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FDA questions third-party review of medical devices

The Wall Street Journal: The FDA is considering ending a program that allows medical-equipment makers to have their products reviewed by third-party companies instead of by FDA officials.

15 Mar 2010

High ABI may indicate risk for future heart attacks

The prevalence of abnormal ankle-brachial index (ABI) test results among individuals tested for peripheral arterial disease (PAD)—and who are not considered at high risk of a coronary heart event by Framingham-based risk factors—is high and provides another way to identify those who may be at risk for future heart attacks, say researchers at the Society of Interventional Radiology's 35th Annual Scientific Meeting in Tampa, Fla.

15 Mar 2010

'Vaccine court' finds no link between vaccines and autism

A federal court finds no link between vaccines and autism after examining three cases that started in 2007. CNN reports: "A federal court ruled Friday that the evidence supporting an alleged causal link between autism and a mercury-containing preservative in vaccines is unpersuasive, and that the families of children diagnosed with autism are not entitled to compensation.

15 Mar 2010

Advertising on heath overhaul picks up again

"A slew of interest groups lobbying on the health care overhaul is cranking up the volume of advertising spots and grass-roots organizing this week as Congressional leaders race to put the finishing touches on controversial legislation to remake the nation's medical system," Roll Call reports.

15 Mar 2010

Surprise stimulus temporarily blinds subsequent events

Reading this story requires you to willfully pay attention to the sentences and to tune out nearby conversations, the radio and other distractions. But if a fire alarm sounded, your attention would be involuntarily snatched away from the story to the blaring sound.

15 Mar 2010

MannKind receives FDA Complete Response letter for AFREZZA NDA

MannKind Corporation today announced that it has received a Complete Response letter from the U.S. Food & Drug Administration (FDA) regarding the New Drug Application (NDA) for AFREZZA™ (insulin human [rDNA origin]) Inhalation Powder for the treatment of adult patients with type 1 and type 2 diabetes mellitus for the control of hyperglycemia.

15 Mar 2010

Stimulus funds spur Indiana doctors, hospitals to switch to electronic records more quickly

The offer of federal stimulus funds is spurring Indiana health care providers to convert to electronic medical records, The (Fort Wayne, Ind.) Journal Gazette reports.

15 Mar 2010

CytRx plans five Phase 2 clinical trials with oncology drug candidates

CytRx Corporation, a biopharmaceutical company specializing in oncology, today reported financial results for the twelve months ended December 31, 2009, and affirmed its 2010 milestones of commencing up to five Phase 2 clinical trials with its oncology drug candidates.

15 Mar 2010

COBRA health insurance program changes confuse consumers

Kaiser Health News staff writer Jenny Gold writes about the confusion currently surrounding consumers. "Every day, dozens of confused, laid-off workers call the COBRA Help Center in Long Island, N.Y., a small private company which administers COBRA group health insurance plans.

15 Mar 2010

Program to obtain transplant organs from ER patients creates controversy

The Washington Post: "In the hope of expanding a controversial form of organ donation into emergency rooms around the United States, a federally funded project has begun trying to obtain kidneys, livers and possibly other body parts from car-accident victims, heart-attack fatalities and other urgent-care patients.

15 Mar 2010

Metastatic melanoma: Involvement of immune system in response to PV-10 therapy

Provectus Pharmaceuticals, Inc., a development-stage oncology and dermatology biopharmaceutical company, announced today that Dr. Sanjiv Agarwala, in his presentation at the Seventh International Symposium on Melanoma and Other Cutaneous Malignancies on March 12, 2010, commented on the involvement of the immune system in response to PV-10 therapy and its role in the “bystander effect” in treating metastatic melanoma. Dr. Agarwala’s presentation, entitled “Chemoablation in Melanoma: An Update,” was given in the session entitled “Unique Approaches to Melanoma Therapy.”

15 Mar 2010

Caliper Life Sciences enters into settlement agreement with Shimadzu and its subsidiary Shimadzu Scientific Instruments

Caliper Life Sciences, Inc., a leading provider of tools and services for drug discovery and life sciences research, today announces that it has entered into a settlement agreement with Shimadzu Corporation and its wholly owned subsidiary Shimadzu Scientific Instruments, Inc., resolving a lawsuit filed by Caliper in the United States District Court for the Eastern District of Texas that claimed that Shimadzu's MultiNA microchip-based electrophoresis system infringed several U.S. patents relating to Caliper's microfluidic LabChip® technology.

15 Mar 2010

Hemispherx Biopharma reports net loss of $13,438,000 for fiscal year 2009

Hemispherx Biopharma, Inc., announced its financial results for the fiscal year ended December 31, 2009. The net loss for the year (including non-cash charges) was approximately $13,438,000 or $0.12 per share as compared to a net loss of $12,219,000 or $0.16 per share in 2008.

15 Mar 2010

YM BioSciences: Two posters on nimotuzumab accepted for presentation at AACR

YM BioSciences Inc., today announced that two posters have been accepted for presentation at the American Association for Cancer Research (AACR) Annual Meeting to be held from April 17-21 in Washington, DC. The first poster describes the results of the previously reported collaboration with researchers at the University of Toronto for the development of highly potent antibody-radionuclide conjugates for use in the treatment of cancer. The poster will describe activity of 111In-NLS-nimotuzumab against breast cancer cells with high and low EGFR expression.

15 Mar 2010

Alnylam Pharmaceuticals presents data on RNAi therapeutic targeting PCSK9 for hypercholesterolemia

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today the presentation of new pre-clinical data from its hypercholesterolemia program, performed in collaboration with scientists at the University of Texas Southwestern Medical Center at Dallas. The data were presented at the PCSK9 Conference: From Gene to Therapeutics held in Nantes, France from March 11-13, 2010.

15 Mar 2010

Insmed posts net profit of $2.3M for fourth-quarter 2009

Insmed Inc., a biopharmaceutical company, today reported results for the fourth quarter and full-year ended December 31, 2009.

15 Mar 2010

IMIX, Sunstone Capital sign investment agreement

Sunstone Capital has signed an investment agreement with IMIX, an end-user provider of superior digital radiography (DR) systems for hospitals and specialist clinics. Simultaneously IMIX and ARCOMA AB, a leading OEM supplier of medical and radiology systems and sub-systems, have signed a Letter of Intent to combine the activities of the two companies in a single holding company, IMIX Holding AB. The combined company will become a leading global supplier of radiographic solutions.

15 Mar 2010

Healthways, Blue Zones establish Healthways-Blue Zones Vitality Quest to improve community well-being

Today, Healthways, Inc. and Blue Zones, LLC, announced the establishment of Healthways-Blue Zones Vitality QuestSM, an exclusive, strategic relationship to create, support and sustain a national movement to improve community health and well-being, initially for cities in the U.S.

15 Mar 2010

StockPreacher.com announces investment report featuring GenVec

StockPreacher.com announces an investment report featuring GenVec Inc. The report includes financial, comparative and investment analyses, and industry information you need to know to make an educated investment decision.

15 Mar 2010