HTA, pricing and reimbursement: EU HTA Regulation, G-BA, HAS, NICE, ICER, IRA and payers.
Merit Medical has issued a field safety notice, published by the Dutch inspectorate, over resistance when Philips Bridge balloons are advanced over the guidewire in the Bridge Prep Kit.
The Danish Medicines Agency says there is no shortage of Pfizer's Rapamune 1 mg/ml oral solution after all, reversing an earlier supply notice.
DKMA's notice on Rimactan 300 mg hard capsules, first posted in March, was updated on 27 October 2026; supply problems began in mid-February with no end date.
DKMA has updated its notice on Sandoz's Rimactan 300 mg capsules, citing increased demand and an expected disruption from mid-February to the end of December 2026.
The Czech regulator's list covers registered products traded between April and September 2026 that receive no public health insurance reimbursement, plus certain products with a set maximum price.
The Czech medicines authority has released the monthly reimbursement list, with maximum prices, reimbursement levels, indication restrictions and change files for products paid by public health insurance.
Preliminary, unaudited figures show wholesalers bought 792 LYMPHIR units in the quarter to 30 September 2026, with 54 institutions having ordered the lymphoma therapy.
Preliminary, unaudited figures show wholesalers bought 792 units of the cutaneous T-cell lymphoma therapy in the September quarter, against 360 in the previous quarter.
CBER says Ebola transmission through cells and tissue products has never been described, but suggests establishments consider 21-day exposure and travel history for donors during the Bundibugyo outbreak.
Italy's medicines agency has issued updated lists of reimbursed and hospital-use products, ordered by active ingredient and trade name, to support prescribing by active substance.
DG SANTE has revised its procedural guidance for HTA joint scientific consultations on medicines and on medical devices and in vitro diagnostics, introducing a role described as 'watcher'.
Italy's medicines agency has issued updated reference tables of NHS-dispensed Class A and Class H products, supporting prescribing by active substance and noting an equivalence code change for amiodarone injection.
The Dutch inspectorate IGJ has published a manufacturer field safety notice covering Philips' Lumify diagnostic ultrasound system, citing issues that could prevent or slow scanning.
Spain's regulator says some LUNA X5 carriages used in portable configuration with an extension arm may not lock fully, risking a hoist fall and injury during patient transfers.
Italy's medicines agency has made available the results of the Scientific and Economic Committee's meeting, which covers reimbursement, pricing and classification matters.
The Czech medicines authority has issued the November edition of its list of prices and reimbursements for foods for special medical purposes, reflecting 12% VAT and the current ministerial price decision.
Italy's medicines agency has revised the HETRONIFY registry for serplulimab in extensive-stage small cell lung cancer, following a determination published in the Official Gazette on 21 October 2026.
Italy's medicines agency says monitoring of panobinostat (Farydak) in its registry stops on 22 October 2026, following a determination published in the Official Gazette the day before.
The Austrian regulator lists Northern Burgenland, Vienna and northern Vienna surroundings as regions with confirmed locally acquired West Nile virus infections.
Spain's medicines agency says indirect contact with treated owners can cause severe cardiovascular toxicity and death in companion animals, and urges vets and prescribers to report cases.
The Dutch health inspectorate has published a manufacturer warning on a Patient Lifting Solutions trolley coupling, where a weld below specification may let the blocking arm detach.
The marketing authorisation holder has pulled its prior evaluation request for osilodrostat in endogenous Cushing's syndrome, and INFARMED has posted the public report on Infomed.
Medtronic has revised the Abre self-expanding venous stent IFU to add an approved manual deployment alternative, aimed at limiting harm if a stent is only partially deployed.
SÚKL has published a notice from Janssen-Cilag on the interruption of supplies of Invega 9 mg tablets in the 49-tablet pack, giving no cause or restart date.
The government has decided CE marked devices and IVDs approved for the EU will keep access to the GB market long term, following a consultation with over 1,000 responses.
Companies can now apply electronically to the German regulator for exemption from the extra rebate that applies from 1 January 2027, ahead of the rule taking effect.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.