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Cleveland Medical Devices Inc. spins off Great Lakes NeuroTech

Cleveland Medical Devices Inc. (CMDI) has announced the formation of Great Lakes NeuroTech (www.GLNeuroTech.com), a spin-off company which has acquired the rights to develop, market, and manufacture clinical motor assessment and therapy systems for the movement disorders market as well as physiological monitors for research and education markets. Great Lakes NeuroTech (GLN) will perform R&D, engineering, manufacturing, distribution, and exporting of these technologies through two divisions: Movement Disorders and Research & Education Systems.

28 Mar 2011

PHOENIX phase III trial of PHP for distributive shock to continue after positive midpoint recommendation from DMB

The PHOENIX trial is a European, placebo-controlled, Phase III study treating catecholamine-resistant patients in distributive shock with the Nitric Oxide (NO) scavenger Pyridoxalated Haemoglobin Polyoxyethylene Conjugate (PHP). The study was launched by Curacyte AG in Austria, Belgium, Germany, Spain, The Netherlands and in the United Kingdom in 2009.

28 Mar 2011

Bionovo initiates enrollment in Menerba Phase 1 clinical trial for menopausal hot flushes

Bionovo, Inc., a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer, today announced that enrollment has started for the Phase 1 clinical trial testing the safety of two doses of Menerba in postmenopausal women for the treatment of menopausal hot flushes (study # MF101-008), also known as "menopausal hot flashes."

28 Mar 2011

GE Healthcare launches Centricity Research, a new clinical research management solution

GE Healthcare, a global leader in healthcare information technology, today announced Centricity Research, a new clinical research management solution (CRMS). Centricity Research will help improve the efficiency and efficacy of clinical research studies, enterprise-wide, by driving better management of treatment plans, processes, and protocols while supporting research billing compliance.

28 Mar 2011

Cancer drug Gleevec may hold promise against scleroderma: Study

A drug approved to treat certain types of cancer has shown promising results in the treatment of patients with scleroderma, according to results from an open-label Phase II trial. While the drug's efficacy must be demonstrated in a Phase III trial, the gold standard for testing a drug, researchers are optimistic that Gleevec- (imatinib) could potentially be a weapon against the chronic connective tissue disease for which a treatment has remained elusive.

28 Mar 2011

A.P. Pharma fourth quarter revenue decreases to $1.6 million

A.P. Pharma, Inc., a specialty pharmaceutical company, today reported financial results for its fourth quarter and full year ended December 31, 2010 and provided a corporate update.

28 Mar 2011

BMY receives FDA approval for YERVOY to treat metastatic melanoma

Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration approved YERVOY 3 mg/kg for the treatment of patients with unresectable or metastatic melanoma.

28 Mar 2011

Study finds increased risk of VTE during first year of combination oral contraceptive usage

Bayer HealthCare Pharmaceuticals Inc. today announced that interim results from a large, prospective, observational cohort safety study offer insights into the increased risk of venous thromboembolism (VTE), or blood clots, which is a well-established risk in women who use combination oral contraceptives (COCs), also known as "the Pill".

25 Mar 2011

Mersana commences XMT-1001 Phase 1b extension study in gastric cancer and non-small cell lung cancer

Mersana Therapeutics today announced the initiation of a Phase 1b extension study with its lead cancer product, XMT-1001, a novel DNA topoisomerase I inhibitor based on the company's Fleximer® polymer conjugate platform, in second-line gastric cancer and second-/third-line non-small cell lung cancer. The study will be carried out in 10 clinical centers in the US.

25 Mar 2011

Purdue demonstrates efficacy of Butrans transdermal delivery system for chronic pain in opioid-naive patients

Physicians from Purdue Pharma LP, Stamford, CT, showcased study results that demonstrate the analgesic efficacy and safety of Butrans for the relief of moderate to severe chronic low back pain in opioid-naive patients. Butrans is a transdermal delivery system that provides systemic delivery of buprenorphine, a Schedule III medication, continuously over a 7-day period.

25 Mar 2011

Tengion 2010 adjusted net loss decreases to $25.8 million

Tengion, Inc. today provided a business update and reported its financial results for the year ended December 31, 2010.

25 Mar 2011

Emory plays key role in bringing advanced proton cancer therapy to Georgia

Emory Healthcare is a key player in plans to bring the world's most advanced radiation treatment for cancer patients to Georgia. In furtherance of that role, Emory Healthcare has signed a letter of intent with Advanced Particle Therapy, LLC, of Minden, Nevada, opening the door to a final exploratory phase for development of The Georgia Proton Treatment Center - Georgia's first proton therapy facility.

