Mission MSA’s Post

"Based on the evidence, we support the FDA’s conclusions that the [Accelerated Approval] AA program is working as intended: Earlier approval of drugs based on initial evidence of safety and effectiveness addresses unmet medical needs of patients with serious conditions. Because of AA, patients with #cancer and their clinicians have treatment options earlier than they otherwise would, and this has likely led to more than 250,000 life-years gained. Upon further postmarketing study, a minority of drugs fail to meet FDA benchmarks and are withdrawn, but most drugs meet confirmation benchmarks and continue to unlock value for patients and society." https://lnkd.in/eeJKFFSx Nice recap of evidence for AA program by Julie Patterson, PharmD, PhD, John O'Brien, PharmD, MPH, and Jon Campbell, PhD of National Pharmaceutical Council

Radiopharmaceuticals have proven to be effective agents since they can be successfully applied for both diagnostics and therapy. Radionuclide drug conjugates (RDCs) combine a radioactive compound, a tailored-targeting molecule for specific receptors enriched on diseased cells, and a linker for stable attachment. By attacking only cancerous cells, this approach enables more effective radiation delivery and significantly reduces side effects. WuXi AppTec has developed a comprehensive workflow for radiopharmaceutical discovery and development, from target selection and ligand ID to stability testing and in vivo efficacy/safety assessment. Curious to learn more? Watch the video ⬇️ https://lnkd.in/e_XeBg-C #DrugDiscovery #RDC #Radionuclide #Radiopharmaceutical

𝐕𝐞𝐫𝐮 𝐈𝐧𝐜. 𝐑𝐞𝐜𝐞𝐢𝐯𝐞𝐬 𝐅𝐃𝐀 𝐂𝐥𝐞𝐚𝐫𝐚𝐧𝐜𝐞 𝐟𝐨𝐫 𝐄𝐧𝐨𝐛𝐨𝐬𝐚𝐫𝐦 𝐏𝐡𝐚𝐬𝐞 𝟐𝐛 𝐓𝐫𝐢𝐚𝐥 Veru Inc. (NASDAQ: VERU) Veru Inc. is thrilled to announce FDA clearance of our Investigational New Drug (IND) application for Phase 2b clinical trial of enobosarm, a selective androgen receptor modulator (SARM), to combat muscle loss associated with Glucagon-like peptide-1 receptor agonist (GLP-1 RA) drugs for weight loss. Our Phase 2b trial will assess enobosarm's potential to preserve muscle mass and enhance fat loss in sarcopenic obese or overweight elderly patients. Scheduled to commence by April 2024, with top-line results expected by Q4 2024. Following the efficacy dose-finding phase, participants will enter an open-label extension study to evaluate enobosarm's ability to reverse muscle loss post-GLP-1 RA cessation. Results anticipated by Q2 2025. Mitchell Steiner Mitchell Steiner, MD, FACS, M.D., Veru Inc.'s Chairman, President, and CEO, highlights the importance of this study for preventing muscle loss and improving overall weight loss quality. #ClinicalTrial #FDAApproval #Enobosarm #SARM #MuscleLoss #WeightLoss #MedicalResearch #Healthcare #Innovation #Pharmaceuticals

Antisense oligonucleotides (ASOs) an emerging drug modality that is having clinical impact in neurological and rare diseases, including ALS/Motor Neuron Disease. In this webinar experts from Amylyx Pharmaceuticals and Charles River discuss design and screening of ASO, and considerations for designing successful in vivo efficacy studies. https://okt.to/tFBCK5 

🚀 We have some exciting news to share! Clarity Pharmaceuticals has signed a Clinical Manufacturing Agreement with us, enhancing our joint commitment to innovative healthcare solutions. This new agreement builds upon our previous Master Services and Supply Agreements, focusing on the streamlined production of the 64Cu isotope and the 64Cu-SAR-bisPSMA product at a single facility. As part of the agreement, SpectronRx will ensure reliable, on-demand manufacturing and distribution of Clarity’s novel diagnostic, 64Cu-SAR-bisPSMA, across all 50 states. This will enable universal access to Clarity’s Phase III trials, including the ongoing CLARIFY trial and the upcoming pivotal trial for prostate cancer patients experiencing biochemical recurrence (BCR). This partnership enhances Clarity’s supply network with a robust, multifaceted approach unique to the radiopharmaceutical sector. Why is this significant? It guarantees a continuous and ample supply chain, providing widespread access to 64Cu-SAR-bisPSMA throughout the United States. 👉 You can read the full announcement in today's edition of BioSpace: https://lnkd.in/gzJWN5FT #NuclearMedicine #Radiopharmaceuticals #ClinicalTrials #SpectronRx #ClarityPharmaceuticals

Go check out the latest APAC news article in the biopharma industry! 🌏🔬 Exciting updates and insights await! 🌏🔬 #Biopharma #APACNews"

Race for #Keytruda Biosimilars Heats Up! As Merck Group approaches #LossofExclusivity for its blockbuster drug #Keytruda in 2028, multiple biosimilar players are now entering into clinical development phase. On Feb 20, 2024, Samsung Bioepis initiated a Phase 1 trial comparing the safety, efficacy, PK and immunogenicity of SB27 vs US and EU-sourced Keytruda, as adjuvant treatment in Stage II/IIIA NSCLC patients. Additionally, the company has also registered a parallel Phase 3 study in metastatic NSCLC patients (Not yet recruiting). This development positions Samsung Bioepis as the 4th global #biosimilar player to either initiate or publicly register a clinical study for a #Keytruda biosimilar. The other 3 contenders in the race include Sandoz (Parallel Phase 1 and Phase 3), mAbxience (Phase 3) and Biothera Pharmaceuticals, Inc. (Phase 1). Additionally, Formycon AG also recently announced plans to start a clinical study for Keytruda by Q4 2024 or Q1 2025, further intensifying the competition. Furthermore, few other companies are conducting clinical studies for their #Keytruda biosimilar for regional markets. #oncology #biosimilars #keytruda #strategy #pipelineanalysis #loe #competitiveintelligence #datazymes #clinicaltrials

Novel approaches and targets in #neurodegeneration at the AngloNordic Sceince Conference. Five Big Pharma key projects are in CNS drug discovery. 💡

AlzeCure - develops new innovative drug therapies AlzeCure is a Swedish pharmaceutical company that develops new innovative drug therapies for the treatment of severe diseases and conditions that affect the central nervous system, such as Alzheimer’s disease and pain – indications for which currently available treatment is very limited. NeuroRestore consists of two symptomatic drug candidates where the unique mechanism of action allows multiple indications – Alzheimer’s disease, as well as cognitive disorders associated with traumatic brain injury, sleep apnea and Parkinson’s disease. The Alzstatin platform focuses on developing disease- modifying and preventive drug candidates for early treatment of Alzheimer’s disease and comprises two candidates. Painless is the company’s research platform in the field of pain and contains two projects: ACD440, which is a drug candidate in the clinical development phase for the treatment of neuropathic pain, and TrkA-NAM, which targets severe pain in conditions such as osteoarthritis. AlzeCure aims to pursue its own projects through preclinical research and development to an early clinical phase and is continually working on business development to find suitable solutions for outlicensing to other pharmaceutical companies. https://lnkd.in/enfcx4G #alzheimers #alzheimer #alzecure #neuropaticpain #osteoarthritis #aktiespararna #Analysguiden #Alzheimerfonden #painmanagement #redeye #avanza #nordnet #edisongroup #seb #swedbank #nordea #privataaffarer #vatorsecurities #finwire