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Functional biomarker could help guide treatment of patients with BRAF-mutant melanomas

A functional biomarker that can predict whether BRAF-mutant melanomas respond to drugs targeting BRAF could help guide the treatment of patients with these cancers, according to results presented here at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, held Oct. 19 - 23.

23 Oct 2013

FDA alerts on voluntary recall of sterile use products from Specialty Compounding

The U.S. Food and Drug Administration is alerting hospitals, health care providers, veterinarians, and patients of a voluntary recall of certain human and veterinary products produced and distributed for sterile use by Specialty Medicine Compounding Pharmacy of South Lyon, Mich.

23 Oct 2013

FDA seeks permanent injunction against dietary supplement manufacturer James G. Cole

The U.S. Food and Drug Administration, in a complaint filed by the U.S. Department of Justice, is seeking a permanent injunction against the dietary supplement manufacturer James G. Cole, Inc., its president, James G. Cole, and its general manager, Julie D. Graves, following the company's repeated distribution of unapproved drugs and adulterated dietary supplements in violation of the Federal Food, Drug, and Cosmetic Act.

23 Oct 2013

FDA grants Breakthrough Therapy designation to MK-5172/MK-8742 for chronic HCV infection

Merck, known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration has granted MK-5172/MK-8742 Breakthrough Therapy designation for treatment of chronic hepatitis C virus infection.

23 Oct 2013

Study evaluates role of enteroviruses in human type 1 diabetes

Type 1 diabetes is a disease caused by the destruction of the insulin-producing cells in the pancreas. It is often diagnosed in childhood and requires life-long treatment with daily insulin injections. It is associated with an increased risk for long-term complications which decrease the quality of life and average life-expectancy.

23 Oct 2013

FDA issues final approval for Lupin's sNDA for Antara capsules

Pharma Major Lupin Limited announced today that it has received final approval for its supplemental New Drug Application for Antara (Fenofibrate) capsules, 30 mg & 90 mg strengths from the United States Food and Drug Administration.

23 Oct 2013

CSI receives PMA approval to market Diamondback 360 Coronary Orbital Atherectomy System

Cardiovascular Systems, Inc., today announced that it has received PMA approval from the U.S. Food and Drug Administration to market its Diamondback 360® Coronary Orbital Atherectomy System (OAS) as a treatment for severely calcified coronary arteries.

22 Oct 2013

Pfizer to continue development of Remoxy Extended-Release Capsules CII

Pfizer Inc. announced today that, having achieved technical milestones related to manufacturing, it will continue the development program for Remoxy (oxycodone) Extended-Release Capsules CII.

22 Oct 2013

FDA grants orphan drug designation to Aduro's CRS-207 for treatment of pancreatic cancer

Aduro BioTech, Inc. announced today that the Office of Orphan Products Development of the Food and Drug Administration has granted orphan drug designation for CRS-207, a novel immunotherapy, for the treatment of pancreatic cancer.

22 Oct 2013

diaDexus amends agreement with Comerica Bank to expand existing loan facility

diaDexus, Inc., a company developing and commercializing proprietary cardiovascular diagnostic products, today announced that it has amended its agreement with Comerica Bank to expand its existing loan facility from $5 million to $10 million.

22 Oct 2013

Psychotherapy: New treatment choice for anorexia nervosa

A large-scale study has now shown that adult women with anorexia whose disorder is not too severe can be treated successfully on an out-patient basis. Even after conclusion of therapy, they continue to make significant weight gains.

22 Oct 2013

Capsugel launches Coni-Snap sprinkle capsule for people with difficulties swallowing

Capsugel is launching an innovative capsule design to improve adherence to treatment regimens for patients with difficulties swallowing. These patients include babies, children, and older adults as well as patients with medical conditions such as Alzheimer's, Parkinson's, and Multiple Sclerosis. The new Coni-Snap sprinkle capsule is expected to be available in 2014.

22 Oct 2013

Republicans see new political battleground because of bumpy health exchange rollout

Though the health law came through the most recent budget battle unscathed, its opponents view the problems with the website as a potential opportunity -- both in terms of the fight to derail the law and as an election issue for the upcoming campaign cycle.

22 Oct 2013

Researchers identify agricultural management practices that can reduce contamination risk in produce

Researchers from Cornell University have identified some agricultural management practices in the field that can either boost or reduce the risk of contamination in produce from two major foodborne pathogens: salmonella, the biggest single killer among the foodborne microbes, and Listeria monocytogenes.

22 Oct 2013

Pancreatic cancer patients may benefit from antibody-drug conjugates

Patients with pancreatic cancer may benefit from an investigational member of an emerging class of anticancer drugs called antibody-drug conjugates, according to preclinical results presented here at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, held Oct. 19-23.

22 Oct 2013

FDA approves SC formulation of Genentech's Actemra for rheumatoid arthritis

Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration has approved a subcutaneous formulation of Actemra (tocilizumab) for the treatment of adults with moderately to severely active rheumatoid arthritis who have used one or more disease-modifying antirheumatic drugs, such as methotrexate, that did not provide enough relief.

22 Oct 2013

Guerbet receives FDA Orphan Drug Designation for Lipiodol Injection

Guerbet LLC, USA -- Guerbet, a pioneer in the field of contrast agents with more than 80 years of experience, announced that it has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) for Lipiodol (Ethiodized Oil) Injection for management of patients with known hepatocellular carcinoma (HCC).

22 Oct 2013

Food News and Research

Functional biomarker could help guide treatment of patients with BRAF-mutant melanomas

FDA alerts on voluntary recall of sterile use products from Specialty Compounding

FDA seeks permanent injunction against dietary supplement manufacturer James G. Cole

FDA grants Breakthrough Therapy designation to MK-5172/MK-8742 for chronic HCV infection

Study evaluates role of enteroviruses in human type 1 diabetes

FDA issues final approval for Lupin's sNDA for Antara capsules

CSI receives PMA approval to market Diamondback 360 Coronary Orbital Atherectomy System

Pfizer to continue development of Remoxy Extended-Release Capsules CII

FDA grants orphan drug designation to Aduro's CRS-207 for treatment of pancreatic cancer

diaDexus amends agreement with Comerica Bank to expand existing loan facility

Psychotherapy: New treatment choice for anorexia nervosa

Capsugel launches Coni-Snap sprinkle capsule for people with difficulties swallowing

Republicans see new political battleground because of bumpy health exchange rollout

Researchers identify agricultural management practices that can reduce contamination risk in produce

Pancreatic cancer patients may benefit from antibody-drug conjugates

FDA approves SC formulation of Genentech's Actemra for rheumatoid arthritis

Guerbet receives FDA Orphan Drug Designation for Lipiodol Injection

Dietary change should be considered in chronic prostatitis

FDA approves Cubist Pharmaceuticals' sNDA for ENTEREG

DOH releases SPHHS study investigating prescribing of antipsychotics to District seniors

The future is bioengineered: Synthetic biology and global sustainability eBook

Managing vibration in IVF laboratories

A New Approach to Preventing Bladder Cancer Recurrence

Bringing real-time analytics to downstream bioprocess monitoring

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