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Amylin, Lilly submit BYETTA sNDA for type 2 diabetes

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced that a supplemental New Drug Application (sNDA) has been submitted to the U.S. Food and Drug Administration (FDA) for the expanded use of BYETTA® (exenatide) injection as an add-on therapy to basal insulin, with or without metformin and/or a thiazolidinedione (TZD) in conjunction with diet and exercise for adults with type 2 diabetes who are not achieving adequate glycemic control.

23 Dec 2010

mTORC1 cellular pathway affects aging phenotype

Whitehead Institute researchers have linked hyperactivity in the mechanistic target of rapamycin complex 1 (mTORC1) cellular pathway, to reduced ketone production, which is a well-defined physiological trait of aging in mice.

23 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

Therapies to target self-renewing population of chemotherapy-resistant cells needed

Leukemia patients whose cancers express higher levels of genes associated with cancer stem cells have a significantly poorer prognosis than patients with lower levels of the genes, say researchers at the Stanford University School of Medicine. The finding is among the first to show that the cancer stem cell hypothesis - which posits that some cancers spring from and are replenished by a small, hardy population of self-renewing cells - can be used to predict outcomes in a large group of patients and one day to tailor treatments in the clinic.

22 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

Study aims to deliver safer bone marrow transplant treatment strategy in patients with multiple myeloma cancer

A national clinical trial, which opens imminently, will aim to assess the impact of a novel anti-cancer drug in the setting of donor bone marrow transplantation for myeloma.

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

Genetic sequencing may serve as new diagnostic tool for unknown disease

A collaborative team of scientists and physicians at the Medical College of Wisconsin and Children's Hospital of Wisconsin uses genetic sequencing to identify and treat an unknown disease.

21 Dec 2010

FMCNA recommends dialysis patients to take precautions during severe weather

Fresenius Medical Care North America, the nation's leading network of dialysis facilities, reminds dialysis patients to take precautions now so they are not caught off guard when severe weather hits in their home community.

21 Dec 2010

Study: Chemotherapy can improve survival rate in older adolescents with leukemia

Research led by St. Jude Children-s Research Hospital investigators will likely impact how acute lymphoblastic leukemia is treated in young adults and shows older adolescent age does not dictate worse outcomes against the most common childhood cancer.

21 Dec 2010

Positive results from Incyte's COMFORT-I INCB18424 pivotal Phase III clinical trial in myelofibrosis

Incyte Corporation announced today positive top-line results from COMFORT-I, the pivotal Phase III clinical trial of INCB18424 (also known as INC424) in patients with myelofibrosis (MF) being conducted under a Food and Drug Administration (FDA) Special Protocol Assessment (SPA) Agreement. COMFORT-I (COntrolled MyeloFibrosis Study with ORal JAK Inhibitor Treatment) is a double-blind, placebo-controlled Phase III trial involving 309 patients.

21 Dec 2010

New study finds racial, ethnic disparities in cancer treatment

Black people with early stage liver cancer were more likely than white patients to die from their disease, according to a new study from the University of Michigan Comprehensive Cancer Center.

21 Dec 2010

Exome sequencing leads to correct diagnosis and life-saving treatment for mysterious genetic disorder

A genetic testing approach called exome sequencing—which provides a clinically practical alternative to whole-genome sequencing—led to correct diagnosis and life-saving treatment in a child with a previously unknown genetic disease, reports an upcoming paper in Genetics in Medicine, the official peer-reviewed journal of The American College of Medical Genetics (ACMG). The journal is published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health.

21 Dec 2010

Health-care coverage program for kids ends in Ariz.; Florida Medicaid patient information may be at risk

A new audit criticizes the Florida Agency for Health Care Administration and a contractor for failing to properly control access to computer systems that include sensitive information about Medicaid beneficiaries (Saunders, 12/17).

20 Dec 2010

Isotechnika, Paladin receive screening acceptance for Voclera for approval in Canada

Isotechnika Pharma Inc. and Paladin Labs Inc. announced today that they have submitted the dossier and received screening acceptance for VocleraTM (voclosporin) for approval in the Canadian market. VocleraTM is a novel immunosuppressive drug in the class of calcineurin inhibitors and is indicated for the treatment of moderate to severe psoriasis.

20 Dec 2010

First Edition: December 20, 2010

Today's headlines include more analysis on the continuing legal challenges to the health law and the path they might take to the Supreme Court.

20 Dec 2010

Possible stem cell cure for AIDS

An explosion of stem cell breakthroughs, including a possible cure for AIDS, is reshaping the possibilities for curing deadly and debilitating diseases around the globe, says Emerging Healthcare Solutions President and CEO Cindy Morrissey.

17 Dec 2010

Pediatric plastic surgeon reconstructs patient's jaw

Pediatric plastic surgeon Rohit Khosla, MD, had never seen a case like it: the 12-year-old boy's face ballooned with a rare, aggressive bone tumor. Although it was non-cancerous, the tumor was destroying the patient's jaw. Khosla knew he would need an innovative approach to save the boy's ability to chew.

17 Dec 2010

UIC introduces robotic kidney transplantation surgery for obese recipients

Surgeons at the University of Illinois Medical Center at Chicago are the first to offer robotic kidney transplantation to morbidly obese patients and report fewer complications among this high risk population.

17 Dec 2010

Gen-Probe announces GTI Diagnostics acquisition from Riverside Company

Gen-Probe Incorporated announced today that the Company has acquired GTI Diagnostics, a privately held specialty diagnostics company focused on the transplantation, blood bank and specialty coagulation markets, for $53 million in cash.

17 Dec 2010

Transplant News and Research

Amylin, Lilly submit BYETTA sNDA for type 2 diabetes

mTORC1 cellular pathway affects aging phenotype

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

Therapies to target self-renewing population of chemotherapy-resistant cells needed

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

Study aims to deliver safer bone marrow transplant treatment strategy in patients with multiple myeloma cancer

Genzyme provides information on peak sale of alemtuzumab for multiple sclerosis

Genetic sequencing may serve as new diagnostic tool for unknown disease

FMCNA recommends dialysis patients to take precautions during severe weather

Study: Chemotherapy can improve survival rate in older adolescents with leukemia

Positive results from Incyte's COMFORT-I INCB18424 pivotal Phase III clinical trial in myelofibrosis

New study finds racial, ethnic disparities in cancer treatment

Exome sequencing leads to correct diagnosis and life-saving treatment for mysterious genetic disorder

Health-care coverage program for kids ends in Ariz.; Florida Medicaid patient information may be at risk

Isotechnika, Paladin receive screening acceptance for Voclera for approval in Canada

First Edition: December 20, 2010

Possible stem cell cure for AIDS

Pediatric plastic surgeon reconstructs patient's jaw

UIC introduces robotic kidney transplantation surgery for obese recipients

Gen-Probe announces GTI Diagnostics acquisition from Riverside Company

Sensing a Healthier Future

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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