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Biogen Idec and Elan Want to Resume Selling Their MS Drug Tysabri in the U.S.
Tysabri Recalled From the Market in Early 2005 Due to PML, a Fatal Brain Condition Biogen Idec Inc. and Elan Corp., the makers of the multiple sclerosis ("MS") drug Tysabri, filed papers with the…
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New Drug Industry Web Site Intended to Give Access to Findings From Clinical Trials
Doctors and Patients Can Search for Drug-safety Information Using IFPMA Clinical Trials Portal On September 21, 2005 the International Federation of Pharmaceutical Manufacturers and Associations ("IFPMA") established a new web site called the IFPMA…
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FDA Warning Letters About Misleading DTC Ads Tripled During Last Year
Most Common Offense is De-emphasizing Serious Side Effect Risks in Advertisements On September 19, 2005 Thomas Abrams, head of FDA’s Division of Drug Marketing and Communications, told food and drug regulatory lawyers attending a…
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Pfizer Agrees to New Celebrex Safety Guidelines in Canada
Health Canada Revisions to Celebrex Label Accepted by Pfizer Canada On September 21, 2005 Pfizer Canada announced the drug company had agreed to make changes suggested by Health Canada that add new safety guidelines…
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FDA To Hold Two-Day Direct-To-Consumer Advertising Meeting In November 2005
Public Meeting to Review Rules Concerning Prescription Drug DTC Advertisements The FDA is considering revising rules about, first, how much side-effect risk information prescription drug commercials must include and, second, whether all direct-to-consumer ("DTC")…
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Even One Day of Vioxx Use Can Cause Heart Attack or Stroke Says Expert
Dr. Benedict Lucchesi Testifies at Humeston Vioxx Trial in New Jersey Dr. Benedict Lucchesi, a prominent heart and medication expert from the University of Michigan, told the jury hearing evidence at the Humeston Vioxx…
