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Antares Pharma, Population Council report positive Phase 2 results for novel NES/E2 contraceptive gel

Antares Pharma, Inc. and the Population Council today announced successful results from a dose-finding Phase 2 trial for a novel contraceptive gel containing the progestin Nestorone and estradiol (NES/E2) utilizing the Antares ATD (advanced transdermal delivery) gel system. Based on this successful data, the two parties continue to expect to partner with a worldwide or regional pharmaceutical company in order to commercialize this novel contraceptive gel.

12 Jan 2010

Positive results from KemPharm's KP106 Phase 1 clinical trial for ADHD

KemPharm, Inc. today announced positive results from a Phase 1 clinical trial of KP106, its novel prodrug for attention-deficit hyperactivity disorder (ADHD). KP106, a new chemical entity (NCE) composed of the active pharmaceutical compound d-amphetamine and a ligand, was created using KemPharm’s proprietary Ligand Activated Therapy (LAT) prodrug approach.

12 Jan 2010

Interim results from Phase I clinical trials utilizing PLX-PAD for treatment of CLI reported

Pluristem Therapeutics Inc. today announced interim results from their Phase I clinical trials utilizing their placenta derived cell therapy product, PLX-PAD, for the treatment of critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD).

12 Jan 2010

Positive top-line results from Protox Therapeutics' Phase 2b study of PRX302 announced

Protox Therapeutics Inc., a leader in the development of receptor targeted fusion proteins, today announced positive top-line results from its double-blinded placebo controlled Phase 2b study of PRX302 (study name: TRIUMPH) in patients with moderate to severe benign prostatic hyperplasia (BPH), a painful and bothersome urological condition that affects more than 50 million men worldwide.

11 Jan 2010

Amarin commences enrollment in its AMR101 Phase 3 clinical trials for cardiovascular disease

Amarin Corporation plc, a clinical-stage biopharmaceutical company focused on improving the treatment of cardiovascular disease, today announced that first patients were enrolled in the MARINE and ANCHOR Phase 3 clinical trials for AMR101, the Company's lead product candidate. These clinical trials are designed to demonstrate that AMR101 lowers triglyceride levels in patients with very high triglycerides (the MARINE Study) and high triglycerides in patients with mixed dyslipidemia being treated with statins (the ANCHOR Study).

11 Jan 2010

New data from phase 3 study of avanafil for treatment of ED announced

VIVUS, Inc. today announced new data from an analysis of the recently completed phase 3 study (REVIVE TA-301) of avanafil, an investigational drug candidate for the treatment of erectile dysfunction (ED).

11 Jan 2010

Results from Phase 2a clinical trial of Raptor Pharmaceutical's cysteamine bitartrate published

Raptor Pharmaceutical Corp. ("Raptor" or the "Company"), today announced the publication of results from a Phase 2a clinical trial of a prototype formulation of its proprietary delayed-release cysteamine bitartrate ("DR Cysteamine") in patients with nephropathic cystinosis ("cystinosis").

11 Jan 2010

Vertex Pharmaceuticals plans proof-of-concept clinical trials in RA and epilepsy

Vertex Pharmaceuticals Incorporated today provided an update on key 2010 business priorities in conjunction with the 28th Annual J.P. Morgan Healthcare Conference in San Francisco. The company also discussed recent progress in its lead development programs in hepatitis C virus (HCV) infection and cystic fibrosis (CF) and outlined proof-of-concept clinical trials planned in other serious diseases for 2010.

11 Jan 2010

Key mechanism for systemic delivery of RNAi therapeutics using LNPs discovered

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today that it has discovered a key mechanism related to the systemic delivery of RNAi therapeutics using lipid nanoparticles (LNPs). The new pre-clinical research was presented at the “Advances in Biopharmaceuticals” Keystone Symposium held January 8-13, 2010 in Midway, Utah, and was performed in collaboration with scientists at the Max Planck Institute of Molecular Cell Biology and Genetics.

9 Jan 2010

Research determines and validates the efficacy of T category in IASLC's Staging Manual

Research released in the January 2010 issue of the Journal of Thoracic Oncology sought to determine and validate the efficacy of the recent reclassification of the T category in the IASLC's Staging Manual in Thoracic Oncology.

9 Jan 2010

Recent releases in Global Health

A Lancet Comment examines the "grossly insufficient" progress towards meeting the Millennium Development Goal (MDG) of reducing under-5 child mortality. "Accelerated progress can be achieved, even in the poorest environments, through: integrated, evidence-driven, and community-based programmes that focus on addressing the major causes of death, including pneumonia, diarrhoea, newborn disorders, malaria, HIV, and undernutrition; reaching the unreached with a basic package of interventions at large scale and achieving coverage with equity; and using data for action and advocacy," the comment concludes (You et al., 1/9).

