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Alchemia initiates HA-Irinotecan Phase II clinical study in SCLC

Alchemia Limited, today announced the initiation of recruitment for a Phase II clinical study of its lead cancer drug HA-Irinotecan in Small Cell Lung Cancer (SCLC). Two patients have received their first doses of therapy. This investigator sponsored trial is being conducted at Monash Cancer Centre, Southern Health and Peninsula Oncology Centre in Melbourne, Victoria.

12 Sep 2011

Genentech submits NDA to FDA for vismodegib to treat advanced basal cell carcinoma

Curis, Inc., a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced that its collaborator Genentech, a member of the Roche Group, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking sales and marketing approval for vismodegib to treat people with advanced basal cell carcinoma (BCC), which includes metastatic and locally advanced BCC for whom surgery is inappropriate.

12 Sep 2011

Genentech submits vismodegib NDA to FDA for treatment of advanced basal cell carcinoma

Genentech, a member of the Roche Group, today announced that the company has submitted a New Drug Application for vismodegib to the U.S. Food and Drug Administration (FDA) for the treatment of people with advanced basal cell carcinoma (BCC) for whom surgery is considered inappropriate.

12 Sep 2011

EpiCept announces FDA's feedback on Ceplene clinical development for AML

EpiCept Corporation today announced that at a recent meeting with the U.S. Food and Drug Administration (FDA) the Company was provided more definitive guidance regarding the clinical development of Ceplene, the Company's lead product administered with interleukin-2 (IL-2) for the remission maintenance and prevention of relapse of patients with acute myeloid leukemia (AML) in first complete remission.

12 Sep 2011

FDA advisory panel suggests warning for bisphosphonates but does not specify wording

Two independent advisory panels to the Food and Drug Administration (FDA) on Friday recommended increasing the cautionary language on the product labels of bone-building drugs taken by more than five million women in the United States. They did not however mention the exact words of the safety warnings and did not recommend limiting use of the drugs to a proposed five years. About 11 percent of women 55 and older take the drugs to prevent bone fractures.

12 Sep 2011

Boston Scientific releases statement on safety, effectiveness of surgical mesh for POP and SUI

Boston Scientific Corporation today issued the following statement from John Pedersen, Senior Vice President and President of the Company's Urology and Women's Health Division, following the conclusion of a two-day meeting of the U.S. Food and Drug Administration (FDA) Obstetrics & Gynecology Devices Advisory Committee.

12 Sep 2011

General anesthesia can cause cognitive impairment in children

General anesthesia administered to the developing animal brain depresses much needed neuronal activity and communication resulting in long-lasting cognitive impairment, according to an article published in the August issue of Current Opinion in Anesthesiology.

12 Sep 2011

Diamyd receives NIH grant to develop NTDDS for Chemotherapy Induced Peripheral Neuropathy

Diamyd Medical AB with collaborators has received a three million dollar grant from the US National Institutes of Health to develop the Company's patented Nerve Targeting Drug Delivery System (NTDDS) for prevention of Chemotherapy Induced Peripheral Neuropathy.

12 Sep 2011

FDA grants orphan drug designation for Avedro's VibeX to treat Keratoconus

Avedro, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the Company's VibeX for use with its KXL System (UVA irradiation) for Corneal Cross-linking to treat Keratoconus.

12 Sep 2011

UMSOM to receive FDA approval for whole parasite malaria vaccine clinical trials

For the first time, a malaria vaccine that uses the entire malaria parasite has proven safe and shown promise to produce a strong immune response in a clinical trial, according to a new study co-authored by researchers at the University of Maryland School of Medicine Center for Vaccine Development.

12 Sep 2011

Australian scientists create iron-rich 'super rice'

Scientists from three universities in South Australia and the University of Melbourne have created genetically modified rice that "has up to four times more iron than conventional rice and twice as much zinc" in an effort to "provide a solution to the iron and zinc deficiency disorders that affect billions of people throughout the world," News Corp Australian Papers/Fox News reports.

12 Sep 2011

Black children more at risk for peanut allergy: Study

U.S. researchers examined the genetic profiles of more than 1,100 urban children of different races, averaging around 3 years of age, and found that black children were more likely to have allergic antibodies to food allergens. The study also found that African ancestry was linked with levels of allergic antibodies to peanut typically associated with clinical peanut allergies.

9 Sep 2011

FDA panel votes 9-2 in favor of new blood thinner drug

A new stroke preventer from Bayer and Johnson & Johnson – Xarelto moved one step closer to U.S. approval, but questions remained about restrictions on labeling and the need for more studies.

