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Invivo Therapeutics receives FDA conditional approval to advance its first clinical trial

InVivo Therapeutics Holdings Corp. (NVIV) announced today that it has received conditional approval from the Food and Drug Administration for proposed changes to the protocol and supporting documents for the safety trial of its first investigational product, a degradable polymer scaffold for spinal cord injury.

27 Dec 2013

Takeda terminates development activities for fasiglifam (TAK-875)

Takeda Pharmaceutical Company Limited (Takeda) announced today that it has decided voluntarily to terminate the development activities for fasiglifam (TAK-875), an investigational treatment for type 2 diabetes, due to concerns about liver safety.

27 Dec 2013

FNIH Biomarkers Consortium announces initial results of I-SPY 2 trial for breast cancer

The I-SPY 2 TRIAL, a randomized phase II clinical trial for breast cancer launched through a unique partnership with the Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium and sponsored by QuantumLeap Healthcare Collaborative has graduated the first two drugs from its innovative, multidrug standing platform trial.

27 Dec 2013

EMA accepts Otsuka's marketing authorisation application for tolvaptan for treatment of ADPKD

Otsuka Pharmaceutical Co., Ltd. announced today that the European Medicines Agency (EMA) has accepted the submission of a marketing authorisation application (MAA) for the potential approval of tolvaptan for the treatment of autosomal dominant polycystic kidney disease (ADPKD).

27 Dec 2013

Actavis' subsidiary files ANDA for generic version of NuvaRing

Actavis plc today confirmed that its subsidiary, Warner Chilcott Company LLC, has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Ethinyl Estradiol and Etonogestrel Vaginal Ring, 0.015 mg/24 hour and 0.12 mg/24 hour.

26 Dec 2013

Synergy Pharmaceuticals closes patient enrollment in plecanatide phase 2b clinical trial in IBS-C

Synergy Pharmaceuticals Inc. today announced it has closed patient enrollment in its plecanatide phase 2b clinical trial in irritable bowel syndrome with constipation.

24 Dec 2013

ANP reports positive interim results from ATL1103 Phase II clinical trial for acromegaly

Antisense Therapeutics Limited is pleased to advise that positive results have been achieved from the interim analysis of a subset of available data from its Phase II clinical trial of ATL1103 in patients with the growth disorder, acromegaly.

23 Dec 2013

Can-Fite reports positive results from CF101 Phase IIb study for rheumatoid arthritis

Can-Fite BioPharma Ltd., a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, announced results from a 12-week, placebo-controlled Phase IIb study involving 79 patients with active rheumatoid arthritis ("RA") for its proprietary drug CF101, an A3 adenosine receptor ("A3AR") agonist.

23 Dec 2013

Biocryst seeks FDA NDA approval for Peramivir to treat influenza

BioCryst Pharmaceuticals, Inc., a pharmaceutical company focused on the development and commercialization of treatments for rare and infectious diseases, today announced that it has submitted a New Drug Application (NDA) filing for intravenous (i.v.) peramivir to the U.S. Food & Drug Administration (FDA). BioCryst is seeking an indication as the first i.v. neuraminidase inhibitor approved in the U.S. for the treatment of acute uncomplicated influenza in adults. Peramivir is approved in Japan and Korea for the treatment of influenza.

20 Dec 2013

Oramed reports positive results from ORMD-0801 pharmacokinetic study in type 1 diabetes patients

Oramed Pharmaceuticals Inc., a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today successful results in a clinical trial testing the pharmacokinetic dose response of its oral insulin capsule (ORMD-0801) in type 1 diabetes patients.

20 Dec 2013

Experimental drug inhibits BTK molecule in patients with chronic lymphocytic leukemia

A new study led by researchers at The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC - James) helps confirm that a molecule targeted by the experimental drug ibrutinib is critical for the development of chronic lymphocytic leukemia, the most common form of adult leukemia.

20 Dec 2013

IQWiG reassesses vemurafenib for treatment of advanced melanoma

Pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) reassessed vemurafenib (trade name: Zelboraf), a drug for the treatment of adults with a certain type of advanced melanoma.

