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Spectranetics receives FDA clearance for its new VisiSheath Dilator Sheath device

Spectranetics Corporation today announced it has received Food and Drug Administration (FDA) 510(k) clearance for its new VisiSheathTM Dilator Sheath device. This expands the market for VisiSheath, which recently also received CE Mark approval in Europe.

3 Dec 2009

GTSI named value-added reseller of the Intel Health Guide RPM solution

GTSI Corp. an enterprise technology solutions and services provider was recently named a value-added reseller to deliver the Intel® Health Guide, a comprehensive, next-generation remote patient monitoring (RPM) solution that combines an in-home patient device, the Intel Health Guide PHS6000, with the Intel® Care Management Suite, an online interface that allows clinicians to monitor patients and remotely manage care.

3 Dec 2009

Milestone Scientific announces new joint venture with two PRC pharmaceutical companies

Milestone Scientific Inc., the recognized leader in advanced injection technologies, today announced that it had entered into a joint venture with China National Medicines Corporation Ltd. (d/b/a "Sinopharm") and Yichang Humanwell Pharmaceutical Co. Ltd., both incorporated in the People's Republic of China (the "PRC"), to develop orthopedic and epidural drug delivery instruments.

3 Dec 2009

Endo Pharmaceuticals receives FDA complete response letter for AVEED NDA

Endo Pharmaceuticals today announced that it received a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for its extended-duration testosterone undecanoate injection, AVEED(TM), for men diagnosed with low testosterone.

3 Dec 2009

Avisio forms new subsidiary to market its virus detecting nano sensory technology

Avisio, Inc. announced today that it has formed a majority-owned subsidiary to market and commercialize Instant Detect, the company's new nano sensory technology that instantly detects biological viruses. The new company, Diagnostic Nano Applications (DNA), will be headquartered in Riverside, California.

3 Dec 2009

IsoRay to distribute Oncura's I-125 brachytherapy seed

IsoRay, Inc. announced today that it has signed a distribution agreement with Oncura to distribute the I-125 brachytherapy seed, OncoSeed™.

3 Dec 2009

New health IT grants to be 'models' for the nation

The federal government will offer $235 million in grants for communities to upgrade and improve their health information technology, The Dallas Morning News reports. Only organizations that are already using health IT are eligible. Health secretary Kathleen Sebelius said, "Our hope is that the communities will become models for the rest of the country" (Roberson, 12/2).

3 Dec 2009

FDA approves manufacture of Amneal Pharmaceuticals' Nizatidine Oral Solution

Amneal Pharmaceuticals is pleased to announce that it has received U.S. FDA approval to manufacture Nizatidine Oral Solution in the 15 mg/mL strength effective November 18, 2009. It is an AA-rated, therapeutically equivalent alternative to Axid® Oral Solution (a licensed trademark of Braintree Labs). Nizatidine Oral Solution is the first available generic in oral solution form and marks Amneal’s fourth liquid approval.

3 Dec 2009

CBO report shows hundreds of millions spent on direct marketing of drugs to consumers

The Congressional Budget Office released an "interesting report" on on how "pharmaceutical companies market prescription drugs, a subject that has received some scrutiny during the debate on ways to control health care spending," The New York Times reports.

3 Dec 2009

Ingredia Nutritionals to distribute Nutrition 21's Chromax and Diachrome ingredients in the EU

Nutrition 21, Inc., the developer and marketer of nutritional ingredients for the dietary supplement, and functional food and beverage markets announced today that chromium picolinate has been added to the approved list of ingredients allowed to be used in food supplements in the European Union (EU).

3 Dec 2009

Breastfeeding reduces a woman's risk of developing Metabolic Syndrome

Breastfeeding a child may lower a woman's risk of developing Metabolic Syndrome, a condition linked to heart disease and diabetes in women, according to a Kaiser Permanente study that was published today online ahead of print and will appear in the February issue of Diabetes, a journal of the American Diabetes Association (link: http://dx.doi.org/10.2337/db09-1197).

3 Dec 2009

Hyperion Therapeutics commences enrollment in its HPN-100 episodic hepatic encephalopathy trial

Hyperion Therapeutics, Inc. today announced that the first patient has been enrolled in its phase II clinical trial of investigational compound HPN-100 (glycerol phenylbutyrate).

3 Dec 2009

CLC bio, imaGenes announce collaboration in high-throughput sequencing analyses

Today, the leading provider of High-Throughput Sequencing analysis solutions, CLC bio, announced that they're collaborating with premier German sequencing service provider, imaGenes, to better support the fast growing German market of high-throughput sequencing analyses. imaGenes, will provide all customers receiving Next Generation Sequencing data with a temporary license for CLC Genomics Workbench for assembly and downstream sequence analyses.

