Articles by Dr. Elena Rossi
RAPS Euro Convergence 2026: Regulatory News - Day 1 Roundup
RAPS Euro Convergence 2026 commenced on May 5, 2026, in Lisbon, Portugal, bringing together European regulatory affairs professionals to discuss EMA guidelines, compliance strategies, and market access pathways. No breaking pharmaceutical announcements were reported on Day 1.
Heart Failure 2026: Vutrisiran Data & European Pharma News
Alnylam Pharmaceuticals to present new data analyses for vutrisiran in ATTR-CM at Heart Failure 2026. The Hello Tomorrow Global Summit positions itself as Europe's leading deeptech crossroads.
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.
Swiss Biotech Day: Key Takeaways and Biotech Innovations
Swiss Biotech Day brought together European biotech leaders to discuss innovation in therapeutics, regulatory pathways, and strategic partnerships. Key themes included advances in cell and gene therapy, artificial intelligence in drug discovery, and the importance of cross-border collaboration for accelerating market access.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.