Mega-merger's top US drug candidates are seeking space in crowded fields. That means they have to get through the FDA fast, and priority review vouchers figure prominently in both improving and lowering the odds.

The rebate rule is dead, but we should pay tribute to the failed endeavor.

A court in Dusseldorf ruled that Praluent infringes a patent for Amgen's better-selling PCSK9 inhibitor Repatha, saying that Sanofi and Regeneron must stop selling their biologic in Germany. It's unclear whether there will be any readthrough to ongoing patent disputes in other countries.

Sponsors should realize that only a very few people – think 4, not 50 – will be permitted to be unblinded, CDER's Laura Lee Johnson tells the DIA annual meeting.

Former US FDA Commissioner Robert Califf remains eager to encourage broader use of real-world evidence – but his blunt, pessimistic read on the state of biopharma innovation is remarkable coming from a former FDA head.

The Council of the EU has published its conclusions on making the EU a “best practice region” in combatting antimicrobial resistance. While there are plenty of recommendations, little concrete action is proposed.

White House will not move forward with a rebate proposal the drug industry supported as a way to lower patient drug spending.

News and views from day four of the BIO International Convention: Former FDA official Amy McKee said "everything worked right" with accelerated approval and removal of Lilly's Lartruvo; emerging company M&A deals nearly double in 2018; and the ASCO effect on the 3-6 June BIO meeting.

Much like Genzyme’s Ceredase did two decades ago, Novartis’ Zolgensma is setting a new pricing benchmark. The first million-dollar product is launching in the US and it will actually cost more than $2 million.

After 20 years in the making, the landmark GMP inspection MRA between the US and the EU is finally fully implemented. In addition, a batch test waiver has started to apply under the deal.

Now that US FDA has approved the final EU authority, mutual recognition efforts could expand and deepen. Former FDA chief counsel Rebecca Wood discusses the future of approval standards harmonization in Pink Sheet interview.