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Category Archives: Legal
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, Market Access, Orphan Drugs, People, R&D, Regulatory, Strategy, leadership Tagged access, breakthrough therapies, CDER, Cole Werble, FDA, IMS, Rachel Sherman, Regulatory 2 Comments
Will Congress Provide Sequester "Flexibility" for User Fees?
Just about every federal program and affected interest group is pressing for relief from the 8% across-the-board cuts in funding imposed by the budget sequestration mandate. Recent fast action on Capitol Hill to curb personnel furloughs of air traffic controllers by the Federal Aviation Administration, though, has spurred lobbying for similar treatment across many fronts.
Also posted in FDA, Regulatory, healthcare Tagged FDA, Margaret Hamburg, Office of Management and Budget, sequestration Leave a comment
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, Strategy, healthcare Tagged Affordable Care Act, Congress, healthcare, HHS, Obamacare, Politics, POTUS, Sen. Charles Grassley (R-IA), state health exchanges 3 Comments
Does India's Glivec Decision Make April Fools of Us All?
By Helen Disney, Pugatch Consilium.
On April 1, India’s Supreme Court denied an appeal challenging the rejection of a patent for Novartis’s cancer drug, Glivec. The drug is a life-saving medicine for certain forms of cancer, patented in nearly 40 other countries — including many which are not noted for the strength of their intellectual property [...]
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