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Positive results from Puma's neratinib Phase II trials presented at CTRC-AACR San Antonio Breast Cancer Symposium

Puma Biotechnology, Inc., a development stage biopharmaceutical company, announced that results from ongoing Phase II clinical trials of Puma's investigational drug PB272 (neratinib) were presented at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium that is currently taking place in San Antonio, Texas.

9 Dec 2011

VIVUS announces results of Qnexa clinical study on cardiometabolic disease

VIVUS, Inc. today announced that results from the SEQUEL study were published in The American Journal of Clinical Nutrition, a peer-reviewed journal with broad, multidisciplinary readership.

9 Dec 2011

FDA committee votes against CardioMEMS' Champion Heart Failure Monitoring System

CardioMEMS announced today that the U.S. Food and Drug Administration's (FDA) Circulatory Systems Devices advisory panel voted against the Champion Heart Failure Monitoring System, the first wireless, permanently implantable device that allows cardiologists to monitor heart failure patients from their homes.

9 Dec 2011

Galectin Therapeutics to initiate GM-CT-01 Phase 1/2 combination study in advanced MM

Galectin Therapeutics, the Cancer Centre at the Cliniques universitaires Saint-Luc and the Ludwig Institute for Cancer Research (LICR) announced today that they will initiate a Phase 1/2 safety and efficacy trial testing a novel treatment combination in patients with advanced metastatic melanoma.

9 Dec 2011

ChemoCentryx commences CCX140 Phase II trial in diabetic nephropathy

ChemoCentryx, Inc. today announced the initiation of a Phase II clinical trial for CCX140, an orally-administered small molecule for the treatment of diabetic kidney disease.

9 Dec 2011

FDA advisory panel OKs anemia drug peginesatide

Once approved by the FDA, the once-monthly injection could capture a share of the $3 billion U.S. market for anemia drugs used for kidney dialysis patients, currently dominated by Amgen Inc's blockbuster Epogen. Affymax, which developed the drug with partner Takeda Pharmaceutical Co Ltd, is also expected to price its product below Epogen.

8 Dec 2011

CRD to conduct review of safety and effectiveness of BMP-2

The Centre for Reviews and Dissemination (CRD) at the University of York is to conduct a major independent review of the effectiveness and safety of bone morphogenetic protein-2 (BMP-2), a product used in spinal surgeries to promote bone growth.

From Medtronic 8 Dec 2011

Olympus releases Acecide-C High-Level Disinfectant and Sterilant

Olympus, a precision technology leader in designing and delivering innovative solutions in Medical and Surgical Products, among other core businesses, announces the release of Acecide-C, a new, peracetic acid-based high-level disinfectant and sterilant.

From Evident Corporation - Life Sciences 8 Dec 2011

Updated data from Novartis Afinitor plus everolimus Phase III study on advanced breast cancer

Updated results of a Phase III study of Afinitor (everolimus) tablets plus exemestane, a hormonal therapy, show everolimus provided additional time women with advanced breast cancer lived without their disease progressing.

8 Dec 2011

Positive results from Pearl Therapeutics' PT001 Phase 2b trial on COPD

Pearl Therapeutics Inc. today announced positive top-line results from a randomized, double-blind, Phase 2b, dose-ranging study of glycopyrrolate, a long-acting muscarinic agonist (LAMA) delivered twice a day (BID) via metered-dose inhaler in patients with moderate-to-severe COPD.

8 Dec 2011

Milk powder outperforms lower-dose therapy for treatment of food allergies

A small study by researchers at the Johns Hopkins Children's Center and Duke University shows that eating higher doses of milk protein in the form of dry powder substantially outperforms lower-dose therapy — a few drops of liquid milk extract under the tongue — for treatment of food allergies.

7 Dec 2011

Hormone-blocking therapy for prostate cancer does not raise risk of heart attacks

Hormone-blocking therapy for prostate cancer doesn't raise the risk of fatal heart attacks - as some recent studies had suggested - according to a new report from Dana-Farber/Brigham and Women's Cancer Center.

7 Dec 2011

INT-777 shows promise against metabolic syndrome

Heart disease is a major cause of death in industrialised countries, and is strongly associated with obesity and diabetes. Many scientists believe that what links these conditions is a chronic, low-grade inflammation.

