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Spectrum's Prior Approval Supplement for Indium-111 ZEVALIN accepted for review by FDA

Spectrum Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement containing data providing for the removal of the Indium-111 ZEVALIN® (ibritumomab tiuxetan) pre-treatment imaging evaluation, more commonly referred to as the "bioscan" requirement.

23 Mar 2011

Use of fibrates for high lipid levels increases despite uncertain improvement in clinical outcomes

Although recent evidence suggests that the clinical benefit may be uncertain for fibrates, a class of drugs used for the treatment of high lipid levels, use of these drugs is common in the U.S. and Canada, with usage increasing steadily in the last decade in the U.S., especially for a brand-name fibrate product, according to a study in the March 23/30 issue of JAMA.

23 Mar 2011

FDA approves Harvest's BMAC System IDE trial to treat non-reconstructable Critical Limb Ischemia

Harvest Technologies Corp. announced today that the FDA has approved the company sponsored 210-patient IDE clinical trial to be conducted at twenty-five sites in the U.S. using the company's proprietary Bone Marrow Aspiration Concentrate (BMAC) System to treat patients with non-reconstructable Critical Limb Ischemia (CLI).

23 Mar 2011

Dabigatran etexilate cost-effective compared to current care for stroke prevention in AF patients

A new health economic analysis, published today online in Thrombosis and Haemostasis, suggested that Boehringer Ingelheim's novel oral direct thrombin inhibitor, dabigatran etexilate, is cost-effective compared to current treatment options, particularly in "real-world" clinical practice.

23 Mar 2011

Cellerant commences CLT-008 Phase I/II trial in patients with leukemia

Cellerant Therapeutics Inc., a biotechnology company developing novel hematopoietic stem cell-based cellular and antibody therapies for blood disorders and cancer, announced the initiation of a Phase I/II clinical trial of CLT-008 in patients receiving intensive post-remission chemotherapy for high-risk leukemia or myelodysplasia.

23 Mar 2011

Enrollment complete in Aradigm's inhaled ciprofloxacin Phase 2b study in non-cystic fibrosis bronchiectasis

Aradigm Corporation announced the last patient was enrolled in a Phase 2b study designed to evaluate the Company's inhaled liposomal ciprofloxacin (CFI, ARD-3100) in patients with non-cystic fibrosis bronchiectasis (BE), a severe progressive respiratory disease for which there is currently no approved treatment in the U.S.

23 Mar 2011

Astellas announces positive results from mirabegron phase III trials against OAB

Astellas Pharma Inc. today announced the results of two pivotal phase III clinical trials for mirabegron, the first of a new class of compounds under development for the treatment of overactive bladder, show mirabegron significantly improves key OAB symptoms - urinary incontinence and frequency of micturition.

23 Mar 2011

Positive results from TheraVida THVD-201 Phase 1 trial in patients with OAB, UUI

TheraVida, Inc., a clinical stage biopharmaceutical company developing novel combination drug products, today presented positive results from a Phase 1 clinical trial of its lead product candidate THVD-201 for the treatment of overactive bladder and urge urinary incontinence.

23 Mar 2011

Five year course of tamoxifen can offer long-term benefit for women with breast cancer

Experts are urging breast cancer patients to complete their full prescription of tamoxifen, following long-term results from a major Cancer Research UK-funded trial which showed the cancer was less likely to come back in women who took the drug for five years, compared to two years.

22 Mar 2011

Positive results from Meda's Dymista Phase III trial in patients with SAR

Meda announced today positive results from a Phase III clinical trial of Dymista, a novel formulation of azelastine hydrochloride and fluticasone propionate, in patients with seasonal allergic rhinitis.

22 Mar 2011

Shire's Replagal and VPRIV data on Gaucher and Fabry patients presented at ACMG meeting

Shire plc, the global specialty biopharmaceutical company, presented new data for Replagal in patients with Fabry disease, and VPRIV in patients with type 1 Gaucher disease, at the 2011 American College of Medical Genetics' Annual Clinical Genetics Meeting, held in Vancouver, BC, from March 16-20, 2011.

22 Mar 2011

CSL Behring presents Hizentra study data against PI at AAAAI meeting

Data presented by CSL Behring today suggest that treatment with higher dose Hizentra correlates with reduced risk of infection and missed school or work among patients with primary immunodeficiencies.

