial in Alzheimer's disease

Prana Biotechnology has today released the top line results of the 12-month Phase II Imaging trial in Alzheimer's Disease ("IMAGINE" Trial), based on draft results.

31 Mar 2014

Enrollment commences for Daiichi Sankyo's ENSURE-AF multinational phase 3 study in NVAF patients

Daiichi Sankyo Company, Limited today announced that it has started enrolling patients into the ENSURE-AF multinational phase 3 study, which will evaluate the efficacy and safety of its investigational oral, once-daily direct factor Xa-inhibitor edoxaban compared to enoxaparin/warfarin for the prevention of stroke and other blood clot complications in patients with non-valvular atrial fibrillation (NVAF) undergoing electrical cardioversion (low-energy shocks to trigger normal heart rhythm).

31 Mar 2014

Amgen reports positive findings from AMG 145 Phase 3 studies in patients at risk for cardiovascular disease

Amgen (NASDAQ: AMGN) today announced new detailed data from three Phase 3 studies that showed treatment with its novel investigational cholesterol-lowering medication, evolocumab (AMG 145), resulted in a statistically significant reduction of 55-66 percent in low-density lipoprotein cholesterol (LDL-C) compared to placebo in patients with high cholesterol.

31 Mar 2014

e-Therapeutics announces interim results from ETS2101 phase Ia trial for advanced solid tumours

e-Therapeutics plc announced today interim results from its phase Ia UK study evaluating the safety, dosing and anti-tumour activity of ETS2101 (dexanabinol) in patients with advanced solid tumours.

31 Mar 2014

Forest Laboratories, Richter report positive results from cariprazine Phase IIb trial for bipolar depression

Forest Laboratories, Inc. and Gedeon Richter Plc. today announced positive topline results from a Phase IIb trial evaluating the efficacy and safety of the investigational antipsychotic cariprazine in patients with bipolar depression.

31 Mar 2014

SEATTLE II study confirms safety and efficacy of thrombolytic therapy for acute PE

EKOS Corporation, a BTG International group company, notes the presentation of the results of the SEATTLE II trial this afternoon at ACC.14, the 63rd Annual Scientific Session and Exposition of the American College of Cardiology in Washington, DC in the United States.

31 Mar 2014

Anacor Pharmaceuticals enrolls first patient in AN2728 Phase 3 trial for treatment of atopic dermatitis

Anacor Pharmaceuticals announced today that the first patient has been enrolled in the Phase 3 trial of AN2728, a novel boron-based phosphodiesterase-4 (PDE-4) inhibitor, for the topical treatment of mild-to-moderate atopic dermatitis. Atopic dermatitis is a chronic rash characterized by inflammation and itch and affects approximately 10% - 20% of infants and young children.

31 Mar 2014

Two doses of HPV-16/18 AS04-adjuvanted vaccine Cervarix non-inferior to three-doses

A recent study in the journal Human Vaccines & Immunotherapeutics, showed that two doses of the HPV-16/18 AS04-adjuvanted vaccine Cervarix (GlaxoSmithKline) are non-inferior to three-doses in the current schedule.

29 Mar 2014

Idera Pharmaceuticals reports positive top-line results from Phase 2 trial of IMO-8400

Idera Pharmaceuticals, Inc. today announced positive top-line data from its randomized, double-blind, placebo controlled Phase 2 trial of IMO-8400 in 32 patients with moderate-to-severe plaque psoriasis.

28 Mar 2014

Takeda to present results from global EXAMINE CV safety outcomes trial at ACC 2014

Takeda Pharmaceuticals Company Limited will present sub-analyses from the global EXAMINE (EXamination of CArdiovascular OutcoMes: AlogliptIN vs. Standard of CarE in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome) cardiovascular (CV) safety outcomes trial in a poster session at the American College of Cardiology’s 63rd Annual Scientific Session in Washington, DC.

28 Mar 2014

$Patrys reports final results from PAT-SM6 Phase I/IIa study in patients with refractory or relapsed MM$

Patrys reports final results from PAT-SM6 Phase I/IIa study in patients with refractory or relapsed MM

Patrys Limited, a clinical stage biotechnology company, is pleased to announce the final results from its Phase I/IIa, open-label study in patients with refractory or relapsed multiple myeloma (MM).

28 Mar 2014

Novartis’ investigational compound achieves overall response rate of 58% in patients with ALK+ NSCLC

Novartis today announced that The New England Journal of Medicine (NEJM) published clinical trial results showing the investigational compound LDK378 (ceritinib) achieved an overall response rate (ORR, including complete response [CR] and partial response [PR]) of 58% and a median progression-free survival (PFS) of seven months in adults with advanced anaplastic lymphoma kinase positive (ALK+) non-small cell lung cancer (NSCLC) who received 400 mg or higher of LDK378 per day.

28 Mar 2014

Drug Trial News

Northwestern University awarded NIH grant to conduct phase III Parkinson's neuroprotective study

Study demonstrates efficacy, tolerability of vemurafenib in aggressive form of metastatic melanoma

Teva granted certiorari petition related to Mylan's ANDA for Copaxone

rEVO Biologics commences ATryn Phase 3 clinical program for treatment of preeclampsia in pregnant women

Halozyme meets primary endpoint in Hylenex CONSISTENT 1 trial

Heron initiates SUSTOL Phase 3 clinical trial for CINV prevention associated with emetogenic chemotherapy

BioLight seeks FDA IND approval for subconjunctival Latanoprost controlled release insert Phase I/IIa study

CytRx’s aldoxorubicin receives European orphan medicinal product designation for treatment of advanced soft tissue sarcomas

Prana Biotechnology releases top-line results of PBT2 Phase II Imaging trial in Alzheimer's disease

Enrollment commences for Daiichi Sankyo's ENSURE-AF multinational phase 3 study in NVAF patients

Amgen reports positive findings from AMG 145 Phase 3 studies in patients at risk for cardiovascular disease

e-Therapeutics announces interim results from ETS2101 phase Ia trial for advanced solid tumours

Forest Laboratories, Richter report positive results from cariprazine Phase IIb trial for bipolar depression

SEATTLE II study confirms safety and efficacy of thrombolytic therapy for acute PE

Anacor Pharmaceuticals enrolls first patient in AN2728 Phase 3 trial for treatment of atopic dermatitis

Two doses of HPV-16/18 AS04-adjuvanted vaccine Cervarix non-inferior to three-doses

Idera Pharmaceuticals reports positive top-line results from Phase 2 trial of IMO-8400

Takeda to present results from global EXAMINE CV safety outcomes trial at ACC 2014

Patrys reports final results from PAT-SM6 Phase I/IIa study in patients with refractory or relapsed MM

Novartis’ investigational compound achieves overall response rate of 58% in patients with ALK+ NSCLC

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