Archive for the 'FDA' Category
April 26th, 2011 by admin
A researching team from the University of Leicester has offered the promise of a simple injection that could be developed to restrict the damage that results from heart attacks and strokes. Described by the lead researcher as ‘a fascinating new achievement’, work has already begun to translate the research into novel clinical therapies.
Continue reading ‘Preventing Damage from Heart Attacks & Strokes with an Injection’
April 21st, 2011 by admin
New research has shown that nasal vaccines are much more effective in providing protection against the flu. In fact the research also proved that nasal vaccines will soon protect not only against the flu and pneumonia, but also against bioterrorism agents such as Yersinia pestis that causes the plague. The research, presented at the Society for General Microbiology’s Spring Conference in Harrogate, presented Professor Dennis Metzger who described how including a natural immune chemical with standard vaccines has the potential to increase their protective impact when delivered through the nose.
Continue reading ‘Nasal Spray Vaccines More Effective against Flu’
April 20th, 2011 by admin
An investigational combination of drugs already approved to treat obesity, migraine and epilepsy produced up to a 10 percent weight loss in obese individuals participating in a one-year clinical trial, according to researchers at Duke University Medical Center.
Continue reading ‘New Drug Shows Unprecedented Weight Loss in Clinical Trials’
March 25th, 2011 by admin
Novartis has completed its acquisition of 85% in the Chinese vaccines firm Zhejiang Tianyuan Bio-Pharmaceutical. The deal, roughly valued at $125 million, was first announced in November 2009. Swiss drugs giant Novartis has said that the acquisition will provide it with an expanded presence in the Chinese vaccines market and also facilitate the introduction of additional Novartis’ vaccines into the country. The firms claims that China represents the world’s third largest vaccines market, with annual industry sales of over $1 billion, and the expectation of double-digit growth over coming years.
Continue reading ‘Novartis Completes $125M Acquisition of Tianyuan’
March 21st, 2011 by admin
Many of the ads for “anti-radiation” potassium iodide pills flooding the Internet may be scams run by hucksters seeking to profit from the Japan nuclear scare, the Food and Drug Administration warned Thursday. “We found many different offers for potassium iodide and other products that we’re taking a look at,” says Gary Coody, the FDA’s national health fraud coordinator.
Continue reading ‘FDA Warns of Drug Scams that Play on Radiation Fear’
March 15th, 2011 by admin
Every vaccine scientist wants to discover just one thing – how to stimulate immunity that lasts for a lifetime! There are many live vaccines, such as the ones for smallpox and yellow fever that are able to stimulate immunity against the disease that lasts for many decades. However, in spite of the success of such vaccines, researchers are still unable to manufacture a vaccine that will provide lifetime immunity. Furthermore, vaccine scientists are also not able to understand how vaccines such as the smallpox one, induces such long lasting immunity.
Continue reading ‘Now – Nanoparticles for Long Lasting Immunity’
March 4th, 2011 by admin
It looks as if user fees really are in the offing for generic drugs. After generics makers said last week that they’re supporting the idea as a way to speed approvals of their products, FDA Commissioner Margaret Hamburg backed it, too. Revamping the current approvals process is “critical,” she said, because agency funding won’t provide the resources to clear the backlog of apps.
Continue reading ‘Generic Fees Gain Traction with FDA Backing’
February 25th, 2011 by admin
Sanofi-Aventis continues its diversification march. The company got the FDA’s permission to sell its blockbuster allergy treatment Allegra without a prescription. Sanofi has been hoping for that OK to bolster its U.S. consumer healthcare business that was created last year with the $1.9 billion purchase of Chattem.
Continue reading ‘OTC Allegra Nod Fortifies Sanofi’s U.S. Consumer Ops’
February 25th, 2011 by admin
Sustained high vaccination coverage is key to preventing deaths from measles. Despite the availability of a vaccine, measles remains an important killer of children worldwide, particularly in less-developed regions where vaccination coverage is limited. A team of researchers, led by scientists at the Johns Hopkins Bloomberg School of Public Health and the University of Colorado, developed and successfully tested a dry powder, live-attenuated measles vaccine that can be inhaled. The novel vaccine was studied in rhesus macaques.
Continue reading ‘Inhalable Measles Vaccine Tested’
February 17th, 2011 by admin
Want proof that achieving FDA approval is more difficult than in the past? A study released by the BIO and BioMedTracker that the overall success rate for drugs moving through clinical trials to FDA approval from late 2003 to the end of 2010 is near one in 10. Previously the rate of approval were one in five to one in six. Oncology drugs faced the toughest road to approval despite the fact that the disease area is the most closely studied in all of drug development. And large molecule drugs are twice as likely to be approved than than small molecule drugs.
Continue reading ‘Rate of Drug Approvals Dropping’
