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BDSI enrolls first patient in Clonidine Topical Gel Phase 3 trial for treatment of painful diabetic neuropathy

BioDelivery Sciences International, Inc. announced today the enrollment of the first patient in the RHAPSODY Study, a Phase 3 clinical trial of Clonidine Topical Gel for the treatment of painful diabetic neuropathy.

3 Apr 2014

Janssen begins Phase 3 OPTIMIST trials for treatment of chronic Genotype 1 HCV infection

Janssen R&D Ireland (Janssen) announced today that two Phase 3 trials are recruiting patients to examine the efficacy and safety of the NS3/4A protease inhibitor simeprevir in combination with the nucleotide inhibitor sofosbuvir for the treatment of chronic genotype 1 hepatitis C virus (HCV) infection in treatment-naive and treatment-experienced patients with and without cirrhosis.

3 Apr 2014

CardioCell receives IND approval for Phase IIa clinical study of itMSC therapy to treat heart failure

CardioCell LLC has just received the FDA's investigational new drug (IND) approval for a United States-based, Phase IIa clinical study using its allogeneic stem-cell therapy to treat subjects with chronic heart failure (CHF), which generates more than 1 million hospitalizations annually.

3 Apr 2014

Gilead reports topline results from sofosbuvir Phase 3 trial in Japan for treatment of HCV infection

Gilead Sciences, Inc. today announced topline results from a Phase 3 clinical trial (Study GS-US-334-0118) in Japan evaluating the once-daily nucleotide analog polymerase inhibitor sofosbuvir in combination with ribavirin (RBV) for the treatment of genotype 2 chronic hepatitis C virus (HCV) infection.

3 Apr 2014

Jain Foundation's dysferlinopathy clinical study exceeds original goal of 150 patients

The Jain Foundation is delighted to announce that 193 patients have been recruited into the Clinical Outcome Study for Dysferlinopathy (COS), exceeding the original goal of 150 patients.

2 Apr 2014

Synthon’s SYD985 ADC demonstrates anti-tumor activity, outperforms leading anti-HER2 ADC

Synthon Biopharmaceuticals today announced the results of a head-to-head comparative program of its antibody-drug conjugate (ADC) SYD985 with Roche's market leading anti-HER2 ADC, T-DM1 (Kadcyla).

2 Apr 2014

ANP reports positive results from chronic toxicity study of ATL1102 in multiple sclerosis

Antisense Therapeutics Limited is pleased to advise that results from a chronic toxicity study in monkeys indicate that ATL1102, an antisense oligonucleotide currently under development for the treatment of multiple sclerosis (MS), was well-tolerated when given subcutaneously for a 6-month dosing period at the 2 dose levels tested (1.5 and 3mg/kg/dose).

2 Apr 2014

FDA grants orphan drug designation to ERYTECH’s lead product for AML treatment

ERYTECH Pharma, a French biopharmaceutical company that develops innovative treatments for acute leukemia and other oncology indications with unmet medical needs, announces that its lead product GRASPA®/ERY-ASP has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of Acute Myeloid Leukemia (AML), an aggressive form of blood cancer.

2 Apr 2014

Boston Scientific presents new data on cardiology-related clinical trials at ACC 2014

Reinforcing its position as a global leader in bringing new therapies to patients with heart and cardiovascular disease, Boston Scientific Corporation (NYSE: BSX) reported favorable results in studies related to cardiac resynchronization therapy (CRT), platinum chromium stent platforms and transcatheter aortic valve replacement (TAVR).

2 Apr 2014

RPCI receives FDA approval to enroll patients in phase II clinical trial using I-PDT approach

Roswell Park Cancer Institute (RPCI) has received U.S. Food and Drug Administration (FDA) approval to enroll patients in a phase II clinical trial that will use a unique and highly precise method of delivering interstitial photodynamic therapy (I-PDT) to recurrent tumors of the head and neck.

2 Apr 2014

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

Drug Trial News

BDSI enrolls first patient in Clonidine Topical Gel Phase 3 trial for treatment of painful diabetic neuropathy

Janssen begins Phase 3 OPTIMIST trials for treatment of chronic Genotype 1 HCV infection

CardioCell receives IND approval for Phase IIa clinical study of itMSC therapy to treat heart failure

Gilead reports topline results from sofosbuvir Phase 3 trial in Japan for treatment of HCV infection

Jain Foundation's dysferlinopathy clinical study exceeds original goal of 150 patients

Synthon’s SYD985 ADC demonstrates anti-tumor activity, outperforms leading anti-HER2 ADC

ANP reports positive results from chronic toxicity study of ATL1102 in multiple sclerosis

FDA grants orphan drug designation to ERYTECH’s lead product for AML treatment

Boston Scientific presents new data on cardiology-related clinical trials at ACC 2014

RPCI receives FDA approval to enroll patients in phase II clinical trial using I-PDT approach

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

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

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