Rx For Software: Can Medidata Solutions Save Drug Companies Billions Of Dollars?


Tarek Sherif, a small-time fund manager, plopped his cathode-ray-tube monitor and desktop computer on an office chair and wheeled it a mile down Park Avenue from his fund’s offices into a small room...

Johnson & Johnson Shares Clinical Trial Data


In a major victory for advocates of open access to data from clinical trials, Johnson & Johnson today announced that it will make all of its clinical trial data available to outside researchers....

How To Prevent Antibiotic Apocalypse


Want to protect your kids from drug-resistant bacteria? Open your  wallet. Governments and insurance companies need to commit to paying 10 or 50 times more than they already do if industry is...

FDA Panel Once Again Rejects New Indication For J&J Drug


The FDA’s Cardiovascular and Renal Drugs Advisory Committee once again turned down the supplemental new drug application for an acute coronary syndrome indication for Johnson & Johnson’s Xarelto...
    






FDA Advisory Panel Votes In Favor Of Approval For Merck’s Vorapaxar


The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 10-1 in favor of approval for vorapaxar, Merck's novel thrombin receptor antagonist. The “roller coaster ride” cliché might have...
    






Johnson & Johnson Faces Uphill Battle At FDA Advisory Panel


The third time may not be the charm. Twice before the FDA has turned down the supplemental new drug application for an acute coronary syndrome indication for Johnson & Johnson’s Xarelto (...
    






How to Make Sales With a Tablet


This article is by Bill Rosenthal, the chief executive of Communispond, a provider of communications training. It’s a common occurrence when a salesperson makes a proposal: The customer gets on the...
    






Beyond Economics: How Price Controls Are Killing Millions Of Patients


Due to maximum-wage policies, it currently takes about a decade for working medical therapies to reach patients. Stronger incentives in the clinical trial process responsible for the delays would...
    






The Avorn-Stossel Debate On GSK Halting Payment To Doctors For Drug Promotion


GSK recently announced that it would no longer pay doctors to promote its drugs, a move that has generated a good deal of discussion.  The PBS Newshour entered the fray by featuring a debate between...
    






Did One Of The Top 10 Upside Surprises In The History Of The Biotech Sector Just Happen?


On Friday, the Food and Drug Administration approved a pill called Orenitram, to treat pulmonary arterial hypertension. It is an oral version of an injected drug called Remodulin, which treats the...