At the end of the day, does it really matter whether the Federal Circuit takes a fresh look at the construction of patent claims or defers to a lower court's interpretation of issues of fact?
In its ongoing scrutiny of heparin producers, the FDA has added a Beijing firm to a growing list of companies that are on import alert due to concerns about the potential for contamination.
In its ongoing scrutiny of heparin producers, the FDA has added a Beijing firm to a growing list of companies that are on import alert due to concerns about the potential for contamination.
The Supreme Court will hear arguments in a case Wednesday that could ultimately rein in the Federal Circuit in its review of patent claims, making it toe the same review line as the other circuit courts.
It’s not every day that drugmakers get a chance to take on an entirely new market. Biosimilars are offering that opportunity. And hundreds of drugmakers, research institutions and governments are hoping to make the most of it. The result is more than 700 follow-on biologics (FOBs) already approved or in the global pipeline, according to a new report by BioWorld. Those entering the field are as diverse as the FOBs they’re developing. Biologics pioneers, big pharma and generic drugmakers are being joined by “pure-play” start-ups, conglomerates, public-private consortia, contract manufacturers, contract research organizations, government agencies, nonprofits and research institutions. Some...
Perhaps the most anticipated biosimilar guidance the FDA is working on is the one that will guide the development of interchangeable biologics. Some drugmakers are counting on it to turn interchangeables into biogenerics, at least in the U.S.
U.S. drugmakers' quest for tax-friendly foreign addresses could get waylaid by the Treasury Department's efforts to end corporate inversions. The inversions, which involve U.S.-based multinationals moving their tax residence overseas to take advantage of more favorable corporate tax rates, have become a popular theme in the pharmaceutical industry over the past few years, with several companies acquiring addresses in Ireland.
After a year of listening, the FDA is proposing four projects to reduce the burden of risk evaluation and mitigation strategies (REMS) on doctors, patients and pharmacies, but noticeably missing is any discussion of balancing the burden among drugmakers of a shared REMS.
Testifying in a joint Senate committee hearing on Ebola this week, the CDC’s Beth Bell compared the epidemic spreading through West Africa with a forest fire. She stressed that any ember left undetected could quickly flare up and re-ignite the conflagration. Her analogy took me back more than 25 years to my time as a news director for a radio station in Idaho. It was the summer of 1988, and Yellowstone National Park was on fire. The park neighbored the county where I lived, and the smoke from the fires formed a dense fog that blocked the sun for several...
