WASHINGTON – When it comes to nanotechnology, size does matter, the FDA said in a new draft guidance, which is more of a conversation starter than an actual guidance.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.

WASHINGTON – In a big win for biopharma and scientists, the Supreme Court put the skids on what amounted to an intellectual land grab by universities.

With the submission of its new drug application for ruxolitinib, Incyte Corp. is counting on having the myelofibrosis field to itself for a few years with a first-in-class treatment.

WASHINGTON – Part of the price of a patent has been disclosure of trade secrets, but the patent reform bill headed for the House floor would no longer require that tit for tat.

Seizing opportunity from the failure of others, Neumedicines Inc. is breathing new life into Interleukin-12 (IL-12), a biologic once seen as the great hope for cancer.

S. 990 was signed into law last week. At first glance, it looks like it extends the life of Small Business Administration programs that are near and dear to the bottom line of many small biotechs. But somewhere along its pat through the Senate, the bill was stripped of the language that would have extended the Small Business Innovation Research (SBIR) program through Sept. 30, 2012. In its place are a few short paragraphs renewing the Patriot Act. But the title of the bill remains “To provide for an additional temporary extension of programs under the Small Business Act and...

Facebook is forcing biotechs to get out of the neighborhood or get more friendly – a move that could set drug companies up for a potential run-in with the regulatory police.

WASHINGTON – Small biotechs waiting for Congress to breathe new life into the Small Business Innovation Research (SBIR) program will have to wait a little longer.