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An Ohio federal judge denied a new trial to plaintiffs in a lawsuit against Abbott Laboratories who claimed their son was born with birth defects because the company failed to warn of the risks associated with its anticonvulsant drug Depakote. Read More
The Supreme Court appeared divided Monday on the constitutionality of the PTO’s patent re-examination process of inter partes review — in a debate with wide implications for drugmakers on whether patents are considered private property and if they can only be invalidated through a trial by jury. Read More
The UK’s competition watchdog agency claimed the drugmaker Concordia overcharged the NHS by millions for its hypothyroid medication liothyronine, also known as Cytomel, following price increases of almost 6,000 percent over a decade. Read More
A federal judge blocked Aegerion’s proposed $36 million deal to settle claims of illegal marketing tactics for its cholesterol drug Juxtapid, ordering the case to trial. Read More
Genentech filed a lawsuit aiming to stop Pfizer’s proposed Herceptin biosimilar from reaching the market — asking the court to compensate for losses in sales should the copy launch before 2019, when several patents are set to expire. Read More
The European Medicines Agency revised two guidelines on the development and labeling of factor VIII products used to treat hemophilia A, removing requirements for sponsors to conduct clinical trials in previously untreated patients. Read More
Finger-pointing abounded during a Senate hearing on prescription drug prices, where branded and generic industry representatives testified alongside pharmacy, wholesale distributor and benefit manager groups. Read More
The FDA continues to work to restore drug manufacturing crippled by hurricane Maria in Puerto Rico, with special response teams set up to tackle the job, but none of the plants has reached 70 percent of its pre-storm capacity, FDA Commissioner Scott Gottlieb told a congressional committee. Read More