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The Pennsylvania Supreme Court has affirmed that drugmakers can be held liable for negligent drug design, opening up a new avenue for patients seeking financial relief for injury claims in the state. Read More
The Supreme Court on Wednesday, in a closely-watched case, issued a unanimous 9-0 ruling stating that regardless of whether a patent holder is the plaintiff or defendant in a patent infringement case, the burden-of-proof for infringement remains with the patent holder. Read More
Ranbaxy’s regulatory woes deepened Thursday as the FDA prohibited the drugmaker’s Toansa, India, plant from manufacturing and distributing active pharmaceutical ingredients (APIs) for U.S. products after a poor inspection. Read More
Proposed international guidelines on metal impurities in finished drugs may be impossible to meet because they lack specificity and are impractical for suppliers, drugmakers say. Read More
Brand drugmakers are denying accusations they’re behind a covert campaign to block proposed patent law changes that would improve access to generics in South Africa. Read More
The Department of Justice wants to rid the pharmaceutical industry of pay-for-performance sales compensation packages, believing they fuel fraud, off-label marketing and other deceptive behaviors, a former top prosecutor says. Read More
The FDA has approved a new formulation of Nuvo Research and Mallinckrodt’s osteoarthritis drug Pennsaid for the treatment of osteoarthritis knee pain, but not the broader indication of signs and symptoms of the disease — adding a new wrinkle to the fight between the two partner companies co-developing the drug. Read More
Drugmakers angling for longer patent-term adjustments scored a big win Wednesday as a federal appeals court ruled that the U.S. Patent and Trademark Office (PTO) incorrectly calculated adjustments for three Novartis patents, a ruling that will affect patents across the board. Read More
French authorities in December fined Merck US $21.5 million for attempting to stall market entry of generic versions of its opioid-dependence drug Subutex. Read More
Foreign pharma can continue to invest directly in existing Indian drug companies, provided there is no “noncompete” clause in the transaction, the government says. Read More