Regeneron Pharmaceuticals Inc. sold an FDA advisory committee on the benefits of its Eylea as an every-other-month treatment for the neovascular form of age-related macular degeneration (wet AMD).
WASHINGTON – The battle lines have been drawn over how big of an increase the FDA needs in fiscal 2012. House Republicans have said 11 percent should do it, but the president wants a lot more.
WASHINGTON – While Congress may be on the verge of passing the first major patent reform in nearly 60 years, the courts have been steadily shaping and redefining the nation's patent system in a series of recent decisions that may be "game changers" for biotech.
When it comes to getting an injection in the eye, the fewer the better. That's what Regeneron Pharmaceuticals Inc. is counting on to drive its Eylea into the market for the neovascular form of age-related macular degeneration (wet AMD).
WASHINGTON – When it comes to nanotechnology, size does matter, the FDA said in a new draft guidance, which is more of a conversation starter than an actual guidance.
Disclosure and transparency. They’re recurring themes often sung by lawmakers and critics who would have us believe that even the gift of a drug-labeled pen will put doctors and medical students under the influence of biopharma. You’ve heard the refrain. Calls for disclosure on journal articles and citizen petitions. Reminders to disclose drug ties when testifying before Congress or an advisory committee. Requirements for doctors and researchers to disclose personal or family ties with industry when serving on an FDA advisory committee. What you haven’t heard are demands that biopharma critics disclose where they get their funding. And when’s the...
WASHINGTON – The FDA is putting the cart before the horse, Talecris Biotherapeutics Inc. said in a comment on the agency's proposed biosimilar fee structure.
