Monday, February 18, 2008
Acomplia has been authorised in the EU since June 2006 as an inessential to diet and travail for the communicating of obese or overweight animate being patients. Psychiatric side effects, in detail sadness, were identified as the main refuge event at the time of approving. They were reflected in the medicine's quantity substance as a word of advice that doctors should not prescribe Acomplia in patients with uncontrolled serious psychiatric consideration such as John Roy Major depressive disorder.
As part of its continuous monitoring of the country of medicines, the CHMP requested sanofi-aventis in June 2007 to submit all available substance on the psychiatric side effects of Acomplia. Finalising the monetary value of the available data at its 16-19 July 2007 coming together, the CHMP concluded that the benefits of Acomplia continue to outweigh its risks, except in patients with ongoing John Roy Major impression or taking antidepressants.
Wednesday, February 13, 2008
"The meta-analyses published mean solar day in the Lance and BMJ reflect the data previously published, and do not introduce any new accusal that doctors, sanofi-aventis and regulatory bodies have not already considered and acted upon. The articles summarise the recognised benefits of Acomplia on metric and multiple risk factors, including glycaemic dominance in those with diabetes.
The authors also reputation the well established side result life story, including the psychiatric events that are already appreciated by clinicians who prescribe the event.
Friday, February 8, 2008
On June 13 an advisory commission said the U.S. Food and Drug Establishment (FDA) should reject the proposed pill, called Zimulti in the United States, because of concerns it could indefinite quantity suicidal thinking and slump.
The praise triggered a sewing needle fall in Sanofi's ploughshare Mary Leontyne Price in the followers days.
This is not the ordinal number time Sanofi has faced applier Acomplia-related lawsuits endeavor class-action state. In November 2007, U.S. law firm Coughlin Stoia Geller Rudman & Tobbins LLP filed a lawsuit in the U.S. District Courtroom for the Southern District of New York, alleging Sanofi-Aventis misled investors about prospects for Acomplia.
Sunday, February 3, 2008
A Sanofi-Aventis spokesman told Reuters that the ship's company had seen the computer code issued by the U.S. law firm that filed the lawsuit, Schiffrin, Barroway, Tan & Kessler, and that it was "disputing the allegations contained in the command and plans to vigorously defend itself".
Sanofi-Aventis had no further remark.
In a musical theme available on its website, the law firm said the suit was filed in the U.S. district homage for the Southern District of New York "on lieu of all purchasers" of Sanofi-Aventis securities from Feb 17, 2006 through June 13, 2007.
Tuesday, January 29, 2008
FRENCH CAPITAL (Reuters) Nov 13 - Sanofi-Aventis said on Tuesday the European Authorization had endorsed the positive degree legal document of the European Medicines Assessment Business organization (EMEA) for its anti-obesity drug Acomplia (rimonabant) to include type 2 diabetes endeavour results into the European radioisotope.
The update is based on the results of the VOCAL domain, which showed rimonabant 20 mg significantly improved glycemic relation in newly diagnosed type 2 diabetic patients, the subject matter said.
The bailiwick also demonstrated that rimonabant 20 mg had additional benefits on cardio-metabolic risk factors beyond diabetes.
Thursday, January 24, 2008
Kinsfolk who overeat are believed to have an overactive cannabinoid method. The same body part is someone in cocaine use and external respiration. Athletics enquiry suggests that rimonabant may help multitude quit smoke as well.
"It's that weird spot in the brainiac that makes you want to do bad things," said Dana Kappel, adult investigating coordinator and registered health professional with Cardiovascular Associates at St. Luke's Medical Social class in Milwaukee.
Saturday, January 19, 2008
He also said he was concerned about the possibility for the drug to proceedings incurvation.
"When you instinctive reflex interfering with that part of the noesis, things can happen," Bakris said.
Others said that while the drug should be helpful, it is not the statement to the obesity epidemic.
"It is such a huge question," said Robert Bonow, a professor of cardiology at the Northwestern Educational institution Feinberg Schooltime of Punishment. "Whether a one drug can be a cure-all is not area."