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Today's opinions: Ariz. hospital and abortion; Wall Street Journal's issues with PolitiFact; Calif.'s anti-smoking success

St. Joseph's Hospital and Medical Center in Phoenix announced on Tuesday that it will continue to provide life-saving abortion care to patients even though it means losing its affiliation with the local Roman Catholic Diocese (12/23).

24 Dec 2010

Promising initial data from STABLE clinical trial for endovascular treatment of Type B aortic dissection

Study investigators reported positive steps in Cook Medical's efforts to gain FDA approval of the treatment assessed in the STABLE clinical trial, designed to evaluate the safety and efficacy of a proximal endograft and a distal uncovered stent for the endovascular treatment of Type B aortic dissection for purposes of seeking FDA approval. The findings were presented by Dr. Joseph Lombardi at the 37th annual VEITHsymposium.

23 Dec 2010

Immunization with VLP vaccine results in functional, protective immune responses against RSV

Novavax, and scientists at the University of Massachusetts Medical School, led by Dr. Trudy Morrison, published in the January 2011 issue of The Journal of Virology, a report indicating that a novel virus-like particle vaccine candidate against respiratory syncytial virus (RSV) protects mice from a live virus challenge.

23 Dec 2010

Gilead stops ARTEMIS-IPF ambrisentan Phase III clinical trial in idiopathic pulmonary fibrosis

Gilead Sciences, Inc. today announced it is stopping ARTEMIS-IPF, the company's ongoing Phase III clinical trial of ambrisentan in patients with idiopathic pulmonary fibrosis (IPF), due to lack of efficacy. This decision follows an interim analysis of unblinded efficacy and safety data by the study's Data Monitoring Committee (DMC) and review of those data by Gilead, which did not show evidence of a treatment benefit in the group of patients randomized to receive ambrisentan.

23 Dec 2010

FDA approves Watson's novel oral contraceptive

Watson Pharmaceuticals today announced the U.S. Food and Drug Administration (FDA) approval of a novel oral contraceptive product – the first and only low dose oral contraceptive to combine 0.8 mg norethindrone and 0.025 mg ethinyl estradiol in chewable form, with four 75 mg ferrous fumarate (iron) placebo tablets. Taken orally, once daily, the product is proven effective in lowering the risk of pregnancy.

22 Dec 2010

Tekmira begins patient dosing in TKM-PLK1 phase 1 trail for cancer

Tekmira Pharmaceuticals Corporation, a leading developer of RNA interference therapeutics, announced today it has initiated patient dosing in a Phase 1 human clinical trial for its lead oncology product, TKM-PLK1. TKM-PLK1 targets polo-like kinase 1, or PLK1, a cell cycle protein involved in tumor cell proliferation and a validated oncology target.

22 Dec 2010

Researchers perform cord blood cell transplantation to treat child with ischemic brain injury

In three monthly injections, researchers transplanted neurally-committed, autologous cord blood derived cells tagged with iron oxide nanoparticles into the lateral cerebral ventricle of a 16-month old child with severe global hypoxic ischemic brain injury.

22 Dec 2010

Antares Pharma submits NDA for Anturol Gel in patients with overactive bladder

Antares Pharma, today announced the filing of a New Drug Application with the U.S. Food and Drug Administration for Anturol Gel in patients with overactive bladder.

22 Dec 2010

Millennia compiles data on 100 wounds treated with Cytomedix AutoloGel System

Cytomedix, Inc. a leading developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis, today announced that its Japanese partner, Millennia Holdings, Inc. ("Millennia"), has compiled data on 100 wounds treated with the Company's AutoloGel™ System, and will use this initial data to support its regulatory and reimbursement filings in Japan. The full data set is expected to be released through presentations at scientific and medical meetings and through publication in a peer-reviewed journal.

22 Dec 2010

FDA issues CRL to Cumberland's Acetadote sNDA for non-acetaminophen acute liver failure

Cumberland Pharmaceuticals Inc. announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding its supplemental new drug application (sNDA) for Acetadote® (acetylcysteine) Injection to treat patients with non-acetaminophen induced acute liver failure.

22 Dec 2010

BioCryst commences BCX4208/allopurinol combination Phase 2b study in gout patients

BioCryst Pharmaceuticals, Inc. announced the initiation of a Phase 2b study of BCX4208 as add-on therapy in gout patients who have not responded to allopurinol therapy alone.

22 Dec 2010

$Emory University study reaffirms benefits of VNS Therapy System for refractory epilepsy$

Emory University study reaffirms benefits of VNS Therapy System for refractory epilepsy

Cyberonics, Inc. announced today that the VNS Therapy System, the only FDA-approved implantable medical device for the treatment of refractory epilepsy, was featured in 22 poster presentations and in the Plenary II session on neurostimulation at the annual American Epilepsy Society Meeting that took place recently in San Antonio, Texas.

