-
Eden, Crucell ink manufacturing agreement
RESEARCH TRIANGLE PARK, N.C. Watson Pharmaceuticals biotech subsidiary Eden Biodesign has signed a manufacturing agreement with Dutch biotech company Crucell that will give Watson access to Crucell’s cell line technology, the two companies announced Wednesday.
Under the agreement, Eden will provide process development and current good manufacturing practice services using Crucell’s PER.C6 technology to licensees using the technology to develop vaccines and gene therapies.
-
Report: FDA’s Hamburg says creating biosimilars pathway likely to be complex
NEW YORK To express it in modern parlance, follow-on biologics will be a hot mess.
While speaking at the Reuters Health Summit, according to Reuters, Food and Drug Administration commissioner Margaret Hamburg didn’t put it quite that colorfully, but she had said the science will evolve, meaning a regulatory approval pathway never will be a truly done deal.