Posted on | December 12, 2012 | Comments Off
“India has revoked a patent granted to an asthma drug made by Schering Corp, later bought by U.S.-based Merck & Co (MRK.N), citing lack of invention, after Indian drugmaker Cipla Ltd (CIPL.NS) challenged an earlier decision.”
“The move is the latest in a series of patent cancellations by India, where …http://in.reuters.com/article/2012/12/11/india-merck-patent-idINDEE8BA09Y20121211“
Posted on | November 14, 2012 | Comments Off
I just read Ameridose’s 483.
Posted on | September 28, 2012 | Comments Off
The President’s Council of Advisors on Science and Technology urged the Food and Drug Administration to expand its use of faster drug approvals to a wider range of diseases. The council suggested the FDA could begin to approve drugs that may help only a narrow and high-risk patient population, such as people who are morbidly obese, under what the council called “special medical use” approvals.
The advisory report gave few details of what new laws or …more“
Posted on | August 21, 2012 | Comments Off
“Here’s an updated list of biotech and pharmaceutical companies with pending FDA drug approval decisions for the rest of 2012 and into early 2013. This refresh includes changes and additions to the FDA calendar last published at the end of July. ” http://www.thestreet.com/story/11668461/1/31-drugs-facing-fda-approval-in-2012-2013.html
Posted on | August 20, 2012 | Comments Off
Posted on | July 26, 2012 | Comments Off
Derek Lowe, writes for “In the Pipeline”. Check out his investigation of the total mess at the FDA and employee surveillance scandal to brew! Wow, I hope these stories aren’t true. It sounds like a terrible place to work, with many other issues to boot.
Top Secret Writers writes “A hugely damning report published by the New York Times blew the lid on a secret FDA surveillance conspiracy.
What started in 2010 as a small-scale investigation of five FDA scientists suspected of leaking confidential agency information, rapidly escalated into a much more comprehensive surveillance campaign.”