HTA, pricing and reimbursement: EU HTA Regulation, G-BA, HAS, NICE, ICER, IRA and payers.
The sleep apnea neurostimulation maker's November 2026 presentation covers a Category I CPT code, final 2027 Medicare payments, a growth plan and its full-year 2026 outlook.
Subsidiary Clyra Medical says ViaCLYR has been used in hundreds of patients since its March 2026 launch and is under evaluation at several US health systems.
Italy's medicines agency says risk-sharing procedures are no longer active for HOLOCLAR's registered indication, but treatments first dispensed before the cut-off stay under the existing arrangements.
Italy's medicines agency says monitoring of the HOLOCLAR registry stopped on 31 October for its authorised indication, with treatment of current patients continuing under existing registry rules.
Italy's medicines agency has activated the web registry and published monitoring forms for mepolizumab in uncontrolled eosinophilic COPD, following a determination announced in the Official Gazette.
IGJ has published a Philips field safety notice on a roughly 2mm display offset affecting pulsed wave sample volume gates with the C5-1 transducer and Abd Vasc preset.
A Field Safety Notice published by Dutch inspectorate IGJ says deposits on the Sample Arm B probe of Sysmex CN Series analyzers may produce falsely low measurements.
Medtronic has issued a field safety notice for the Abre self-expanding venous stent system, adding an approved manual-expansion workaround for the rare event of partial stent placement.
IGJ has published a manufacturer's field safety notice on a software malfunction that lets cobas pro and cobas pure analysers accept erroneous calibrations.
Portugal's medicines authority says limited stock for prescription dispensing in community pharmacies reflects a European shortage, and recommends that valid prescriptions be accepted.
The Czech medicines authority has published its November 2026 list of individually prepared medicinal products, incorporating two general-nature measures on radiopharmaceuticals and an advanced therapy medicinal product.
Italy's medicines agency recorded no new innovativeness recognitions for September 2026 and named two oncology products that failed to meet the criterion.
DKMA's supply notice says GlaxoSmithKline Pharma A/S will end marketing of Flolan 1.5 mg epoprostenol infusion powder for commercial reasons, with the withdrawal expected from late December 2027.
GlaxoSmithKline Pharma A/S will end marketing of the epoprostenol infusion product in Denmark for commercial reasons, the Danish Medicines Agency has announced.
Italy's medicines agency recorded no new innovativeness recognitions for September 2026, while confirming that belantamab mafodotin and inavolisib were refused the status for their assessed indications.
Spain's regulator says a gap between bed and handle may trap users; manufacturer Trust Care AB has paused sales and revised the instructions for use.
Following a June inspection at its Montagny site, France's regulator has set deadlines of one to six months for correcting five unresolved MDR non-conformities.
A software problem can stop the RotaFlow Console charging its battery after battery mode has been used, and the manufacturer treats all marketed devices as affected.
Italy's medicines agency has assigned each marketing authorisation holder's 2025 payback share for direct purchases, with no changes made after consulting companies and payment due within 30 days of effectiveness.
Determination 1531/2026 assigns each marketing authorisation holder's payback burden, by region, with no changes after consultation; payment falls due 30 days after the determination takes effect.
AIFA has started a review of its monitoring registries that have been active for several years, the long-running registries used to manage access to and follow up on medicines. The input gives no outcomes or deadlines, but the review may affect registry continuation, data-collection obligations and market access conditions for marketing authorisation holders.
The ophthalmic company lifted its 2026 revenue guidance to $775–785 million and gave preliminary 2027 guidance of $1 billion, citing strong uptake of two recently launched products.
Replimune says its oncolytic HSV-1 therapy, given with nivolumab, became commercially available in early October, with NCCN listing and payer policies emerging while the confirmatory Phase 3 trial enrols.
Amarin posted a slim third-quarter 2026 net profit despite a 20% revenue fall, while partner Recordati began non-reimbursed sales of icosapent ethyl in Poland.
The Danish Medicines Agency is moving secukinumab (Cosentyx) from dispensing group NBS (derma) to NBS (derma, reuma) for its rheumatology uses.
The IGJ has released a report from its supervisory visit to Corcept's Dutch entity, though the source text does not disclose the findings or any required improvements.
The IGJ has released a report following a supervisory visit to Centrafarm Services B.V. in Breda, though the published description gives no findings or required measures.
Italy's medicines agency has revised the Fabhalta monitoring registry, removing a blocking eligibility field for patients with recurrent C3 glomerulopathy after kidney transplant.
The agency's 27 October blood and tissue safety update names the Dutch areas with confirmed human cases and asks that they be considered in donor interviews and selection.
Austria's health safety authority lists three French départements and five overseas départements with confirmed locally acquired dengue, asking blood and tissue services to take this into account in donor screening.
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.