ADMA Biologics, Inc.’s Post

𝐂𝐞𝐫𝐭𝐚 𝐓𝐡𝐞𝐫𝐚𝐩𝐞𝐮𝐭𝐢𝐜𝐬' 𝐅𝐓𝟎𝟏𝟏 𝐆𝐫𝐚𝐧𝐭𝐞𝐝 𝐔𝐒 𝐅𝐃𝐀 𝐎𝐫𝐩𝐡𝐚𝐧 𝐃𝐫𝐮𝐠 𝐃𝐞𝐬𝐢𝐠𝐧𝐚𝐭𝐢𝐨𝐧 𝐟𝐨𝐫 𝐭𝐡𝐞 𝐓𝐫𝐞𝐚𝐭𝐦𝐞𝐧𝐭 𝐨𝐟 𝐒𝐲𝐬𝐭𝐞𝐦𝐢𝐜 𝐒𝐜𝐥𝐞𝐫𝐨𝐬𝐢𝐬 Certa Therapeutics Certa Therapeutics announces FDA Orphan Drug Designation for FT011 in scleroderma, a rare autoimmune condition characterized by skin and organ inflammation. Orphan drug status offers development benefits and marketing exclusivity. CEO Professor Darren Kelly Darren Kelly stated, "This milestone highlights the need for innovative solutions for scleroderma patients." FT011 demonstrated a 60% clinical improvement in a Phase 2 study. Safety profile: well-tolerated, no serious adverse events. Data to be presented at ACR Convergence 2023. #healthcare #inflammation #drugdevelopment #patient #clinicaltrials #patient

In my new article, I talk about the incredible potential of a unique new drug, SPG302, developed by Spinogenix, Inc., for treating amyotrophic lateral sclerosis (ALS) and how the FDA has approved it for ongoing clinical trials. The drug regenerates the synapses damaged by the fatal disease. In Phase 1 trials conducted in Australia, the drug has proven safe and is now being trialled in people with ALS. It could be a watershed moment in ALS treatment. #ALS #synapse #smallmolecule https://lnkd.in/gbJhSmbx

When you work with patients with cancer and rare diseases, any moment might become one where someone's life is on the line. That's what happened to Mindy Moua, a pharmacy tech for Biologics. She was on the phone with a patient when the unexpected happened--and her response saved their life. Watch the video to see her story. #PharmacyTechnicianDay #CPhT

October is #BreastCancerAwarenessMonth! Let's use the rest of this month to show our support, spread awareness, and honor the fighters and survivors. Whether it's getting a mammogram, supporting a friend or family member, every action counts. #Octalsoft invites you to unite in the fight against #BreastCancer. Together, we can make a difference and bring hope to those affected. #Pinktober #BreastCancerAwareness #FightLikeAGirl #CRO #Octalsoft #OctalsoftCares #HealthcareInnovation #Healthcare #ClinicalTrials #ClinicalResearch #eClinicalSolution #Pharma #LifeSciencesTech #PharmaceuticalIndustry #HealthcareIndustry

Long COVID - or post-COVID syndrome - can include a wide range of ongoing health problems, which can last weeks, months or years. Ipsos’ syndicated COVID-19 Therapeutics & Diagnostics Consumer Study has revealed that concerns remain around developing long-COVID, as well as the burden it places on healthcare systems, emphasizing the importance of addressing and understanding the long-term effects of the virus. Contact Ipsos to find out more!  #covid19 #ipsos

Long COVID - or post-COVID syndrome - can include a wide range of ongoing health problems, which can last weeks, months or years. Ipsos’ syndicated COVID-19 Therapeutics & Diagnostics Consumer Study has revealed that concerns remain around developing long-COVID, as well as the burden it places on healthcare systems, emphasising the importance of addressing and understanding the long-term effects of the virus. Contact me to find out more!  #covid19

On February 3, 2023, the Wiskott-Aldrich Foundation convened the Externally Led-Patient Focused Drug Development (EL-PFDD) meeting to educate the FDA and other stakeholders on how X-Linked Thrombocytopenia and Wiskott-Aldrich Syndrome (WAS) impacts our lives, and give our thoughts on current and future therapies. More than 300 individuals participated in the live webcast event, and patients and family members testimony has been captured in the 𝐕𝐨𝐢𝐜𝐞 𝐨𝐟 𝐭𝐡𝐞 𝐏𝐚𝐭𝐢𝐞𝐧𝐭 𝐑𝐞𝐩𝐨𝐫𝐭. This landmark report documents the severe disease burden and unmet medical need in patients' own voices. The Wiskott-Aldrich Foundation wants the FDA and all the stakeholders to listen to our patients' voice, their words, and their experiences, and recommends that these findings be considered when developing potential XLT/WAS therapeutics. The 𝐕𝐨𝐢𝐜𝐞 𝐨𝐟 𝐭𝐡𝐞 𝐏𝐚𝐭𝐢𝐞𝐧𝐭 𝐑𝐞𝐩𝐨𝐫𝐭 has been submitted to the FDA for inclusion in the framework used to evaluate future therapies for XLT and WAS. The report is here: https://lnkd.in/gCEpUB-3 The report, video of the live webcast, are posted below. Our community owes a deep debt of gratitude to the patients and family members who courageously shared their stories, took the time to attend the meeting and to answer questions about how XLT/WAS has impacted their lives and what improvements they would like to see. https://lnkd.in/gCEpUB-3 #WiskottAldrichSyndrome #wiskottwarrior #primaryimmunodeficiency #PID #primaryimmunodeficiency #wiskottaldrichsyndromeawareness #primaryimmunedeficiency #waslife #lowplateletcount #eczema #ELPFDD #PFDD #voiceofpatientreport

[Clinical Trials] AbbVie's phase 2 trial of ABT-981 shows higher response rates in achieving HS Clinical Response in adults with moderate to severe Hidradenitis Suppurativa https://lnkd.in/gy3NVUPT Innovent Biologics' phase 3 Trial of IBI362 Shows Superiority in Weight Loss in Overweight and Obese Individuals https://lnkd.in/gzz6KxpN

Thanks for sharing Targeted Oncology and Sabrina S.! Obviously a significant milestone for MRD (and likely a sign of things to come for other tumor types) . . . More to come later but for for now, here's a link to the meeting information and materials: https://lnkd.in/gMeHzXzN Some interesting tidbits from the article: [FDA representatives] "confirmed that . . . there was a strong individual-level association for PFS and OS, but trial-level associations were weak to moderate in disease subpopulations for PFS and were generally weaker for OS." And "a strong trial-level association could become a validated surrogate end point and support regular approval; however, very few oncology end points have met this standard, and most end points that support accelerated approval have not been assessed for trial-level surrogacy or have weak trial-level associations." #fda #mrd #acceleratedapproval #multiplemyeloma