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Wezlana (ustekinumab-auub) received FDA approval as a biosimilar and interchangeable option with Stelara (ustekinumab) for various inflammatory conditions. The interchangeability designation means Wezlana can seamlessly substitute for Stelara at pharmacies, streamlining patient access. Wezlana is the seventh biosimilar in the US to be given this designation, following Abrilada (adalimumab-afzb), Byooviz (ranibizumab-runa), Cimerli (ranibizumab-eqrn), Cyltezo (adalimumab-adbm), Rezvoglar (insulin glargine-aglr), and Semglee (insulin glargine-yfgn). #FDAApproval #Biosimilar #InnovationinHealthcare #Pharma #Biotech #Symmetric

➡️Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 December 2023   📍Seven new medicines recommended for approval 📍Non-renewal of a conditional marketing authorisation following re-examination 📍Recommendations on extensions of therapeutic indication for four medicines 📍Two positive opinions for medicines intended for use outside the EU 📍Conclusion of referral #pharmacovigilance #CHMP #europe #drugsafety #regulatoryaffairs #icsr #maa #pharmaceuticalindustry #biosimilarmedicines   More information:  https://lnkd.in/dDrzAxYM

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 6-9 November 2023, CHMP, 10/11/2023 >>> lqventures.com #strategy #competitiveintelligence #marketing #productmarketing #healthcare #pharmaceutical #pharma #biotech

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 6-9 November 2023, CHMP, 10/11/2023 >>> lqventures.com #strategy #competitiveintelligence #marketing #productmarketing #pharma #biotech #pharmaceutical #healthcare

A study by Teva Pharmaceuticals has identified the alarming drop in the production of critical generics, with rising costs being a significant factor in this phenomenon. The company highlights the industry shortcomings that have led to this trend, and how they can be rectified. #pharmaceutical #pharma #generics #medicine

In a significant development for the pharmaceutical industry, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has made noteworthy recommendations during its July meeting. Here are the key highlights: 🔍 Rejection of Lecanemab (Leqembi): The CHMP has decided against granting marketing authorisation for lecanemab as a treatment for Alzheimer’s disease. The committee concluded that the serious side effects, particularly the risk of amyloid-related imaging abnormalities (ARIA), outweigh the benefits of delaying cognitive decline. 💊 14 New Medicines Recommended: On a positive note, the committee has recommended 14 new medicines for marketing authorisation, including: Anzupgo (delgocitinib) for moderate to severe chronic hand eczema. Iqirvo (elafibranor) for primary biliary cholangitis, with a conditional marketing authorisation. Kayfanda (odevixibat) for cholestatic pruritus in Alagille syndrome under exceptional circumstances. Yuvanci (macitentan/tadalafil), a single tablet combination for pulmonary arterial hypertension (PAH), enhancing treatment convenience for patients. 📈 Extending Therapeutic Indications: The CHMP also recommended extending indications for 11 existing medicines, further broadening treatment options for various conditions. These developments highlight the ongoing commitment to patient safety and the importance of rigorous evaluation in the approval process for new treatments. As we continue to innovate in healthcare, these decisions will shape the future of patient care across Europe. #Pharmaceuticals #HealthcareInnovation #Alzheimers #EMA #DrugApproval #PatientCare #PharmaIndustry #MedicalResearch

Yorvipath Gains European Commission Approval for Chronic Hypoparathyroidism Ascendis Pharma's Yorvipath has been approved by the European Commission for treating chronic hypoparathyroidism in adults, despite being rejected by the US FDA earlier in the year. Yorvipath is a prodrug of parathyroid hormone and will launch in Germany in January 2024. The approval diverges from the FDA's decision, which cited manufacturing control concerns rather than clinical data. One-year data from a Phase III trial showed positive results, with a significant percentage of patients achieving independence from conventional therapy. Ascendis Pharma aims to make Yorvipath accessible to patients and healthcare providers. For more details please click the link! https://lnkd.in/dFvDKMX6 #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical

Are you hoping to get your drug approved by the European Medicines Agency (EMA)?   Preparing and submitting your Marketing Authorisation Application (MAA) is a significant undertaking, involving a team of 20–30 people preparing the Common Technical Document (CTD) dossier over 18–24 months.    Our latest blog details: 1. The legal basis your medicinal product could fall under 2. How to determine if your medicinal product should be evaluated under the centralised procedure 3. The mandatory and recommended pre-submission steps 4. The timelines associated with each pre-submission requirement   ⬇ If you’re interested in learning more about submitting your MAA and getting your drug approved by the EMA in, get detailed insights in our latest blog ⬇  #regulatoryaffairs #sme #pharmaceuticals  #ATMPs #drugdevelopment https://lnkd.in/eHDbCTrs

Are you hoping to get your drug approved by the European Medicines Agency (EMA)?   Preparing and submitting your Marketing Authorisation Application (MAA) is a significant undertaking, involving a team of 20–30 people preparing the Common Technical Document (CTD) dossier over 18–24 months.    Our latest blog details: 1. The legal basis your medicinal product could fall under 2. How to determine if your medicinal product should be evaluated under the centralised procedure 3. The mandatory and recommended pre-submission steps 4. The timelines associated with each pre-submission requirement   ⬇ If you’re interested in learning more about submitting your MAA and getting your drug approved by the EMA in, get detailed insights in our latest blog ⬇  #regulatoryaffairs #sme #pharmaceuticals  #ATMPs #drugdevelopment https://lnkd.in/eDMRTrf8

💥 Hot Special Issue of EM journal in 2023! 💡 Topic: Beyond Weed: Clinical Applications of #Cannabis and #Cannabinoids (https://lnkd.in/g6bzfMQE) Four Hot Articles with more than 10,000 reads: ✅ A U.S. Food and Drug Administration perspective on cannabis research and drug development 🔗 https://lnkd.in/g7ENYrKd ✅ A large-scale survey of cannabis use for sleep: preferred products and perceived effects in comparison to over-the-counter and prescription sleep aids 🔗 https://lnkd.in/e4ZAwNcS ✅ Cannabis-based medicinal products (CBMPs) for the treatment of Long COVID symptoms: current and potential applications 🔗 https://lnkd.in/efcbzE9g ✅ Cannabis use in cancer patients: acute and sustained associations with pain, cognition, and quality of life 🔗 https://lnkd.in/gx3Rag6N ⭕ Follow me for more special issue information.