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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

Merck provides overview of clinical trial program for HPV vaccine V503

Merck, known as MSD outside the United States and Canada, today provided an overview of the clinical trial program for V503, the company's investigational 9-valent human papillomavirus vaccine, to the Advisory Committee on Immunization Practices in the United States.

25 Oct 2013

Diffregen awarded SBIR Phase 1 grant to advance Angiocidin towards human clinical trials

Diffregen LLC, a Temple University startup company, has been awarded a small business innovation research Phase 1 grant by the National Cancer Institute to advance Angiocidin, a university-created therapeutic to treat acute myeloid leukemia, to the doorstep of human clinical trials.

24 Oct 2013

Researchers improve cytostatic therapy for children with chronic immune deficiency disorder

Researchers at Karolinska Institutet in Sweden, and colleagues at University Children's Hospital Z-rich in Switzerland have managed to improve cytostatic therapy for children with the chronic immune deficiency disorder granulomatous disease prior to stem cell transplantation.

24 Oct 2013

EORTC/GIMEMA trial shows combination of GO and chemotherapy provides no benefit for older patients with AML

Results of the randomized, phase III, EORTC/GIMEMA 06012 intergroup trial (AML-17) reported in the Journal of Clinical Oncology show that sequential combination of gemtuzumab ozogamicin (GO) and standard chemotherapy provides no benefit for older patients with acute myeloid leukemia (AML) and is too toxic for patients 70 years of age or more. GO is an antibody-drug conjugate comprised of an anti-CD33 monoclonal antibody linked to a cytotoxic agent.

23 Oct 2013

New PARP inhibitor shows early responses in patients with advanced BRCA-related cancers

An investigational new PARP inhibitor, BMN 673, is showing early responses in patients with heavily pretreated, advanced, BRCA-related cancers of the breast and ovary, according to phase I clinical trial results presented here at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, held Oct. 19-23.

23 Oct 2013

Drug Trial News

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

Merck provides overview of clinical trial program for HPV vaccine V503

Diffregen awarded SBIR Phase 1 grant to advance Angiocidin towards human clinical trials

Researchers improve cytostatic therapy for children with chronic immune deficiency disorder

EORTC/GIMEMA trial shows combination of GO and chemotherapy provides no benefit for older patients with AML

New PARP inhibitor shows early responses in patients with advanced BRCA-related cancers

Digital pathology and the PathoVerse: A conversation with Dr. Singh

Bioprocess Efficiency with Cell Density Monitoring

Exploring electron microscopy for plant and microbial imaging at the John Innes Centre

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