22 Mar 2011

Ventirx VTX-1463 positive clinical data against allergic rhinitis presented at AAAAI meeting

VentiRx Pharmaceuticals, Inc., a biopharmaceutical company focused on the development of novel Toll-Like Receptor 8 agonists and antagonists for the treatment of cancer, respiratory and autoimmune diseases, announced today the presentation of positive clinical results from its randomized, placebo-controlled clinical trial evaluating VTX-1463 for the treatment of allergic rhinitis.

22 Mar 2011

Polypill may serve as viable option for developing countries to treat CVD risk prevention

For a patient at high risk of cardiovascular disease, keeping up with what pills to take at different times of the day can be tedious. Window sills lined with prescription bottles - a pill for cholesterol, another for blood pressure, and an aspirin to keep blood thin and flowing - the list can get quite long and, as a result, many people, especially the elderly, often forget doses or take the wrong pill at the wrong time.

22 Mar 2011

ACE, ARB combination therapy may increase risk of kidney failure, death

Elderly patients prescribed combination angiotensin converting enzyme inhibitors and angiotensin receptor blockers had a higher risk of kidney failure and death, according to a study published in CMAJ.

22 Mar 2011

BMY's ipilimumab Phase III study against metastatic melanoma meets primary endpoint

Bristol-Myers Squibb Company today announced that a clinical trial -- known as study 024 -- of its investigational compound ipilimumab has met the primary endpoint of improving overall survival in previously-untreated patients with metastatic melanoma.

22 Mar 2011

Second US trial in HIV/AIDS lymphoma patients using Benitec’s ddRNAi technology

Benitec Limited (ASX:BLT), a company involved in RNA-based gene silencing for human therapeutics, announced that the City of Hope research hospital in Duarte, California is planning to initiate a second small Phase I/II study using Benitec’s DNA-directed RNA interference (ddRNAi) technology in lymphoma patients carrying the HIV virus. The aim of the study is to optimize the treatment by modifying a range of clinical parameters.

21 Mar 2011

Intravenous Phenoxodiol-cisplatin combination well tolerated in platinum resistant ovarian cancer

Marshall Edwards, Inc., an oncology company focused on the clinical development of novel therapeutics targeting cancer metabolism, announced today the publication of results from a Phase II clinical trial of intravenous Phenoxodiol in combination with cisplatin in women with platinum-resistant ovarian cancer.

21 Mar 2011

Curemark reaches targeted enrollment in CM-AT Phase III clinical trials for autism

Curemark, LLC, a drug research and development company focused on the treatment of neurological diseases, announced that the company has completed its targeted enrollment of Phase III clinical trials for CM-AT, its autism treatment.

21 Mar 2011

NasVax reports positive results from Phase 2a trial of oral immunotherapy for non-alcoholic steatohepatitis

NasVax announces the success of a Phase 2a clinical trial of a new oral immunotherapy for non-alcoholic steatohepatitis (NASH), an inflammatory disease associated with fatty liver disease and the metabolic syndrome.

21 Mar 2011

Drug Trial News

Spectrum's Prior Approval Supplement for Indium-111 ZEVALIN accepted for review by FDA

Use of fibrates for high lipid levels increases despite uncertain improvement in clinical outcomes

FDA approves Harvest's BMAC System IDE trial to treat non-reconstructable Critical Limb Ischemia

Dabigatran etexilate cost-effective compared to current care for stroke prevention in AF patients

Cellerant commences CLT-008 Phase I/II trial in patients with leukemia

Enrollment complete in Aradigm's inhaled ciprofloxacin Phase 2b study in non-cystic fibrosis bronchiectasis

Astellas announces positive results from mirabegron phase III trials against OAB

Positive results from TheraVida THVD-201 Phase 1 trial in patients with OAB, UUI

Five year course of tamoxifen can offer long-term benefit for women with breast cancer

Positive results from Meda's Dymista Phase III trial in patients with SAR

Shire's Replagal and VPRIV data on Gaucher and Fabry patients presented at ACMG meeting

CSL Behring presents Hizentra study data against PI at AAAAI meeting

Ventirx VTX-1463 positive clinical data against allergic rhinitis presented at AAAAI meeting

Polypill may serve as viable option for developing countries to treat CVD risk prevention

ACE, ARB combination therapy may increase risk of kidney failure, death

BMY's ipilimumab Phase III study against metastatic melanoma meets primary endpoint

Second US trial in HIV/AIDS lymphoma patients using Benitec’s ddRNAi technology

Intravenous Phenoxodiol-cisplatin combination well tolerated in platinum resistant ovarian cancer

Curemark reaches targeted enrollment in CM-AT Phase III clinical trials for autism

NasVax reports positive results from Phase 2a trial of oral immunotherapy for non-alcoholic steatohepatitis

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