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.
In an agency first, the FDA is rescinding an orphan drug exclusivity, saying it made a mistake two years ago in determining that Octapharma USA Inc.'s Wilate was superior to CSL Behring LLC's previously approved Humate-P.
What’s the difference between Congress and a Rube Goldberg contraption? They both use convoluted processes to accomplish a simple task, but the Goldberg invention still manages to keep the end result pretty simple. And while there may be some unintended consequences with both, they’re not unexpected with the absurd processes of a Goldberg machine. One look shows you what kind of mess you’re going to have if the cracker misses its mark, the parrot misses its perch, the seeds miss the bucket, the cigar lighter misses the fuse . . . Not so with Congress. By the time all 435...
WASHINGTON – In vacating a preliminary injunction that protected Momenta Pharmaceuticals Inc.'s $1 billion a year monopoly on generic Lovenox, the Federal Circuit gave the makers of generic drugs a much wider safe harbor under Hatch-Waxman.
