FDA Warning Letter Novo Nordisk Reveals Serious Compliance Failures in Adverse Drug Reporting

By João L. Carapinha

March 11, 2026

The U.S. Food and Drug Administration (FDA) issued the FDA Warning Letter Novo Nordisk dated March 5, 2026, to Novo Nordisk Inc. (NNI)...
Methodological Gaps in Economic Evaluations of Vaccines: A Systematic Review

By João L. Carapinha

March 10, 2026

Economic evaluations of vaccines targeting multi-disease combinations, such as hepatitis A/B or measles-mumps-rubella (MMR), reveal critical methodological shortcomings in this systematic literature review. Synthesiz...
Enhertu Early Breast Cancer: FDA Priority Review for Reducing Recurrence Risk
Enhertu (trastuzumab deruxtecan), developed by AstraZeneca and Daiichi Sankyo, has received P...
Rapid Genetic Testing Mitigates Gentamicin-Induced Hearing Loss in Neonates

By João L. Carapinha

March 9, 2026

Rapid genetic testing is dramatically improving neonatal care by detecting the m.1555A>G mitochondrial variant in newborns at risk of profound hearing loss from gentamicin, allowing swift switches to alternative antibiotics without delaying treatment. Developed through the
EMA’s Clinical Trials Guidance for Enhancing Flexibility During Public Health Emergencies
The European Medicines Agency (EMA) has released draft clinical trials guidance for public consultation from 4 March to 30 April 2026. This guidance outlines regulatory flexibi...
Portugal Clinical Trials Regulation: A Comprehensive Framework for EU Compliance and Participant ...
Portugal Aligns with EU Standards Portugal clinical trials regulation is now firmly established through Lei n.º 9/2026, published on March 6, 2026, which implements the European Parliament and Council
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FDA Warning Letter Novo Nordisk Reveals Serious Compliance Failures in Adverse Drug Reporting

By João L. Carapinha

March 11, 2026

The U.S. Food and Drug Administration (FDA) issued the FDA Warning Letter Novo Nordisk dated March 5, 2026, to Novo Nordisk Inc. (NNI)...

Latest

Methodological Gaps in Economic Evaluations of Vaccines: A Systematic Review

By João L. Carapinha

March 10, 2026

Economic evaluations of vaccines targeting multi-disease combinations, such as hepatitis A/B or measles-mumps-rubella (MMR), reveal critical methodological shortcomings in this systematic literature review. Synthesiz...

Latest

Enhertu Early Breast Cancer: FDA Priority Review for Reducing Recurrence Risk
Enhertu (trastuzumab deruxtecan), developed by AstraZeneca and Daiichi Sankyo, has received P...

Latest

Rapid Genetic Testing Mitigates Gentamicin-Induced Hearing Loss in Neonates

By João L. Carapinha

March 9, 2026

Rapid genetic testing is dramatically improving neonatal care by detecting the m.1555A>G mitochondrial variant in newborns at risk of profound hearing loss from gentamicin, allowing swift switches to alternative antibiotics without delaying treatment. Developed through the

Global Updates

Methodological Gaps in Economic Evaluations of Vaccines: A Systematic Review

By João L. Carapinha

March 10, 2026

Economic evaluations of vaccines targeting multi-disease combinations, such as hepatitis A/B or measles-mumps-rubella (MMR), reveal critical methodological shortcomings in this systematic literature review. Synthesiz...

Global Updates

HERNEXEOS Lung Cancer Treatment: First FDA Approval for HER2-Mutant NSCLC

By HEOR Staff Writer

March 2, 2026

FDA Greenlights HERNEXEOS Lung Cancer Treatment as First-Line Option HERNEXEOS lung cancer treatment (zongertinib tablets), developed by

Global Updates

KEYTRUDA Padcev MIBC Survival: New Era in Treatment Revealed by KEYNOTE-B15 Trial Results
KEYTRUDA Padcev MIBC Survival Breakthrough in Cisplatin-Eligible Patients KEYTRUDA Padcev MIBC Survival benefits shone in the Phase 3 KEYNOTE-B15 trial, where perioperative KEYTRUDA (pembrolizumab) plus Padce...

