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Aceto Corporation 2010 fourth quarter net sales increase to $105.8 million

Aceto Corporation, a global leader in the sourcing, quality assurance, regulatory support, marketing and distribution of pharmaceuticals, nutraceuticals, specialty chemicals and crop protection products, today announced results of operations for its fiscal 2010 fourth quarter and year ended June 30, 2010.

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

USIBC to embark Life Sciences Executive Mission for India

The U.S.India Business Council will embark on a Life Sciences Executive Mission to coincide with the Biotechnology Industry Organization's First Annual International Partnering Conference in Hyderabad, India from September 21-22. The mission will be led by Amgen's Dr. Romi Singh, Executive Director of Global Regulatory Affairs and Safety.

10 Sep 2010

Campaign for Tobacco-Free Kids applauds FDA for action against electronic cigarette distributors

We applaud the U.S. Food and Drug Administration for taking appropriate enforcement action today against five distributors of electronic cigarettes for various violations of the Federal Food, Drug and Cosmetic Act (FDCA), including unsubstantiated claims and poor manufacturing practices.

10 Sep 2010

Numerate awarded new contract by Defense Threat Reduction Agency

Numerate, Inc. announced today that it has been awarded a new three-year contract by the Defense Threat Reduction Agency (DTRA), an agency within the U.S. Department of Defense, to adapt its pioneering small-molecule drug design platform to the rapid design and optimization of drugs against biowarfare agents.

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

FDA issues warning letters to five electronic cigarette distributors

The U.S. Food and Drug Administration today issued warning letters to five distributors for various violations of the Federal Food, Drug, and Cosmetic Act (FDCA) including unsubstantiated claims and poor manufacturing practices.

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

SAEC collaborates with Newcastle University for drug induced liver injury research

The International Serious Adverse Events Consortium (SAEC) announced today it will collaborate with Newcastle University to research the genetics of drug induced liver injury.

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

Summit negotiators seek to get MDGs 'back on track'

"World powers are moving slowly toward an accord on the strategy to be embraced at a looming United Nations summit aiming to get the lofty Millennium Development Goals [MDGs] back on track," Agence France-Presse writes in an article examining the ongoing debates over how best to achieve the MDGs before the 2015 deadline.

10 Sep 2010

Research into role of genetic variation in drug-induced hypersensitivity reactions

The International Serious Adverse Events Consortium (SAEC) announced today it will collaborate with The University of Liverpool (www.liv.ac.uk/pharmacogenetics) to research the genetics of a form of serious adverse drug reaction called hypersensitivity. These are thought to involve the body's immune system, and mostly involve serious skin rashes.

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

UK researchers discover new tactic used by cancer cells to cheat death

Cancer Research UK scientists have uncovered a new strategy that could be used by cancer cells to side step the body's normal safety checks and become immortal a key step for a cancer cell according to a study published in Nature today (Thursday).

10 Sep 2010

FDA approves Abreu BTT 700 System for temperature monitoring

Brain Tunnelgenix Technologies Corp. announced today that the U.S. Food and Drug Administration (FDA) has granted the company clearance to market its Abreu BTT 700 System for continuous temperature monitoring.

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

BioMedTracker launches Thought Leader Opinions service for drug information

BioMedTracker, a product of Sagient Research Systems, the leading provider of competitive intelligence and investment analytics on the biotech/pharmaceutical sector, today announced the recent launch of its new service, Thought Leader Opinions (TLO). This service provides its subscribers with direct access to the latest expert opinions in the disease areas that they follow within the intuitive BioMedTracker drug information platform.

9 Sep 2010

UC San Diego proferssor awarded 2010 Harvey Prize in human health by Technion

Michael Karin, PhD, Distinguished Professor of Pharmacology and Pathology at the University of California, San Diego School of Medicine has been awarded the 2010 Harvey Prize in human health by the Technion, Israel's premier institute of technology.

9 Sep 2010

Nation's four leading ADHD organizations seek to end persistent myths about ADHD

Four national organizations – ADHD Coaches Organization; Attention Deficit Disorder Association; ADDitude magazine; and Children and Adults with Attention-Deficit/Hyperactivity Disorder – are issuing a joint call to the public to assist children, adults, and families who are affected by ADHD.

9 Sep 2010