Neuroscience
From today's Boston Globe
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- Business World: Biogen Idec, Elan, & Tysabri (natalizumab) And Ms
From the AP, via the New York Times website: FDA Panel Supports MS Drug's Market Return By THE ASSOCIATED PRESS Published: March 8, 2006 Filed at 11:24 a.m. ET WASHINGTON (AP) -- A Food and Drug Administration panel said Wednesday the agency should...
- Methylphenidate
From The New York Times:Panel Recommends Warnings for Ritalin and Other Stimulants By THE ASSOCIATED PRESS Published: February 9, 2006 Filed at 4:13 p.m. ET WASHINGTON (AP) -- Federal science advisers voted narrowly Thursday to recommend the most serious...
- The Amateur Pharmacists
From The New York Times:Young, Assured and Playing Pharmacist to Friends By AMY HARMON Published: November 16, 2005 The New York Times [snip] For a sizable group of people in their 20's and 30's, deciding on their own what drugs to take - in...
- Strattera (atomoxetine) And Attention Deficit Disorder
A press release from the Food and Drug Administration (FDA):FOR IMMEDIATE RELEASE P05-65 September 29, 2005 Media Inquiries: Susan Cruzan, 301-827-6242 Consumer Inquiries: 888-INFO-FDA FDA Issues Public Health Advisory on Strattera (Atomoxetine) for...
- Business World: Biogen Idec, Elan, & Tysabri (natalizumab)
From today's Boston Globe:A fourth death may be tied to Biogen's MS drug Finding could be blow to marketplace hopes By Jeffrey Krasner, Boston Globe Staff June 2, 2005 Biogen Idec Inc. has told the Food and Drug Administration that a fourth...
Neuroscience
Anti-Epileptic Medications: FDA Request
From today's Boston Globe
FDA requests anticonvulsants be reexamined
By Liz Kowalczyk
The Boston Globe
April 20, 2005
The Food and Drug Administration has asked the makers of epilepsy drugs, which are the fifth best-selling group of medications and are taken by millions of Americans, to reexamine their data to determine if the drugs increase patients' risk of suicide.
The agency has requested an analysis similar to the one it commissioned to evaluate whether antidepressants pose a similar risk to children and teenagers. That sweeping reexamination of clinical trial data found that antidepressants can increase suicidal thoughts and behavior in young people, and last year the FDA required manufacturers to include a stronger, more prominent warning, known as a ''black box," on the drugs' labels.
The agency, which has been the target of growing criticism from members of Congress over how it monitors drug safety, is under pressure to more carefully scrutinize anticonvulsants, particularly Neurontin, which is made by Pfizer Inc. and is the market leader.
[ ... Read the full article ... ]
- Business World: Biogen Idec, Elan, & Tysabri (natalizumab) And Ms
From the AP, via the New York Times website: FDA Panel Supports MS Drug's Market Return By THE ASSOCIATED PRESS Published: March 8, 2006 Filed at 11:24 a.m. ET WASHINGTON (AP) -- A Food and Drug Administration panel said Wednesday the agency should...
- Methylphenidate
From The New York Times:Panel Recommends Warnings for Ritalin and Other Stimulants By THE ASSOCIATED PRESS Published: February 9, 2006 Filed at 4:13 p.m. ET WASHINGTON (AP) -- Federal science advisers voted narrowly Thursday to recommend the most serious...
- The Amateur Pharmacists
From The New York Times:Young, Assured and Playing Pharmacist to Friends By AMY HARMON Published: November 16, 2005 The New York Times [snip] For a sizable group of people in their 20's and 30's, deciding on their own what drugs to take - in...
- Strattera (atomoxetine) And Attention Deficit Disorder
A press release from the Food and Drug Administration (FDA):FOR IMMEDIATE RELEASE P05-65 September 29, 2005 Media Inquiries: Susan Cruzan, 301-827-6242 Consumer Inquiries: 888-INFO-FDA FDA Issues Public Health Advisory on Strattera (Atomoxetine) for...
- Business World: Biogen Idec, Elan, & Tysabri (natalizumab)
From today's Boston Globe:A fourth death may be tied to Biogen's MS drug Finding could be blow to marketplace hopes By Jeffrey Krasner, Boston Globe Staff June 2, 2005 Biogen Idec Inc. has told the Food and Drug Administration that a fourth...