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Debiopharm, Aurigene commence IND enabling studies for Debio 0617 inhibitor

Debiopharm Group, a Swiss-based global biopharmaceutical group of companies with a focus on the development of innovative prescription drugs that target unmet medical needs, and Aurigene Discovery Technologies Ltd., a Bangalore based fully integrated, global biotech focused on small molecule and peptide drug discovery and development from target identification and validation to pre IND drug candidates, today announced the successful nomination of a development candidate, Debio 0617, a novel inhibitor of an undisclosed oncology pathway.

13 Sep 2010

FDA approves FASLODEX 500mg dose for metastatic breast cancer in postmenopausal women

AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has approved the 500mg dose of FASLODEX® (fulvestrant) Injection, replacing the previously approved monthly dose of 250mg, for the treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy.

13 Sep 2010

Rib-X Pharmaceuticals presents preclinical data of radezolid drug at ICAAC Conference

Rib-X Pharmaceuticals, Inc., a development-stage antibiotics company with a broad product pipeline based on its innovative discovery platform, today announced the presentation of positive preclinical data for radezolid at the 50th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) conference.

13 Sep 2010

CRT agrees with AstraZeneca for AZD-3965 clinical trial

Cancer Research UK and Cancer Research Technology the charity's development and commercialisation arm have reached an agreement with AstraZeneca to take compound AZD-3965 a first-of-its-kind experimental drug to potentially treat a range of cancers into clinical trial.

13 Sep 2010

Covidien supports FDA labeling changes for gadolinium-based contrast agents

Covidien, a leading global provider of healthcare products, today announced it supports the U.S. Food and Drug Administration's (FDA) labeling changes for gadolinium-based contrast agents for patients with acute kidney injury or chronic, severe kidney disease.

13 Sep 2010

FDA approves CorMatrix ECM for Pericardial Closure

CorMatrix Cardiovascular, Inc., a medical device company developing and delivering unique extracellular matrix (ECM) biomaterial devices that harness the body's innate ability to repair damaged cardiovascular tissue, announced today that FDA has granted conditional approval for the start of a multi-center, prospective, randomized clinical trial to demonstrate the safety and efficacy of the CorMatrix ECM for Pericardial Closure to reduce the incidence of new onset postoperative atrial fibrillation.

13 Sep 2010

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

Pharmaceutical News

Debiopharm, Aurigene commence IND enabling studies for Debio 0617 inhibitor

FDA approves FASLODEX 500mg dose for metastatic breast cancer in postmenopausal women

Rib-X Pharmaceuticals presents preclinical data of radezolid drug at ICAAC Conference

CRT agrees with AstraZeneca for AZD-3965 clinical trial

Covidien supports FDA labeling changes for gadolinium-based contrast agents

FDA approves CorMatrix ECM for Pericardial Closure

Researchers develop mathematical framework for vaccine stockpile implications

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

Advaxis publishes research article on Her2 antigen for Listeria vaccine

MRSA infection hVISA linked to mortality

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

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

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

PurCotton brand promotional events held in Shenzhen

Current treatment strategies for mood and addictive disorders

395 new vaccines being developed for infectious diseases: PhRMA

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

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

Illinois researcher urges CDC to revisit pediatric vaccine stockpile policies

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

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