9 Sep 2011

Viewpoints: 4th Circuit decision; Advice for the FDA; Docs and the AMA

Minutes after President Obama signed his health-care program into law on March 23, 2010, Virginia Attorney General Ken Cuccinelli II raced to become the first state official to challenge it in court. But as a federal appeals court panel concluded Thursday, being first isn't the same as being right. ... Even if timing were not an issue, the notion that a state could nullify a federal program in this way is absurd (9/8).

9 Sep 2011

Ultrasonic neuromodulation can be quickly applied in neurocritical care situations

The discovery that low-intensity, pulsed ultrasound can be used to noninvasively stimulate intact brain circuits holds promise for engineering rapid-response medical devices.

9 Sep 2011

Rich countries watering down NCD commitments to appease multinational companies

Professor and director of the WHO Collaborating Centre for Obesity Prevention at Deakin University in Australia, examines how "rich countries, ... particularly the U.S. and European Union but also Australia, Canada and New Zealand, ... are joining forces with tobacco, food, alcohol and pharmaceutical corporations to water down commitments that might flow from" this month's U.N. High-level Meeting on Non-Communicable Diseases (NCDs) in New York.

9 Sep 2011

Novel solution for purifying stem cell mixtures

Stem cells show great potential to enable treatments for conditions such as spinal injuries or Lou Gehrig's disease, and also as research tools. One of the greatest problems slowing such work is that researchers have found major complications in purifying cell mixtures, for instance to remove stem cells that can cause tumors from cells developed for use in medical treatments.

9 Sep 2011

Duties, role of clinical laboratory microbiologists could change significantly in the future

With the increasing availability of sophisticated technologies to rapidly diagnose and treat infectious diseases, the duties and the role of clinical laboratory microbiologists, who traditionally perform these tests, could see significant changes in the next few years. That is one of the conclusions of a series of reports published in a special supplement to the September 2011 Journal of Clinical Microbiology.

9 Sep 2011

FDA grants final approval for Mylan's Promethazine HCl Tablets

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Promethazine Hydrochloride (HCl) Tablets USP, 12.5 mg, 25 mg and 50 mg. Promethazine HCl Tablets are used to relieve the symptoms of certain allergic reactions, such as perennial and seasonal allergic rhinitis.

9 Sep 2011

Longer looks: Unknowns in sports medicine; shackling pregnant prisoners

Medical experts say that multiple futile treatments is all too familiar and points to growing problems in sports medicine, a medical subspecialty that has been experiencing explosive growth. now researchers are questioning many of the procedures, including new ones that often have no rigorous studies to back them up. "Patients come in and say, 'I want the same thing that Tiger Woods had,' " said Dr. McDevitt, the sports medicine orthopedist in Maryland.

9 Sep 2011

Food News and Research

Alchemia initiates HA-Irinotecan Phase II clinical study in SCLC

Genentech submits NDA to FDA for vismodegib to treat advanced basal cell carcinoma

Genentech submits vismodegib NDA to FDA for treatment of advanced basal cell carcinoma

EpiCept announces FDA's feedback on Ceplene clinical development for AML

FDA advisory panel suggests warning for bisphosphonates but does not specify wording

Boston Scientific releases statement on safety, effectiveness of surgical mesh for POP and SUI

General anesthesia can cause cognitive impairment in children

Diamyd receives NIH grant to develop NTDDS for Chemotherapy Induced Peripheral Neuropathy

FDA grants orphan drug designation for Avedro's VibeX to treat Keratoconus

UMSOM to receive FDA approval for whole parasite malaria vaccine clinical trials

Australian scientists create iron-rich 'super rice'

Black children more at risk for peanut allergy: Study

FDA panel votes 9-2 in favor of new blood thinner drug

Viewpoints: 4th Circuit decision; Advice for the FDA; Docs and the AMA

Ultrasonic neuromodulation can be quickly applied in neurocritical care situations

Rich countries watering down NCD commitments to appease multinational companies

Novel solution for purifying stem cell mixtures

Duties, role of clinical laboratory microbiologists could change significantly in the future

FDA grants final approval for Mylan's Promethazine HCl Tablets

Longer looks: Unknowns in sports medicine; shackling pregnant prisoners

Understanding cultivated meat and its global potential eBook

Improving healthcare sustainability through carbon data

A New Approach to Preventing Bladder Cancer Recurrence

Bringing real-time analytics to downstream bioprocess monitoring

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