Clinical Trial Monitoring: Insights from Q1 2026 EU/EEA Report
Clinical Trial Monitoring: Insights from Q1 2026 EU/EEA Report

By HEOR Staff Writer

May 22, 2026

Clinical trial monitoring shows that in the first quarter of 2026, an average of 208 new clinical trial applications were submitted monthly through the Clinical Trials Information System, yielding 668 total submissions of which 538 received authorisation. The median time from submission to decisi...
Novartis Oncology Advancements: Key Trial Findings and Market Implications
Novartis Oncology Advancements: Key Trial Findings and Market Implications
Novartis oncology advancements take center stage as the company prepares to unveil findings from more than 65 abstracts at the upcoming ASCO and EHA meetings. These presentations spotlight progress with Pluvicto, Kisqali, and Scemblix while reinforcing the firm’s commitment to transforming outcom...
EUDAMED Implementation 2026: Key Changes and National Adaptations
EUDAMED Implementation 2026: Key Changes and National Adaptations
The EUDAMED Implementation 2026 will require mandatory use of four key modules in the European database on medical devices from 28 May 2026. These cover registration of economic operators, device registration via UDI, notified bodies and certificates, plus market surveillance, following earlier v...
Baxfendy Hypertension Treatment: FDA Approves First-in-Class Aldosterone Synthase Inhibitor
Baxfendy Hypertension Treatment: FDA Approves First-in-Class Aldosterone Synthase Inhibitor
Baxfendy hypertension treatment received US Food and Drug Administration approval as the first aldosterone synthase inhibitor for adults with hypertension not adequately controlled on other antihypertensive medications. AstraZeneca’s Baxfendy (baxdrostat) demonstrated statistically significant an...
TrumpRx.gov Expansion: Enhancing Medication Price Transparency and Competition
TrumpRx.gov Expansion: Enhancing Medication Price Transparency and Competition
TrumpRx.gov expansion marks a major step toward greater medication price transparency, as detailed in President Donald J. Trump’s announcement to list more than 600 generic drugs on the platform. Patients can now compare competitive cash prices from Amazon Pharmacy, Cost Plus Drugs, and GoodRx fo...
Trastuzumab-Deruxtecan Reimbursement: A Careful Evaluation of Cost-Effectiveness for Advanced Gastric Cancer
Trastuzumab-Deruxtecan Reimbursement: A Careful Evaluation of Cost-Effectiveness for Advanced Gas...
Zorginstituut Nederland advises against routine trastuzumab-deruxtecan reimbursement for adults with HER2-positive gastric or gastro-oesophageal junction adenocarcinoma after two or more prior therapies, unless price negotiations secure at least a 62 percent reduction. The drug meets scientific s...
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Clinical Trial Monitoring: Insights from Q1 2026 EU/EEA Report

Latest

Clinical Trial Monitoring: Insights from Q1 2026 EU/EEA Report
Clinical trial monitoring shows that in the first quarter of 2026, an average of 208 new clinical trial applications were submitted monthly through the Clinical Trials Information System, yielding 668 total submissions of which 538 received authorisation. The median time from submission to decisi...
Novartis Oncology Advancements: Key Trial Findings and Market Implications

Latest

Novartis Oncology Advancements: Key Trial Findings and Market Implications
Novartis oncology advancements take center stage as the company prepares to unveil findings from more than 65 abstracts at the upcoming ASCO and EHA meetings. These presentations spotlight progress with Pluvicto, Kisqali, and Scemblix while reinforcing the firm’s commitment to transforming outcom...
EUDAMED Implementation 2026: Key Changes and National Adaptations

Latest

EUDAMED Implementation 2026: Key Changes and National Adaptations
The EUDAMED Implementation 2026 will require mandatory use of four key modules in the European database on medical devices from 28 May 2026. These cover registration of economic operators, device registration via UDI, notified bodies and certificates, plus market surveillance, following earlier v...
Baxfendy Hypertension Treatment: FDA Approves First-in-Class Aldosterone Synthase Inhibitor

Latest

Baxfendy Hypertension Treatment: FDA Approves First-in-Class Aldosterone Synthase Inhibitor
Baxfendy hypertension treatment received US Food and Drug Administration approval as the first aldosterone synthase inhibitor for adults with hypertension not adequately controlled on other antihypertensive medications. AstraZeneca’s Baxfendy (baxdrostat) demonstrated statistically significant an...
TrumpRx.gov Expansion: Enhancing Medication Price Transparency and Competition

Global Updates

TrumpRx.gov Expansion: Enhancing Medication Price Transparency and Competition
TrumpRx.gov expansion marks a major step toward greater medication price transparency, as detailed in President Donald J. Trump’s announcement to list more than 600 generic drugs on the platform. Patients can now compare competitive cash prices from Amazon Pharmacy, Cost Plus Drugs, and GoodRx fo...
First-in-Human Trials: Foundations and Market Implications in Health Economics

Global Updates

First-in-Human Trials: Foundations and Market Implications in Health Economics

By HEOR Staff Writer

May 21, 2026

First-in-Human Trials mark the initial transition of a drug candidate from extensive preclinical research into human subjects, supplying the earliest clinical evidence on safety, pharmacokinetics, and pharmacodynamics to inform later development stages. These studies rely on a comprehensive found...
PSA Response Improvement: Promising Data from Pluvicto in mHSPC Treatment

Global Updates

PSA Response Improvement: Promising Data from Pluvicto in mHSPC Treatment

By João L. Carapinha

May 19, 2026

New data from the PSMAddition study indicate that Pluvicto combined with standard of care, consisting of an androgen receptor pathway inhibitor plus androgen deprivation therapy, produced a 58% lower risk of prostate-specific antigen progression compared with standard of care alone. Patients rece...
Pharmaceutical Onshoring Agreements: Navigating Tariff Relief and National Security Policies

Global Updates

Pharmaceutical Onshoring Agreements: Navigating Tariff Relief and National Security Policies

By João L. Carapinha

May 18, 2026

The US Bureau of Industry and Security published formal procedures enabling manufacturers of patented pharmaceutical products to apply for company-specific pharmaceutical onshoring agreements with the Department of Commerce. These agreements allow qualifying firms to secure a reduced Section 232 ...

