While the FDA Safety and Innovation Act (FDASIA) includes a number of provisions to ensure the quality of drugs and protect against counterfeits, it's what it's missing that could have the biggest impact on the supply chain in a few years.
Calling it "one of the most significant unresolved legal questions currently affecting the pharmaceutical industry," Merck & Co. Inc. hit the pay-for-delay ball into the Supreme Court, asking the court to, once and for all, determine whether the reverse settlements violate federal antitrust laws.
Researchers who have acclimated to a publish-or-perish environment are in for a climate change when the first-to-file provision of the America Invents Act (AIA) settles over the land next March. At the front of that change is the Patent and Trademark Office's (PTO) proposed rule to expand the reach of prior art. If the rule is finalized, researchers who publish too soon before a patent application is filed could see the claims perish.
An appeals court Friday upheld federal funding of human embryonic stem cell (hESC) research and, in a case involving cigarette labeling, gave a boost to corporate free speech rights that could encourage biopharma to challenge restrictions on off-label promotion.
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.
