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BioLineRx obtains regulatory approval to initiate BL-7010 Phase 1/2 trial for celiac disease

BioLineRx, a biopharmaceutical development company, announced today that it has received regulatory approval from the Finnish National Supervisory Authority for Welfare and Health (Valvira) to commence a Phase 1/2 safety trial for BL-7010, for the treatment of celiac disease.

4 Nov 2013

Boehringer Ingelheim's Phase II trial of interferon-free hepatitis C treatment shows promising results

Interim data presented today show that all patients (13/13) who reached their 4-week post-treatment follow-up have undetectable levels of hepatitis C virus (SVR4) after completing a 12-week regimen of faldaprevir, deleobuvir, PPI-668 and ribavirin.

4 Nov 2013

GeNeuro's GNbAC1 antibody demonstrates safety profile in Phase 2a study for MS

GeNeuro announced today that its GNbAC1 humanized monoclonal antibody was found to have a very good safety profile when administered to patients with relapsing and progressive forms of Multiple Sclerosis as part of a Phase 2a study.

4 Nov 2013

Immunocore’s Phase IIa clinical trial for IMCgp100 in melanoma initiates in the UK and USA

Immunocore Limited, the Oxford-based biotechnology company developing novel biological drugs to treat cancer and viral disease, announced that its most advanced ImmTAC drug, IMCgp100 for the treatment of late stage melanoma, has reached Maximum Tolerated Dose (MTD) and the dose escalation part of this Phase I clinical study has been completed. The company has now initiated a Phase IIa clinical trial in the UK and USA.

1 Nov 2013

Interim data from Phase 1B trial of an investigational anti-PD-1 immunotherapy in patients with previously-treated NSCLC announced by Merck

Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced the presentation of interim data from a Phase 1B trial (PN001) evaluating MK-3475, an investigational anti-PD-1 immunotherapy, in patients with previously-treated non-small cell lung cancer (NSCLC). The data were presented today by Dr. Edward Garon, Director of Thoracic Oncology, Jonsson Comprehensive Cancer Center, University of California, Los Angeles, at the 15th World Conference on Lung Cancer in Sydney, Australia (Abstract #2416).

31 Oct 2013

Actavis seeks FDA approval to market Isotretinoin Capsules

Actavis plc today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Isotretinoin Capsules, 10 mg, 20 mg, 30 mg and 40 mg.

31 Oct 2013

Kamada announces new data from Glassia Phase I/II study in pediatric patients with type 1 diabetes

Kamada Ltd., a plasma-derived protein therapeutics company focused on orphan indications, today reported preliminary data from the Company's ongoing extension study of a Phase I/II clinical trial with its lead product Glassia® to treat pediatric patients with a recently diagnosed type 1 diabetes (T1D).

31 Oct 2013

e-Therapeutics begins ETS6103 phase IIb trial for major depressive disorder

e-Therapeutics plc announces that it has started a randomised double-blind controlled phase IIb trial of ETS6103 in major depressive disorder.

31 Oct 2013

Results of Nordic-Baltic Bifurcation IV trial presented at TCT 2013

A new clinical trial shows that a two-stent technique for treatment of bifurcation lesions with a large stenotic side branch was not associated with significant improved outcomes compared to a provisional stenting approach.

31 Oct 2013

CytoDyn submits protocol to FDA for Phase IIb clinical trial of PRO 140

CytoDyn Inc. ("CytoDyn") (OTCQB:CYDY), a biotechnology company focused on the development of new therapies for combating infection with immune deficiency viruses, today announced that CytoDyn Chief Medical Officer David Feigal, M.D., has submitted a revised protocol to the U.S. Food and Drug Administration relating to an upcoming Phase IIb clinical trial of PRO 140, CytoDyn's leading product under development as a treatment for Human Immunodeficiency Virus (HIV) infection.

31 Oct 2013

Some safety questions remain unanswered in expedited FDA drug approvals

Fewer patients were studied as part of expedited reviews of new drugs approved by the U.S. Food and Drug Administration (FDA) in 2008 and some safety questions remain unanswered, according to a study published by JAMA Internal Medicine, a JAMA Network publication.

30 Oct 2013

Promising melanoma drug demonstrates potential for non-small cell lung cancer treatment

An experimental new cancer drug called MK-3475, which has shown dramatic promise for treating melanoma is also showing early potential as an effective treatment for patients with non-small cell lung cancer, the leading cause of cancer death of men and women worldwide.

