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🇪🇺 EMA
Charlotte Meyer

Charlotte Meyer MSc, Regulatory Science

EMA Regulatory Affairs Correspondent

19 articles 🇪🇺 Europe

Charlotte Meyer tracks EMA opinions, CHMP decisions, and post-authorization commitments across Europe. With 11 years in regulatory intelligence, she helps teams understand how policy harmonization and national reimbursement dynamics influence launch strategy.

EMAorphan drugsmarket access

Articles by Charlotte Meyer

BioCryst Secures $70M Upfront in European Licensing Deal for Navenibart Hereditary Angioedema Treatment
NewsMay 4, 2026

BioCryst Secures $70M Upfront in European Licensing Deal for Navenibart Hereditary Angioedema Treatment

BioCryst receives $70M upfront plus milestone payments up to $275M for navenibart licensing agreement with Neopharmed Gentili's Irish affiliate in Europe.

Charlotte Meyer
Auvelity FDA Approval: New Hope for MDD Patients
NewsMajor Depressive Disorder (MDD)May 3, 2026

Auvelity FDA Approval: New Hope for MDD Patients

The FDA has approved Auvelity, a groundbreaking oral antidepressant from Axsome Therapeutics, marking a significant advancement in treating major depressive disorder (MDD). This approval introduces a novel mechanism of action for patients seeking effective relief.

Charlotte Meyer
Curaleaf Appoints Torsten Greif to Board as European Medical Cannabis Market Expands
NewsMay 2, 2026

Curaleaf Appoints Torsten Greif to Board as European Medical Cannabis Market Expands

Curaleaf Holdings appoints Torsten Greif to its board of directors to strengthen European medical cannabis operations and EU-GMP certified product distribution.

Charlotte Meyer
HUTCHMED's Sovleplenib Receives Priority Review and Breakthrough Designation in China for Rare Blood Disorder
NewsHematology/Immunology - Autoimmune Hemolytic AnemiaApr 30, 2026

HUTCHMED's Sovleplenib Receives Priority Review and Breakthrough Designation in China for Rare Blood Disorder

HUTCHMED announces NDA acceptance with priority review status for sovleplenib to treat warm antibody autoimmune hemolytic anemia in China.

Charlotte Meyer
EnteroBiotix Raises £19M to Launch Phase 2b Microbiome Trial for Irritable Bowel Syndrome Treatment
NewsApr 29, 2026

EnteroBiotix Raises £19M to Launch Phase 2b Microbiome Trial for Irritable Bowel Syndrome Treatment

EnteroBiotix secures £19M funding to initiate the largest Phase 2b microbiome trial for IBS treatment, with patient dosing starting Q2 2026.

Charlotte Meyer
MEA Immunotherapy Guidelines: Comparative Analysis with Global Oncology Standards
AnalysisoncologyApr 29, 2026

MEA Immunotherapy Guidelines: Comparative Analysis with Global Oncology Standards

This article provides a detailed comparative analysis of MEA Immunotherapy Guidelines against global oncology standards for cancer treatment.

Charlotte Meyer
NMPA Data Integrity Compliance: What Foreign Pharma Must Know in APAC
AnalysisApr 29, 2026

NMPA Data Integrity Compliance: What Foreign Pharma Must Know in APAC

Navigating NMPA data integrity compliance is crucial for foreign pharmaceutical companies in APAC. Discover essential guidelines for successful drug registration.

Charlotte Meyer
Real-World Evidence Generation in MEA: Complementing Clinical Trials
AnalysisGeneral Clinical ResearchApr 29, 2026

Real-World Evidence Generation in MEA: Complementing Clinical Trials

This article delves into how real-world evidence generation complements clinical trials for drug XYZ in the MEA region, improving treatment insights for condition ABC.

Charlotte Meyer
COVID-19 Impact on Clinical Trials LATAM: New 2024 Standards & Procedures
AnalysisOncologyApr 29, 2026

COVID-19 Impact on Clinical Trials LATAM: New 2024 Standards & Procedures

This article examines the lasting impact of COVID-19 on clinical trials in LATAM, highlighting new 2024 standards and procedures for drug development and patient engagement.

