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Two House Republicans are accusing the FDA of shirking its responsibility when it comes to explaining the limits of off-label promotion, leaving it up to the courts to decide the matter for it. Read More
Fifteen House Democrats are calling on top U.S. trade officials to clarify the administration’s position on compulsory licensing for Novartis’ cancer drug Gleevec in Colombia. Read More
A U.S. district court has dismissed patent infringement claims against Hikma Pharmaceuticals, ruling that Takeda Pharmaceuticals USA lacked any “plausible claim to relief” in the case. Read More
In an effort to lower prescription drug spending, China is slashing prices for three drugs by more than 50 percent, a move that will hit both GlaxoSmithKline and AstraZeneca in the wallet. Read More
GlaxoSmithKline is appealing a $54 million fine from the UK’s Competitions and Market Authority over pay-for-delay allegations, contending the company’s conduct was “objectively justified.” Read More
UK regulators have fined Pfizer $14,000 for failing to explain a questionable claim meant to justify price increases on the generic seizure medication Epanutin. Read More
Despite grave doubts, an Indian high court judge is allowing two drugmakers to market and produce contested biosimilars of Roche’s breast cancer therapy Herceptin. Read More