–The company plans to perform 40 clinical trials in 5 years with Entresto. Novartis announced today an enormous clinical trial program with its promising but…
Possible Setback For Califf On Road To FDA
Rob Califf may have just run into his first serious roadblock on his path to become the FDA’s next commissioner. According to a report in the…
A Premature SPRINT To The Finish Line
On Friday the NHLBI declared victory in the SPRINT trial. As was widely reported here and elsewhere, the NHLBI announced that the trial had been stopped…
US Proposal Would Greatly Expand Transparency Of Clinical Trials
The US Department of Health and Human Services today proposed new rules that would greatly expand the number of clinical trials that companies and researchers are required to…
Novartis Trial Was Stopped Early Because Of A Significant Drop In Cardiovascular Mortality
The largest-ever trial in heart failure was stopped early because of a highly statistically significant reduction in cardiovascular mortality, according to one of the trial’s…
Early Success For Novel Novartis Heart Failure Drug
A large clinical trial testing a novel compound from Novartis for chronic heart failure has been stopped early for efficacy. In a press release Novartis…
Wall Street Journal Op-Ed On Sham Surgery Gets It Wrong
In an op-ed piece in the Wall Street Journal Scott Gottlieb, a former FDA official under George W. Bush, argues that the FDA should stop requiring medical device…
Why Is Actelion Suppressing Phase III Data?
I highly recommend a terrific article by Ian Parker in this week’s New Yorker about Merck’s efforts to develop a novel insomnia drug, suvorexant. Normally I don’t write about non-cardiology topics…
Hot Line Trials For European Society Of Cardiology Congress Announced
The European Society of Cardiology has published the full program for the 2013 Congress taking place in Amsterdam from August 31 through September 4. There will be…
Get Ready For Munich: ESC Releases List Of Hot Line Sessions
Here is the list of Hot Line sessions scheduled for the European Society of Cardiology ESC) meeting in Munich: