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Pricing & Reimbursement

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Round Two: BioMarin Resubmits Hemophilia A Gene Therapy Roctavian In US

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.

Gene Therapy Strategy

Amylyx’s Relyvrio Could See Fast Sales Growth, But Also Spark Pricing Debate

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.

Approvals Market Access

Cage Fighting: Novel Drugs From MNCs, Chinese Rivals Compete In China Reimbursement Sector

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.

China Reimbursement

China Drug Price Negotiations: Another Race To The Bottom?

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?

China Reimbursement

Rising Tide Lifts Many Ships In Wake Of Eisai/Biogen’s Lecanemab Readout

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.

Clinical Trials Neurology

ICER Pushes ALS Drug Makers To Moderate Launch Price While Awaiting Confirmatory Data

The US drug pricing watch dog issued a final assessment on Amylyx's AMX0035 and Mitsubishi Tanabe's Radicava for ALS.

Pricing Debate Neurology

BMS Aims To Unseat Otezla In Psoriasis With US FDA-Approved Sotyktu

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.

Launches Dermatology

Outlook Eyes Blockbuster-Sized Sales For An Old Eye Drug In Wet-AMD

The company is seeking FDA approval for a first-time ophthalmic formulation of bevacizumab and also refiled its BLA.

Ophthalmic Business Strategies

China Price-Gouging Includes 'Huge' Sum For Antibiotic

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.

China Reimbursement

Bluebird’s Zynteglo Approval Kicks Off Commercial Operations

Bluebird bio’s Tom Klima told Scrip launch preparations are well under way, including negotiations with payers on outcomes-based reimbursement agreements.

Launches Pricing Strategies

Blueprint’s Ayvakit Mastocytosis Results Raise Commercial Uncertainty

The Phase III PIONEER study in indolent systemic mastocytosis met the primary endpoint, but the magnitude of benefit came up short of analysts’ expectations.

Cancer Business Strategies

Medicare Price ‘Negotiation’ Process Gets Broad Brush Treatment In New Law

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.

Pricing Debate Reimbursement
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