Category Archives: Strategy
FDA: From Risk Aversion to Approval Activism
During the Rutgers Business School’s annual healthcare symposium, an FDA official encouraged industry to put its drugs on the reviewing table and be prepared for good news.
On a panel titled “Activist FDA: Transformation Agent,” Prevision Policy founder and former Pink Sheet editorial head Cole Werble relayed the tale of Acadia Pharmaceuticals, a San Diego-based [...]
Also posted in Agency Insight, Biotech, FDA, Legal, Market Access, Orphan Drugs, People, R&D, Regulatory, leadership Tagged access, breakthrough therapies, CDER, Cole Werble, FDA, IMS, Rachel Sherman, Regulatory 2 Comments
Congress 'Tip Toes' Around Obamacare
by Tom Norton
Of the many issues involved with the actual implementation of the 2010 Affordable Care Act, aka, “Obamacare”, few are more intriguing to me than those that personally impact Members of Congress (MOCs). Here’s a good example of what I’m talking about — Today, on Capitol Hill, MOCs, along with thousands of their personal [...]
Also posted in Guest Blog, Legal, healthcare Tagged Affordable Care Act, Congress, healthcare, HHS, Obamacare, Politics, POTUS, Sen. Charles Grassley (R-IA), state health exchanges 3 Comments
Physicians in ACOs Dare Pharma to Step up Its Game
Pharma, according to physicians currently embedded within Accountable Care Organizations (ACOs), is not living up to its potential. A survey conducted by Oliver Wyman has most of its 200 respondents saying the industry could play a more active role with value-based healthcare providers in helping to deliver better care at a lower cost, but it [...]
Also posted in healthcare Tagged Accountable Care Organization, ACOs, commercial health, physicians, quality of care Leave a comment

Xofigo Approval Keeps the Ball Rolling For Bayer Oncology