Alnylam decision has been seized by opponents of Medicare price negotiation as evidence the nascent program will undermine innovation, particularly for small molecule drugs.
Rare disease treatment developer Alnylam Pharmaceuticals Inc. has scrapped plans to begin a Phase III study on use of its second-generation RNAi product Amvuttra (vutrisiran) in a second orphan drug indication because having more than one orphan indication could make the drug subject to Medicare price negotiation under the Inflation Reduction Act.
The study would have investigated use of vutrisiran in Stargardt disease, a rare genetic eye disorder that can cause vision...
The Centers for Medicare and Medicaid Services is considering imposing price inflation rebates on Part B drugs furnished to enrollees in Medicare Advantage plans in addition to those covered by fee-for-service Medicare.
Doctors are increasingly falling victim to financial scams due to their high incomes, busy schedules, and trust in professional networks. Recognizing the tactics scammers use and the reasons behind physicians’ susceptibility is essential for protecting medical professionals.
Hemgenix has now secured reimbursement in several European markets, and while the path to reimbursement for the high-cost product has not always been easy, innovative access deals have helped to smooth the way.
Senate HELP Committee chair Sanders trying to broker a deal between Novo Nordisk and the major pharmacy benefit managers that will lead to lower list prices.
It is unclear in a revised staff manual guide whether Commissioner's National Priority Voucher program approval “recommendations” from the drug and biologic center directors will be advisory or decisional, experts told the Pink Sheet.
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
