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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
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
The FDA slapped an Indian manufacturer with a warning letter for creating phony records, falsifying training tests and failing to clean up a moldy and insect-infested facility. Read More
Baxter continues to be plagued with particulate problems, recalling two lots of a dialysis solution and a lot of saline solution that is currently in short supply. Read More
A federal court has ruled that generic manufacturer Mylan does not have to recall its already-shipped versions of Hospira’s sedative Precedex, a move that reverses the court’s earlier mandate to recall all existing generic versions of the drug. Read More
In a widely expected move, the Drug Enforcement Administration has clamped down on misuse of hydrocodone combination products (HCPs) by classifying them as Schedule II controlled substances, a designation that already applies to oxycodone and non-combo hydrocodone painkillers. Read More
Hospira has won a temporary restraining order blocking Mylan from marketing a generic version of its sedative Precedex, which the FDA authorized this week under the controversial section viii statement pathway that foregoes a patent challenge and instead allows manufacturers to “carve out” indications not protected by patents. Read More