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Market Access
ZIN, the Dutch health technology assessment body, estimates that the number of patients eligible for treatment with a PARP inhibitor will be halved following a reassessment of drugs in the class.
From a letter of intent with BIRAC sealed at BIO 2025 to supporting Immuneel’s CAR-T efforts and a study for point-of-care manufactured anti-CD19 CAR-T cell therapy, Miltenyi Biotec is moving on multiple fronts in India. The German group also expects to advance its own CAR-T candidates.
Roche’s filing for Elevidys in the EU followed applications in Middle Eastern countries because those markets accept applications based on approval by the US Food and Drugs Administration.
GSK tells Scrip about timelines for data expected from two Phase II trials for its Bharat Biotech-partnered shigella vaccine candidate, which puts it ahead of Limmatech/Valneva. Meanwhile, a global-first malaria vaccine, also partnered with Bharat, sees an over 50% price cut
Expanded confidential pricing for pharmaceuticals is intended to help manage medicines expenditure, according to Amgros, the procurement agency that will negotiate the prices.
Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.
Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.
Jason Menzo, CEO of the Foundation Fighting Blindness, says the organization is adapting its funding strategy, navigating regulatory challenges and accelerating the translation of academic discoveries into industry-led clinical development.
Jana Grieb, European regulatory and market access legal expert at McDermott Will & Emery, explains why the healthtech and pharma industries are warming to the new EU health commissioner as he faces calls to make the MDR more “user friendly.”
There is a place for using external reference pricing to set prices of advanced therapies, but any such mechanism must take into account the specificities of the Brazilian market and health system.
Too many “uninformative” drug trials fail to justify the excessively high prices of many medicines, while there is too much evidentiary uncertainty in European pricing and reimbursement systems, warned Anja Schiel from Norway’s NOMA.
Key expert panel go-ahead with a trial waiver put’s Eisai's Alzheimer's therapy on track for a debut in India where tailored pricing will be pivotal. Lilly’s Kisunla is also under regulatory review.