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Athersys reports positive results from MultiStem phase I clinical trial in heart attack patients

Athersys, Inc. announced today positive results from its phase I clinical trial of MultiStem®, its allogeneic cell therapy product, administered to individuals following acute myocardial infarction (AMI), more commonly referred to as a heart attack. The study results, based on four months of post-treatment patient data, demonstrate that MultiStem was well tolerated at all dose levels and also suggest improvement in heart function in treated patients.

29 Jul 2010

Kyowa Hakko Kirin initiates Phase 2 trial of ARQ 197 for gastric cancer: ArQule

ArQule, Inc. today announced the initiation of a Phase 2, single agent trial with ARQ 197 in gastric cancer by Kyowa Hakko Kirin, its exclusive licensee for the development and commercialization of ARQ 197 in the Asian territory consisting of Japan, China (including Hong Kong), South Korea and Taiwan. Initiation of this trial will trigger a $5 million milestone payment to ArQule from Kyowa Hakko Kirin.

28 Jul 2010

ViroPharma second-quarter net sales increase 33% to $109.0 million

ViroPharma Incorporated reported today its financial results for the second quarter ended June 30, 2010.

28 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

Medtronic reports FDA Panel's affirmative votes on AMPLIFY rhBMP-2 Matrix for posterolateral spine fusion

The U.S. Food and Drug Administration (FDA) Orthopaedic and Rehabilitation Devices Panel today voted 9 for and 4 against (1 abstention) on safety and 10 for and 3 against (1 abstention) on effectiveness, that data including results from a large, prospective randomized clinical trial demonstrated the safety and effectiveness of AMPLIFY™ rhBMP-2 Matrix for fusions of the lower spine in patients with degenerative disc disease.

28 Jul 2010

BiondVax receives 2010 European Influenza Vaccines Technology Innovation Award

Frost & Sullivan is pleased to announce the award of its prestigious 2010 European Influenza Vaccines Technology Innovation Award to BiondVax Pharmaceuticals for their breakthrough work on a universal influenza vaccine. This vaccine, the Multimeric-001, is designed to provide multi-season and multi-strain protection against most influenza virus strains, including both seasonal and pandemic strains, and has the potential to eliminate the need for annual flu vaccination. BiondVax is entering Phase II clinical trials for the development of the Multimeric-001 universal influenza vaccine.

28 Jul 2010

NYU Langone opens vascular-targeted photodynamic therapy trial to men with localized prostate cancer

NYU Langone Medical Center has begun a clinical trial offering vascular-targeted photodynamic therapy to patients with localized prostate cancer. This novel, minimally invasive procedure uses a light-activated drug to deliver light energy waves by way of laser fibers in order to destroy prostate cancer cells.

28 Jul 2010

LLS collaborates with Shape Pharmaceuticals to advance treatment for CTCL

The Leukemia & Lymphoma Society (LLS) and Shape Pharmaceuticals announced today that they have entered into a partnership to advance Shape's novel, topical treatment for cutaneous T-Cell lymphoma (CTCL) into clinical development. The compound, SHP-141, is a first-in-class topical histone deacetylase inhibitor with the potential to treat both early- and late-stage CTCL.

28 Jul 2010

InterMune second-quarter total revenue decreases to $5.9 million

InterMune, Inc. today announced results from operations for the second quarter and six months ended June 30, 2010. InterMune also highlighted its recent clinical development and business activities, and provided forward-looking financial guidance for 2010.

28 Jul 2010

Omeros initiates enrollment in OMS302 Phase 2b clinical trial in patients undergoing cataract surgery

Omeros Corporation, a biopharmaceutical company committed to discovering, developing and commercializing products focused on inflammation and disorders of the central nervous system, today announced that it has enrolled the first patient in its Phase 2b clinical trial evaluating OMS302 in patients undergoing cataract surgery.

27 Jul 2010

QLT second-quarter total revenue increases 15.4% to $12.4 million

QLT Inc. today reported financial results for the second quarter ended June 30, 2010. Unless specified otherwise, all amounts are in U.S. dollars and in accordance with U.S. GAAP.

27 Jul 2010

Researchers reveal biological rationale for why corticosteroids help people with lupus

Researchers at UT Southwestern Medical Center have uncovered the biological rationale for why large doses of corticosteroids given repeatedly over several weeks may help individuals with lupus, a chronic inflammatory disease that affects more than 1 million people in the U.S.

