ADVERTISEMENT

Market Access

Industry Criticizes Dutch Decision To Slash PARP Inhibitor Reimbursement

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.

Watch This Space: Miltenyi‘s ‘Brain-To-Vein,’ Point-Of-Care CAR-T Efforts In India

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.

How Will Regulatory Filing Winds Blow Globally For Elevidys Following Patient Deaths?

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, Bharat On Shigella Vaccine Phase II Data Timelines, Malaria Vaccine Price Halving

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

Denmark Introduces First Confidential Pricing Framework For Primary Care Medicines

Expanded confidential pricing for pharmaceuticals is intended to help manage medicines expenditure, according to Amgros, the procurement agency that will negotiate the prices.

Mexico’s New Procurement Rules Aim To Increase Healthcare Investment, But May Face Legal Trouble

Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.

New Drug Procurement Rules Aim To Drive Pharma Investment In Mexico

Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.

In Conversation With Foundation Fighting Blindness

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.

Wide Of The Mark: ‘The Worst EU Medtech Predictions Have Not Come True’

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.”

Brazil Could Look To Germany, UK And Australia For ATMP Drug Pricing Rules

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.

HTA Expert Warns Of Escalating Measures If Pharma Fails To Tame Prices

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.

Alzheimer’s Drug Leqembi May Be On Course To India, Kisunla In The Wings

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.