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Sumavel DosePro and Levadex to earn up to $400M by 2018

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that Zogenix/Astellas Pharma/Desitin Pharmaceuticals' needle-free Sumavel DosePro, which launched earlier this month in the United States, and MAP Pharmaceuticals' orally-inhaled Levadex will earn approximately $400 million in combined sales by 2018 in the migraine drug market.

27 Jan 2010

Osiris Therapeutics completes enrollment in Prochymal MSC therapy Phase II trial for type 1 diabetes

Osiris Therapeutics, Inc. today announced that it has achieved a $750,000 milestone payment from the Juvenile Diabetes Research Foundation (JDRF) for completing enrollment in a Phase II clinical trial evaluating Prochymal, an adult mesenchymal stem cell (MSC) therapy, as a treatment for patients recently diagnosed with type 1 diabetes. The milestone is the fourth in a series of payments resulting from JDRF’s partnership with Osiris for the development of a therapy for type 1 diabetes.

27 Jan 2010

Dynavax Technologies to present data on its SD-101 Phase 1b trial for chronic HCV infection

Dynavax Technologies Corporation announced today data from two studies that differentiate SD-101 from standard-of-care as well as emerging treatments for chronic HCV infection. The findings of a Phase 1b clinical trial and an in vitro study of SD-101's mechanism of action show that the second-generation TLR9 agonist is well tolerated and safe and induces both IFN-lambda and IFN-alpha at concentrations producing antiviral activity. The data will be presented at the 45th Annual Meeting of the European Association for the Study of the Liver in Vienna, Austria in April 2010.

27 Jan 2010

Curemark commences CM-AT Phase III autism clinical trial enrollment at ten sites

Curemark, LLC, a drug research and development company focused on the treatment of neurological diseases, announced that the company is now enrolling patients in Phase III clinical trials for CM-AT, its autism treatment, at ten sites across the country.

27 Jan 2010

FDA approves first heart valve conduit that can delay need for open-heart surgery

The U.S. Food and Drug Administration today approved the Medtronic Melody Transcatheter Pulmonary Valve and Ensemble Delivery System, the first heart valve to be implanted through a catheter, or tube, in a leg vein and guided up to the heart. This new approach to the treatment of adults and children with previously implanted, poorly functioning pulmonary valve conduits can delay the need for open-heart surgery.

27 Jan 2010

Sagefrog Marketing Group awarded a contract for Agency of Record

Penn Pharma Americas announced today that Sagefrog Marketing Group, LLC, a full service marketing, interactive and public relations company, has been awarded a contract for Agency of Record for both marketing and public relations.

25 Jan 2010

Researchers identify new gene signature that predicts cancer recurrence in certain breast tumors

Researchers at Dana-Farber Cancer Institute have discovered a gene activity signature that predicts a high risk of cancer recurrence in certain breast tumors that have been treated with commonly used chemotherapy drugs.

24 Jan 2010

New book on fraud and abuse laws and regulations affecting health care industry published

BNA Books, a division of specialized news and information publisher BNA, announced today the publication of the 2009 Cumulative Supplement to Health Care Fraud and Abuse: Practical Perspectives, Second Edition.

23 Jan 2010

Dark chocolates may ease emotional stress

There may well be another important reason for giving your sweetheart sweets for Valentine's Day besides the traditional romantic one: The "chocolate cure" for emotional stress is now getting new support from a clinical trial published online in ACS' Journal of Proteome Research. It found that eating about an ounce and a half of dark chocolate a day for two weeks reduced levels of stress hormones in the bodies of people feeling highly stressed.

23 Jan 2010

FDA's Ampyra approval wonderful news for people with MS experiencing walking problems

The U.S. Food and Drug Administration has approved the marketing of Ampyra™ (dalfampridine, formerly known as fampridine SR, from Acorda Therapeutics) for its ability to improve walking speed in people with any type of multiple sclerosis.

23 Jan 2010

FDA approves fampridine-SR drug for treatment of multiple sclerosis

The Food and Drug Administration has approved the drug fampridine-SR for the treatment of multiple sclerosis. Researchers at the University of Rochester Medical Center (URMC) have been evaluating the effects of the drug in MS for more than 10 years- it is the first medication shown to enhance some neurological functions in people with the disease - and their efforts helped pave the way for today's action by the FDA.

