ADMA Biologics, Inc.’s Post

𝗣𝗮𝗻𝗲𝗹 𝗗𝗶𝘀𝗰𝘂𝘀𝘀𝗶𝗼𝗻: 𝗘𝗳𝗳𝗲𝗰𝘁𝗶𝘃𝗲 𝗣𝗿𝗮𝗰𝘁𝗶𝗰𝗲𝘀 𝗙𝗼𝗿 𝗜𝗻𝗳𝗮𝗻𝘁 𝗠𝗶𝗰𝗿𝗼𝗯𝗶𝗼𝗺𝗲 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹𝘀 Up next at 13:30, we will be welcoming the following speakers to the stage: • Nikole Kimes, Founder & CEO, Siolta Therapeutics • Ellen Turner, MD, FIDSA, Medical Officer, FDA Center for Biologics Evaluation and Research/Division of Vaccines and Related Products Applications • Dr. Amine ZORGANI, Founder, The Microbiome Mavericks This panel discusses the regulatory adjustments to infant clinical trials and the importance for the microbiome industry to include this underserved patient population. #MicrobiomeConnect #MicrobiomeConnectUSA #MicrobiomeConnectSeries

At the conclusion of the #AUTM2024 annual meeting, the 2024 Better World Project finalists were acknowledged, highlighting the global impact of research commercialization and the vital role that technology transfer plays in the process. Although we were not named the winner, we are honored to have been a finalist. Thank you to everyone who voted! The translational capabilities of Nationwide Children's Hospital, such as the Office of Research Regulatory Affairs which manages filings with the FDA for Investigational New Drug Applications (INDs), and the Clinical Research Services that manage clinical trials at Nationwide Children’s, facilitated attracting an industry partner. We initially entered into an option agreement with Sarepta Therapeutics in late 2016, after which we licensed the technology in 2018 following promising positive Phase I clinical trial results. This licensing deal helped to move the therapy into clinical trials quickly and efficiently. Sarepta Therapeutics filed a Biologics License Application with the FDA in the fall of 2022. On June 22, 2023, the FDA announced accelerated approval for the therapy. To date, Sarepta has dosed over 140 individuals with ELEVIDYS, delivering corrected genes to cells and providing hope for boys affected by DMD. #InnovateWithUS #GeneTherpy #BetterWorld

A question below for our fellow small biotech company team members... Comment with your responses below and if you are feeling exceptionally generous today 😀, add in how your company/team overcame the challenge! #radiopharmaceuticals #biotechindustry #pharma #radiationoncology #smallbiotech

Want to explore the regulatory landscape of mRNA-based therapeutics in the EU and US? Join our webinar on May 14 to learn about the requirements and regional differences for mRNA drug substances. Obtain the latest regulations and unlock opportunities for your #mRNA drug development strategies. Register now! #CTDMO

Clouds of competition surround Regeneron's Eylea Another biosimilar developer, Sandoz, announced that its biosimilar referencing Eylea showed no clinically meaningful differences with the originator in a Phase III trial in patients with wet macular degeneration estabilishing theraeputic equivalence. Sandoz has also announced plans to file its biosimilar in both US and EU in coming months. Sandoz would be the fourth company to file a bEylea in the US after Biocon, Celltrion Healthcare Co.,Ltd., and Formycon AG/Coherus BioSciences. And its not only the looming biosimilars, increasing popularity for Roche's Vabysmo and CRL for 8mg Eylea have put Eylea in a difficult spot. https://lnkd.in/dTymMMJf

Thoughts on this? >> #EASL24: Aligos, Arbutus, Atea, Barinthus and Bluejay unveil hepatitis results >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #healthcare #productmarketing #pharmaceutical #biotech #pharma

The comparability strategy for a post-approval production cell line change of a bevacizumab biosimilar (IBI305 from Innovent) is presented. Cell line changes are considered to have a relatively high potential risk to product safety and efficacy. Demonstrating the comparability for post-approval production cell line change poses a big challenge. Therefore, such changes are often done before pivotal studies during clinical trials. Altruist Biologics' recent case study demonstrates a three-way analytical and non-clinical comparability study strategy. Learn more about the successful outcome of this post-approval cell line change and its alignment with Altruist’s CDMO mission today. https://hubs.ly/Q02s0s410

Thoughts on this? >> #EASL24: Aligos, Arbutus, Atea, Barinthus and Bluejay unveil hepatitis results >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharmaceutical #pharma #biotech #productmarketing #healthcare

Join FSR Chief Strategy Officer, Tricha Shivas, for the Rare and Orphan Disease Conference, presented by Critical Path Institute (C-Path), to be held Sept. 11-13 in Washington DC! Attendees of the 2.5 day conference will include patients, providers, researchers, clinicians, biopharmaceutical companies, regulatory reviewers and scientists. Topics include: - C-Path's Rare and Orphan Disease Program's current and future impact on drug development in rare diseases from the perspectives of patients, regulators and industry partners - The Critical Path for Rare Neurodegenerative Disease (CP-RND) initiative's first year impact and highlights - How RDCA-DAP has been enhanced in the last year, and how the platform informs rare disease drug development - Transversal solutions to address bottlenecks in drug development Learn more and register now: https://loom.ly/yIq7LwI #raredisease #chronicillness #sarcoidosis #conference

Welcome to Ascelia Pharma AB Investor Update: Bringing Orviglance to Patients Today Ascelia Pharma AB welcomes investors, analysts and media to the virtual update and live Q&A, where executive management further explains the strong Phase 3 headline results and plans for the upcoming regulatory and commercialization activities. Presentations are available on the Company’s website and the live Q&A starts on Tuesday, 7 May at 14:00 CEST. #investorupdate #orphanoncology #Phase3