Kathryn Teti’s Post

Exciting news from Paragonix Technologies, Inc.. With this newest 510(k) clearance from the FDA, we are the first and only company with U.S. regulatory clearance for all five solid organs. Read the news release below to learn how we continue to improve the field of transplant!

Attralus has received Breakthrough Therapy Designation for our pan-amyloid diagnostic PET imaging candidate 124I-evuzamitide (AT-01) for cardiac amyloidosis from the US FDA. ✳ Read the press release – https://lnkd.in/egNHUjnT. ✳ 124I-evuzamitide (AT-01) has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration for positron emission tomography (PET) imaging in patients with suspected or known cardiac amyloidosis. ✳ FDA granted BTD for 124I-evuzamitide (AT-01) based on clinical data from Attralus-sponsored and investigator-initiated studies evaluating the use of 124I-evuzamitide in patients with cardiac amyloidosis, representing experience in more than 200 trial participants. #amyloidosis #rarediseases

✅ #BreakingNews: The FDA has approved #acoramidis (#Attruby®), a new oral transthyretin stabilizer, for treating adult patients with TTR-mediated amyloid cardiomyopathy. This therapy aims to reduce cardiovascular deaths and hospitalizations related to #CardiovascularDisease, according to a press release from its developer, BridgeBio. “With the landmark approval of Attruby, we gain the ability to serve patients with ATTR-CM. I’m grateful to each trial participant, their families, and the physicians, scientists and our team at BridgeBio who made this possible,” said Neil Kumar, PhD, the founder and chief executive officer of BridgeBio. Read more: https://bit.ly/3YXSOIg

📢 Exciting Announcement: We're thrilled to share that Crohn’s Colitis Cure (CCCure) has entered into a strategic partnership with a 'Top 5' Global Pharma company for our revolutionary IBD patient data platform, Crohn’s Colitis Care (CCCare). This partnership marks a significant milestone in advancing IBD research and development, expected to accelerate the development of innovative therapies and improve patient care. Read the full media release below! ⬇️ #IBDResearch #HealthTech #PatientCare #MedicalInnovation #PharmaPartnership #CrohnsColitisCare #HealthData #CrohnsDisease #UlcerativeColitis #InflammatoryBowelDisease #IBDCommunity #Gastroenterology #HealthcareTechnology #PatientCentricCare #ResearchAndDevelopment #HealthcarePartnerships #MedicalResearch #ChronicIllness #DataAnalytics #HealthcareAdvancement #HealthTechInnovation #HealthcareInnovation #CrohnsColitisCure

👁️ PolyActiva is thrilled to report our latest clinical data from our Phase 2a trial testing PA5108, a 6-month sustained-release ocular implant for patients suffering from glaucoma. PA5108 has successfully met the safety and efficacy endpoints in the repeat-dose cohort, demonstrating a statistically significant change from baseline in intraocular pressure (IOP) at weeks 12, 21, 33 and 42 (p<0.0001). Clinically meaningful IOP reductions of 26-35% were observed over 48 weeks. Most importantly to us, the implant was found to be safe and generally well tolerated by trial participants following repeat-dosing over 48 weeks of monitoring! These results demonstrate that PA5108 could be used to treat patients' glaucoma long-term over multiple doses without the compliance and dosing issues that come with drop therapy. PolyActiva is scaling up our manufacturing capabilities to support the commencement of late-stage clinical trials in early 2025, with trials to be conducted under an IND submission to the FDA. Read the full statement here: https://lnkd.in/gvB4QRhW #Glaucoma #DrugDelivery #Biotechnology #Innovation

MindMed Is Now Dosing Patients In Phase III Clinical Trial For LSD MindMed (NASDAQ: MNMD) has officially begun dosing the first patients in their Phase III clinical trial for MM120 ODT for the treatment of generalized anxiety disorder. MindMed’s novel drug MM120 ODT is pharmaceutically optimized form of LSD and this is the first Phase III clinical trial ever that is focused on validating LSD as a potential therapeutic treatment for anxiety. What's happening, the big idea, and more: https://lnkd.in/epFcs2rP Featured | cc: Robert Barrow, Dan Karlin, Stephanie Fagan, Francois Lilienthal MD, MBA, Gregg Pratt, Mark R. Sullivan, Carole Abel, Phong T. Duong, Peter Mack, Rafael Muniz, MD, Javier A. Muniz, MD, Michael Seggev #biotech #healthcare #treatment

IGC PHARMA announces promising #preclinical data for TGR-63, our innovative treatment for #AlzheimersDisease. Preliminary analyses confirm TGR-63’s ability to cross the blood-brain barrier and its excellent safety profile, with no adverse effects observed in extended studies. This marks a significant step forward in our mission to combat #Alzheimer's. Key highlights: • TGR-63 penetrates the blood-brain barrier, a critical milestone in #Alzheimer’s #treatment. • Eight-month safety studies in mice show no toxicity or adverse effects. • Validated potential to reduce #amyloid plaque buildup. Read more at https://lnkd.in/ePcj3HfF   #AlzheimersResearch #IGCPharma #PreclinicalData #ClinicalTrials #BloodBrainBarrier #AlzheimersTreatment #TGR63

MASH is the newest area of intervention in metabolic health. Earlier this year, Rezdiffra (resmetirom) was launched, but at $48K a year and with very minimal results, there is still a lot to be desired. #GLP1 are also under the microscope in this space. Lilly released information on their trial this past week- https://lnkd.in/gT88XYuD And more novel therapies to come: https://lnkd.in/gKKQ84h7 https://lnkd.in/gkCZAfkU Lots to watch in this space over the next few years! #Pharmacists #Pharmacybenefits #liver #newdrugapproval #GLP1

In ONCO Life's featured interview of the principal investigator of GenFleet's KROCUS study, Dr. Rafael Rosell analyzed the favorable efficacy and safety of this first-line combination therapy. The phase II trial data of KROCUS Study, fulzerasib (KRAS G12C inhibitor) in combination with cetuximab (EGFR inhibitor), was orally presented at ASCO annual meeting in June. "Notably, in our study, about 32.5% of patients had brain metastases at the start of the treatment, which is particularly challenging as brain metastases usually correlate with poor survival and quality of life. Impressively, 70% of these patients showed a response without the need for brain irradiation. The ability to combine these new KRAS inhibitors with established treatments can potentially prolong survival significantly. This was evidenced in the KROCUS study, where we observed promising response rates and anticipate longer durations of response with these combinations." Please view the full text from page 7 of the online magazine, at the link of https://lnkd.in/gu9tW4XW For more of GenFleet's information, please visit the official website at

We are excited to have our work presented at the upcoming AMCP Nexus Conference in Las Vegas this October. The results of our collaboration with Sun Pharma and key opinion leaders will be showcased in a poster titled "A Systematic Literature Review and Meta-Analysis of the Real-World Effectiveness, Quality of Life, and Safety of Tildrakizumab for Moderate-to-Severe Plaque Psoriasis." This presentation highlights the practical benefits of tildrakizumab in real-world clinical settings, offering valuable insights into its efficacy and impact on patient quality of life. Our poster L17 will be displayed in The Expo – Marquee Ballroom on October 16 from 1:00 pm – 2:30 pm https://lnkd.in/g_VsFa7g