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Medtronic launches Defeat-HF clinical trial to evaluate SCS for heart failure

Medtronic, Inc. today announced the global launch of the Defeat-HF (Determining the Feasibility of Spinal Cord Neuromodulation for the Treatment of Chronic Heart Failure) clinical trial. It is the industry's first prospective, randomized study evaluating the clinical feasibility of spinal cord stimulation, or neurostimulation, to improve clinical signs and symptoms of heart failure.

30 Jul 2010

New Zealand MEDSAFE approves ABRAXANE for metastatic breast cancer

Abraxis BioScience, Inc., a fully integrated, global biotechnology company, and Specialised Therapeutics Ltd. today announced that MEDSAFE, the New Zealand Medicines and Medical Devices Safety Authority, has approved for marketing ABRAXANE® (nanoparticle albumin-bound paclitaxel) for the treatment of metastatic breast cancer after failure of anthracycline therapy.

29 Jul 2010

Scientists develop new version of medication to relieve severe forms of pain

Scientists have developed a new version of a medication, first isolated from the saliva of sea snails, that could be taken in pill form to relieve the most severe forms of pain as effectively as morphine but without risking addiction. An article on the topic appears in the current issue of Chemical & Engineering News, ACS' weekly newsmagazine.

29 Jul 2010

NEI, FDA to sponsor Glaucoma Endpoints conference

The National Eye Institute and the Food and Drug Administration are sponsoring a Glaucoma Endpoints conference on September 24, 2010, to develop definitions and standards for describing structural changes in the glaucomatous optic nerve and functional changes in vision, as criteria for approval of new glaucoma therapeutics in clinical trials. The one-day meeting will take place at the Natcher Center, National Institutes of Health in Bethesda, Md.

28 Jul 2010

Merck signs non-exclusive license agreement with LabCorp for commercialization of genetic test

Merck announced a non-exclusive license agreement with Laboratory Corporation of America Holdings for the commercialization of a genetic test that may help predict the response of patients with Hepatitis C virus infection to peginterferon alpha-based therapy.

28 Jul 2010

Onyx reports positive results from carfilzomib Phase 2b 003-A1 study in multiple myeloma

Onyx Pharmaceuticals, Inc. today announced positive top-line results from the Phase 2b 003-A1 study of single-agent carfilzomib, a selective, next generation proteasome inhibitor, in patients with relapsed and refractory multiple myeloma.

26 Jul 2010

Taiho Pharmaceutical receives approval to market ABRAXANE IV Infusion 100 mg in Japan

Abraxis BioScience, Inc., a fully integrated, global biotechnology company, today announced that Taiho Pharmaceutical Co., Ltd. has received approval from the Ministry of Health, Labor and Welfare to market ABRAXANE IV Infusion 100 mg, Paclitaxel Injection (Suspension with Albumin), for use in the treatment of breast cancer. The New Drug Application (J-NDA) for ABRAXANE was filed with the Ministry of Health, Labor and Welfare in 2008.

23 Jul 2010

California companies are developing new medicines for diabetes: Report

Pharmaceutical research and biotechnology companies based in California are researching and developing 58 new medicines for diabetes, a chronic disease that afflicts 220 million patients worldwide, including 23.6 million Americans, a new report shows.

21 Jul 2010

Genentech disappointed with FDA ODAC's recommendation against Avastin

Genentech, Inc., a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 12 to one that use of Avastin® (bevacizumab) in combination with paclitaxel for previously untreated (first-line) advanced HER2-negative breast cancer be removed from Avastin's U.S. label.

21 Jul 2010

Arcion reports top-line results from ARC-4558 Phase 2b clinical trial for painful diabetic neuropathy

Arcion Therapeutics, a venture backed clinical stage biotechnology company developing topical therapies for chronic pain, today announced top-line results from a successful Phase 2b double-blind, randomized, placebo-controlled clinical trial of its lead topical pain candidate, ARC-4558, in adult patients with painful diabetic neuropathy (PDN). Arcion recently held an End of Phase 2 meeting with the United States Food and Drug Administration (FDA) and the ARC-4558 program is now poised to enter Phase 3 studies.

20 Jul 2010

Pfizer suspends chronic low back pain, diabetic peripheral neuropathy studies in tanezumab clinical program

Pfizer Inc. today announced, at the request of the U.S. Food and Drug Administration (FDA), the suspension of the chronic low back pain and painful diabetic peripheral neuropathy studies in the clinical program for the investigational compound tanezumab. Investigation of the compound continues in some areas of high unmet medical need, including cancer pain.

20 Jul 2010

ZIOPHARM Oncology commences palifosfamide Phase III clinical trial for metastatic soft tissue sarcoma

ZIOPHARM Oncology, Inc. today announced the initiation of the pivotal Phase III clinical trial for palifosfamide in patients with front-line metastatic soft tissue sarcoma. The study, called PICASSO 3, is an international, randomized, double-blinded, placebo-controlled trial designed to enroll approximately 424 patients with metastatic soft tissue sarcoma who have never been treated with chemotherapy for metastatic disease.