9 Jan 2010

AIIRA/CCB drug combination provides superior safety and efficacy compared to other fixed-dose combinations

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that a hypertension drug that requires less-frequent dosing than Novartis's Diovan/Tareg (valsartan) would earn 30 percent patient share according to surveyed U.S. cardiologists

9 Jan 2010

Therma-Med develops plans to provide health and wellness products throughout North America

In an effort to move forward with plans to expand the scope of their business in the Health and Wellness industry, Therma-Med, Inc. has developed a plan to provide premium quality vitamins, supplements and natural wellness products throughout North America.

9 Jan 2010

NexMed updates corporate activities

NexMed, Inc., a specialty CRO and a developer of products based on the NexACT® technology, today provided an update on ongoing corporate activities and the status of the Company’s NASDAQ listing.

9 Jan 2010

Plexxikon commences dosing in PLX4032 Phase 3 trial for metastatic melanoma

Plexxikon Inc. announces that enrollment has been initiated and the first patient has been dosed in a pivotal Phase 3 trial of PLX4032 (RG7204) in patients with metastatic melanoma. PLX4032 is a novel, oral and highly targeted drug that is designed to inhibit the BRAF cancer-causing mutation that occurs in about 50 percent of melanomas and about eight percent of all solid tumors. The randomized, controlled, Phase 3 “BRAF Inhibitor in Melanoma” (BRIM3) trial in previously untreated patients is part of the planned registration program for PLX4032.

9 Jan 2010

Savient Pharmaceuticals announces filing of KRYSTEXXA BLA resubmission on track

Savient Pharmaceuticals, Inc. provided an update on its activities directed toward the resubmission of its Biologics License Application (BLA) for KRYSTEXXA(TM) (pegloticase) as a treatment for chronic gout in patients refractory to conventional therapy and reaffirmed its belief that it continues to be on track for the filing of the BLA resubmission for KRYSTEXXA in the first quarter of 2010.

9 Jan 2010

Boston Scientific's PROMUS Everolimus-Eluting Coronary Stent System receives Japanese marketing approval

Boston Scientific Corporation announced today that it has received approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to market its PROMUS® Everolimus-Eluting Coronary Stent System for the treatment of coronary artery disease. The Company plans to launch the product as soon as reimbursement approval is granted, which is expected in the coming weeks.

9 Jan 2010

FDA grants unconditional approval for World Heart's Levacor VAD BTT study

World Heart Corporation, a developer of mechanical circulatory systems, announced today that it has received unconditional approval from the U.S. Food and Drug Administration ("FDA") for the bridge-to-transplant ("BTT") study of the Levacor Ventricular Assist Device ("VAD"). Study enrollment will encompass 160 subjects, a reduction from the approximately 200 subjects of the original statistical plan. As previously announced, the BTT study will begin initially at ten clinical sites.

8 Jan 2010

AUA updates clinical practice guideline on female stress urinary incontinence

A complete evaluation, including an assessment of post-void residual volume, is key when evaluating a female patient for surgery to treat stress urinary incontinence (SUI), according to a new clinical practice guideline released today by the American Urological Association (AUA).

8 Jan 2010

Japanese MHLW approves Abbott's XIENCE V Everolimus Eluting Coronary Stent System

Abbott announced today that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved its XIENCE V® Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease.

8 Jan 2010

Efficacy News and Research

Antares Pharma, Population Council report positive Phase 2 results for novel NES/E2 contraceptive gel

Positive results from KemPharm's KP106 Phase 1 clinical trial for ADHD

Interim results from Phase I clinical trials utilizing PLX-PAD for treatment of CLI reported

Positive top-line results from Protox Therapeutics' Phase 2b study of PRX302 announced

Amarin commences enrollment in its AMR101 Phase 3 clinical trials for cardiovascular disease

New data from phase 3 study of avanafil for treatment of ED announced

Results from Phase 2a clinical trial of Raptor Pharmaceutical's cysteamine bitartrate published

Vertex Pharmaceuticals plans proof-of-concept clinical trials in RA and epilepsy

Key mechanism for systemic delivery of RNAi therapeutics using LNPs discovered

Research determines and validates the efficacy of T category in IASLC's Staging Manual

Recent releases in Global Health

AIIRA/CCB drug combination provides superior safety and efficacy compared to other fixed-dose combinations

Therma-Med develops plans to provide health and wellness products throughout North America

NexMed updates corporate activities

Plexxikon commences dosing in PLX4032 Phase 3 trial for metastatic melanoma

Savient Pharmaceuticals announces filing of KRYSTEXXA BLA resubmission on track

Boston Scientific's PROMUS Everolimus-Eluting Coronary Stent System receives Japanese marketing approval

FDA grants unconditional approval for World Heart's Levacor VAD BTT study

AUA updates clinical practice guideline on female stress urinary incontinence

Japanese MHLW approves Abbott's XIENCE V Everolimus Eluting Coronary Stent System

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