This morning, we provided an update on our progress on the FDA review for the pz-cel (prademagene zamikeracel) BLA for recessive dystrophic epidermolysis bullosa #RDEB, including completion by the FDA of both a Bioresearch Monitoring (BIMO) inspection of Abeona and the BLA mid-cycle review meeting. We are on track for the PDUFA date of May 25, 2024. Read our press release here bit.ly/3vZNGsm
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The science is there on drug resistance – we know it’s one of the biggest problems we face today. What’s lacking is the political will to make the changes we need. It’s therefore great, and humbling, to be spending two days with the world’s top minds at the very first Evidence for Action (E4A) Dialogue on Antimicrobial Resistance - including Kevin Outterson, Executive Director at CARB-X, the Novo Nordisk Foundation's newest partner on drug resistance. The goal of the event is to mobilize political action that can help ensure effective antibiotics are available when and where they’re needed. #AMR #antimicrobialresistance
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🚀 Exciting News! The Pharmacotherapy in Emergencies on-demand program is now fully available on Xpeer! 🏥 Accredited content by UEMS - EACCME in partnership with SEMES and SEFH. With 12 current topics, delivered by leading opinion leaders in the field of pharmacotherapy, it's a unique opportunity to expand your knowledge and skills. Highlighted topics include pneumonia management, sepsis code, drug administration in emergencies, non-atrial fibrillation arrhythmia, among others. ✨Available with Xpeer Premium subscription https://lnkd.in/grsWmGHm #Pharmacotherapy #Emergencies #MedicalEsducation
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𝐅𝐘𝐁𝟐𝟎𝟐 𝐚𝐩𝐩𝐫𝐨𝐯𝐞𝐝 𝐛𝐲 𝐭𝐡𝐞 𝐄𝐮𝐫𝐨𝐩𝐞𝐚𝐧 𝐂𝐨𝐦𝐦𝐢𝐬𝐬𝐢𝐨𝐧 The European Commission has issued a marketing authorization for FYB202 (ustekinumab), covering all countries of the European Economic Area (EEA), including the 27 member states of the European Union (EU) as well as Iceland, Liechtenstein and Norway. “FYB202 is our second biosimilar with market approval in Europe, and this marks another very important step on our way to a leading, profitable and sustainable pure play biosimilar company. Chronic inflammatory diseases are globally on the rise and negatively impact the quality of life of millions of people. With FYB202/Otulfi® we are – together with our partner Fresenius Kabi – committed to providing a safe, effective and cost-efficient treatment option for this large number of patients.”, commented Dr. Stefan Glombitza, Chief Executive Officer (CEO) of Formycon AG. Read more in our Corporate News: https://lnkd.in/dpgbXe7 #TeamFormycon #Biosimilars #Fresenius #EMA #Uste #Psoriasis #CB
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Life Sciences & Healthcare Expert │ Transactions | IP | Product Liability │ Partner, Attorney (advokat) at Gorrissen Federspiel
LIFE SCIENCE | SHORTAGES | NATIONAL MINIMUM STOCKS In today's MedWatch, I offer my perspectives to the national laws passed by the German, Swedish and Danish Governments to force marketing authorisation holders to establish certain minimum stocks on national soil. I am not impressed by the initiatives and very concerned that these will lead other member states to implement similar or worse minimum stock requirements. This is not what the #EUHealthUnion needs. Lif - Lægemiddelindustriforeningen, Lægemiddelstyrelsen (Danish Medicines Agency), Indenrigs- og Sundhedsministeriet, DANISH BIO - DANSK BIOTEK, EFPIA - European Federation of Pharmaceutical Industries and Associations, Dansk Erhverv - Sundhed og Life Science
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With the recent approval of Budesonide by the Food and Drug Administration, this second-generation, synthetic, non-halogenated form of the corticosteroid budesonide is poised to provide physicians with an alternative #treatment option to conventional corticosteroids. Learn more on how Budesonide will impact the market for IgA nephropathy/Berger’s disease and the hurdles it may need to overcome to reach blockbuster status in the new #DrugstoWatch report: https://ow.ly/gLnx50QiilQ #kidneydiseaese #renaldisease #blockbuster #patienthealth
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The CHMP Grants Positive Opinion to Roche’s PiaSky for Treating Paroxysmal Nocturnal Haemoglobinuria (PNH) #roche #piasky #paroxysmalnocturnalhaemoglobinuria #regulatory #chmp #phase3 #commodore1 #commodore2 #commodore3 #positiveopinion #eculizumab #atypicalhaemolyticuremicsyndrome #sicklecelldisease https://lnkd.in/gmi5CBWr
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So great to see more animal-free testing alternatives being developed and gaining traction in pharma/biotech like LAL alternative: rFC! 👏 👩🔬 🤩 Michael Mestaz #sustainable #animalwelfare #endotoxin #rFC #LAL #lifesciences #pharma #biotech
June 20 was International Horseshoe Crab Day! 🦀 For too long, this species has been used for its blood to detect #endotoxins in biomedical testing. At bioMérieux Pharma QC, we're proud to have developed an alternative #Endotoxin testing method - rFC - that doesn't rely on these animals, while still offering lot-to-lot consistency for greater #laboratory efficiency and competitive testing costs. #WeActForAPositiveImpact #PioneeringDiagnostics
Recombinant Factor C Methods for Endotoxin Testing: Towards Sustainable Development and Reliable...
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Are you up to date with the NICE guidance on lipid modification, including statins and the newer medicines? Find out the latest recommendations on risk assessment and medicines choice with a person-centred approach. Watch our webinar, delivered in collaboration with NICE earlier this year: bit.ly/3Rm5F48
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#CRAB #POLIMIXIN #CLSI "A Susceptible* category for polymyxins cannot be established because there is no MIC for which likely clinical efficacy can be predicted. When used, polymyxins should be administered at maximally tolerated doses and in combination with a second agent.”24 Work with your antimicrobial stewardship program to determine the appropriate lab testing and reporting strategy for your facility. If you are going to use a polymyxin as part of your treatment regimen, polymyxin B is preferred over colistin given its more favorable pharmacokinetic profile." Dr. Tamma interview 2024. (CLSI Newdoc).
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