omni
aaps
Precision Medicine and the 21st Century Cures Act
Precision Medicine and the 21st Century Cures Act
On July 10, 2015, a bill for the 21st Century Cures Act passed the House of Representatives by a very large margin: 344 to 77. The bill is currently before the Senate, and although nothing in life is certain but death and taxes, the bill is expected to...
Complicated vs Complex Challenges in Pharma
Complicated vs Complex Challenges in Pharma
The pace, scope, and variety of challenges we face as executives in Pharma are both invigorating and overwhelming. They span macro trends such as personalized medicine, real-world-evidence (RWE), onerous regulatory pressures, collaborative R&D and Digi...
Too Many 'Me-Too' Cancer Drugs? FDA Official Asks
Too Many 'Me-Too' Cancer Drugs? FDA Official Asks
A new type of cancer drug that takes the brakes off the body's immune system has given drugmakers some remarkable wins against the deadly disease, but a top U.S. regulator says too many companies are focused on the same approach.
A Faster, More Flexible, and Frugal FDA?
A Faster, More Flexible, and Frugal FDA?
A top priority for FDA this year has been to gain speedy Congressional approval of new user fee reauthorization bills. Now, White House proposals to slash funding for federal health agencies and to boost FDA reliance on medical product fees makes that ...
US Approves First Drug for Psychosis Linked to Parkinson's
US Approves First Drug for Psychosis Linked to Parkinson's
Acadia Pharmaceuticals’s drug for psychosis linked to Parkinson’s disease was approved in the United States on Friday, becoming the first treatment for the condition to get a nod in the country. The U.S. Food and Drug Administration, howeve...