Pricing & Reimbursement
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BioMarin maintains its lead in the race to win approval for a hemophilia A gene therapy in the US by resubmitting Roctavian two years after the FDA issued a CRL in response to the original BLA.
The FDA gave full approval based on a Phase II study, without the need for Phase III confirmatory data, for Amylyx’s ALS drug Relyvrio but the $158,000 WAC could spark a debate over pricing.
After slashing the prices of their blockbuster drugs to gain wider patient access through China's main reimbursement program, multinationals are now beginning to face increasing challenges from local competitors.
With the fourth quarter just around the corner, China's closely-watched annual drug reimbursement and prices negotiations are entering a key final stage. But will applicants need to be more strategic than expedient?
Eisai and Biogen had double-digit stock price gains based on the positive Phase III readout for lecanemab. The good news also lifted competitors Lilly and Roche as well as earlier-stage Alzheimer’s drug developers.
The US drug pricing watch dog issued a final assessment on Amylyx's AMX0035 and Mitsubishi Tanabe's Radicava for ALS.
Chief commercialization officer Chris Boerner said BMS plans to replace Otezla as the oral standard of care for moderate-to-severe psoriasis with Sotyktu (deucravacitinib); its list price is about 40% higher than Amgen’s product.
The company is seeking FDA approval for a first-time ophthalmic formulation of bevacizumab and also refiled its BLA.
A rare disclosure by China’s national health insurance payer shows how a major state-owned drug maker used its market-dominating position to dodge price-lowering schemes and increase drug prices more than 10-fold.
Bluebird bio’s Tom Klima told Scrip launch preparations are well under way, including negotiations with payers on outcomes-based reimbursement agreements.
The Phase III PIONEER study in indolent systemic mastocytosis met the primary endpoint, but the magnitude of benefit came up short of analysts’ expectations.
With enactment of the drug pricing reform provisions in the Inflation Reduction Act, stakeholders now turn their attention to the implementing regulations that will be developed by the Centers for Medicare and Medicaid Services.
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