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Novartis AG

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Latest From Novartis AG

BioMarin CEO Suggests Hemophilia Gene Therapy Pricing In $2m-$3m Range

During BioMarin’s earnings call Feb. 21, CEO Bienaime indicated the company may be looking to price its valoctocogene roxaparvovec gene therapy at $2m-$3m, as it would represent a savings over the annual cost of infused clotting factor therapy.

Business Strategies Commercial

Modus CEO On Its Plans For An At-Home Injectable For Sickle Cell Crises

Modus Therapeutics has begun a Phase I study with subcutaneously administered sevuparin. Its CEO says this new formulation of its lead asset has the potential to be self-administered by sickle cell disease patients at home for the treatment of vaso-occlusive crises.

Clinical Trials Companies

Biosimilars: US FDA Asked To Clarify Thinking On Pediatric Studies, Indication Carve-Outs

Draft guidance raises questions about Pediatric Research Equity Act obligations of biosimilar applicants and reference product holders, comments say; industry seeks clarity on review of indications with unexpired exclusivity and requests allowances for situations where a biosimilar's dosage form or labeled conditions of use do not align exactly with those of the reference product.

Biosimilars Pediatrics

Cell Therapies Forge Ahead In Japan with Reimbursement, Approval Decisions

A controversial cell therapy for spinal injuries receives coverage under Japan’s national health scheme, amid signs that the pricing of regenerative therapies may come under more scrutiny, while the first CAR-T treatment in the country takes a step closer to market.

Japan Approvals
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