Recently in Drugs and Medications News Category
NEW YORK (Reuters Health) Mar 20 - Laws that mandate disclosure of payments to physicians by pharmaceutical companies provide limited public information, according to a new report.
At present, five states and the District of Columbia have legislation requiring payment disclosure. Among these states, Minnesota and Vermont require that the information be made available to the public.
In the current study, reported in the March 21st issue of the Journal of the American Medical Association, Dr. Joseph S. Ross, from Mount Sinai School of Medicine in New York, and colleagues examined the accessibility and quality of information provided by the disclosure laws in Minnesota and Vermont.
LONDON, March 7, 2007-The Medicines and Healthcare products Regulatory Agency (MHRA) has requested Pfizer to withdraw an advertisement making potentially misleading claims about Zyvox (linezolid), an antibiotic used to treat certain types of serious infection.
The MHRA became aware of the advertisement in the British Medical Journal (BMJ) claiming that Zyvox has superior cure rates compared to products containing the active ingredient vancomycin. At the time, Pfizer was in discussion with the MHRA about emerging concerns relating to the efficacy and safety of Zyvox compared to vancomycin in a clinical trial in patients with catheter-related infections.
U.S. senators vowed on Wednesday to move forward with legislation to legalize the importation of cheaper prescription drugs from certain countries, despite resistance from regulators and drugmakers.
One Democrat and three Republicans said their plan would provide money and safeguards for the Food and Drug Administration to assure the imports were not dangerous.
"I believe this legislation puts in place an effective regulatory framework to make importation of FDA-approved drugs safe for consumers," Sen. Byron Dorgan (news, bio, voting record), a North Dakota Democrat, said at a hearing.
The use of drugs to treat attention-deficit/hyperactivity disorder, or ADHD, has more than tripled worldwide since 1993, U.S. researchers reported on Tuesday.
And spending on such drugs rose nine-fold between 1993 and 2003, the team at the University of California, Berkeley reported.
"ADHD could become the leading childhood disorder treated with medications across the globe," Richard Scheffler, an expert in health economics and public policy who led the study, said in a statement.
A court ruled Pfizer can no longer use the name Wei Ge, or mighty brother, to market Viagra as China's Guangzhou Welman had registered the brand.
While Pfizer markets the anti-impotence pill as Wan Ai Ke in China, it is commonly called Wei Ge by the public.
By Evelyn Pringle
Over the past year, the Bush administration's FDA has been the focus of non-stop investigations and with the Democrats in control of Congress, a long overdue overhaul of the agency is in the cards.
The Government Accountability Office has identified serious problems within the FDA. In an April 21, 2006, report, the GAO found the FDA's performance "disorganized," "bureaucratic," and undermined by infighting between drug evaluation administrators whose allegiance is with the pharmaceutical industry, and the Office of Drug Safety.
According to the GAO, the drug safety office is under-funded, lacks independence and lacks decision-making responsibility. It also criticized the way FDA scientists were prevented from speaking at advisory committee meetings on drugs they were studying.
Sunil Shaunak, professor of infectious diseases at Imperial College, based at Hammersmith hospital, calls their revolutionary new model "ethical pharmaceuticals".
Improvements they devise to the molecular structure of an existing, expensive drug turn it technically into a new medicine which is no longer under a 20-year patent to a multinational drug company and can be made and sold cheaply.
The British Medical Journal research looked at studies in six areas and found animal studies agreed with human trials in just three.
The high-profile London drug trial which left six men ill was carried out after animal studies showed the drug TGN1412 was effective.
This study, led by Professor Ian Roberts, suggests animal studies should be used, but not for all drug research.
These outstanding issues can be quite complex, involving a great deal of time and investment, such as new clinical trials, or relatively simple, such as a label adjustment or a manufacturing process issue. In any case, it means a delay, either slight or lengthy, in getting to market.
New River Pharmaceuticals (NRPH) and Shire (SHPGY)- A second approvable letter was issued to these two companies for a treatment for Attention Deficit Hyperactivity Disorder [ADHD]. The first approvable letter was issued on October 6, 2006 and the company speedily submitted a response on October 24, 2006. According to Yahoo Finance, the FDA is not requesting new studies.