AbangeLabs2h ago
EMA oncology updates just tightened expectations for comparative-evidence planning in ADC programs.
https://www.mattheneus.com/editorial/ema-adc-regulatory-clarity-evidence-planning-2026-02-22
#HTA #RegulatoryAffairs #Pharma
EMA oncology updates raise the bar for comparative-evidence planning in antibody-drug conjugates

Recent EMA oncology communications reinforce the need for clear evidence logic when direct head-to-head data are limited. This brief outlines practical implications for Health Technology Assessment submissions and comparative-evidence framing.

AbangeLabs Editorial
AbangeLabs7h ago
Australia’s PBAC has broadened nivolumab + ipilimumab access in advanced cancer—here’s what that means for HTA evidence planning. https://www.mattheneus.com/editorial/pbs-australia-nivolumab-ipilimumab-broad-listing-advanced-cancer-2026-03-01 #HTA #Pharma #RegulatoryAffairs
Australia Moves to Broad PBS Listing for Nivolumab and Ipilimumab, Replacing Indication-Specific Codes

From 1 March 2026, the Australian Government Pharmaceutical Benefits Scheme (PBS) has replaced multiple indication-specific reimbursement codes for nivolumab (Opdivo) and ipilimumab (Yervoy) with a single broad listing covering advanced or metastatic cancers.

AbangeLabs Editorial
Jamie Dowling12h ago

Side effects wrongly listed as "uncommon" in a Parkison's medication.

The Chair of the Commons Health Select Committee is not happy and wants government action against the UK's drug safety regulator, the MHRA.

https://www.bbc.co.uk/news/articles/ckg0xxwn041o

#MHRA #Pharma #Medicine #NHS

'He would have been horrified' - error in drug warnings 'misled' families

Warnings for dopamine agonist drugs are to be reviewed after BBC identified an error in patient leaflets.

BBC News
AbangeLabs1d ago
FDA broadens COSENTYX use to paediatric hidradenitis suppurativa via efficacy supplement pathway. https://www.mattheneus.com/editorial/fda-cosentyx-pediatric-hidradenitis-suppurativa-efficacy-supplement-2026-03-12 #HTA #RegulatoryAffairs #Pharma
FDA broadens COSENTYX use to paediatric hidradenitis suppurativa via efficacy supplement pathway

The FDA approved a COSENTYX efficacy supplement dated 12 March 2026 that supports moderate to severe hidradenitis suppurativa treatment in patients aged 12 years and older, using adult randomized trial evidence and population pharmacokinetic extrapolation in the primary label package.

AbangeLabs Editorial
China Business Forum2d ago
[#TRADESHOW] #CPHI & #PMEC #China 2026 from June 16 to 18, 2026, at the #Shanghai New #International #Expo #Center (#SNIEC). As #Asia’s leading #pharmaceutical #sourcing and #networking #platform, the #exhibition #event has more than 20 years of experience connecting #Chinese and international #pharma professionals. It serves as a key #meeting point for #innovation, #SupplyChain #collaboration, and #market expansion within the #global pharmaceutical #ecosystem. https://cnbusinessforum.com/event/cphi-pmec-china-2026/
CPHI & PMEC China 2026 | Pharma Manufacturing Expo Shanghai

Join 110,000+ pharma professionals and 3,600 exhibitors in Shanghai, June 16–18, 2026. Discover APIs, machinery and biotech innovation. Register for a free ticket.

China Business Forum
AbangeLabs2d ago
EU Joint Scientific Consultations: The 2026 Application Window and What It Demands from Evidence Teams. https://www.mattheneus.com/editorial/eu-hta-jsc-application-window-2026-evidence-strategy-playbook #HTA #RegulatoryAffairs #Pharma
EU Joint Scientific Consultations: The 2026 Application Window and What It Demands from Evidence Teams

The European Commission's HTA Coordination Group opened a new application window for Joint Scientific Consultations (JSC) under EU Regulation 2021/2282 on 25 March 2026. JSCs provide pre-submission guidance from EU HTA bodies on evidence requirements — clinical trial design, endpoints, comparators, patient populations — before marketing authorisation. This playbook explains what JSCs are, who qualifies, what the consultation process demands, and how evidence teams should prepare their...

AbangeLabs Editorial
AbangeLabs2d ago
CADTH Reimbursement Reviews: ITC and NMA Evidence Standards for Canadian Market Access. https://www.mattheneus.com/editorial/cadth-reimbursement-review-itc-nma-evidence-standards-canada-market-access-playbook-2026-03-26 #HTA #NMA #MAIC #EvidenceSynthesis #Pharma
CADTH Reimbursement Reviews: ITC and NMA Evidence Standards for Canadian Market Access

Canada’s CADTH Reimbursement Review (CRR) process imposes distinct indirect treatment comparison (ITC) and network meta-analysis (NMA) evidence standards that differ materially from EMA, NICE, and G-BA requirements. This playbook decodes CADTH’s pharmacoeconomic guidelines, the expert review committee’s approach to unanchored matching-adjusted indirect comparisons, and the evidence-synthesis quality thresholds that determine whether a reimbursement recommendation is positive, conditional, or...

AbangeLabs Editorial
AbangeLabs2d ago
IQWiG A25-156: Added Benefit Not Proven for Iptacopan in Paroxysmal Nocturnal Haemoglobinuria. https://www.mattheneus.com/editorial/iqwig-iptacopan-pnh-a25-156-added-benefit-not-proven-comparator-mismatch-2026-03-12 #HTA #EvidenceSynthesis #Pharma
IQWiG A25-156: Added Benefit Not Proven for Iptacopan in Paroxysmal Nocturnal Haemoglobinuria

IQWiG's March 2026 A25-156 assessment concluded no added benefit proven for iptacopan in PNH due to comparator misalignment in the submitted evidence. The AMNOG decision reflects evidence-design constraints, not absence of clinical effect.

AbangeLabs Editorial
AbangeLabs2d ago
Sweden's TLV Opens Consultation on New Regulations Governing Medicine Subsidy and Pricing Applications. https://www.mattheneus.com/editorial/tlv-new-regulations-subsidy-pricing-consultation-july-2026-03-20 #HTA #EvidenceSynthesis #Pharma
Sweden's TLV Opens Consultation on New Regulations Governing Medicine Subsidy and Pricing Applications

On 20 March 2026, Tandvards- och lakemedelsformansverket (TLV), Sweden's Dental and Pharmaceutical Benefits Agency, opened a public consultation on proposed new regulations for medicine subsidy and pricing applications — with changes to application requirements for new medicines and a new simplified procedure for established substances. The deadline for comments is 10 April 2026, with the regulations proposed to enter into force on 1 July 2026.

AbangeLabs Editorial
AbangeLabs2d ago
Non-Proportional Hazards in Network Meta-Analysis: A Five-Step Governance Protocol for Time-to-Event HTA Submissions. https://www.mattheneus.com/editorial/fallback-canary-non-proportional-hazards-nma-tte-governance-playbook-2026-03-25 #HTA #NMA #EvidenceSynthesis #Pharma
Non-Proportional Hazards in Network Meta-Analysis: A Five-Step Governance Protocol for Time-to-Event HTA Submissions

The proportional hazards (PH) assumption underpins the standard hazard ratio approach to network meta-analysis (NMA) of time-to-event outcomes. When that assumption fails — as increasingly observed in oncology with immunotherapy and combination regimens — evidence teams must switch to non-PH NMA methods or risk producing biased comparative effectiveness estimates. This playbook sets out a five-step governance protocol covering PH diagnostics, model selection, sensitivity analysis, result...

AbangeLabs Editorial