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FDA extends Tarceva's sNDA review period

OSI Pharmaceuticals, Inc. and Genentech, Inc., a wholly owned member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for Tarceva® (erlotinib) as a first-line maintenance therapy in advanced non-small cell lung cancer (NSCLC) by an additional 90 days.

18 Jan 2010

Scientists manipulate and expand the number of stem/progenitor cells

Scientists at Fred Hutchinson Cancer Research Center have cleared a major technical hurdle to making umbilical-cord-blood transplants a more widely-used method for treating leukemia and other blood cancers.

18 Jan 2010

Dramatically enhanced image contrast could revolutionize diagnostics and therapeutics

A Northwestern University study shows that coupling a magnetic resonance imaging (MRI) contrast agent to a nanodiamond results in dramatically enhanced signal intensity and thus vivid image contrast.

18 Jan 2010

Fourth edition of IDF Diabetes Atlas reports high incidence of diabetes in developing countries

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18 Jan 2010

Massage, manipulation and other hands-on approaches can reduce chronic pain

The January issue of Mayo Clinic Women's HealthSource discusses the uses and benefits of massage, spinal manipulation, and Rolfing, as well as the Alexander technique and the Feldenkrais method

18 Jan 2010

Obama signals interest in reducing the protections for biologic drugs

Lobbyists for generic biologic drugmakers are fighting to undercut a provision in the proposed health overhaul that would protect brand-name pharmaceutical companies from lower-cost, generic competition over new products for 12 years, the Associated Press reports. The generic companies have friends in high places: "White House officials and Rep. Henry Waxman, D-Calif., chairman of the House Energy and Commerce Committee, are trying to reduce the curbs against competition to 10 years or less" (Fram, 1/14).

18 Jan 2010

Also in global health news: Anti-gay bill; Bush Institute TV show; funds for HIV programs in Kenya; EU aid commitments

Ugandan President Yoweri Museveni on Tuesday publicly acknowledged the need to address the impact an anti-gay bill before the Ugandan parliament could have on foreign policy, Agence France-Presse reports (1/12).

18 Jan 2010

Joubert Syndrome - an inherited neurological disease found among Ashkenazi Jews

Two scientists from Cold Spring Harbor Laboratory (CSHL) are part of an international team that has discovered a genetic mutation that causes Joubert Syndrome. JBTS, as it is commonly called, is a devastating inherited neurological disease that is very rare in the general population but found relatively more often among Ashkenazi Jews.

18 Jan 2010

FDA: Data from Spiriva HandiHaler do not support increased risks for stroke, heart attack or death

The U.S. Food and Drug Administration today announced that data from a recent review of the Spiriva HandiHaler, a long-acting respiratory treatment for chronic obstructive pulmonary disease (COPD), do not support an increased risk of stroke, heart attack, or death in patients using the medicine.

18 Jan 2010

Evidence suggests insulin pumps may help in maintaining blood glucose levels in type 1 diabetic patients

A new evidence review suggests that using a pump to deliver insulin continuously — instead of taking three or more daily injections — might result in better control of blood sugar for people with type 1 diabetes.

18 Jan 2010

Common head injury not taken seriously

Despite growing public interest in concussions because of serious hockey injuries or skiing deaths, a researcher from McMaster University has found that we may not be taking the common head injury seriously enough.

18 Jan 2010

Majority of healthcare professionals fail to advise patients about their fitness to drive

Many healthcare professionals are failing to advise people with medical conditions that could affect their ability to drive whether they should get behind the wheel, according to research from the University of Warwick.

18 Jan 2010

FDA approves TCA-CT's adult stem cell protocol for conducting Phase I clinical trials in ALS

TCA Cellular Therapy, LLC (TCA-CT) announced today that the U.S. Food and Drug Administration (FDA) has approved its adult stem cell protocol to conduct Phase I clinical trials to treat Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig’s disease).

