Price transparency reports from the big pharmas also show continued increases in price concessions in 2017, but a slow-down in list price increases.

As two high-profile pharma veterans make their move into pharmacy benefit management leadership, Viren Mehta, founding partner of Mehta Partners LLC, ponders the challenges they face and the impact their actions will have on the pharma industry.

The US drug pricing policy environment is facing changes. Much of the action, whether Congressional or regulatory, is good for industry – but there have been a few setbacks and more may come.

If 2017 was the year of talk (tweets) on prescription drug pricing policy, 2018 is shaping up to be the year of action.

The FDA Commissioner called on payers to take steps to build the US biosimilar market and discouraged some early contracting schemes, calling them pay-for-delay tactics "dressed in the guise of rebates" in a notable speech at AHIP.

The US FDA gives Sweden's privately held Modus Therapeutics rare pediatric disease designation for sickle cell disease.

Reversing an earlier decision, FDA accepted Alkermes' new drug application (NDA) for ALKS 5461 for review, with a target action date of Jan. 31. But the company could still face a tough FDA review.

CEO Richard Pops called FDA's letter for ALKS 5461 "surprising and troubling." Alkermes had been ramping up to launch the depression drug later this year, though some investors had remained skeptical.

Celgene said the US FDA issued a refuse-to-file letter for ozanimod in multiple sclerosis because "the nonclinical and clinical pharmacology sections in the NDA were insufficient to permit a review." It's yet another big blow for a company whose value has been falling since October.

The pharma hopes showing a PFS benefit in first-line NSCLC patients with a high tumor mutation burden may provide a way to compete with Merck in that setting, but analysts think it will need overall survival data.