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22 Jul 2011, 2:34 pm by Tom Lamb
Food and Drug Administration (FDA) is reviewing data from a clinical trial [the Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy (PALLAS) study, sponsored by Sanofi Aventis (the maker of Multaq)]that was evaluating the effects of the antiarrhythmic drug Multaq (dronedarone) in patients with permanent atrial fibrillation. [read post]
21 Jul 2011, 5:03 pm
Some data from the clinical trial indicated immune molecules may wane after three to five years. [read post]
8 Jul 2011, 8:38 pm by Jeralyn
The opportunity for scientists to conduct clinical research with marijuana exists under the HHS policy supporting clinical research with botanical marijuana. [read post]
2 Jul 2011, 10:32 am by Schachtman
Marianne Bowler used the recent United States Supreme Court decision in Matrixx Initiatives, Inc. v. [read post]
22 Jun 2011, 7:57 am by Stephen Albainy-Jenei
June 21, 2011 VOTE NO ON H.R. 1249 SPECIAL INTEREST PATENT BILL BENEFITS FOREIGN MULTINATIONAL CORPORATIONS OVER U.S. [read post]
17 Jun 2011, 12:38 pm
The complaint alleges that each defendant manufactures, provides, sells, offers for sale, imports and/or distributes products and services that infringe the patent at issue, which is described as "a novel and clinically important critical event notification system that can continuously monitor patient statistics and lab data to detect complex critical events[.] [read post]
16 Jun 2011, 7:07 am by Mark Zamora
Food and Drug Administration today announced it has begun a safety review of the diabetes drug Actos (pioglitazone), after receiving preliminary results from a long-term observational study designed to evaluate the risk of bladder cancer associated with use of this drug.The preliminary results are based on five-year data from an ongoing, 10-year observational study by the manufacturer, Takeda Pharmaceuticals North America Inc., San Diego. [read post]
25 May 2011, 3:21 am by Sean Wajert
Metabolife Int’l, Inc., 401 F.3d 1233, 1242 (11th Cir. 2005) (causation “requires not simply proof of exposure to the substance, but proof of enough exposure to cause the plaintiff’s specific illness”). [read post]
16 May 2011, 10:24 am by Lyle Denniston
Jeppesen Dataplan, Inc., et al. (10-778) — the latest appeal seeking to challenge the closing down of a lawsuit, because the government claims a “state secrets” privilege, seeking to hold someone liable for the Central Intelligence Agency’s once-secret program of “extraordinary rendition. [read post]
4 May 2011, 7:52 am by Tron Emptage
  Author Tron Emptage, who holds a BS in Pharmacy, is Chief Clinical & Compliance Officer with Progressive Medical. [read post]
4 May 2011, 7:36 am by Tron Emptage
If the PBM captures the data, then the PBM should be able to provide reports based on those data elements. [read post]
22 Apr 2011, 2:49 pm by Lyle Denniston
The law was challenged in federal court by three data-mining companies, IMS Health Inc., Verispan LLC, and Source Healthcare Analytics, Inc., and by the trade group for drug manufacturers, the Pharmaceutical Research and Manufacturers of America. [read post]