Europe

Clinical Trial Monitoring: Insights from Q1 2026 EU/EEA Report
Clinical Trial Monitoring: Insights from Q1 2026 EU/EEA Report

By HEOR Staff Writer

May 22, 2026

Clinical trial monitoring shows that in the first quarter of 2026, an average of 208 new clinical trial applications were submitted monthly through the Clinical Trials Information System, yielding 668 total submissions of which 538 received authorisation. The median time from submission to decisi...
Novartis Oncology Advancements: Key Trial Findings and Market Implications
Novartis Oncology Advancements: Key Trial Findings and Market Implications
Novartis oncology advancements take center stage as the company prepares to unveil findings from more than 65 abstracts at the upcoming ASCO and EHA meetings. These presentations spotlight progress with Pluvicto, Kisqali, and Scemblix while reinforcing the firm’s commitment to transforming outcom...
EUDAMED Implementation 2026: Key Changes and National Adaptations
EUDAMED Implementation 2026: Key Changes and National Adaptations
The EUDAMED Implementation 2026 will require mandatory use of four key modules in the European database on medical devices from 28 May 2026. These cover registration of economic operators, device registration via UDI, notified bodies and certificates, plus market surveillance, following earlier v...
Portugal Health Spending 2025 Reaches Record €4.417 Billion Amid Rising Demand
Portugal Health Spending 2025 Reaches Record €4.417 Billion Amid Rising Demand
Portugal health spending 2025 hit a fresh peak as the country’s publicly funded National Health Service recorded its highest annual outlay on medicines, reaching €4.417 billion according to Infarmed data. This total, already net of industry rebates and contributions, was propelled chiefly by expa...

North America

Novartis Oncology Advancements: Key Trial Findings and Market Implications
Novartis Oncology Advancements: Key Trial Findings and Market Implications
Novartis oncology advancements take center stage as the company prepares to unveil findings from more than 65 abstracts at the upcoming ASCO and EHA meetings. These presentations spotlight progress with Pluvicto, Kisqali, and Scemblix while reinforcing the firm’s commitment to transforming outcom...
Baxfendy Hypertension Treatment: FDA Approves First-in-Class Aldosterone Synthase Inhibitor
Baxfendy Hypertension Treatment: FDA Approves First-in-Class Aldosterone Synthase Inhibitor
Baxfendy hypertension treatment received US Food and Drug Administration approval as the first aldosterone synthase inhibitor for adults with hypertension not adequately controlled on other antihypertensive medications. AstraZeneca’s Baxfendy (baxdrostat) demonstrated statistically significant an...
TrumpRx.gov Expansion: Enhancing Medication Price Transparency and Competition
TrumpRx.gov Expansion: Enhancing Medication Price Transparency and Competition
TrumpRx.gov expansion marks a major step toward greater medication price transparency, as detailed in President Donald J. Trump’s announcement to list more than 600 generic drugs on the platform. Patients can now compare competitive cash prices from Amazon Pharmacy, Cost Plus Drugs, and GoodRx fo...
PSA Response Improvement: Promising Data from Pluvicto in mHSPC Treatment
PSA Response Improvement: Promising Data from Pluvicto in mHSPC Treatment

By João L. Carapinha

May 19, 2026

New data from the PSMAddition study indicate that Pluvicto combined with standard of care, consisting of an androgen receptor pathway inhibitor plus androgen deprivation therapy, produced a 58% lower risk of prostate-specific antigen progression compared with standard of care alone. Patients rece...

Sub-Saharan Africa

Substandard Medicines in South Africa: Regulatory Challenges and Economic Implications
Substandard Medicines in South Africa: Regulatory Challenges and Economic Implications

By HEOR Staff Writer

May 21, 2026

Substandard medicines in South Africa continue to infiltrate supply chains through informal markets, unlicensed outlets, and online platforms, leaving patients exposed to unregulated weight-loss injections amid stock shortages and high costs for approved options such as Ozempic. Comp...
Transforming Healthcare Value: Strategic Purchasing in South Africa
Transforming Healthcare Value: Strategic Purchasing in South Africa

By João L. Carapinha

May 20, 2026

Strategic Purchasing Healthcare offers a pathway for South Africa’s healthcare system to deliver improved patient outcomes amid constrained resources, where traditional passive purchasing models relying on historical budgets or uncapped fee-for-service payments have fallen short in prioritising e...
Learning from Global Best Practices in Healthcare Pricing Regulation
Learning from Global Best Practices in Healthcare Pricing Regulation
South Africa continues to face persistent challenges in establishing sustainable healthcare pricing regulation mechanisms, as highlighted in the keynote address at the CMS Industry Indaba. Countries including the United Kingdom, Japan, South Korea, and Thailand have implemented structured price-s...
Financing Boosts Vaccine Manufacturing Africa: New Facility to Enhance Local Production Capacity
Financing Boosts Vaccine Manufacturing Africa: New Facility to Enhance Local Production Capacity

By João L. Carapinha

May 19, 2026

In a major step forward for vaccine manufacturing Africa, Biovac has secured a financing package from the International Finance Corporation (IFC), the EIB Group, and the European Commission to build the continent’s first end-to-end multi-vaccine production facility. Landmark Funding ...