Moe Alsumidaie

📢EMA's human medicines committee, the #CHMP, recommended 13 new medicines for approval in the 🇪🇺, including: ☑️ 1 medicine for #HIV-1 pre-exposure prophylaxis #PrEP to be taken twice a year ☑️ 1 medicine to treat patients with #Niemann-Pick type C ☑️ 1 medicine to be taken orally to treat hereditary angioedema #HAE Read more in the highlights published today: https://lnkd.in/eb3CBgVC #PublicHealth

340

3 comentários

Pharma R&D often gets attention for its breakthrough science, but it's the hidden parts behind the scenes that make it all possible. * Extensive studies within each program * Protocols adapted as science evolves * Late night data reviews to catch subtle signals * Ethics committees protecting patient safety * Lessons learned from every setback * Mentorship shaping future scientists * Resilience when facing adversity What other aspects would you add? #TevaCareers #PharmaRnD

636

18 comentários

The State of Clinical Trials: Charting the Path to 2030 – Executive Summary Now Available In May, 150 leaders from across the clinical research ecosystem came together to explore what’s working, what’s not, and what’s next for clinical trials. Now, we’re sharing the executive summary from that meeting, capturing the key themes, bold ideas, and actionable opportunities that emerged.    Whether you’re a sponsor, site, regulator, patient advocate, or tech partner, this summary offers important insights and next steps for advancing clinical trials.    Read the executive summary and join us in shaping a more efficient, patient-centered future for clinical research: https://ow.ly/AUBc50WyFEw

51

4 comentários

Did you know? ~90% of drug candidates fail in clinical trials, often because the biological targets prove unreliable or lack translational potential. TargetPro addresses this challenge by integrating 22 multimodal data sources into disease-specific models that learn which targets are most likely to reach clinical testing. It identifies context-dependent patterns by disease and achieves higher accuracy than other target ID models. TargetBench 1.0 is the first standardized benchmark for target discovery, built to evaluate target identification models, including LLMs. By building an AI system that outperforms general-purpose models and widely used public resources, we are generating actionable intelligence not just predictions. Combined with TargetBench 1.0, this framework sets a new standard for reliability and transparency, enabling biopharma companies to move faster and smarter toward breakthrough therapies. 📄 Paper: https://lnkd.in/eJzVyUYa #AI #DrugDiscovery #TargetDiscovery #GenerativeAI #PharmaAI

37

1 comentário

Today we announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion recommending marketing authorization for an updated formulation of the COVID-19 vaccine Spikevax®, targeting the SARS-CoV-2 variant LP.8.1, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals six months of age and older.   Read more: https://lnkd.in/ejxV-jqJ

542

18 comentários

The Critical Medicines Act is essential to boost Europe’s manufacturing resilience and reduce market consolidation on risky supply chains. ⚙️ Currently, 46% of EU critical medicines have only one supplier, exposing healthcare systems to significant risks - including supply shortages and delays in access. 📈 Sustainable market policies must be implemented to protect critical medicines supply chains, such as: ➡️ Public procurement decisions that consider more than just price, mandatory MEAT criteria - including quality, supply security and sustainability criteria ➡️ Mandatory multi-slot tenders to encourage multiple suppliers and reduce shortages ➡️ Introducing flexible pricing frameworks that reflect inflation, manufacturing costs, and supply resilience needs ➡️ Ensuring coordinated national stockpiling rules and guaranteeing fair compensation for manufacturers contributing to preparedness We must develop timely and sustainable solutions to safeguard Europe's health security. #EUCriticalHealth

65

2 comentários

Regulators worldwide are heightening expectations for risk management strategies — and sponsors must be ready to adapt. At World Drug Safety Congress Europe 2025, Syneos Health is spotlighting our Global Risk Management Technology: A digital aRMM solution purpose-built to align with the EMA’s fresh emphasis on creative outreach and measurable evaluation. This platform unites two applications, built on our next-generation modular technology, to address risk management challenges and support both global and local needs: -GRM Tracker to manage global risk management plan commitments and enable oversight of local risk minimization measures -GRM Central to either enable local safety teams to rapidly establish a digital education program or implement a complex and rare risk minimization control tools project Join us in Amsterdam to see how we’re helping sponsors align with EMA and FDA guidance, strengthen compliance and optimize patient safety outcomes. Book a meeting: https://lnkd.in/eWY8fBcq #SyneosHealth #WDSC2025 #Pharmacovigilance #RiskManagement #DrugSafety

48