20 Dec 2013

Amgen reports that Phase 3 DESCARTES study for high cholesterol meets primary endpoint

Amgen today announced that the Phase 3 DESCARTES (Durable Effect of PCSK9 Antibody CompARed wiTh PlacEbo Study) study evaluating the long-term 52-week safety and efficacy of evolocumab for the treatment of high cholesterol met its primary endpoint of percent reduction from baseline in low-density lipoprotein cholesterol (LDL-C) at week 52.

20 Dec 2013

FibroGen starts patient enrollment in FG-3019 Phase 2 study for idiopathic pulmonary fibrosis treatment

FibroGen, Inc., announced today that patient enrollment has started in a new Phase 2 clinical study of FG-3019 in patients who suffer from idiopathic pulmonary fibrosis.

20 Dec 2013

MicuRx announces initiation of global clinical development program for MRX-I compound

MicuRx Pharmaceuticals, Inc., a privately-held biopharmaceutical company developing next-generation antibiotics, today announced the initiation of a global clinical development program for its lead compound MRX-I, a novel oxazolidinone antibiotic for treatment of Gram-positive infections including methicillin-resistant Staphylococcus aureus and vancomycin-resistant enterococci.

20 Dec 2013

BeiGene doses first patient in Phase 1 study of BGB-283

BeiGene (Beijing), Co., Ltd., today announced dose administration for the first patient in a Phase 1 study of BGB-283 in patients with B-RAF or K-RAS mutations. BGB-283 is an investigational, oral, selective, potent second generation inhibitor of B-RAF, making it a targeted therapeutic candidate to potentially treat and bring benefit to patients with cancers that harbor BRAF mutations and/or aberrations in the RAS-MAPK (mitogen-activated protein kinase) pathway.

20 Dec 2013

Blaze Bioscience to initiate first Phase 1 clinical study of BLZ-100 in patients with skin tumors

Blaze Bioscience, Inc. and its subsidiary, Blaze Bioscience Australia Pty Ltd, today announced the initiation of the first Phase 1 clinical study of the first Tumor Paint product candidate, BLZ-100. The study, titled "A Phase I Dose Escalation/Expansion Study of BLZ-100 Administered by Intravenous Injection in Adult Subjects with Skin Cancer," will enroll up to 30 patients with basal cell carcinoma, squamous cell carcinoma, or amelanotic melanoma.

19 Dec 2013

Drug Trial News

Invivo Therapeutics receives FDA conditional approval to advance its first clinical trial

Takeda terminates development activities for fasiglifam (TAK-875)

FNIH Biomarkers Consortium announces initial results of I-SPY 2 trial for breast cancer

EMA accepts Otsuka's marketing authorisation application for tolvaptan for treatment of ADPKD

Actavis' subsidiary files ANDA for generic version of NuvaRing

Synergy Pharmaceuticals closes patient enrollment in plecanatide phase 2b clinical trial in IBS-C

ANP reports positive interim results from ATL1103 Phase II clinical trial for acromegaly

Can-Fite reports positive results from CF101 Phase IIb study for rheumatoid arthritis

Biocryst seeks FDA NDA approval for Peramivir to treat influenza

Oramed reports positive results from ORMD-0801 pharmacokinetic study in type 1 diabetes patients

Experimental drug inhibits BTK molecule in patients with chronic lymphocytic leukemia

IQWiG reassesses vemurafenib for treatment of advanced melanoma

Amgen reports that Phase 3 DESCARTES study for high cholesterol meets primary endpoint

FibroGen starts patient enrollment in FG-3019 Phase 2 study for idiopathic pulmonary fibrosis treatment

MicuRx announces initiation of global clinical development program for MRX-I compound

BeiGene doses first patient in Phase 1 study of BGB-283

Blaze Bioscience to initiate first Phase 1 clinical study of BLZ-100 in patients with skin tumors

EORTC, GIMEMA clinical trial results show high-dose cytarabine improves outcome in AML patients

Merck and CNIO sign agreement to collaborate in area of cancer drug development

Randomized control trials to study clinical effectiveness of high dose flu vaccine in nursing homes

How does norepinephrine influence anxiety-related behaviours?

Transforming Lab Workflows with Cell Culture Automation

Building Bridges to Scalable Allogeneic Cell Therapy

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