18 Jan 2010

Research reveals gene activation is linked to most aggressive type of brain cancer

Glioblastoma (GBM), the brain cancer better known for having killed Senator Ted Kennedy a few months ago, is the most aggressive and lethal of all brain tumours.

18 Jan 2010

Research article addressing incidental findings in MRI-enterography in patients with CD to be published

MRI is increasingly used in the assessment of small bowel CD. Unlike conventional radiology, MRI enables visualization of disease extension beyond the intestinal wall, i.e., abscesses and fistulas. However, some extra-intestinal findings are unexpected and without relation to CD.

18 Jan 2010

Chamber of Commerce says health fight over -- but sees room to maneuver

Kaiser Health News staff writer Phil Galewitz reports on the Chamber's latest take on the next steps in health reform. "Despite unleashing a new round of TV spots last week that blasts congressional Democrats' health overhaul, the U.S. Chamber of Commerce acknowledged at a media briefing Tuesday that the fight is just about over.

18 Jan 2010

Medpace acquires Medical Consulting Dr. Schlichtiger

Medpace, a privately held, global, full-service clinical research organization, is pleased to announce that it has acquired Medical Consulting Dr. Schlichtiger GmbH, a European CRO with extensive drug development expertise providing customized regulatory and pharmacovigilance services to pharmaceutical, biotechnology and nutritional companies of all sizes based in Munich, Germany.

18 Jan 2010

Karolinska Development AB and BioChromix AB form BioChromix Pharma AB

Karolinska Development AB (publ), and BioChromix AB announced today the formation of BioChromix Pharma AB, a new company working to develop a novel Alzheimer treatment with its unique knowledge of molecular chemistry. Karolinska Development will initially take 28 percent ownership in the new company.

18 Jan 2010

Large number of infected cases in Australia attribute to failure in containing H1N1 pandemic

The rapid and widespread entry of the pandemic H1N1 infection that led to a large number of infected cases in Australia suggested a public health management failure in containing the pandemic when it broke out in April 2009.

18 Jan 2010

Republicans hint at strategy to defeat health bill

Rep. John Shadegg, R-Ariz., speaks as Reps. Joe Barton, R-Texas, and John Fleming, R-La., listen during a news conference. Shadegg held the news conference to discuss the costs of health care reform.

18 Jan 2010

Medical News

FDA extends Tarceva's sNDA review period

Scientists manipulate and expand the number of stem/progenitor cells

Dramatically enhanced image contrast could revolutionize diagnostics and therapeutics

Fourth edition of IDF Diabetes Atlas reports high incidence of diabetes in developing countries

Massage, manipulation and other hands-on approaches can reduce chronic pain

Obama signals interest in reducing the protections for biologic drugs

Also in global health news: Anti-gay bill; Bush Institute TV show; funds for HIV programs in Kenya; EU aid commitments

Joubert Syndrome - an inherited neurological disease found among Ashkenazi Jews

FDA: Data from Spiriva HandiHaler do not support increased risks for stroke, heart attack or death

Evidence suggests insulin pumps may help in maintaining blood glucose levels in type 1 diabetic patients

Common head injury not taken seriously

Majority of healthcare professionals fail to advise patients about their fitness to drive

FDA approves TCA-CT's adult stem cell protocol for conducting Phase I clinical trials in ALS

Research reveals gene activation is linked to most aggressive type of brain cancer

Research article addressing incidental findings in MRI-enterography in patients with CD to be published

Chamber of Commerce says health fight over -- but sees room to maneuver

Medpace acquires Medical Consulting Dr. Schlichtiger

Karolinska Development AB and BioChromix AB form BioChromix Pharma AB

Large number of infected cases in Australia attribute to failure in containing H1N1 pandemic

Republicans hint at strategy to defeat health bill

Evolving spectrophotometry for modern biopharma workflows

Scaling B-cell cloning workflows for antibody development

Fluidics in Modern Healthcare & Medical Device Innovation

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