HTA, pricing and reimbursement: EU HTA Regulation, G-BA, HAS, NICE, ICER, IRA and payers.
IGJ has published a manufacturer warning for exocad's exoplan planning software after a dentist found one implant, sleeve and drill combination could drill 2.0 mm deeper than expected.
The Dutch health inspectorate IGJ has posted a manufacturer warning saying the Altair ceiling lift's strap clip can contribute to localised strap wear or damage under certain conditions of use.
The Dutch inspectorate IGJ has published a manufacturer field safety notice covering the Aerogen Solo Continuous Nebulization Tube Set, citing incorrect enteral syringes in some products.
The Dutch inspectorate has published a manufacturer field safety notice on unintended stimulation during charging, or failure to charge, with the Evoke CLS.
The Danish Medicines Agency will deactivate its section 29(2) permission for German-authorised Paracetamol AL "Aliud" suppositories because marketed Danish packs are available again.
Greece's EOF has published a notice that the marketing authorisation holder will permanently stop marketing EMEND (aprepitant), with Greece named among the affected countries.
The National Organisation for Medicines has issued a corrected repeat of its 31 October 2026 list of medicinal products with limited availability on the Greek market.
The Danish Medicines Agency is inactivating its section 29(2) exemption for German-authorised Paracetamol AL 'Aliud' suppositories, as marketed Danish packs are available again.
Abiomed has reported more complaints that its Automated Impella Controller fails to detect the purge cassette, which it links to defects in a purge pressure sensor component.
IGJ has posted a manufacturer warning after market reports of abnormal waveforms and inaccurate physiological measurements, with an investigation pointing to gaps in Intersurgical's internal testing.
Customers reported ammonia results reading about 6% to 15% low after switching standard lots, with the manufacturer warning of possible serious patient harm.
IGJ has published a manufacturer field safety notice after complaints that vacuum tubing in the cell rinse unit of the cobas c 303 deteriorated earlier than expected.
Intersurgical is recalling several lots of Smoothbore-based breathing systems in Canada after market reports of soft connectors coming off the tube, with insufficient bonding solvent identified.
Italy's medicines agency has activated the web registry and published clinical forms for vorasidenib, with reimbursed use under the national health service possible from 6 November 2026.
Italy's medicines agency has revised the amivantamab registries for two lung cancer indications, adding subcutaneous schedules and their marketing authorisation numbers from 6 November 2026.
Italy's medicines agency has updated the durvalumab registry for resectable non-small cell lung cancer, adding a further platinum-based combination to the neoadjuvant phase in two registry forms.
Italy's medicines agency has revised the registries for Enhertu in breast and gastric cancer, removing a block on treating patients with active, symptomatic or uncontrolled brain metastases.
Italy's medicines agency has revised the monitoring registry for amivantamab in advanced EGFR exon 20 insertion lung cancer, adjusting when carboplatin-containing combinations are selected on the request form.
Italy's medicines agency has revised the registries for tislelizumab in gastric/GEJ adenocarcinoma and oesophageal squamous cell carcinoma, effective 6 November 2026, following Determination PRES/1512/2026.
Italy's medicines agency has revised the Lunsumio registry for relapsed or refractory follicular lymphoma, with changes effective 6 November 2026 following Determination PRES/1504/2026.
Italy's medicines agency has activated the web registry and published clinical forms for vorasidenib, with reimbursed use for grade 2 IDH-mutant astrocytoma or oligodendroglioma starting 6 November 2026.
Italy's medicines agency has revised the registries for trastuzumab deruxtecan in breast and gastric cancer, removing a treatment block for patients with active, symptomatic or uncontrolled brain metastases.
Italy's medicines agency has changed the timing of selecting carboplatin-containing combination regimens in the Rybrevant (amivantamab) monitoring registry's drug request form for first-line NSCLC.
Italy's medicines agency has revised the Tevimbra (tislelizumab) registries for two first-line oesophageal and gastric cancer indications, effective 6 November 2026.
The Italian medicines agency has amended the Lunsumio (mosunetuzumab) registry from 6 November 2026, adding the new subcutaneous posology to the request form and new AIC codes to the dispensing form.
The report on camizestrant (Etcamah), prepared by Austria and Belgium under the EU HTA Regulation, will feed into national decision-making by Member States.
The report on camizestrant (Etcamah), assessed by Austria and Belgium under the EU HTA Regulation, was endorsed by Member States on 19 August 2026.
AIFA's monitoring of Italian public pharmaceutical expenditure for January-April 2026 shows total spend (convenzionata, direct purchases and oxygen) of €9,036.9 million, equal to 19.26% of the national health fund (FSN), based on the provisional 2026 FSN value communicated by the Ministry of Health. It is relevant mainly to market access and pricing/reimbursement teams tracking spending-ceiling pressure; it has no direct pharmacovigilance or quality implications.
A Dutch IGJ notice reports that Bolton Medical's internal review found about 1% of units may exceed the endotoxin specification, prompting a field safety notice.
The long-term care pharmacy provider reported $371.1 million in third-quarter revenue, higher net income and adjusted EBITDA growth of 24%, and raised its full-year guidance.
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.