Nature Reviews Drug Discovery reports that the FDA approved 50 new therapeutics in 2024, including approvals for a novel schizophrenia drug and the first NASH (Non-alcoholic steatohepatitis) medicine. Link to the article in the comments.
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In mid-December, the pharmaceutical company Cognition Therapeutics reported encouraging topline results from their Phase 2 clinical trial of CT1812, an investigational drug being studied in people with dementia with Lewy bodies (DLB). An early phase trial funded by the National Institutes of Health (NIH), the SHIMMER study met its primary endpoints of demonstrating safety and tolerability. Further, improvements were seen in behavioral, functional, cognitive and movement measures. Read more from Lewy Body Dementia Association here: https://hubs.li/Q032nW940 #dementiafriendlypa #dementiasupport #dementiaawareness
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1. Recent clinical trials for Novo Nordisk’s CagriSema and Amgen’s MariTide did not meet the 25% average weight-loss target, causing investor disappointment. 2. The failures in these trials have opened opportunities for other pharmaceutical companies to develop new weight-loss drugs. 3. GLP-1 or incretin drugs, like Ozempic and Wegovy, have gained popularity for their ability to regulate blood sugar and suppress appetite. 4. Novo Nordisk and Eli Lilly have become highly valuable pharmaceutical companies due to the booming sales of their weight-loss medications. 5. New treatments must achieve over 20% weight loss to be competitive with current options. 6. Novo Nordisk’s CagriSema showed a 22.7% weight loss in trials, while Eli Lilly’s retatrutide resulted in a 17% weight loss. 7. Amgen’s MariTide achieved an average of 20% weight loss in a 52-week trial. 8. Zealand Pharma's petrelintide is being developed as an alternative for patients intolerant to GLP-1 treatments, with an 8.6% weight loss reported. 9. Novo Nordisk’s experimental pill amycretin led to a 10.4% weight loss in three months, while Eli Lilly’s orforglipron is in phase 3 trials. 10. Viking Therapeutics reported a 6.8% weight loss for its weight-loss pill in early studies, outperforming Novo Nordisk’s amycretin.
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WATCH: Dr. Peter Marks, Director, Center for Biologics Evaluation and Research (CBER) at the FDA joins Pat to chat about the development of PPMD’s Dystrophinopathy Clinical Research Network (DCRN), and the need for a better understanding of long-term safety, efficacy, and potential risks and benefits of add-on therapies in this growing landscape of approved and investigational therapies for #Duchenne. Stay tuned to learn more about PPMD’s plans for the DCRN and how innovative trial design and data sharing can accelerate the pace of research.
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Dermal drug delivery is a popular method for administering therapeutics, and a preferential route because of its ease of use, and potential to enhance user compliance during clinical trials. In issue 39 of The Altascientist, we look at some of the approaches and considerations needed for advancing your dermal studies, from nonclinical to Phase I clinical trials. Learn more: https://lnkd.in/g5PiNsaV #ClinicalTrials #DrugDevelopment #DermalStudies
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The US FDA Grants RMAT Designation to Intellia Therapeutics, Inc. Nexiguran Ziclumeran for Treating Hereditary Transthyretin (ATTR) Amyloidosis with Polyneuropathy #intelliatherapeutics #nexiguranziclumeran #hereditarytransthyretin #amyloidosiswithpolyneuropathy #regulatory #usfda
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📣 𝐅𝐃𝐀 𝐂𝐥𝐞𝐚𝐫𝐬 𝐅𝐢𝐫𝐬𝐭 𝐂𝐑𝐈𝐒𝐏𝐑-𝐂𝐚𝐬13 𝐑𝐍𝐀-𝐄𝐝𝐢𝐭𝐢𝐧𝐠 𝐓𝐫𝐢𝐚𝐥 𝐟𝐨𝐫 𝐌𝐚𝐜𝐮𝐥𝐚𝐫 𝐃𝐞𝐠𝐞𝐧𝐞𝐫𝐚𝐭𝐢𝐨𝐧 The FDA has cleared HuidaGene Therapeutics's investigational new drug application for HG202, the first CRISPR-Cas13 RNA-editing therapy to enter clinical trials. HG202 is designed to treat neovascular age-related macular degeneration, which is a leading cause of blindness in people over the age of 60. Read more in our latest update: https://lnkd.in/dAyvEm6Q #crisprmedicinenews #crisprmedicine #huidagenetherapeutics #crispr #rnaediting #genediting #blindness HuidaGene Therapeutics Alvin Luk
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Viking Therapeutics, Inc. will move VK2735, its injectable GLP-1/GIP obesity drug, directly into a Phase 3 trial, as per Elaine Chen at STAT. There are additional plans to explore monthly dosing, versus weekly injections – which could be a huge gain. Shares of Viking rose over 20% in post-market trading. The past study of Viking’s drug led to 15% weight loss at three months; in addition, an oral formulation of VK2735 posted just over 3% weight loss at four weeks. https://lnkd.in/etuamqTR
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Recently attended a webinar hosted by SPSR on "Eyeing the Future: Platforms for Enhanced Ocular Therapeutics". Learned about new developments in the field of eye care, including the most recent developments in ocular medications. The future of ocular drug delivery systems and their accessibility on the international market were of greater significance towards it. #SPSR #OcularTherapeutics #Pharmaceuticalscience #futuresciences #webinars #knowledgeenhancement #research #clinicalresearch #clinicalresearchanddevelopment
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Thoughts on this? >> Higher dose of Spinraza helped spinal muscular atrophy patients, Biogen says >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #productmarketing #pharmaceutical #biotech #pharma #healthcare
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🎥 In a recent interview with JustStocks, our CEO Gary Phillips shared insights on the first set of interim data from our Phase 2 trial, which will be presented at the American Society of Haematology Annual Meeting in December. While we won't have the full 12-month data, the results from patients with 6-9 months of treatment will provide critical insights into the safety and efficacy of SNT-5505 in combination with a JAK inhibitor. This data will shape important discussions with the FDA, as we prepare for the pivotal study that could lead to registration of SNT-5505, creating significant opportunities for both patients and potential pharma partners. Watch the full interview: https://lnkd.in/gt4b9JrQ #Syntara #Myelofibrosis #SNT5505 #ClinicalTrials #ASH2024 #FDA #Biotech #Innovation #BloodCancer #SNT
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Read the paper here: https://go.nature.com/3E46XNf 🔒