G1 Therapeutics, Inc.的动态

LaNova Medicines Begins the P-I Trial of LM-299 for Solid Tumors and Concludes Series C1 Financing #lanovamedicines #lm299 #solidtumors #pharma #seriesC1financing #seriesC2financing

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

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

More news to exhilarate you about what's to come, thanks to employing AI! Check out the medical literature: https://lnkd.in/eru9Xveh

What is Joint Clinical Assessment (JCA) process and how will it impact your product launch? Amanda Hansson Hedblom, FIECON's JCA expert, provides an in-depth overview of the forthcoming mandatory evaluations commencing January 2025. These evaluations are set to standardise drug assessments across EU member states, covering a range of medicines from oncology to orphan drugs. Amanda details the chronological steps of this streamlined assessment process, highlighting how it will influence future healthcare decisions. Discover the key insights from the full interview article here: https://lnkd.in/eVtp7cbU and stay tuned for the upcoming JCA updates on our website. #JCA #Pharma #EURegulations #HEOR #MedicalAccess

We are pleased to provide a summary of our activities for the quarter ended 30 September 2024. CEO Gary Phillips commented: “It was a productive period for the company from a clinical, operational and financial perspective. Our lead program, the Phase 2 trial of SNT-5505 targeting myelofibrosis, reached full recruitment and before the end of the calendar year we plan to announce interim data and present it at the American Society of Haematology (ASH) annual conference in San Diego held from 7-10 December. We expect we will seek a meeting with the FDA in 1H 2025 once we have enough data to fully characterise the safety and efficacy profile of the drug. It was also pleasing to broaden out the scope of SNT-5505 with the awarding of the A$2.5m grant in Germany for a new Phase 1b/2 trial for high risk MDS and CMML patients, beginning next quarter. This study and a further study in low/intermediate risk MDS that has received funding from the Australian government is expected to start recruitment in 1H 2025. These are clinically and commercially important studies given the relatively poor outcomes for patients in this disease and a corresponding interest from pharmaceutical companies. I want to again take the opportunity to thank the new and existing shareholders that supported our capital raising during the quarter, which has put us on a strong financial footing. We’ve supplemented this with investor relations activities to continue to increase awareness of the compelling opportunity we see in Syntara and subsequently introduce new investors to the register. We look forward to updating the market with the SNT-5505 data and other developments in due course.” View the full Quarterly Report here: https://lnkd.in/gBedDFyA View the Appendix 4C here: https://lnkd.in/gVauTvXy #Syntara #SNT #Myelofibrosis #SNT5505 #ClinicalTrials #Biotech #Innovation #BloodCancer

Top 3 news for July, 2024! 1.?Eli Lilly and Company got the FDA's approval of the Donanemab-azbt, branded as Kisunla?, for the treatment of Early Symptomatic Alzheimer's Disease. The treatment includes people with mild cognitive impairment (MCI) as well as people with the mild dementia stage of AD, with confirmed amyloid pathology. https://lnkd.in/eH_r7cSH 2. Vertex Pharmaceuticals has struck a deal with South Korea's?Orum Therapeutics?to license their degrader-antibody conjugate technology for $15 million upfront, plus $310 million per target in milestones and royalties on future sales. https://lnkd.in/ehK7_YR7 3. Bristol Myers Squibb has terminated the co-development agreement with Eisai Co., Ltd. for?MORAb-202, or?farletuzumab?ecteribulin, an ADC molecule targeting FRα?for?several?solid?tumors?and?is currently in phase 2 trials. https://lnkd.in/ew5Rw6ME

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!

????There is something just so fundamentally wrong with a medical supply/pharmaceutical supply mega-company owning the medical practices from which its medical supplies and drugs are ordered. Talk about a conflict of interest!

??Exciting News!!! Today, we announced that Lantern Pharma Inc. (Nasdaq: LTRN) ’s Investigational Drug-Candidate, LP-184, Receives Fast-Track Designation in #Glioblastoma from the #FDA ? Why is it exciting... ??Fast Track Designation is designed to expedite FDA review of important new drugs to treat serious conditions and fill an unmet medical need. ??Fast Track Designation for LP-184 (STAR-001) recognizes Glioblastoma (#GBM) as a serious condition impacting more than 13,000 U.S. adults each year and approximately 300,000 globally. ??A phase 1b/2a clinical trial for recurrent GBM is targeted to start in late 2024/early 2025. ??LP-184, which will be developed as STAR-001 for CNS and other neuro-oncology indications by?Starlight Therapeutics, a wholly owned subsidiary of Lantern Pharma, has the potential to be the first new drug for treating GBM in more than 20 years. Read the full release: https://bit.ly/3YmdfQ2 Visit our website: www.lanternpharma.com Visit Starlight's website: www.starlightthera.com