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Dr. Elena Rossi

Dr. Elena Rossi PhD Pharmaceutical Sciences

EMA Regulatory Affairs Editor

20 articles 🇪🇺 Europe

Dr. Rossi specializes in European Medicines Agency approvals and CHMP opinions.

EMA policygene therapyrare diseases

Articles by Dr. Elena Rossi

Vanda Pharmaceuticals Launches NEREUS (Tradipitant) - First New Motion Sickness Drug in 40+ Years Now Available
NewsMay 4, 2026

Vanda Pharmaceuticals Launches NEREUS (Tradipitant) - First New Motion Sickness Drug in 40+ Years Now Available

Vanda Pharmaceuticals announces commercial availability of NEREUS (tradipitant), the first new prescription motion sickness treatment in over 40 years.

Dr. Elena Rossi
Swiss Biotech Day: Key Takeaways and Industry Trends
NewsbiotechMay 4, 2026

Swiss Biotech Day: Key Takeaways and Industry Trends

Swiss Biotech Day 2024 convened industry leaders to discuss emerging technologies, regulatory frameworks, and strategic partnerships shaping the European biotech landscape. Key themes included precision medicine, digital health integration, and investment trends in a competitive global market.

Dr. Elena Rossi
EULAR 2026: Immutep's IMP761 Phase I Data Preview
NewsimmunologyMay 4, 2026

EULAR 2026: Immutep's IMP761 Phase I Data Preview

Immutep will present Phase I clinical trial data for its investigational drug IMP761 at the EULAR 2026 Congress. IMP761, a first-in-class LAG-3 agonist antibody, is being developed for the treatment of autoimmune diseases.

Dr. Elena Rossi
Swiss Biotech Day 2026: AI, Oncology, Microbiome Highlights
NewsbiotechMay 4, 2026

Swiss Biotech Day 2026: AI, Oncology, Microbiome Highlights

Swiss Biotech Day 2026 in Basel highlights AI in drug discovery, precision oncology, and microbiome therapies, featuring presentations from Evotec, Nvidia, and Ferring Pharmaceuticals.

Dr. Elena Rossi
COFEPRIS Approval Pathway: Insights on Novel Immunotherapies for Advanced Melanoma
AnalysisoncologyMay 2, 2026

COFEPRIS Approval Pathway: Insights on Novel Immunotherapies for Advanced Melanoma

This article delves into the COFEPRIS approval process for innovative immunotherapies targeting advanced melanoma, highlighting key insights and drug developments.

Dr. Elena Rossi
Plozasiran TGA Approval: REDEMPLO® Now Available in Australia for FCS
NewsFamilial Chylomicronemia Syndrome (FCS)May 2, 2026

Plozasiran TGA Approval: REDEMPLO® Now Available in Australia for FCS

Arrowhead Pharmaceuticals has secured TGA approval for REDEMPLO® (plozasiran) in Australia, marking a significant step in providing treatment options for patients with Familial Chylomicronemia Syndrome (FCS). This approval expands global access to the novel therapy for this rare genetic disorder.

Dr. Elena Rossi
GoodRx Offers Ozempic Pill Access for Type 2 Diabetes Patients at $149 Monthly
NewsMay 2, 2026

GoodRx Offers Ozempic Pill Access for Type 2 Diabetes Patients at $149 Monthly

GoodRx now provides self-pay access to Novo Nordisk's oral Ozempic for type 2 diabetes patients starting at $149/month nationwide.

Dr. Elena Rossi
Mounjaro FDA Approval Obesity: Eli Lilly's Tirzepatide Awaits
Analysisobesity, cardiovascular outcomesMay 1, 2026

Mounjaro FDA Approval Obesity: Eli Lilly's Tirzepatide Awaits

Eli Lilly's Mounjaro (tirzepatide) is poised for a significant label expansion, seeking FDA approval for obesity and cardiovascular risk reduction. This potential approval could reshape the weight management and cardiovascular health markets.

Dr. Elena Rossi
Northwest Biotherapeutics Appoints Dr. Annalisa Jenkins as Strategic Adviser for DCVax Cancer Vaccine Development
NewsMay 1, 2026

Northwest Biotherapeutics Appoints Dr. Annalisa Jenkins as Strategic Adviser for DCVax Cancer Vaccine Development

Northwest Biotherapeutics names Dr. Annalisa Jenkins as Strategic Adviser to advance DCVax dendritic cell cancer vaccine platform with 25+ years biopharma experience.