30 Oct 2013

Janssen submits Marketing Authorization Application for Ibrutinib

Janssen-Cilag International NV (Janssen) announced today it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for ibrutinib for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL) or relapsed or refractory mantle cell lymphoma (MCL), two forms of blood cancer.

30 Oct 2013

Acacia Pharma begins APD403 Phase II study to prevent chemotherapy-induced nausea & vomiting

Acacia Pharma, a pharmaceutical company specialising in the development of drugs for supportive care, announces the initiation of a Phase II study of APD403 in the prevention of chemotherapy-induced nausea & vomiting (CINV).

30 Oct 2013

Clinical trial finds COREVALVE reduces rate of death, stroke in patients with aortic stenosis

In a clinical trial, a self-expanding transcatheter aortic valve met the key performance objective of reducing death and stroke in patients with severe aortic stenosis at "extreme risk" for surgery.Results of the COREVALVE EXTREME RISK trial were presented today at the 25th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.

30 Oct 2013

Phase 3 study shows STELARA inhibits structural damage in patients with active psoriatic arthritis

New findings from two integrated Phase 3 Janssen Research & Development, LLC (Janssen)-sponsored studies showed treatment with STELARA- (ustekinumab) resulted in significantly greater inhibition of structural damage in patients with active psoriatic arthritis compared with placebo.

29 Oct 2013

UCR, CRF initiate PROSPECT II trial to identify plaques that may lead to coronary events

The Cardiovascular Research Foundation (CRF) of New York, NY and the Uppsala Clinical Research Center (UCR) of Uppsala, Sweden announced today the initiation of the PROSPECT (Providing Regional Observations to Study Predictors of Events in the Coronary Tree) II trial and the PROSPECT ABSORB sub study.

29 Oct 2013

Incyte announces results of Phase II clinical trial of oral JAK1 inhibitor in patients with RA

Incyte Corporation (Nasdaq: INCY) announced results from a 12-week, placebo-controlled, dose-escalationin involving 60 patients with active rheumatoid arthritis for its proprietary oral JAK1 inhibitor.

29 Oct 2013

Pulmatrix reports positive results from initial PUR0200 Phase IB clinical study in COPD

Pulmatrix today announced the successful completion and positive results of the first part of a two-part Phase IB clinical study in chronic obstructive pulmonary disease (COPD) patients with their lead clinical candidate PUR0200.

29 Oct 2013

Polaris Group reports positive results from ADI-PEG 20 Phase 2 trial for malignant pleural mesothelioma

Polaris Group announced today that positive results from a randomized Phase 2 trial of ADI-PEG 20, arginine deiminase formulated with polyethylene glycol, for the treatment of malignant pleural mesothelioma were presented at the World Conference on Lung Cancer in Sydney, Australia.

28 Oct 2013

Drug Trial News

BioLineRx obtains regulatory approval to initiate BL-7010 Phase 1/2 trial for celiac disease

Boehringer Ingelheim's Phase II trial of interferon-free hepatitis C treatment shows promising results

GeNeuro's GNbAC1 antibody demonstrates safety profile in Phase 2a study for MS

Immunocore’s Phase IIa clinical trial for IMCgp100 in melanoma initiates in the UK and USA

Interim data from Phase 1B trial of an investigational anti-PD-1 immunotherapy in patients with previously-treated NSCLC announced by Merck

Actavis seeks FDA approval to market Isotretinoin Capsules

Kamada announces new data from Glassia Phase I/II study in pediatric patients with type 1 diabetes

e-Therapeutics begins ETS6103 phase IIb trial for major depressive disorder

Results of Nordic-Baltic Bifurcation IV trial presented at TCT 2013

CytoDyn submits protocol to FDA for Phase IIb clinical trial of PRO 140

Some safety questions remain unanswered in expedited FDA drug approvals

Promising melanoma drug demonstrates potential for non-small cell lung cancer treatment

Janssen submits Marketing Authorization Application for Ibrutinib

Acacia Pharma begins APD403 Phase II study to prevent chemotherapy-induced nausea & vomiting

Clinical trial finds COREVALVE reduces rate of death, stroke in patients with aortic stenosis

Phase 3 study shows STELARA inhibits structural damage in patients with active psoriatic arthritis

UCR, CRF initiate PROSPECT II trial to identify plaques that may lead to coronary events

Incyte announces results of Phase II clinical trial of oral JAK1 inhibitor in patients with RA

Pulmatrix reports positive results from initial PUR0200 Phase IB clinical study in COPD

Polaris Group reports positive results from ADI-PEG 20 Phase 2 trial for malignant pleural mesothelioma

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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