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Generic versions of Ferring Pharmaceutical’s menstrual bleeding drug Lysteda can move forward after the brandmaker lost a pair of appeals in patent infringement lawsuits seeking to block ANDAs against the product. Read More
Drugmaker ViiV Healthcare is set to launch its triple combination HIV therapy Triumeq in the U.S., after receiving a green light from the FDA. Read More
Swiss pharmaceutical company Roche said yesterday it will acquire California-based biotechnology firm InterMune for $8.3 billion, in a deal that allows Roche to strengthen its respiratory therapy portfolio. Read More
European regulators approve new drugs at a faster clip than their Canadian counterparts, but both jurisdictions have the same rate of pulling drugs from the market due to safety reasons, a new study finds. Read More
The FDA has cleared Mylan’s generic version of Upsher-Smith’s potassium drug Klor-Con, and the generics firm has already started shipping the product. Read More
Regulators in Australia are seeking input on proposed changes to drug labelling regulations that could save the public health system up to $30 million annually in hospital admission costs attributed to medication errors, but would cost industry millions of dollars to implement. Read More
Brazil's Anvisa issued a rule on June 18 establishing criteria for the priority review of small molecule drugs and biologics. Rule No. 37 applies to marketing authorization, postauthorization and clinical study applications. Read More