IQVIA’s Post

Exciting News in Cardiovascular Research! Today marks a significant milestone as a groundbreaking small molecule drug, CardiolRx™ currently in Phase II trials for recurrent pericarditis, receives Orphan Drug Designation from the FDA. This achievement underscores its potential to transform the lives of patients. Kudos to the team at Cardiol Therapeutics Inc. for their dedication. 👇Learn more about this groundbreaking development and the ongoing MAvERIC-Pilot study in the comments below. #MedicalInnovation #healthcareadvancements #cardiovascularresearch

We are thrilled to announce that Cadrenal Therapeutics, Inc. has received FDA Orphan Drug Designation (ODD) for tecarfarin, our novel blood thinner, aimed at preventing thromboembolism and thrombosis in patients with LVADs, RVADs, Biventricular Assist Devices, and Total Artificial Hearts.    This designation not only provides potential market exclusivity for up to seven years after approval, but also opens up expanded partnering opportunities for tecarfarin.    At Cadrenal, we are deeply committed to addressing unmet needs in anticoagulation therapy. With this second FDA ODD, we're one step closer to making a meaningful difference in the lives of patients with rare cardiovascular conditions who require chronic anticoagulation.    Read more about this milestone: https://lnkd.in/gkdCV25y   #CadrenalTherapeutics #FDAODD #OrphanDrugDesignation #novelbloodthinner #Tecarfarin #HealthcareInnovation #CVKD Quang Pham

We are thrilled to announce that Cadrenal Therapeutics, Inc. has received FDA Orphan Drug Designation (ODD) for tecarfarin, our novel blood thinner, aimed at preventing thromboembolism and thrombosis in patients with LVADs, RVADs, Biventricular Assist Devices, and Total Artificial Hearts.    This designation not only provides potential market exclusivity for up to seven years after approval, but also opens up expanded partnering opportunities for tecarfarin.    At Cadrenal, we are deeply committed to addressing unmet needs in anticoagulation therapy. With this second FDA ODD, we're one step closer to making a meaningful difference in the lives of patients with rare cardiovascular conditions who require chronic anticoagulation.    Read more about this milestone: https://lnkd.in/gkdCV25y   #CadrenalTherapeutics #FDAODD #OrphanDrugDesignation #novelbloodthinner #Tecarfarin #HealthcareInnovation #CVKD Quang Pham

I wrote this long, in-depth and thorough overview of the #FDA Ad-Comm meeting for the Lykos Therapeutics NDA for #MDMA-AT as a treatment for #PTSD. https://lnkd.in/esiQgMuU Please consider reading and sharing!

The FDA has approved Anktiva (nogapendekin alfa inbakicept-pmln) intravesical solution, in combination with Bacillus Calmette-Guérin (BCG), for the treatment of adult patients with BCG-unresponsive non–muscle invasive #bladdercancer with carcinoma in situ with or without papillary tumors. For all the latest drug news, check out our drug referential resource: https://ow.ly/jfz450Rnclg #DrugNews #Pharmacy #Medication

SIM0501, a small-molecule inhibitor of Ubiquitin Specific Peptidase 1 (USP1) and an anti-tumor drug candidate independently developed by Simcere Zaiming has been approved for clinical trials by the U.S. Food and Drug Administration (FDA). SIM0501 is intended to be investigated in the clinical trials for advanced solid tumors.   #USP1 #syntheticlethality #SIM0501 https://lnkd.in/g7SXbM7n

First US FDA Approval for Denosumab #biosimilars ! Sandoz’s Jubbonti/Wyost is the first US FDA approved biosimilar to Amgen’s Prolia/Xgeva (denosumab) and can now be used to treat #osteoporosis and hypercalcemia as well as to prevent skeletal-related events associated with bone metastases from solid tumors. At the moment there are no #denosumab biosimilars approved in the European Union but there are several candidates in the pipeline and Biomedcode is supporting such efforts through offering #preclinical drug testing services using the unique #TghRANKL mouse model that develops spontaneously severe osteoporosis due to the overexpression of human #RANKL (https://lnkd.in/dgdWrthj) Let’s discuss how we can support your drug development pipeline! #cro , #drugtesting, #Prolia, #Xgeva, #fda

On Thursday, March 14, Autolus Therapeutics held its Q4 2024 earnings call (press release: https://bit.ly/48YCpGz / presentation: https://bit.ly/49VcGQt) highlighting the recent submission of a Market Authorization Application (MAA) for obe-cel (#CD19 CAR-T) in r/r ALL, while noting that its Nucleus manufacturing facility has successfully passed its first GMP inspection enabling the commercial product supply for obe-cel. Additionally, the Ph1 #CARLYSLE confirmatory trial evaluating obe-cel in severe, refractory SLE, and the Ph1 #MAGNETO trial (https://bit.ly/43jTSba) studying #AUTO6NG (#GD2 CAR-T) in pediatric #glioblastoma have been initiated. Celltelligence provides insights on Autolus’s preparedness for obe-cel potential launch in 2024, while discussing its efforts to accelerate obe-cel’s evaluation in the #autoimmune disease space: https://bit.ly/CT-862354

When navigating oncology drug development, it’s crucial to stay on top of the FDA’s Oncology Center of Excellence’s recent projects and how they can affect your program. Watch our webinar to make sure your program is addressing the projects it needs to! https://ow.ly/4Oer50QGIEe

Today Atara announced that it submitted a Biologics License Application (BLA) to the U.S. FDA for tabelecleucel (tab-cel®) indicated as monotherapy for treatment of adult and pediatric patients two years of age and older with Epstein-Barr virus (#EBV) positive post-transplant lymphoproliferative disease (#PTLD) who have received at least one prior therapy. For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate. This represents the first-ever #allogeneic #Tcell therapy BLA submission to the FDA, and if approved, tab-cel would be the first approved therapy in the U.S. for EBV+ PTLD. Read more about this significant milestone for Atara: https://bit.ly/4dL7elE