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A change to European rules on drug manufacturing that could benefit makers of generics and biosimilars is edging closer, after lawmakers agreed draft legislation that tweaks rules on export and manufacture of drugs that are off-patent outside the EU.
Kowa Pharmaceuticals America announced the U.S. Court of Appeals for the Federal Circuit has affirmed the decision by the U.S. District Court for the Southern District of New York, upholding the validity of U.S. Patent No. 8,557,993....