Dr. Elena Rossi
EU Biopharma Clinical Trials: AI & Gene Therapy Surge
NewsgeneralMay 1, 2026

EU Biopharma Clinical Trials: AI & Gene Therapy Surge

EU biopharma clinical trials are undergoing rapid transformation in 2026, driven by AI integration, global trial expansion, and breakthrough advances in cell and gene therapies. These shifts are compressing development timelines and lowering costs, though regulatory pressures and Chinese competition present significant headwinds.

Dr. Elena Rossi
BioPharma Clinical Trials EU: Daily Insights
NewsgeneralApr 30, 2026

BioPharma Clinical Trials EU: Daily Insights

The BioPharma Clinical Trials EU conference highlights emerging innovations in clinical trial design, including decentralized models, adaptive pathways, and real-world evidence integration. Recent EMA regulatory updates are reshaping how pharmaceutical sponsors approach drug development timelines and patient engagement across Europe.

Dr. Elena Rossi
PureTech Reports Positive LYT-200 Clinical Results for Myeloid Malignancies in 2025 Annual Results
NewsApr 29, 2026

PureTech Reports Positive LYT-200 Clinical Results for Myeloid Malignancies in 2025 Annual Results

PureTech announces positive clinical results for LYT-200 in myeloid malignancies, alongside Phase 3-ready deupirfenidone and advancing neuropsychiatric pipeline.

Dr. Elena Rossi
EU BioPharma Clinical Trials: Daily Insights & Key Takeaways
NewsgeneralApr 29, 2026

EU BioPharma Clinical Trials: Daily Insights & Key Takeaways

The EU biopharma clinical trials landscape continues to evolve with emphasis on patient-centric methodologies, regulatory harmonization, and innovative trial designs. Key developments include implementation of the Clinical Trials Regulation, adoption of decentralized trial models, and integration of real-world evidence in drug development.

Dr. Elena Rossi
HTA Outcomes Oncology Therapies: G-BA vs NICE Post-Brexit Analysis
AnalysisoncologyApr 29, 2026

HTA Outcomes Oncology Therapies: G-BA vs NICE Post-Brexit Analysis

This article analyzes HTA outcomes for oncology therapies, focusing on Keytruda's evaluation by G-BA and NICE in the post-Brexit landscape.

Dr. Elena Rossi
Regulatory Harmonization Impact on Cross-Border Clinical Trial Approvals in EAC
AnalysisClinical TrialsApr 29, 2026

Regulatory Harmonization Impact on Cross-Border Clinical Trial Approvals in EAC

This article examines the impact of regulatory harmonization on the approval process for clinical trials in the East African Community, enhancing drug accessibility.

Dr. Elena Rossi
EU BioPharma Clinical Trials: Daily Insights
NewsgeneralApr 29, 2026

EU BioPharma Clinical Trials: Daily Insights

Explore the evolving landscape of EU biopharmaceutical clinical trials, including regulatory frameworks, innovative trial designs, and collaboration opportunities shaping drug development across Europe.

Dr. Elena Rossi
Idorsia Reports 74% QUVIVIQ Sales Growth in Q1 2026, Expands European Market Reach
NewsApr 29, 2026

Idorsia Reports 74% QUVIVIQ Sales Growth in Q1 2026, Expands European Market Reach

Idorsia's insomnia drug QUVIVIQ achieves 74% year-over-year sales growth in Q1 2026, with European expansion and pediatric data driving future growth.

Dr. Elena Rossi
Artiva Biotherapeutics' AlloNK Receives FDA Fast Track Designation for Refractory Rheumatoid Arthritis Treatment
NewsApr 29, 2026

Artiva Biotherapeutics' AlloNK Receives FDA Fast Track Designation for Refractory Rheumatoid Arthritis Treatment

FDA grants Fast Track Designation to Artiva's AlloNK (AB-101) for refractory rheumatoid arthritis, accelerating development of innovative NK cell therapy.

Dr. Elena Rossi
BioPharma Clinical Trials: Gene Therapy, Obesity, and Oncology Updates
NewsgeneralApr 29, 2026

BioPharma Clinical Trials: Gene Therapy, Obesity, and Oncology Updates

Updates on gene therapy, oncology, and obesity treatments were presented this week, including Benitec Biopharma's BB-301 for OPMD and Boehringer Ingelheim's survodutide for obesity.

Dr. Elena Rossi
AB Science Secures Loan Repayment Deferrals to Fund R&D Operations Through 2028
NewsApr 28, 2026

AB Science Secures Loan Repayment Deferrals to Fund R&D Operations Through 2028

AB Science reaches agreement with creditors for 2-year state loan deferral and 12-month EIB credit extension, redirecting savings to R&D investments.

Dr. Elena Rossi