ADMA Biologics, Inc.’s Post

Dear LI Community, I deeply appreciate all the support that our Classic Galactosemia Change.org petition received from you over the past couple of months! A quick update: the biopharmaceutical company with a potential treatment for this orphan disease successfully completed a rare, preliminary meeting with the FDA to discuss their study data and is now planning to submit a New Drug Application in the fourth quarter of 2023. Your advocacy support was a critical part of this success! To find out more about the potential treatment and NDA process, Applied Therapeutics' press release is here: https://lnkd.in/gTgcrJD9 Galactosemia is considered an orphan disease because so few people are affected by it (In US: 1 in 100,000). This means there is currently no treatment and no cure. To learn more about Classic Galactosemia, check out this website: https://lnkd.in/g3KVJU-y #pavethewayfda #thisisgalactosemia #galactosemia #raredisease #fda

#Ustekinumab Biosimilar - Clinical Trials Data - #BioFactura/#CuraTeQ Biologics BioFactura, published Phase 1 data on its Ustekinumab biosimilar. There were no marked differences in the safety, immunogenicity, and tolerability profiles for subjects receiving BFI-751 as compared to EU/US ustekinumab. This successful pivotal study paves the way to conduct a global efficacy and safety trial in in adult male and female subjects with moderate to severe plaque psoriasis, due to start early 2024. BioFactura & CuraTeQ Biologics have entered into an exclusive global license to commercialize Ustekinumab Biosimilar.

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

It is Eczema Awareness Month. Check out this video to see how biologics improved this patient's life. https://1l.ink/NGBKJT4 Do you or a loved one struggle with Eczema? We can help!

There's still time to register - secure your spot today to learn from our experts Mahdi Roohnikan and Sahil Shah in our upcoming webinar on CMC testing in protein-based therapeutics! You'll gain insights into FDA expectations for NDA submissions, the unique analytical challenges associated with mAB/ADC, techniques for demonstrating product quality attributes, and tips for a successful CMC testing program. Register now 👉 https://bit.ly/4cc59hu #drugdevelopment #SGSNorthAmerica #biologicstesting #biopharmatesting

If you missed the interview with Horst Ruppach discussing the impact of ICH Q5A R2 on biologics and viral safety strategy, check it out here: https://okt.to/bOdGWU #biologicstesting #cellbanking #viralclearance #BPIWest

Astellas earmarks $354.2M for Irish build; Samsung Biologics get into ADCs; Rentschler gets UK facility approved >>> lqventures.com #strategy #competitiveintelligence #marketing #healthcare #pharmaceutical #pharma #biotech #productmarketing

It was an honor to speak at SOCRA on the challenges faced when conducting decentralized clinical trials involving biologics. The meeting focused on decentralized clinical trials and we had great discussion. Including the risk assessment for biologics leads to interesting logistical and safety challenges that go beyond what is normally considered for traditional clinical trials. #Advarra #clinicaltrials #clinicalresearch #genetherapy #raredisease #cellandgenetherapy #mrnavaccines #SOCRA

Idiopathic pulmonary fibrosis (#IPF) is a progressive and life-limiting #lungdisease. Explore the evolving IPF treatment landscape and learn how early-stage biopharmaceutical teams can meet emerging development challenges and chart a new roadmap to success in our whitepaper. https://ow.ly/hRqm50Q4qzI #WorldCOPDDay #COPD #BreathingisLife-ActEarlier