Pfizer announced today that marketing authorization applications for maraviroc will receive accelerated review in both the United States and Europe. Accelerated reviews are granted to potential medicines that, if approved, would represent significant improvements over current therapies. If approved by the regulatory agencies, maraviroc will be the first in a new class of HIV/AIDS treatments called CCR5 antagonists that work by blocking viral entr...Tuesday, 13-Feb-2007 / [ Details... ]
The government of Thailand, has already upset some of the big drug companies by overriding patent licenses for generic versions of heart and HIV/AIDS pills, and is now planning to go one step further unless drug giants cut their prices.The Thai health ministry is considering which drugs Thailand needs and will either make or buy generic copies while haggling for "appropriate" prices of patented versions.Government officials say a discount from drug companies will ensure this will not happ...Tuesday, 13-Feb-2007 / [ Details... ]
The following highlights recent news of state actions on human papillomavirus vaccine proposals. Merck's HPV vaccine Gardasil and GlaxoSmithKline's HPV vaccine Cervarix in clinical trials have been shown to be 100% effective in preventing infection with HPV strains 16 and 18, which together cause about 70% of cervical cancer cases. ...Tuesday, 13-Feb-2007 / [ Details... ]
The AIDS Healthcare Foundation last week announced that it will ban Pfizer sales representatives from its facilities during business hours in response to how the drug maker markets its erectile dysfunction drug Viagra, the ...Tuesday, 13-Feb-2007 / [ Details... ]
A bill passed last month by the House that would require the HHS secretary to negotiate prices directly with pharmaceutical companies under the Medicare prescription drug benefit "would have very little effect" on prices "because it forbids Med...Tuesday, 13-Feb-2007 / [ Details... ]
The Food and Drug Administration (FDA) in the United States has issued a warning about an antibiotic used to treat sinusitis and bronchitis.The FDA say the controversial drug Ketek was too risky to treat those diseases and although it will remain on the market to treat pneumonia, stronger warnings about possible side effects such as blurred vision and loss of consciousness, will be placed on the drug's labels.The FDA also says the drug in future will carry a "black box" warning, the stron...Monday, 12-Feb-2007 / [ Details... ]
The Baltimore Sun on Friday examined how Democrats' takeover of Congress and the expiration of a law that requires drug manufacturers to pay user fees to FDA "is driving a flurry of activity that could lead to major changes" in the agency's drug safety pol...Monday, 12-Feb-2007 / [ Details... ]
In what will be seen by many as perfect timing, from Valentine's Day on men in Britain will be able to buy the impotence treatment Viagra over the counter for the first time.The chemist chain Alliance Boots says as part of a trial scheme three of it's Manchester pharmacies will sell the prescription-only medication from February 14th over the counter.The pilot programme will mean men aged between 30 and 65 suffering from erectile dysfunction will be able to buy four Viagra pills for 50 po...Sunday, 11-Feb-2007 / [ Details... ]
The U.S. Food and Drug Administration (FDA) today approved orlistat capsules as an over-the-counter (OTC) weight loss aid for overweight adults. Orlistat was initially approved in 1999 as a prescription drug to treat obesity, and remains a prescription drug for obesity at a higher dose than the OTC version. OTC orlistat will be manufactured by GlaxoSmithKline under the name Alli and is indicated ...Wednesday, 7-Feb-2007 / [ Details... ]
The U.S. Food and Drug Administration (FDA) has issued a warning about topical anesthetics that have skin-numbing effects.Topical anesthetics are most commonly used for cosmetic procedures and to relieve burning and itching and they contain anesthetic drugs such as lidocaine, tetracaine, benzocaine, and prilocaine in a cream, ointment, or gel form.The FDA says such products can cause serious and life-threatening side effects such as irregular...Wednesday, 7-Feb-2007 / [ Details... ]