The patent backlog at the Patent and Trademark Office (PTO) is likely to get worse before it gets better, especially as the March 16, 2013, deadline approaches for switching from the current first-to-invent system to the new first-to-file process laid out in the America Invents Act (AIA).
To save time and money, the FDA is making its website the sole go-to source for its agreements with other federal and state departments, agencies and organizations.
Drugmakers that have been splashing in the social media waters may get official pool rules – in another two years. That's how long Congress, under the FDA Safety and Innovation Act (FDASIA), has given the FDA to issue guidance on its policy regarding drug promotion via social media.
As the Trans-Pacific Partnership (TPP) talks head into their 14th round early next month, U.S. lawmakers continue to press the president to ensure the negotiations protect the 12-year data exclusivity for biologics.
Isolated DNA is patent-eligible because it is a "non-naturally occurring composition of matter," so said an appellate court in determining, once again, the validity of Myriad Genetics Inc.'s claims for its BRACAnalysis breast cancer gene test.
With the PDUFA date for Gilead Sciences Inc.'s Quad less than a fortnight off, the company is coming under congressional pressure to reduce the expected price of what is likely to be the next big HIV therapy.
Sponsors of biosimilars must demonstrate similarity, not safety and efficacy, FDA officials reiterated as they discussed ways to do that at an advisory committee meeting Wednesday.
In passing PDUFA V, Congress piled on the homework for the FDA, and much of it has nothing to do with user fees. Some of the assignments, for instance, deal with implementing incentives for new antibiotics.
Hoping to make shortages of critical drugs more the exception than the rule, the generic drug industry is diving into an initiative to give the FDA access to timely manufacturing data.