27 Jul 2010

Report finds geographic variation in the use of carotid endarterectomy, carotid stenting

Medicare beneficiaries in some parts of the United States appear more likely to receive carotid endarterectomy, a surgical procedure to clear blockages in the artery supplying blood to the head, whereas those in other regions more often receive stents for the same condition, according to a report in the July 26 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

27 Jul 2010

Idenix second-quarter total revenues decrease to $1.3 million

Idenix Pharmaceuticals, Inc., a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today reported unaudited financial results for the second quarter and six months ended June 30, 2010. At June 30, 2010, Idenix's cash and cash equivalents totaled $51.0 million.

27 Jul 2010

Ampio finalizes negotiations to acquire DMI BioSciences

Ampio Pharmaceuticals, Inc. today announced it has finalized negotiations with the directors of DMI BioSciences, Inc. (DMI) to acquire DMI BioSciences, Inc. This acquisition will give Ampio access to all rights, royalties and patents associated with DMI's major assets, drugs for male sexual dysfunction including premature ejaculation (PE) and combination drugs to treat premature ejaculation and erectile dysfunction (ED).

27 Jul 2010

UCLA Health System launches hand transplantation program

The UCLA Health System has launched the new UCLA Hand Transplantation Program, the first of its kind on the West Coast and only the fourth such center in the United States. The program will help those who have suffered the traumatic loss of a hand or forearm and allow them to regain function and improve their quality of life. Qualified candidates are now being sought for a clinical study of the procedure.

27 Jul 2010

Can-Fite's CF102 decreases HCV viral load in liver cancer patients

Can-Fite BioPharma Ltd, a biotechnology company traded on the Tel Aviv Stock Exchange reported today that a significant decrease in HCV viral load was detected in 3 patients with liver cancer who are treated daily orally with CF102. The company is studying CF102 as a treatment for liver cancer (hepatocellular carcinoma, or HCC). The results announced today relate to data which came out of a Phase 1/2 clinical trial of CF102 in the treatment of patients with advanced HCC.

26 Jul 2010

Hospira commences EPO Phase I U.S. clinical trial in renal dysfunction patients with anemia

Hospira, Inc., the world leader in generic injectable pharmaceuticals, today announced the start of a U.S. Phase I clinical trial of its biosimilar erythropoietin (EPO) in patients with renal (kidney) dysfunction who have anemia, an important step on the road toward introducing a biosimilar product in the United States. Erythropoietin is a treatment for anemia associated with chronic renal failure and chemotherapy.

26 Jul 2010

Today's OpEds: Health reform and long-term care; Health care incentives; Reasons for optimism or repeal and replace?

Our system of long-term care does not provide adequate or coordinated human services and medical treatment for our growing aging population. … Thanks to a provision of the new health care law known as the Community Living Assistance Services and Supports program, tomorrow's continuum of care does not have to be so unforgiving. For the first time, a voluntary public insurance program will be available to help adults and families pay for long-term care services (Bruce Chernof, 7/23).

26 Jul 2010

KIKA Clinical Solutions reports 47% increase in service bookings during first-half of 2010

KIKA™ Clinical Solutions is on track for unprecedented 2010 growth. KIKA is the leading provider of advanced EDC solutions for Clinical Asset Management™ for the pharmaceutical, biotechnology and medical device markets.

26 Jul 2010

Clinical Trial News and Research

Athersys reports positive results from MultiStem phase I clinical trial in heart attack patients

Kyowa Hakko Kirin initiates Phase 2 trial of ARQ 197 for gastric cancer: ArQule

ViroPharma second-quarter net sales increase 33% to $109.0 million

NEI, FDA to sponsor Glaucoma Endpoints conference

Medtronic reports FDA Panel's affirmative votes on AMPLIFY rhBMP-2 Matrix for posterolateral spine fusion

BiondVax receives 2010 European Influenza Vaccines Technology Innovation Award

NYU Langone opens vascular-targeted photodynamic therapy trial to men with localized prostate cancer

LLS collaborates with Shape Pharmaceuticals to advance treatment for CTCL

InterMune second-quarter total revenue decreases to $5.9 million

Omeros initiates enrollment in OMS302 Phase 2b clinical trial in patients undergoing cataract surgery

QLT second-quarter total revenue increases 15.4% to $12.4 million

Researchers reveal biological rationale for why corticosteroids help people with lupus

Report finds geographic variation in the use of carotid endarterectomy, carotid stenting

Idenix second-quarter total revenues decrease to $1.3 million

Ampio finalizes negotiations to acquire DMI BioSciences

UCLA Health System launches hand transplantation program

Can-Fite's CF102 decreases HCV viral load in liver cancer patients

Hospira commences EPO Phase I U.S. clinical trial in renal dysfunction patients with anemia

Today's OpEds: Health reform and long-term care; Health care incentives; Reasons for optimism or repeal and replace?

KIKA Clinical Solutions reports 47% increase in service bookings during first-half of 2010

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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