HTA, pricing and reimbursement: EU HTA Regulation, G-BA, HAS, NICE, ICER, IRA and payers.
PAVmed's preliminary Q3 update says Lucid has been paid by Medicare since October, while Veris Health has frozen its monitor design and started an animal study ahead of an early-2027 submission.
The Danish Medicines Agency says quality problems are disrupting supply of Laboratoires Thea's diclofenac eye drops, with foreign packs allowed under section 29(2) of the Medicines Act.
Essential Pharma Limited has permanently stopped marketing Methergin solution for injection in Denmark from early November 2026, citing production problems, according to the Danish Medicines Agency.
The Danish Medicines Agency has revised the expected period during which a foreign estradiol 25 micrograms/24 hours depot patch can be supplied under section 29(2) of the Medicines Act.
Denmark's medicines agency says production problems at Sandoz A/S are disrupting Vivelle Dot 37.5 micrograms/24 hours patches, with foreign packs allowed as a stopgap.
The Dutch inspectorate has published a manufacturer field safety notice after reports of soft connectors coming off Intersurgical's sterile and non-sterile breathing systems.
Lucid Diagnostics says Medicare is paying EsoGuard claims at the full fee schedule rate, with coverage granted case by case while a wider MolDX reconsideration remains pending.
CorMedix suspended 2027 DefenCath guidance after CMS reimbursement changes, while its Heron asset acquisition and a REZZAYO FDA Priority Review proceed.
The IGJ has released a supervisory report on Maddox Pharma Swiss BV, but the available description does not state any findings or the severity of any deficiencies.
The Slovak medicines agency has cancelled the original dates for submitting data to match EUDAMED with its national medical device database, with further steps set out in a separate document.
The Health and Youth Care Inspectorate has released a supervisory report on Waymade BV, but the material available gives no findings, deficiencies or required corrective measures.
The EU framework brings existing animal, public and occupational health measures into one reference document, as bird flu detections in wild birds reach a record level.
Ravimiamet says the new influenza vaccine batch is split between pre-booked institutions and the open market, and warns that November supplies will not cover everyone who wants a jab.
The wound-care device maker says a CMS proposed rule on skin substitute pricing and CPT code 97610 curbed Ultramist system sales, which fell to 40 units from 155.
CMS reversed its proposed nonpayment stance on QTscan diagnostic breast exams, while Middle East conflict delayed shipments and pushed the company to lower its full-year outlook.
Ocugen has granted Sydney-based Celairis exclusive regional rights to its investigational modifier gene therapy, with Phase 3 top-line data expected in the first quarter of 2027.
The US company reported third-quarter TriNav revenue of $12.9 million, revised its 2026 guidance, and flagged an FDA clearance and final CMS payment changes for 2027.
The manufacturer has flagged an increased risk of false positive KPC resistance gene results on certain kit lots of three BIOFIRE panels, according to Dutch inspectorate IGJ.
The French regulator's refreshed situation update lists contrast media currently available from Bayer and Bracco, and says tensions have persisted since a change in distribution circuit.
The agency has replaced its October list with a November 2026 version naming UK companies whose licences to manufacture or wholesale medicines have been terminated, cancelled or revoked.
The regulator has replaced October's file with a November 2026 CSV listing sites granted manufacturing or wholesale dealer licences, a monthly resource for checking supply-chain partners.
JAZMP has called on wholesalers to temporarily bring in two strengths of cefaclor oral suspension from other EU states, with bridging quantities set for six months.
The Czech medicines agency's draft list, dated 10 November 2026, sets out reimbursed PZLÚ products, manufacturer prices, reimbursement levels and co-payments, and is open for comment until the 20th of the month.
SÚKL has called for proposals for a Specific Treatment Programme covering oral ferrous sulfate heptahydrate for neonates and young children, as no suitable product is marketed in the Czech Republic.
SÚKL says Erdostein Zentiva 300 mg hard capsules can be dispensed without a prescription from 29 October 2026, though the product is not yet marketed in the Czech Republic.
The Dutch inspectorate IGJ has published a manufacturer field safety notice saying certain Carestation 850 and 850c units may release less anaesthetic vapour than the user selects.
The US genetic testing company held its full-year revenue guidance at $475-490 million while lowering volume and revenue growth expectations for exome and genome testing.
Edesa Biotech grants Kyorin Pharmaceutical exclusive Japanese rights to its anti-TLR4 antibody for acute respiratory distress syndrome, with $12m upfront and further milestones and royalties.
The gene-therapy maker reported 15 patients treated since launch, an eight-site QTC network and one batch that failed its identity assay release criterion.
Internal validation of replacement batteries revealed the ROTAFLOW Console can stop charging its battery once battery operation mode has been used, according to a manufacturer warning published by Dutch regulator IGJ.
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.