TEVOGEN BIO’s Post

𝐌𝐚𝐫𝐢𝐧𝐮𝐬 𝐏𝐡𝐚𝐫𝐦𝐚𝐜𝐞𝐮𝐭𝐢𝐜𝐚𝐥𝐬 𝐑𝐞𝐯𝐞𝐚𝐥𝐬 𝐏𝐡𝐚𝐬𝐞 𝟑 𝐓𝐫𝐢𝐚𝐥 𝐑𝐞𝐬𝐮𝐥𝐭𝐬 𝐨𝐧 𝐆𝐚𝐧𝐚𝐱𝐨𝐥𝐨𝐧𝐞 𝐟𝐨𝐫 𝐓𝐒𝐂-𝐑𝐞𝐥𝐚𝐭𝐞𝐝 𝐄𝐩𝐢𝐥𝐞𝐩𝐬𝐲 & 𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐜 𝐅𝐨𝐜𝐮𝐬 𝐒𝐡𝐢𝐟𝐭 Today, Marinus Pharma announced topline results from its Phase 3 TrustTSC trial, which evaluated ganaxolone in tuberous sclerosis complex (TSC)-related seizures. While the trial didn't meet its primary endpoint, it offers valuable insights on ganaxolone's use alongside existing therapies. https://lnkd.in/gJnQ4X5N #pharmaceuticals #clinicaltrials #epilepsy #research #biotech #healthcare #neurology #drugdevelopment #marinuspharma #ganaxolone #strategicshift #healthnews 

Decisions of Herantis Pharma Plc.'s Annual General Meeting of shareholders. Here is the link to the release: https://lnkd.in/dcsDD_AH #HerantisPharma #ParkinsonDisease #Biotech #CDNF #HER096 #DiseaseModifying #healthtech #drugdevelopment #pharma #Neurology

Check out Allucent’s recent case study, https://lnkd.in/dhaXSGCq, where our clinical pharmacology A-Team details how they implemented modeling and simulation to determine the feasibility and design of a First-in-Human (FIH) study for their client’s program. The client's challenge lay in determining if their pharmacodynamic (PD) objective was achievable given preclinical toxicities linked to maximum observed concentration (Cmax) and conflicting in vitro brain penetration data. Read how Allucent's Clinical Pharmacology experts were able to determine how much of the drug should be given to achieve the clinical PD objective, while simultaneously ensuring participant safety. This case study has been developed by Allucent A-Team experts Devin Welty, PhD, Rachel (Tyson) Rozakis, PharmD, Marcus Delatte, PhD, and Alison Wakeford, PhD. Read the case study to learn more! #Allucent #BringNewTherapiesToLight #pharmacology #modelingandsimulation #CNS #neurology

𝐄𝐩𝐢𝐥𝐞𝐩𝐬𝐲 𝐏𝐮𝐛𝐥𝐢𝐜 𝐋𝐚𝐧𝐝𝐬𝐜𝐚𝐩𝐞: Key Players in the Market 👇 Companies like Xenon, Bayer, Teva, and Bausch Health are already marketing treatments for epilepsy. On the pediatric side, Jazz Pharmaceuticals, Sanofi, and Marinus are pushing forward, addressing early-onset seizure types like DEEs (Developmental and Epileptic Encephalopathies). It’s exciting to see the innovation happening across adult, pediatric, and combined epilepsy markets, with advancements spanning from pre-clinical to marketed products. 🔬 Meanwhile, companies like Cerevel, Biohaven, uniQure, and Harmony Biosciences are making waves in Phase I/II clinical trials, ensuring the pipeline remains rich with potential new therapies. The diversity of players across different stages of development shows both the competitive nature of this space and the dedication to improving outcomes for epilepsy patients of all ages. Source: TD Cowen #biotech #neurology #epilepsy #biopharma

Modeling and simulation is a powerful tool that can be useful to product development teams under various conditions that include when: animals are more sensitive to the effects of a product compared to humans; when the cost and/or quantity of a test product limits its in vivo testing; when there is no relevant test species or dose-limiting toxicities in relevant species are not clinically relevant. Our experts are available to discuss how to leverage Allucent’s expertise in modeling and simulation, as well as in assessing and managing product risks to mitigate these issues or others in IND/NDA/BLA related submissions for various indications. #Allucent #BringNewTherapiesToLight #pharmacology #modelingandsimulation #CNS #neurology

Nice read on how our Clinical Pharmacology experts were able to determine how much of the drug should be given to achieve the clinical PD objective, while simultaneously ensuring participant safety.

𝐄𝐢𝐬𝐚𝐢 𝐂𝐨., 𝐋𝐭𝐝. and Biogen. announce an important update on the 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐫𝐞𝐯𝐢𝐞𝐰 𝐨𝐟 𝐥𝐞𝐜𝐚𝐧𝐞𝐦𝐚𝐛 𝐢𝐧 𝐀𝐮𝐬𝐭𝐫𝐚𝐥𝐢𝐚. The TGA's initial decision not to register lecanemab for early Alzheimer’s treatment is under reconsideration. Eisai will submit a review request under Section 60 of the Therapeutic Goods Act to make lecanemab available to those with mild cognitive impairment and Alzheimer’s dementia. With approvals in the U.S., Japan, and beyond, we remain committed to global progress in 𝐀𝐥𝐳𝐡𝐞𝐢𝐦𝐞𝐫’𝐬 𝐜𝐚𝐫𝐞. 𝐒𝐭𝐚𝐲 𝐢𝐧𝐟𝐨𝐫𝐦𝐞𝐝 𝐨𝐧 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐮𝐩𝐝𝐚𝐭𝐞𝐬: https://lnkd.in/gxz9CY_q #alzheimersawareness #lecanemab #regulatoryreview #healthcare #pharmaceuticals #biogen #innovation #mildcognitiveimpairment #alzheimerscare #clinicaltrials #section60 #globalhealth #medicaladvances #neurology

Chronic inflammatory demyelinating polyneuropathy (CIDP) can manifest in vague and variable presentations that lead even experts astray in pursuit of its diagnosis. In this program, follow leading specialists – Drs Nicholas Silvestri, Christyn Edmunson, and Kelly Gwathmey – through real cases as they identify common pitfalls, tips and tricks, and novel therapeutic considerations to help optimize the diagnosis and management of this complex condition. Link: https://lnkd.in/eBtvxUxi #PACE #neurology #CME #neuropathy #meded

Amylyx Pharmaceuticals announced today that RELYVRIO did not meet the prespecified primary or secondary endpoints from the Phase III clinical trial for amyotrophic lateral sclerosis (ALS).    The topline results from the Phase III trial found that after studying 664 ALS patients, Amylyx's drug failed to show statistically significant outcomes in comparison to placebo. At this time, RELYVRIO is still available to those living with ALS.    #Amylyx #RELYVRIO #ALS #Neurology   Read more: https://lnkd.in/d-HPn6v6