Global Updates

Novartis Drug Discovery Innovation: Advancing Global Health Through Strategic R&D

By João L. Carapinha

February 26, 2026

Novartis drug discovery innovation is transforming global health through the Biomedical Research group's shift from siloed efforts to an integrated, patient-centric model targeting high-burden diseases in low- and middle-income countries (LMICs). Under Manju Ujjini, Head of Lead Discovery, key mi...

Europe

Rapid Genetic Testing Mitigates Gentamicin-Induced Hearing Loss in Neonates

By João L. Carapinha

March 9, 2026

Rapid genetic testing is dramatically improving neonatal care by detecting the m.1555A>G mitochondrial variant in newborns at risk of profound hearing loss from gentamicin, allowing swift switches to alternative antibiotics without delaying treatment. Developed through the
EMA’s Clinical Trials Guidance for Enhancing Flexibility During Public Health Emergencies
The European Medicines Agency (EMA) has released draft clinical trials guidance for public consultation from 4 March to 30 April 2026. This guidance outlines regulatory flexibi...
Portugal Clinical Trials Regulation: A Comprehensive Framework for EU Compliance and Participant ...
Portugal Aligns with EU Standards Portugal clinical trials regulation is now firmly established through Lei n.º 9/2026, published on March 6, 2026, which implements the European Parliament and Council
Urgent Call for Enhanced Precision Oncology Access in Europe

By João L. Carapinha

March 5, 2026

EFPIA White Paper: Unlocking Precision Oncology Access in Europe The EFPIA Oncology Platform's white paper, "Advancing Precision Oncology Treatment and Testing Across Europe," launched on March 5, 2026, at a high-level...

North America

FDA Warning Letter Novo Nordisk Reveals Serious Compliance Failures in Adverse Drug Reporting

By João L. Carapinha

March 11, 2026

The U.S. Food and Drug Administration (FDA) issued the FDA Warning Letter Novo Nordisk dated March 5, 2026, to Novo Nordisk Inc. (NNI)...
Enhertu Early Breast Cancer: FDA Priority Review for Reducing Recurrence Risk

By João L. Carapinha

March 10, 2026

Enhertu (trastuzumab deruxtecan), developed by AstraZeneca and Daiichi Sankyo, has received P...
KEYTRUDA Padcev MIBC Survival: New Era in Treatment Revealed by KEYNOTE-B15 Trial Results

By HEOR Staff Writer

March 2, 2026

KEYTRUDA Padcev MIBC Survival Breakthrough in Cisplatin-Eligible Patients KEYTRUDA Padcev MIBC Survival benefits shone in the Phase 3 KEYNOTE-B15 trial, where perioperative KEYTRUDA (pembrolizumab) plus Padce...
Novo Nordisk Announces Semaglutide Price Reduction to Improve Patient Access

By João L. Carapinha

February 26, 2026

Novo Nordisk Drives Semaglutide Price Reduction Novo Nordisk slashes the US semaglutide list price—or wholesale acquisition cost (WAC)—for Wegovy®, Ozempic®, and Rybelsus® to $675 per month across key doses, effective January 1, 2027....

Sub-Saharan Africa

Aspen Pharmacare Financial Growth: Navigating H1 2026’s Transitional Financial Landscape

By HEOR Staff Writer

March 5, 2026

Aspen Pharmacare Financial Growth Powers Through Strategic Shifts Aspen Pharmacare's financial growth shines in its H1 2026 results, driven by resilient Commercial Pharmaceuticals,
South Africa’s Push for Local Lenacapavir Production to Enhance HIV Prevention
South Africa has launched a bold bid to enable local lenacapavir production, targeting the twice-yearly injectable long-acting HIV prevention drug from ...
SAHPRA GMP Compliance: Addressing Allegations Against Adcock Ingram’s Clayville Facility

By HEOR Staff Writer

February 25, 2026

SAHPRA GMP compliance at Adcock Ingram's Clayville facility has been reaffirmed by the South African Health Products Regulatory Authority (SAHPRA) in its
Pharmaceutical Tender Investigation Sparks Regulatory Scrutiny in South Africa

By João L. Carapinha

February 12, 2026

Pharmaceutical Tender Investigation Targets Ascendis, Pharma Q, and Sonke The Competition Commission of South Africa has launched a pharmaceutical tender investigation into manufacturers Ascendis, Pharma Q, and...