August 16, 2021
FDA approval of Lumakras was contingent on a trial testing lower doses. It could usher in a new era of optimal dosing instead of the maximum tolerated dosing.
July 13, 2021
Low prices and some gaming of regulations can drive out competitors and create monopolies that allow generic makers to jack up their prices. Experience has shown that it often takes multiple generics to achieve the promised-for downward pressure on prices.
July 08, 2021
The biggest price increase was a 9.5% rise for Zogenix’s Fintepla (fenfluramine), used to treat seizures associated with Dravet syndrome.
July 03, 2021
Merck will withdraw Keytruda's advanced gastric indication after an FDA panel vote, a drug with supply problems gets a new indication, NDAs for an HIV therapy, and other news.
June 19, 2021
A new indication, a nonprescription switch, a recall, and new guidances round out this week’s FDA news.
June 07, 2021
Ten years ago, specialty accounted for 15% to 20% of the money spent on drugs, according to Prem Shah, executive vice president of specialty pharmacy and product innovation at CVS Health.
May 19, 2021
PBMs say exclusions are important for negotiating lower prices on behalf of health plans and members. Some payer and provider groups say they interfere with patient access to medicines.
May 01, 2021
As hearings of the FDA panel have shown, once a drug is approved and in clinical guidelines, pulling it from the market is not so simple, even if later trials do not confirm phase 2 results.
February 18, 2021
Having specialty pharmacies fill prescriptions may lower costs, but critics of the practice see safety issues and other drawbacks.
December 29, 2020
Drug and diagnostic approvals and biosimilars news were popular with readers.