Charlotte Meyer
Silexion Therapeutics Submits Phase 2/3 Trial Application for SIL204 KRAS-Targeted Pancreatic Cancer Treatment
NewsApr 29, 2026

Silexion Therapeutics Submits Phase 2/3 Trial Application for SIL204 KRAS-Targeted Pancreatic Cancer Treatment

Silexion Therapeutics successfully submits Phase 2/3 clinical trial application to Germany's BfArM for SIL204, targeting KRAS-driven pancreatic cancer.

Charlotte Meyer
Opella's Essentiale Shows 2.5x Greater Liver Fat Reduction in Breakthrough EXCEL Trial for Fatty Liver Disease
NewsApr 28, 2026

Opella's Essentiale Shows 2.5x Greater Liver Fat Reduction in Breakthrough EXCEL Trial for Fatty Liver Disease

Opella's Essentiale essential phospholipids demonstrated 2.5 times greater liver fat reduction vs diet/exercise alone in MASLD patients in EXCEL trial.

Charlotte Meyer
Accenture Invests in Iridius to Accelerate AI Compliance Solutions for Life Sciences Companies
NewsApr 24, 2026

Accenture Invests in Iridius to Accelerate AI Compliance Solutions for Life Sciences Companies

Accenture Ventures invests in Iridius to help pharmaceutical companies adopt compliant AI solutions while maintaining regulatory standards and auditability.

Charlotte Meyer
NMPA Accelerated Approval Oncology: Impact on Innovative Drug Market Access in China
AnalysisoncologyApr 24, 2026

NMPA Accelerated Approval Oncology: Impact on Innovative Drug Market Access in China

This article examines the NMPA's accelerated approval process and its significant influence on the market access of innovative oncology drugs in China.

Charlotte Meyer
Estado Actual y Acciones para Impulsar la Investigación Clínica en México: 2025
NewsApr 23, 2026

Estado Actual y Acciones para Impulsar la Investigación Clínica en México: 2025

This whitepaper discusses the current state and future actions to enhance clinical research in Mexico by 2025.

Charlotte Meyer
Repertoire Immune Medicines Doses First Patient in RPTR-1-201 Phase 1/2 Trial for Advanced Solid Tumors
NewsApr 23, 2026

Repertoire Immune Medicines Doses First Patient in RPTR-1-201 Phase 1/2 Trial for Advanced Solid Tumors

Repertoire Immune Medicines begins Phase 1/2 trial of RPTR-1-201, a novel TCR bispecific therapy targeting advanced solid tumors across US and European sites.

Charlotte Meyer
Abivax Presents Obefazimod Phase 3 Data at Digestive Disease Week 2026
NewsApr 23, 2026

Abivax Presents Obefazimod Phase 3 Data at Digestive Disease Week 2026

Abivax showcases comprehensive Phase 3 ABTECT program results for obefazimod in inflammatory bowel disease at DDW 2026 conference.

Charlotte Meyer
Dupixent Becomes First Biologic Approved for Chronic Spontaneous Urticaria in Children Ages 2-11
NewsDermatology/Immunology - Chronic Spontaneous UrticariaApr 23, 2026

Dupixent Becomes First Biologic Approved for Chronic Spontaneous Urticaria in Children Ages 2-11

Sanofi and Regeneron's Dupixent receives FDA approval as the first biologic treatment for pediatric chronic spontaneous urticaria in children 2-11 years old.

Charlotte Meyer
Boston Scientific Reports Strong Q1 2026 Growth with 10.9% US Sales Increase and Clinical Trial Breakthroughs
NewsApr 22, 2026

Boston Scientific Reports Strong Q1 2026 Growth with 10.9% US Sales Increase and Clinical Trial Breakthroughs

Boston Scientific delivers robust Q1 2026 performance with double-digit growth across all regions and presents breakthrough clinical trial data at major conference.

Charlotte Meyer
Polycythemia Vera Market Transformation: 9 Companies Including Protagonist Therapeutics with Rusfertide to Enter by 2036
NewsApr 22, 2026

Polycythemia Vera Market Transformation: 9 Companies Including Protagonist Therapeutics with Rusfertide to Enter by 2036

Nine pharmaceutical companies are advancing polycythemia vera treatments through clinical trials, with Protagonist Therapeutics' rusfertide leading market expansion by 2036.

Charlotte Meyer