20 Jul 2010

Competitive Technologies anticipates $1M revenue from sales of Calmare Pain Therapy Treatment

Competitive Technologies, Inc. today announced it expects revenue from sales of its Calmare® Pain Therapy Treatment for the fourth quarter of fiscal 2010 to be about $1 million, nearly double that of the prior quarter. The Company expects significant additional growth in Calmare medical device sales in upcoming quarters resulting from the growing U.S. sales force of over 35 sales representatives.

19 Jul 2010

New circular external fixator device for diabetic Charcot foot treatment

The alarming increase of morbidly obese diabetics is causing more new cases of a debilitating foot deformity called Charcot foot.Charcot foot can make walking difficult or impossible, and in severe cases can require amputation.But a surgical technique that secures foot bones with an external frame has enabled more than 90 percent of patients to walk normally again.

15 Jul 2010

Circular external fixator enables over 90% of Charcot foot patients to walk normally again

The alarming increase of morbidly obese diabetics is causing more new cases of a debilitating foot deformity called Charcot foot.

14 Jul 2010

Gene mutation that causes auditory neuropathy identified

Researchers have identified a gene mutation that causes a rare form of hearing loss known as auditory neuropathy, according to U-M Medical School scientists.

13 Jul 2010

Researchers discover gene mutation that causes auditory neuropathy

Researchers have identified a gene mutation that causes a rare form of hearing loss known as auditory neuropathy, according to U-M Medical School scientists. In the study published online today in the Proceedings of the National Academy of Sciences USA, U-M's Marci Lesperance, M.D., and Margit Burmeister, Ph.D. led a team of researchers who examined the DNA of individuals from the same large family afflicted with the disorder.

13 Jul 2010

Scientists discover way to enhance nerve regeneration in peripheral nervous system

Faculty of Medicine scientists have discovered a way to enhance nerve regeneration in the peripheral nervous system. This important discovery could lead to new treatments for nerve damage caused by diabetes or traumatic injuries. Peripheral nerves connect the brain and spinal cord to the body, and without them, there is no movement or sensation. Peripheral nerve damage is common and often irreversible. This discovery is published in the July 7, 2010 edition of the Journal of Neuroscience.

12 Jul 2010

Alnylam Pharmaceuticals initiates dosing in Phase I human clinical study with ALN-TTR01

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today it has initiated dosing in a Phase I human clinical study with ALN-TTR01. The study is aimed at evaluating the safety and tolerability of ALN-TTR01 in patients with transthyretin -mediated amyloidosis, and is also designed to provide preliminary data on human proof of concept based on measurements of TTR serum levels.

7 Jul 2010

Phase Ia clinical trial of SYL040012 for treating elevated intraocular pressure, glaucoma completed

Sylentis, a biopharmaceutical subsidiary of Grupo Zeltia and a pioneer in the research and development of new drugs based on gene silencing (interference RNA, RNAi), has completed Phase Ia of its first clinical trial with SYL040012 in the form of ophthalmic drops to treat elevated intraocular pressure and glaucoma.

7 Jul 2010

Neuropathy News and Research

Medtronic launches Defeat-HF clinical trial to evaluate SCS for heart failure

New Zealand MEDSAFE approves ABRAXANE for metastatic breast cancer

Scientists develop new version of medication to relieve severe forms of pain

NEI, FDA to sponsor Glaucoma Endpoints conference

Merck signs non-exclusive license agreement with LabCorp for commercialization of genetic test

Onyx reports positive results from carfilzomib Phase 2b 003-A1 study in multiple myeloma

Taiho Pharmaceutical receives approval to market ABRAXANE IV Infusion 100 mg in Japan

California companies are developing new medicines for diabetes: Report

Genentech disappointed with FDA ODAC's recommendation against Avastin

Arcion reports top-line results from ARC-4558 Phase 2b clinical trial for painful diabetic neuropathy

Pfizer suspends chronic low back pain, diabetic peripheral neuropathy studies in tanezumab clinical program

ZIOPHARM Oncology commences palifosfamide Phase III clinical trial for metastatic soft tissue sarcoma

Competitive Technologies anticipates $1M revenue from sales of Calmare Pain Therapy Treatment

New circular external fixator device for diabetic Charcot foot treatment

Circular external fixator enables over 90% of Charcot foot patients to walk normally again

Gene mutation that causes auditory neuropathy identified

Researchers discover gene mutation that causes auditory neuropathy

Scientists discover way to enhance nerve regeneration in peripheral nervous system

Alnylam Pharmaceuticals initiates dosing in Phase I human clinical study with ALN-TTR01

Phase Ia clinical trial of SYL040012 for treating elevated intraocular pressure, glaucoma completed

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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