HTA, pricing and reimbursement: EU HTA Regulation, G-BA, HAS, NICE, ICER, IRA and payers.
The RECELL maker reported $26.1 million in Q3 revenue, drew the last $10 million of its Perceptive Advisors facility and removed its going-concern qualification.
The Barostim maker lowered its full-year outlook, pointing to weaker sales force productivity and a drawn-out dispute with a major payer, despite a second Medicare Advantage coverage policy.
The Dutch inspectorate has published the manufacturer's field safety notice, which links overheating of the °M Warmer to a misplaced seal causing an internal fluid leak.
The Dutch inspectorate has published a manufacturer field safety notice after routine quality checks found isolated contamination in several lots of Greiner's CRYO.S 2 ml tubes.
The US agency has issued proposed rule CMS-3484-P, titled 'Cutting Administrative Requirements for Excellence in Patient Care (CARE)', but the details are not yet clear from the material available.
The US agency has set lasting policies for negotiating prices of high-cost drugs under Medicare, giving manufacturers more predictability for prices taking effect from 2029.
The US Centers for Medicare & Medicaid Services has issued a final rule covering both the Medicare Drug Price Negotiation Program and the Medicare Prescription Drug Benefit Program.
Portugal's medicines authority has published the public funding assessment report for nonacog beta pegol, which is now authorised for hospital use in young haemophilia B patients.
JAZMP says version 01.13.00.00 of the Android app displayed mg/dL instead of mmol/L; the manufacturer has issued a corrected release, 01.13.01.00.
Spain's medicines agency has published an informative circular on the prescribing, dispensing and use conditions for botulinum toxin medicines when used for aesthetic purposes.
The regulator has added application details and an expression-of-interest form for the newest cycle of its RWE service, now running as an established offer after a pilot.
Sandoz Limited has notified the MHRA of errors in the dosing table of the SmPC for Co-amoxiclav 250/62.5 mg/5 mL Powder for Oral Suspension, issued as a Class 4 (precautionary) defect notification (EL(26)A/46). Because the dosing table guides prescribing and dispensing, the SmPC needs correcting and healthcare professionals should be aware of the error.
Sandoz Limited has notified the MHRA of errors in the dosing table of the SmPC for Co-amoxiclav 250/62.5 mg/5 mL Powder for Oral Suspension (Class 4 defect, EL(26)A/46). Class 4 indicates no risk to patients or the product itself, but prescribers and pharmacists should be aware that the SmPC dosing table is inaccurate, as this could lead to dosing errors if relied upon, and the SmPC will need correcting.
CSL Behring has reported stopper defects in specific Respreeza lots, and AIFA's information note warns of missed doses and possible microbial contamination.
The cancer diagnostics company also bought Convergent Genomics, won Medicare coverage for Prosigna and lowered its full-year testing revenue forecast.
Sera Prognostics reports Florida as the second state Medicaid programme to cover its preterm birth risk test, while it begins EU certification for a kit-based version.
Olympus devices loaned to customers were wrongly used for animal purposes, reprocessed and then sent to hospitals for human use, prompting a Type II recall with sterility concerns.
The US agency has finalised Medicare payment policy changes and other Part B issues taking effect on or after 1 January 2027, though provision-level detail is not yet available.
The US Centers for Medicare & Medicaid Services published rule CMS-1850-F on 4 November 2026, setting Medicare outpatient payment policies and rates for calendar year 2027.
Italy's medicines agency says registry users can now select ranibizumab product RANLUSPEC in the simplified multi-drug form for intravitreal anti-VEGF treatments, covering four eye-disease indications.
From 4 November 2026, Italy's XOSPATA (gilteritinib) registry eligibility form lists quizartinib among earlier treatments that do not rule out gilteritinib use in relapsed or refractory FLT3-mutated AML.
From 4 November 2026, registry users can select Ranluspec (ranibizumab) in AIFA's simplified multi-drug intravitreal anti-VEGF monitoring form, following Determination Pres/1459/2026.
From 4 November 2026, the eligibility form for gilteritinib in FLT3-mutated relapsed or refractory acute myeloid leukaemia lists quizartinib among permitted earlier treatments.
The Danish Medicines Agency has posted a supply notice saying Teva Denmark A/S has stopped marketing Orlistat "Teva" 120 mg hard capsules for commercial reasons.
Denali's Hunter syndrome therapy Avlayah, approved in March, has gained commercial coverage for over 70% of US lives, and a permanent J-code took effect on 1 October.
Rhythm Pharmaceuticals' Q3 2026 update reports a Japanese launch on 13 October, US uptake after March approval, Phase 3 plans for bivamelagon and European reimbursement filings.
France's regulator reviewed 29 manufacturers and distributors of professional aesthetic laser and pulsed-light equipment and found that only one had completed MDR certification by summer 2025.
AIFA has published its updated list of medicines that its Scientific and Economic Commission (CSE) has judged to meet the criterion of therapeutic innovativeness, with the list current to 31 October 2026. The status is relevant to market access and reimbursement, so MAHs should check whether their products are listed.
The manufacturer's internal investigation found the 2D barcode on the calibration card for certain lots assigns calibration values the wrong way round, prompting a field safety notice.
Inspire Medical Systems reports a Q3 2026 revenue decline and net loss, while the AMA approves Category I CPT codes for single-lead hypoglossal nerve stimulation from January 2028.
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.