Biotechnology/Biologics
Drug maker plans to disclose its payments to doctors
In an industry first, Eli Lilly and Co. says it will begin to tell how much money it paid to individual doctors for advice, speeches and other services
Date:
09/24/2008
, Publication:
MSNBC
, Author:
AP
http://www.msnbc.msn.com/id/26858255/
FDA Issues Draft Guidance on Regulating Genetically Engineered Animals
Public comment invited on application of new animal drug provisions of the Federal Food Drug and Cosmetic Act
Date:
09/18/2008
, Publication:
FDA News
, Author:
FDA
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01887.html
Beware of drug names that look, sound alike
Celebrex or Celexa? 1,500 common meds have caused mix-ups, study says
Date:
09/01/2008
, Publication:
MSNBC
, Author:
LURAN NEERGAARD AP
http://www.msnbc.msn.com/id/26497545/
FDA Announces Improved Policies Regarding Transparency, Public Disclosure for Advisory Committees
The improvements include stricter limits on financial conflicts of interest for committee members, ...
Date:
08/05/2008
, Publication:
FDA News
, Author:
FDA
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01871.html
Drug Test a Success for Amgen
The biotechnology company reported a successful trial for an experimental osteoporosis drug that reduced the risk of bone fractures in post-menopausal women.
Date:
07/26/2008
, Publication:
NY TIMES
, Author:
ANDREW POLLACK
http://www.nytimes.com/2008/07/26/business/26amgen.html?ref=health
Health Plan From Obama Spurs Debate
It is one of the most audacious promises in a campaign that has been thick with them.
Date:
07/23/2008
, Publication:
NY TIMES
, Author:
KEVIN SACK
http://www.nytimes.com/2008/07/23/us/23health.html?ref=health
FDA Rule and Companion Guidance Make Early Stage Clinical Drug Development Safe and EfficientDate:
07/19/2008
, Publication:
FDA News
, Author:
FDA
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01863.html
While the U.S. Spends Heavily on Health Care, a Study Faults the Quality
But it has fallen to last place among those countries in preventing deaths through use of timely and effective medical care...
Date:
07/17/2008
, Publication:
NY TIMES
, Author:
REED ABELSON
http://www.nytimes.com/2008/07/17/business/17health.html?ref=health
FDA Revises Process for Responding to Drug Applications
The U.S. Food and Drug Administration today announced that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted.
Date:
07/09/2008
, Publication:
FDA News
, Author:
FDA
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01859.html
Possible lymphoma link to TNF-blockers sparks agency review
...including adalimumab (Humira, Abbott), etanercept (Enbrel, Amgen/Wyeth), infliximab (Remicade, Centocor), and certolizumab pegol (Cimzia, UCB Inc.)for data on all cases of cancer reported in children and young adults...
Date:
06/06/2008
, Publication:
Drug Topics Daily News
, Author:
Heidi Belden, Pharm.D.
http://drugtopics.modernmedicine.com/drugtopics/Allergies/Possible-lymphoma-lin
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