Biologics Drug / Agent News and Research

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GlaxoSmithKline and Cellzome announce major strategic alliance

Cellzome Inc. and GlaxoSmithKline have announced the signing of a worldwide strategic alliance to discover, develop and market novel kinase-targeted therapeutics to treat inflammatory diseases.

10 Sep 2008

Seattle department finds OraSure HIV test to be less accurate than label claims

A report by Public Health -- Seattle and King County in Washington state has found that testing with OraSure Technologies' OraQuick test provides less accurate results than the label claims, Bloomberg reports.

7 Sep 2008

FDA assigns priority review to ATryn from GTC Biotherapeutics

The US Food and Drug Administration, or FDA, has assigned Priority Review to GTC Biotherapeutics, Inc.'s Biologic License Application, or BLA, for ATryn.

4 Sep 2008

FDA grants IND for Davanat to treat breast cancer patient

Pro-Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted an Investigational New Drug (IND) application for use of Davanat in combination with 5-FU to treat a breast cancer patient at the Brown Cancer Center in Louisville, Kentucky. Davanat also is being administered in Phase II clinical trials for first-line treatment of colorectal and biliary cancer patients.

28 Aug 2008

VioQuest Pharmaceuticals issued new U.S. patent for Lenocta

VioQuest Pharmaceuticals today announced that the United States Patent and Trademark Office has issued the first patent for the company's investigational product candidate Lenocta (sodium stibogluconate). U.S. Patent No. 7,416,723 entitled "Therapeutic compositions and methods useful in modulating protein tyrosine phosphatases," encompasses novel compositions including Lenocta for the treatment of cancer and a broad range of other diseases.

26 Aug 2008

Asian-American/Pacific Islanders have higher survival rates than others for gastric cancers

Asian-American/Pacific Islanders with early-stage stomach cancers have an overall median survival rate that is higher than those of other races or ethnicities, according to new research, Reuters Health reports.

26 Aug 2008

GSK begins shipments of Fluarix and FluLaval to U.S. customers for 2008-2009 flu season

GlaxoSmithKline has announced that it will begin shipment of Flulaval [Influenza Virus Vaccine] and Fluarix [Influenza Virus Vaccine] to U.S. customers for the 2008-2009 influenza season.

11 Aug 2008

FDA approves seasons influenza vaccines

The U.S. Food and Drug Administration (FDA) today announced that it has approved this year's seasonal influenza vaccines that include new strains of the virus likely to cause flu in the United States during the 2008-2009 season.

5 Aug 2008

New technique measures formation of clumps of proteins in protein-based pharmaceuticals

Scientists at the National Institute of Standards and Technology (NIST) have developed a technique to measure the formation of clumps of proteins in protein-based pharmaceuticals.

23 Jul 2008

Teva Pharmaceutical Industries to buy Barr Pharmaceuticals

Teva Pharmaceutical Industries Ltd and Barr Pharmaceuticals, Inc. announced today that they have signed a definitive agreement under which Teva will acquire Barr, the fourth largest generic drug company worldwide.

18 Jul 2008

Researchers find better way to distinguish melanoma from some benign moles

University of Rochester Medical Center researchers found a new protein produced excessively in malignant melanoma, a discovery that is particularly relevant as skin cancer rates climb dramatically among young women.

17 Jul 2008

46 percent of Americans show biologic exposure to the deadly toxins found in cigarettes

A new report issued today by the Centers for Disease Control (CDC) exemplifies the need for nonsmoking Americans to be better protected against exposure to secondhand smoke. The report finds that 46 percent of Americans show biologic exposure to the deadly toxins found in cigarettes. Even more startling are the millions of children this statistic includes.

10 Jul 2008

FDA makes changes to drug approval process

The U.S. Food and Drug Administration has announced that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted.

9 Jul 2008

Being born over 10 pounds increases risk of developing rheumatoid arthritis

People who have a birthweight over 10 pounds are twice as likely to develop rheumatoid arthritis when they are adults compared to individuals born with an average birthweight, according to a study published by researchers from Hospital for Special Surgery online in advance of print in the Annals of the Rheumatic Diseases. While the mechanism for this association is unclear, the study identifies a potentially modifiable risk factor and highlights a potential way to decrease the incidence of the disease.

30 Jun 2008

High-content screening as a universal tool for fingerprinting of vytotoxicity of nanoparticles

As researchers develop an ever-expanding toolkit of nanoparticles for use as drug and imaging agent delivery vehicles, there is a growing need to understand how a given nanoparticle's physical and chemical properties affect biological activity and toxicity.

15 Jun 2008

CMS announces $15 million funding increase for Medicare counseling programs

CMS officials on Friday announced that the agency this year will increase funding by $15 million to a total of $50 million to organizations that advise Medicare beneficiaries on prescription drug and health plan choices, CQ HealthBeat reports.

11 Jun 2008

Administration proposes additional funding for FDA for fiscal year (FY) 2009

HHS Secretary Leavitt today announced that the Administration is amending its budget request for fiscal year (FY) 2009 to include an additional $275 million for the U.S. Food and Drug Administration (FDA). He called on Congress to act quickly on this budget amendment and pending Administration legislative proposals to strengthen FDA.

9 Jun 2008

Cancer warning on diabetic ulcer gel

The U.S. watchdog the Food and Drug Administration (FDA) says a warning will be added to the label of a topical gel used to treat leg and foot ulcers which refuse to heal in diabetic patients.

9 Jun 2008

FDA announces label changes for Regranex - boxed warning

The U.S. Food and Drug Administration has announced the addition of a boxed warning to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer mortality in patients who use 3 or more tubes of the product. Regranex is a topical cream indicated for the treatment of leg and foot ulcers that are not healing in diabetic patients.

8 Jun 2008

Survey shows Americans regard reducing the cost of prescription drugs as highest health care priority

In a national survey released today by the Alliance of Minority Medical Associations (AMMA), Americans noted that their highest health care priority is reducing the cost of prescription drugs. Furthermore, survey respondents shared overwhelming support for creating an approval pathway for generic, or follow-on biotechnology therapies, with 86% of likely voters stating their desire for such a system.

4 Jun 2008