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Researchers develop mathematical framework for vaccine stockpile implications

A creative version of a classic engineering technique may improve decisions about building and using supplies of important pediatric vaccines, potentially leading to lower public health costs and healthier children.The United States maintains a six-month supply of common pediatric vaccines to ensure protection from deadly diseases, such as the flu, polio, and diphtheria, despite interruptions in vaccine production.

13 Sep 2010

NanoBio Corporation to present Nanoemulsion Phase I clinical trial data at ICAAC Conference

NanoBio Corporation today announced it will present data from two separate Phase 1 clinical trials at the 2010 Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), taking place in Boston, Mass. from Sept. 12-15.

13 Sep 2010

Advaxis publishes research article on Her2 antigen for Listeria vaccine

Scientists at Advaxis, Inc.,the live, attenuated Listeria monocytogenes (Listeria) immunotherapy company, recently had their research using ADXS31-164, a live Listeria vaccine that targets Her2, published in a leading peer reviewed journal (Shahabi, et al 2010 Cancer Gene Therapy epublished ahead of print).

13 Sep 2010

MRSA infection hVISA linked to mortality

A MRSA infection with a reduced susceptibility to the potent antibiotic drug vancomycin is linked to high mortality, according to a Henry Ford Hospital study.

12 Sep 2010

Lantheus Medical Imaging supports FDA action to ensure appropriate use of gadolinium-based contrast agents

Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic medical imaging, supports the U.S. Food and Drug Administration's (FDA) announcement requiring safety-related label changes for all gadolinium-based contrast agents to highlight the rare and potentially fatal condition known as nephrogenic systemic fibrosis (NSF).

10 Sep 2010

K-V successfully completes FDA inspection for resumption of manufacturing and shipment of products

K-V Pharmaceutical Company announced today that it has received notice from the U.S. Food and Drug Administration ("FDA") of the successful completion of an inspection of the Company's facilities and approval to return its first product to market. Under the Company's Consent Decree, successful FDA inspections of the Company's quality systems, processes and facilities are expected to be required before K-V is permitted to resume manufacturing and shipment of particular products.

10 Sep 2010

Harris Teeter to distribute Oragenics' EvoraPlus and EvoraKids oral care probiotics

Florida-based biopharmaceutical company Oragenics, Inc. has announced the continued retail expansion of its oral care probiotics EvoraPlus and EvoraKids™ with an initial order from Harris Teeter. It is anticipated that the products will be available at Harris Teeter stores in September 2010.

10 Sep 2010

PurCotton brand promotional events held in Shenzhen

Winner Medical Group Inc., a leading manufacturer of medical dressings, medical disposables and non-woven PurCotton(R) materials for the medical and consumer products industries in China, today announced that a successful promotional event was recently held by Winner Medical and U.S. Cotton Incorporated (or "Cotton Inc.") to promote PurCotton(R) brand in a high footprint shopping mall in Shenzhen.

10 Sep 2010

Current treatment strategies for mood and addictive disorders

Sober Living in Delray, Recovery Residences, in conjunction with the "Moment of Change - Intervention Approaches for Professionals - 32nd National Conference" is sponsoring the presentation of "Mood Disorders and Addictive Disorders: Current Treatment Strategies" at 7:00 PM on Wednesday, September 29th, 2010 at the Old Calypso Restaurant in Delray Beach, Florida.

10 Sep 2010

395 new vaccines being developed for infectious diseases: PhRMA

Critical challenges remain in the centuries-old battles against infectious diseases, particularly as bacteria and viruses mutate and as the threat of bioterrorism grows. Responding to this need, America's biopharmaceutical research companies this year have 395 new medicines and vaccines in the pipeline to fight infectious diseases. All 395 are in later stages of development, meaning in clinical trials or under Food and Drug Administration (FDA) review.