7 Dec 2011

Therakos commences enrollment in photopheresis Phase IIb clinical study for chronic GvHD

Therakos, Inc., a pioneer in the innovative treatment of extracorporeal photopheresis (ECP) for immune modulation therapy, today announced that the first patient has been enrolled in its Phase IIb clinical study evaluating the use of the company's photopheresis technology in the treatment of patients with moderate-to-severe chronic Graft-versus-Host Disease (GvHD).

6 Dec 2011

Xeltis receives PEI conditional approval to initiate tissue-engineered cardiovascular graft study

Xeltis, a biomedical technology company developing growing, living and self-healing cardiovascular implants using tissue-engineering technology, has announced conditional approval by the Paul Erlich Institute (PEI) in Germany to commence the first clinical study of its tissue-engineered cardiovascular grafts.

6 Dec 2011

Top-line primary endpoint data from Pfizer's Toviaz trial on overactive bladder

Pfizer Inc. announced today the top-line primary endpoint result for Toviaz (fesoterodine fumarate) Study A0221049 - Efficacy and Safety of Fesoterodine Flexible Dose Regimen in Vulnerable Elderly Patients with Overactive Bladder.

6 Dec 2011

Preliminary top-line results from XenoPort's XP21279 Phase 2 trial for advanced Parkinson’s disease

XenoPort, Inc. announced today preliminary top-line results of a Phase 2, randomized, crossover clinical trial that compared optimized treatment with either Sinemet (immediate-release levodopa/carbidopa) or XP21279 co-formulated with carbidopa (279/CD) in advanced Parkinson's disease patients with motor fluctuations.

5 Dec 2011

NanoViricides submits pre-IND Meeting Request for FluCide to FDA

NanoViricides, Inc. announced today that it has submitted a pre-IND Meeting Request to the US FDA. The Company has requested an initial meeting with the US FDA to review the Company's proposed strategy and plan for conducting safety/toxicology studies and human clinical trials required for approval of its anti-influenza clinical drug candidate, FluCide™ (i.e. NV-INF-1).

5 Dec 2011

Converting patients to lamotrigine extended-release for epilepsy treatment found effective and safe

Epilepsy drug-switching study shows that using more ethical control groups could be the way forward for testing both drug efficacy and safety

5 Dec 2011

CTI seeks license to market Pixuvri in the E.U. for treatment of NHL

Cell Therapeutics, Inc. announced today an update on the status and progress of its European marketing authorization application for Pixuvri.

5 Dec 2011

Efficacy News and Research

Positive results from Puma's neratinib Phase II trials presented at CTRC-AACR San Antonio Breast Cancer Symposium

VIVUS announces results of Qnexa clinical study on cardiometabolic disease

FDA committee votes against CardioMEMS' Champion Heart Failure Monitoring System

Galectin Therapeutics to initiate GM-CT-01 Phase 1/2 combination study in advanced MM

ChemoCentryx commences CCX140 Phase II trial in diabetic nephropathy

FDA advisory panel OKs anemia drug peginesatide

CRD to conduct review of safety and effectiveness of BMP-2

Olympus releases Acecide-C High-Level Disinfectant and Sterilant

Updated data from Novartis Afinitor plus everolimus Phase III study on advanced breast cancer

Positive results from Pearl Therapeutics' PT001 Phase 2b trial on COPD

Milk powder outperforms lower-dose therapy for treatment of food allergies

Hormone-blocking therapy for prostate cancer does not raise risk of heart attacks

INT-777 shows promise against metabolic syndrome

Therakos commences enrollment in photopheresis Phase IIb clinical study for chronic GvHD

Xeltis receives PEI conditional approval to initiate tissue-engineered cardiovascular graft study

Top-line primary endpoint data from Pfizer's Toviaz trial on overactive bladder

Preliminary top-line results from XenoPort's XP21279 Phase 2 trial for advanced Parkinson’s disease

NanoViricides submits pre-IND Meeting Request for FluCide to FDA

Converting patients to lamotrigine extended-release for epilepsy treatment found effective and safe

CTI seeks license to market Pixuvri in the E.U. for treatment of NHL

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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