25 Mar 2011

Positive Phase 3 results from Tarsa's ORACAL study validates Unigene's oral peptide drug delivery technology

Unigene Laboratories, Inc. a leader in the design, delivery, manufacture and development of peptide-based therapeutics announced today that the statistically significant top-line results released by its licensee, Tarsa Therapeutics, validate its proprietary oral peptide drug delivery technology.

25 Mar 2011

Graceway receives FDA approval for Zyclara Cream to treat genital warts

Graceway Pharmaceuticals announced today that the Food and Drug Administration has approved Zyclara Cream for the treatment of external genital and perianal warts in patients 12 years of age and older.

25 Mar 2011

Osteoporosis study: Protelos have significant bone-forming activity than bisphosphonates

Protelos has significantly greater bone-forming activity than the commonly prescribed bisphosphonate, alendronate, according to results of the largest-ever biopsy study in post-menopausal women presented today at the European Congress on Osteoporosis and Osteoarthritis in Valencia.

25 Mar 2011

Stemedica begins allogeneic mesenchymal stem cell Phase I/II trial in patients with ischemic stroke

Stemedica Cell Technologies, Inc., a leader in adult allogeneic stem cell manufacturing, research and development, announced today that its specially formulated ischemic adult allogeneic mesenchymal stem cells have been successfully used to treat the first patient in an ischemic stroke study conducted at the University of California, San Diego.

25 Mar 2011

Positive top-line results from Targacept's TC-5619 Phase 2 trial in adults with ADHD

Targacept, Inc today announced top-line results from a Phase 2 proof of concept trial of TC-5619 as a treatment for adults with attention deficit/hyperactivity disorder.

25 Mar 2011

Positive results from Tarsa's oral calcitonin Phase III trial against postmenopausal osteoporosis

Tarsa Therapeutics today announced that the Phase III ORACAL trial of its oral recombinant salmon calcitonin in the treatment of postmenopausal osteoporosis was successfully concluded and yielded statistically significant, positive top-line results.

25 Mar 2011

Prolia associated with greater adherence than alendronate in postmenopausal women with osteoporosis

Amgen today announced new data that showed postmenopausal women with osteoporosis had significantly greater adherence, compliance, and persistence during Prolia® (denosumab) treatment than during alendronate treatment, an oral bisphosphonate commonly used to treat osteoporosis.

24 Mar 2011

EndyMed's 3DEEP RF technology in real-time skin impedance measurements published in peer reviewed paper

EndyMed Medical, Ltd., a leader in the use of multi-source radiofrequency for professional aesthetic treatments, announced today the publication of the latest peer reviewed paper on 3DEEP radiofrequency technology, "A novel method for real-time skin impedance measurement during radiofrequency skin tightening treatments".

24 Mar 2011

Efficacy News and Research

Cleveland Medical Devices Inc. spins off Great Lakes NeuroTech

PHOENIX phase III trial of PHP for distributive shock to continue after positive midpoint recommendation from DMB

Bionovo initiates enrollment in Menerba Phase 1 clinical trial for menopausal hot flushes

GE Healthcare launches Centricity Research, a new clinical research management solution

Cancer drug Gleevec may hold promise against scleroderma: Study

A.P. Pharma fourth quarter revenue decreases to $1.6 million

BMY receives FDA approval for YERVOY to treat metastatic melanoma

Study finds increased risk of VTE during first year of combination oral contraceptive usage

Mersana commences XMT-1001 Phase 1b extension study in gastric cancer and non-small cell lung cancer

Purdue demonstrates efficacy of Butrans transdermal delivery system for chronic pain in opioid-naive patients

Tengion 2010 adjusted net loss decreases to $25.8 million

Emory plays key role in bringing advanced proton cancer therapy to Georgia

Positive Phase 3 results from Tarsa's ORACAL study validates Unigene's oral peptide drug delivery technology

Graceway receives FDA approval for Zyclara Cream to treat genital warts

Osteoporosis study: Protelos have significant bone-forming activity than bisphosphonates

Stemedica begins allogeneic mesenchymal stem cell Phase I/II trial in patients with ischemic stroke

Positive top-line results from Targacept's TC-5619 Phase 2 trial in adults with ADHD

Positive results from Tarsa's oral calcitonin Phase III trial against postmenopausal osteoporosis

Prolia associated with greater adherence than alendronate in postmenopausal women with osteoporosis

EndyMed's 3DEEP RF technology in real-time skin impedance measurements published in peer reviewed paper

Industry Focus eBook - Cell & Gene Therapy (1st Edition) eBook

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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