Charlotte Meyer MSc, Regulatory Science
EMA Regulatory Affairs Correspondent
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.
Articles by Charlotte Meyer

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.
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.

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.

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.

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.

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.

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.