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Category Archives: Legal
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 [...]
The Patent Black Label: Six Side-Effects of India's Novartis Glivec Ruling
Monday’s decision by India’s Supreme Court to deny a patent for the top-selling oncologic drug Glivec took nearly a decade of litigation to resolve – but the implications in and beyond India are both immediate and lasting. Here’s a list of six that Pharm Exec thinks are most important:
Also posted in Emerging Markets, Global, IP, Manufacturing, Market Access, Strategy, pricing Tagged China, Glivec, Global IP, india, Novartis, oncologics, Patent, Supreme Court, TRIPs 6 Comments
FDA: From Risk Aversion to Approval Activism