22 Dec 2010

U.S. pivotal clinical trial of Medtronic CoreValve begins

Medtronic, Inc. today announced the beginning of its Medtronic CoreValve® U.S. Pivotal clinical trial in the United States. The first CoreValve transcatheter aortic valve implantation (TAVI) procedure was performed by David H. Adams, M.D., and Samin K. Sharma, M.D., at The Mount Sinai Medical Center in New York City.

22 Dec 2010

Anavex files regulatory submission in Germany for ANAVEX 2-73 Phase I trial in Alzheimer's disease

Anavex Life Sciences Corp. announced today that it has filed the regulatory submission for ANAVEX 2-73 with the German Health Authority, BfArM, and the local Ethics Committee of Saxony to begin clinical studies for ANAVEX 2-73, its lead compound for the treatment of Alzheimer's disease.

21 Dec 2010

Medicaid Health Plans of America selects MedAssurant for advanced analytics in healthcare delivery

MedAssurant Inc., a leading provider of data-driven healthcare solutions, today announced that Medicaid Health Plans of America (MHPA) has selected MedAssurant to provide advanced analytics to establish priorities and to inform best practices in healthcare delivery settings for Medicaid patients.

21 Dec 2010

Pro-Pharmaceuticals, Mount Sinai collaborate to evaluate anti-fibrotic effects of Galectin-targeting compounds

Pro-Pharmaceuticals, Inc., the leading developer of Galectin therapeutics to treat cancer and fibrosis, today announced it has entered into a new research collaboration with Mount Sinai School of Medicine to evaluate in pre-clinical models, the anti-fibrotic effects of several of the Company's novel, Galectin-targeting compounds.

21 Dec 2010

Biovest issues FAQ update on BiovaxID personalized cancer vaccine

Biovest International, Inc. today issued the following update in the form of a "Frequently Asked Questions" report in response to the high volume of inquiries received following the Company's recent presentation at the 2010 American Society of Hematology Annual Meeting (ASH 2010) in Orlando, Florida.

21 Dec 2010

UCB's Cimzia and Centocor's Simponi penetrate first line biologic position in RA

In its recently released annual 2010 update, ChartTrends®: Biologics in Rheumatoid Arthritis, BioTrends Research Group, Inc. finds that newer biologic agents such as UCB's Cimzia and Centocor OrthoBiotech's Simponi, although lagging in overall market share, have begun to penetrate the first line biologic position primarily at the expense of Pfizer/Amgen's Enbrel and Abbott's Humira.

21 Dec 2010

Genzyme provides information on peak sale of alemtuzumab for multiple sclerosis

Genzyme Corporation today provided an extensive briefing on the market potential of alemtuzumab for multiple sclerosis at an event for investors and analysts in New York.

21 Dec 2010

Gilenya offers more benefits for MS therapy than previously realized

In September, patients suffering from multiple sclerosis (MS) received the welcome news that the U.S. Food and Drug Administration (FDA) had approved a promising new drug for their condition called Gilenya. Now, a team from The Scripps Research Institute has discovered that this drug's success may involve an unexpected biological mechanism acting within the central nervous system (CNS). This difference may mean that Gilenya offers even more benefits than previously realized and would represent the first MS therapy with direct CNS activities.

21 Dec 2010

Efficacy News and Research

Today's opinions: Ariz. hospital and abortion; Wall Street Journal's issues with PolitiFact; Calif.'s anti-smoking success

Promising initial data from STABLE clinical trial for endovascular treatment of Type B aortic dissection

Immunization with VLP vaccine results in functional, protective immune responses against RSV

Gilead stops ARTEMIS-IPF ambrisentan Phase III clinical trial in idiopathic pulmonary fibrosis

FDA approves Watson's novel oral contraceptive

Tekmira begins patient dosing in TKM-PLK1 phase 1 trail for cancer

Researchers perform cord blood cell transplantation to treat child with ischemic brain injury

Antares Pharma submits NDA for Anturol Gel in patients with overactive bladder

Millennia compiles data on 100 wounds treated with Cytomedix AutoloGel System

FDA issues CRL to Cumberland's Acetadote sNDA for non-acetaminophen acute liver failure

BioCryst commences BCX4208/allopurinol combination Phase 2b study in gout patients

Emory University study reaffirms benefits of VNS Therapy System for refractory epilepsy

U.S. pivotal clinical trial of Medtronic CoreValve begins

Anavex files regulatory submission in Germany for ANAVEX 2-73 Phase I trial in Alzheimer's disease

Medicaid Health Plans of America selects MedAssurant for advanced analytics in healthcare delivery

Pro-Pharmaceuticals, Mount Sinai collaborate to evaluate anti-fibrotic effects of Galectin-targeting compounds

Biovest issues FAQ update on BiovaxID personalized cancer vaccine

UCB's Cimzia and Centocor's Simponi penetrate first line biologic position in RA

Genzyme provides information on peak sale of alemtuzumab for multiple sclerosis

Gilenya offers more benefits for MS therapy than previously realized

Revolutionizing Life Science: An Interview with SCIEX on ASMS, the SCIEX 7500+ System, and AI-Driven Quantitation

From Discovery Biology to ELRIG Chair

Breathing New Life into Diagnostics: Plasmion's SICRIT Technology

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