23 Jan 2010

Biovail comments on Teva Pharmaceutical's proposed Budeprion XL trial

Biovail Corporation today commented on a proposed clinical trial recently announced by Teva Pharmaceutical Industries Ltd. According to Teva, the trial is intended to address reports of inefficacy and adverse events by consumers who switched from Wellbutrin XL® 300 mg, Biovail’s FDA-approved brand of the antidepressant, bupropion hydrochloride, to Budeprion XL, Teva’s generic formulation of the drug. The trial was described in a Dow Jones Newswire article dated December 2, 2009.

22 Jan 2010

Data from GenVec's trial in esophageal cancer showcased at 2010 Gastrointestinal Cancer Symposium

GenVec, Inc. announced today that data from the Company's trial in esophageal cancer were presented at the American Society of Clinical Oncology's 2010 Gastrointestinal Cancer Symposium in Orlando, Florida on January 22, 2010.

22 Jan 2010

Focused Ultrasound Surgery Foundation disbursed $1 million in research awards; looks forward to fund more projects in 2010

The Focused Ultrasound Surgery Foundation has disbursed nearly $1 million in research awards for work on a breakthrough medical technology and is making more project funding available in 2010.

22 Jan 2010

Patheon constructs new pharmaceutical development center in Bourgoin-Jallieu

Patheon a global provider of drug development and manufacturing services to the international pharmaceutical industry announced today it has begun construction of a new pharmaceutical development center at its existing manufacturing facility in Bourgoin-Jallieu, France.

22 Jan 2010

Vitamin D insufficiency associated with higher risk of relapse attacks in patients with MS

Low vitamin D blood levels are associated with a significantly higher risk of relapse attacks in patients with multiple sclerosis (MS) who develop the disease during childhood, according to a study conducted by researchers from the University of California, San Francisco.

22 Jan 2010

CytRx announces its plans to advance multiple oncology development programs in 2010

CytRx Corporation, a biopharmaceutical company specializing in oncology, today announced its plans for 2010 aimed at advancing the clinical development of its high-value drug development pipeline and enhancing shareholder value.

22 Jan 2010

FDA accepts ACT Biotech's ACTB1003 IND

ACT Biotech Inc., a privately held biotechnology company developing a portfolio of oral kinase inhibitors as anti-cancer drugs, today announced the acceptance of the Investigational New Drug (IND) application for ACTB1003 by the US Food and Drug Administration (FDA). The company has now assembled a complete preclinical package, including manufacturing and toxicology studies, allowing ACTB1003 to enter a clinical trial.

22 Jan 2010

MDRNA to receive European patent for its intranasal insulin formulation

MDRNA, Inc., a leading RNAi-based drug discovery and development company, today announced that the European Patent Office intends to grant a patent for application EP06826368 covering formulations for the intranasal delivery of rapid acting insulin, and its use for the treatment of diabetes.

21 Jan 2010

China Pharma Holdings announces completion of clinical trials for Candesartan

China Pharma Holdings, Inc., which develops, manufactures, and markets specialty pharmaceutical products in China, today announced that the Company has completed clinical trials for Candesartan, an anti-hypertension drug, and submitted the generic drug production application to the SFDA.

21 Jan 2010

Clinical Trial News and Research

Sumavel DosePro and Levadex to earn up to $400M by 2018

Osiris Therapeutics completes enrollment in Prochymal MSC therapy Phase II trial for type 1 diabetes

Dynavax Technologies to present data on its SD-101 Phase 1b trial for chronic HCV infection

Curemark commences CM-AT Phase III autism clinical trial enrollment at ten sites

FDA approves first heart valve conduit that can delay need for open-heart surgery

Sagefrog Marketing Group awarded a contract for Agency of Record

Researchers identify new gene signature that predicts cancer recurrence in certain breast tumors

New book on fraud and abuse laws and regulations affecting health care industry published

Dark chocolates may ease emotional stress

FDA's Ampyra approval wonderful news for people with MS experiencing walking problems

FDA approves fampridine-SR drug for treatment of multiple sclerosis

Biovail comments on Teva Pharmaceutical's proposed Budeprion XL trial

Data from GenVec's trial in esophageal cancer showcased at 2010 Gastrointestinal Cancer Symposium

Focused Ultrasound Surgery Foundation disbursed $1 million in research awards; looks forward to fund more projects in 2010

Patheon constructs new pharmaceutical development center in Bourgoin-Jallieu

Vitamin D insufficiency associated with higher risk of relapse attacks in patients with MS

CytRx announces its plans to advance multiple oncology development programs in 2010

FDA accepts ACT Biotech's ACTB1003 IND

MDRNA to receive European patent for its intranasal insulin formulation

China Pharma Holdings announces completion of clinical trials for Candesartan

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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