May will see US FDA decisions for Apellis, Heron and Bristol Myers Squibb, while Provention Bio is set for a panel meeting.
June will be hectic for the US regulator, with many approval decisions due, including one for subcutaneous Arzerra in multiple sclerosis and Tazverik in follicular…
Manufacturing issues prompt the US regulator to knock back projects from Nabriva and Heron Therapeutics, both of which insist that the problems are easily solvable.
Notable US regulatory decisions due in April feature a major pipeline hope from Abbvie, a non-opioid pain medication from Heron and Glaxo’s two-pill HIV regimen.
Medicare is to review ways to encourage use of non-addictive pain relievers, but Heron Therapeutics will miss out on extension of a special payment provision.