Neuroscience
From the FDA (.pdfs of briefing material is available at the link below):
January 20-21, 2011: Peripheral and Central Nervous System Drugs Advisory Committee Meeting Announcement
Read the full announcement
Also, as background, from clinicaltrials.gov:
Phase III study of florbetapir F 18
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A fuller report from The New York Times: F.D.A. Sees Promise in Alzheimer’s Imaging Drug By GINA KOLATA The New York Times Published: January 20, 2011 "A committee voted that the agency should approve the first test that can show the characteristic...
- Alzheimer's Products
FromThe New York Times: Tests Show Promise for Early Diagnosis of Alzheimer’s By GINA KOLATA The New York Times Published: January 18, 2011 "Researchers report major advances on two vexing questions about Alzheimer’s: How do you know if someone who...
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From the FDA: FOR IMMEDIATE RELEASE P06-25 February 16, 2006 Media Inquiries: Susan Cruzan, 301-827-6242 Consumer Inquiries: 888-INFO-FDA FDA Allows Clinical Studies of Tysabri (natalizumab) for Treatment of MS to Proceed The Food and...
- Upcoming Event: Gaithersburg, Md, 17 June 2005
From the FDA: NEUROLOGICAL DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE (FDA) DATE AND TIME: June 17, 8:30 a.m. LOCATION: Hilton Washington, DC North/Gaithersburg, Salons A, B and C, 620 Perry Pkwy., Gaithersburg, MD. CONTACT: Janet L. Scudiero,...
Neuroscience
Upcoming: Alzheimer's: FDA Advisory Committee Meeting (20-21 January 2011)
From the FDA (.pdfs of briefing material is available at the link below):
January 20-21, 2011: Peripheral and Central Nervous System Drugs Advisory Committee Meeting Announcement
Read the full announcement
Agenda
"On January 20, 2011, the committee will discuss new drug application (NDA) 202-008, florbetapir F 18 injection, sponsored by Avid Radiopharmaceuticals, Inc., proposed for use in positron emission tomography (PET) imaging of β-amyloid (beta-amyloid) aggregates in the brain to help rule out Alzheimer's disease.
"On January 21, 2011, the committee will discuss NDA 201-277, gadobutrol injection, sponsored by Bayer HealthCare Pharmaceuticals, proposed for use in diagnostic magnetic resonance imaging (MRI) in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity (abnormal blood supply and circulation) of the central nervous system. The BBB is an area consisting of specialized cells that restrict passage of certain molecules from the bloodstream into the brain."
Also, as background, from clinicaltrials.gov:
Phase III study of florbetapir F 18
- Fda: Approval Of Alzheimer's Neuroimaging Diagnostic Drug, Vizamyl (flutemetamol F 18 Injection)
From the FDA on the 25th of October, quoting the press release: FDA approves second brain imaging drug to help evaluate patients for Alzheimer’s disease, dementia The U.S. Food and Drug Administration today approved Vizamyl (flutemetamol F 18 injection),...
- Fda: Pcns Drugs Advisory Committee Results For Avid's Amyvid Alzheimer's Amyloid Neuroimaging Agent
A fuller report from The New York Times: F.D.A. Sees Promise in Alzheimer’s Imaging Drug By GINA KOLATA The New York Times Published: January 20, 2011 "A committee voted that the agency should approve the first test that can show the characteristic...
- Alzheimer's Products
FromThe New York Times: Tests Show Promise for Early Diagnosis of Alzheimer’s By GINA KOLATA The New York Times Published: January 18, 2011 "Researchers report major advances on two vexing questions about Alzheimer’s: How do you know if someone who...
- Business World: Biogen Idec, Elan, & Tysabri (natalizumab) And Ms
From the FDA: FOR IMMEDIATE RELEASE P06-25 February 16, 2006 Media Inquiries: Susan Cruzan, 301-827-6242 Consumer Inquiries: 888-INFO-FDA FDA Allows Clinical Studies of Tysabri (natalizumab) for Treatment of MS to Proceed The Food and...
- Upcoming Event: Gaithersburg, Md, 17 June 2005
From the FDA: NEUROLOGICAL DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE (FDA) DATE AND TIME: June 17, 8:30 a.m. LOCATION: Hilton Washington, DC North/Gaithersburg, Salons A, B and C, 620 Perry Pkwy., Gaithersburg, MD. CONTACT: Janet L. Scudiero,...