10 Sep 2010

John Theurer Cancer Center plays major role in FDA's fast tracking of ipilimumab for metastatic melanoma

Researchers from the John Theurer Cancer Center at Hackensack University Medical Center played an important role in a study that led to the Food & Drug Administration's (FDA) recent fast tracking of ipilimumab, a promising treatment for metastatic melanoma. The FDA based its decision largely on the results of a pivotal study published in the New England Journal of Medicine on August 19, 2010 – the same day the agency accepted Bristol-Myers Squibb's application for the drug's approval and granted the application priority review status.

10 Sep 2010

Koronis Pharmaceuticals to present KP-1461 clinical trial data at ICAAC Conference

Koronis Pharmaceuticals, Inc., a biotechnology company focused on the development of antiviral therapeutics, today announced that clinical trial data demonstrating that the Company's lead HIV drug, KP-1461, resulted in increased HIV mutations consistent with the Viral Decay Acceleration mechanism will be featured in a late-breaker oral presentation by James Mullins, Ph.D., Professor of Microbiology and Medicine at the University of Washington, at the upcoming 50th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) taking place in Boston, MA.

10 Sep 2010

Illinois researcher urges CDC to revisit pediatric vaccine stockpile policies

Vaccine manufacturers and public health decision-makers need to collaborate in a more efficient and effective manner not only to reduce the likelihood of supply shortages for pediatric vaccines but also to maximize community immunity by using vaccine doses to increase coverage, according to research published by a University of Illinois researcher who specializes in statistics and data analysis.

10 Sep 2010

GBCAs carry new warnings on their labels about risk of NSF: FDA

The U.S. Food and Drug Administration is requiring that gadolinium-based contrast agents (GBCAs) carry new warnings on their labels about the risk of a rare and potentially fatal condition known as nephrogenic systemic fibrosis, if the drug is administered to certain patients with kidney disease.

10 Sep 2010

Meditrina licensor AstraZeneca granted US allowance of patent for endometriosis treatment

Meditrina Pharmaceuticals, Inc., a clinical-stage, specialty pharmaceutical company focused on developing and commercializing innovative therapies that treat women's reproductive system disorders, today announced that the United States Patent and Trademark Office (USPTO) has issued a notice of allowance of a patent entitled "Composition Comprising a Combination of an Aromatase Inhibitor, a Progestin, and an Oestrogen and its Use for the Treatment of Endometriosis" to the Company's licensor AstraZeneca.

10 Sep 2010

Survey finds women mistreat yeast infections

Few women go through life having never suffered from the uncomfortable symptoms of a yeast infection. In fact, nearly 3 in 4 (72 percent) women will experience their first yeast infection before age 25. Furthermore, the incidence of yeast infections is highest among young women ages 18-24, who are new to the category and uncertain about symptoms and available treatment options.

10 Sep 2010

Shire announces expansion of Human Genetic Therapies pipeline

Shire plc, the global specialty biopharmaceutical company, today announced the expansion of its Human Genetic Therapies pipeline through the exclusive license, in markets outside of North America, for the activin receptor type IIB class of molecules being developed by Acceleron Pharma Inc., a private biotechnology company based in Cambridge, Massachusetts.

10 Sep 2010

FDA approves pediatric use of Protopam Chloride

The U.S. Food and Drug Administration has approved the pediatric use of Protopam Chloride (pralidoxime chloride), a drug used to treat poisoning by organophosphate pesticides and chemicals (e.g., nerve agents). The drug is approved to be administered either by intravenous (IV) or intramuscular (IM) injections.

10 Sep 2010

Noscira receives FDA approval for Tideglusib drug to treat PSP

Noscira, a Grupo Zeltia subsidiary specialized in research and development of drugs to treat neurodegenerative diseases, has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track status to its neuroprotector drug Tideglusib (ZentylorTM) to treat Progressive Supranuclear Palsy (PSP), a fast-advancing fatal degenerative brain disorder.

10 Sep 2010

New melanoma drug in the pipeline from Plexxikon and Roche

Researchers from biotech company Plexxikon have found that their candidate drug for skin cancer melanomas can be administered more effectively in early stages of the disease.

9 Sep 2010