3 Dec 2009

Allos Therapeutics to launch the COMPLETE registry for patients with PTCL

Allos Therapeutics, Inc. today announced the launch of an international registry designed to address the urgent need to better understand treatment patterns and outcomes for patients with peripheral T-cell lymphoma (PTCL). The registry, known as COMPLETE (Comprehensive Oncology Measures for Peripheral T-cell Lymphoma Treatment), is a global observational study that will enroll patients with newly-diagnosed PTCL and obtain data regarding longitudinal treatment patterns and outcomes.

3 Dec 2009

Stryker to repurchase $750M of its common stock

Stryker Corporation announced today that its Board of Directors has authorized the Company to repurchase up to $750 million of its common stock. The manner, timing and amount of any purchases will be determined by the Company's management based on their evaluation of market conditions, stock price and other factors and will be subject to regulatory considerations. Purchases may be made from time to time in the open market, in privately negotiated transactions or otherwise.

From Stryker 3 Dec 2009

Update on Celsion's ThermoDox Phase III “HEAT” trial for HCC

Celsion Corporation, a leading oncology drug development company, today provided an update on the progress of its pivotal ThermoDox® Phase III “HEAT” trial for the treatment of hepatocellular carcinoma (HCC), the most common form of primary liver cancer. Following recent regulatory approvals in China, Malaysia, Thailand and the Philippines, the study is now enrolling patients in eleven countries, with the majority of clinical sites located in the Asia Pacific region where HCC is most prevalent.

3 Dec 2009

Cielo MedSolutions, DrFirst partner to provide a comprehensive e-prescribing solution

Cielo MedSolutions today announced a new partnership with DrFirst to provide comprehensive e-prescribing functionality to practices using the company's Cielo Clinic clinical quality management system. The fully integrated e-prescribing solution will enable customers to improve prescribing safety and medical practice efficiency.

3 Dec 2009

Enrollment closed early in Cubist Pharmaceuticals' ecallantide Phase 2 program

Cubist Pharmaceuticals, Inc. today announced the early closing of enrollment in its ecallantide Phase 2 program. Ecallantide, in development as therapy to reduce bleeding in on-pump cardiac surgery, is now known as CB-500,929. After a regularly scheduled review meeting, the Data Safety Monitoring Board (DSMB) contacted the company to recommend a temporary suspension in enrollment in one of the CB-500,929 trials, CONSERV-2.

3 Dec 2009

Psynova Neurotech, Roche collaborate in development of diagnostic immunoassays for schizophrenia treatment

Rules-Based Medicine, Inc. (RBM) today announced that Psynova Neurotech Limited (Cambridge UK), a majority-owned subsidiary of RBM, has executed an exclusive research and licensing agreement with Roche to collaborate on the discovery, development, validation and commercialization of diagnostic immunoassays to aid the clinical development and commercial differentiation of novel treatments for schizophrenia.

3 Dec 2009

ARC workers protest that unfair labor practices can endanger donor and blood safety issues

Teamsters who work at American Red Cross (ARC) Blood Services facilities in Philadelphia went on strike this morning to protest unfair labor practices and problems with working conditions at these facilities that could imperil the safety of donors and the integrity of the blood supply, not to mention the wellbeing of employees.

3 Dec 2009

Medical News

Spectranetics receives FDA clearance for its new VisiSheath Dilator Sheath device

GTSI named value-added reseller of the Intel Health Guide RPM solution

Milestone Scientific announces new joint venture with two PRC pharmaceutical companies

Endo Pharmaceuticals receives FDA complete response letter for AVEED NDA

Avisio forms new subsidiary to market its virus detecting nano sensory technology

IsoRay to distribute Oncura's I-125 brachytherapy seed

New health IT grants to be 'models' for the nation

FDA approves manufacture of Amneal Pharmaceuticals' Nizatidine Oral Solution

CBO report shows hundreds of millions spent on direct marketing of drugs to consumers

Ingredia Nutritionals to distribute Nutrition 21's Chromax and Diachrome ingredients in the EU

Breastfeeding reduces a woman's risk of developing Metabolic Syndrome

Hyperion Therapeutics commences enrollment in its HPN-100 episodic hepatic encephalopathy trial

CLC bio, imaGenes announce collaboration in high-throughput sequencing analyses

Allos Therapeutics to launch the COMPLETE registry for patients with PTCL

Stryker to repurchase $750M of its common stock

Update on Celsion's ThermoDox Phase III “HEAT” trial for HCC

Cielo MedSolutions, DrFirst partner to provide a comprehensive e-prescribing solution

Enrollment closed early in Cubist Pharmaceuticals' ecallantide Phase 2 program

Psynova Neurotech, Roche collaborate in development of diagnostic immunoassays for schizophrenia treatment

ARC workers protest that unfair labor practices can endanger donor and blood safety issues

Expanding research and clinical options for children with cancer

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

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

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