Daniela Visini

📢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

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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

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We are pleased to share that the European Medicines Agency’s Committee for Medicinal Products for Human Use (#CHMP) has issued a positive opinion for our treatment for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with clinically relevant physical function deterioration and in whom surgical options have been exhausted or would induce unacceptable morbidity or disability. This milestone marks an important step forward in our commitment to delivering transformative therapies for patients living with #TGCT - a rare, debilitating disease with limited therapeutic options. Read the press release here: https://lnkd.in/eSdsgM-s

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👉 Big regulatory changes are coming to the EU pharmaceutical sector. 🇪🇺 The EU Medicines Regulation 2025–2026 will reshape how variations are classified and managed across Europe. New definitions like Relevant Authority and Reference Authority ✅ Introduction of supergrouping and annual reporting ✅ Annexes restructured from ABCD ➝ EQCM These updates aim to simplify procedures while ensuring greater transparency and patient safety. ☀️ And since it’s August, it might just be the perfect read for a quiet summer break. Insightful, timely, and essential for everyone in the pharmaceutical field. 📖 Read the full article here: 🇪🇸 https://lnkd.in/dU-EpQVn 🇬🇧 https://lnkd.in/dfwnQKym

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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

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The volume of life sciences publications is doubling every 14 years. How do we keep up and ensure the evidence we rely on is trustworthy? Systematic literature reviews (SLRs) are the answer. Our new whitepaper explores how to conduct SLRs with rigor and transparency, supporting better decisions in pharma, clinical research, and regulatory work. Download the guide: https://ow.ly/gtc950WHosF #LifeSciences #EvidenceBasedMedicine #SLR #PharmaInnovation #ClinicalResearch

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