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The French Competition Authority fined Johnson & Johnson €25 million ($27 million) for delaying market access to generic copies of its painkiller Durogesic, a fentanyl-based patch for treatment of chronic and severe pain. Read More
Sandoz triumphed over Amgen in a biosimilar patent infringement case that went from a Northern California federal court, up the ladder to the Supreme Court and back down again — following victories in both the district court and the Federal Circuit Court of Appeals this past week. Read More
An HHS audit of the Medicaid drug rebate program found hundreds of misclassifications by manufacturers — which may have led to more than $1.3 billion in lost rebates payable to the federal government over the past five years. Read More
The House of Representatives moved closer to passing the final version of the Republicans’ tax reform legislation Tuesday, a sweeping $1.5 trillion measure that reduces or eliminates many deductions and credits — including cutting the orphan drug research tax credit in half. 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
UK’s MHRA reclassified Pfizer’s Viagra (sildenafil), allowing it to be sold over the counter without a prescription, branded as Viagra Connect. Previous versions of the tablet will still be available as a prescription medicine. Read More
CBER said it will prefer using internationally harmonized standards developed by third-party organizations — as opposed to maintaining its own — and it is urging sponsors of biologics to do the same, according to a new draft guidance. Read More
A multistate price-fixing lawsuit against generic drugmakers should be dramatically expanded to target more drugs, more companies and, for the first time, individual company executives, the attorneys general who filed the litigation told a federal court. Read More
The number of “pay-for-delay” patent settlements agreed to by pharmaceutical companies in fiscal 2015 declined from the year before, according to a report from the Federal Trade Commission. Read More