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NeuroBo Pharmaceuticals, Inc. completes enrollment of Part 1 of Its Phase 2a #clinicaltrial evaluating DA-1241 for the treatment of metabolic dysfunction-associated steatohepatitis (#MASH). Part 2, which will explore the efficacy of DA-1241 in combination with sitagliptin versus placebo, is expected to enroll approximately 37 subjects. DA-1241 is a novel G-Protein-Coupled Receptor 119 (GPR119) agonist with development optionality as a standalone and/or combination therapy for both MASH and #type2diabetes. Full data readout is expected in the second half of 2024. #cardiometabolic

The first FDA-approved NASH/MASH drug is here: Madrigal Pharmaceuticals' Rezdiffra (resmetirom). In a major win for the company and patients, the FDA isn't requiring a liver biopsy to determine a patient's eligibility. #NASH #MASH #fattyliverdisease #fdaapproval #fda #Madrigal #Rezdiffra #resmetirom #NASHdrug #drugapproval #liverdisease

📰 FDA approved Tyruko, a natalizumab biosimilar, as a monotherapy for multiple sclerosis (MS), making it the first neurology biosimilar to receive regulatory approval in the US. The product was developed by Polpharma Biologics and will be marketed by Sandoz as a part of a commercialization agreement, in which Sandoz has exclusive commercialization rights to Tyrko in all global markets. There are no MS biosimilars approved in the European Union, Canada, or Australia. The main generic and biosimilar drugs for MS expected to launch over the next 5 years are estimated to generate between €4.5 billion to €5.5 billion in savings between 2023 and 2028 in France, Germany, Italy, Spain, and the United Kingdom 👉 https://lnkd.in/dgfgtvJ8 #biosimilars #pharmaceuticals #biotechnology #pharmconnect

Karuna Therapeutics ($KRTX) and Reviva Pharmaceuticals ($RVPH) are making waves in the world of biopharma. Here's the intriguing part: KRTX boasts a $6B market cap, while RVPH is around $100M. Yet RVPH's prior trials have shown a superior safety profile and minimal drug interactions. Back in August 2022, when KRTX unveiled its Phase 3 results, it gained a staggering $5 BILLION in market cap in just five days! Now, RVPH is on the verge of releasing Phase 3 data for a drug with an even BETTER safety profile. Join the conversation (and read our disclosures) and keep an eye on this underdog! https://ow.ly/Z8v450PSzmW

In an exclusive interview with Thomas Warner from Proactive, Dr Markku Jalkanen, chief executive of Faron Pharmaceuticals Limited (AIM:FARN, OTC:FPHAF), discussed the encouraging results from their ongoing phase I/II trial called BEXMAB. The study aims to evaluate the efficacy of bexmarilimab in treating acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS). The results have exceeded expectations, showing a 50% remission rate among patients who had relapsed or were resistant to standard treatments. Thomas Warner: You've got a smile on your face there, I can see. And it's all to do with these latest results from your BEXMAB study, isn't it? More at #Proactive #ProactiveInvestors #faronpharmaceuticals http://ow.ly/qnfo104XUTL

Preclinical research is essential to improve the well-being of people with #spinalmuscularatrophy . #genetherapy research has paved the road for #fda approved #genetic therapy for people with SMA.  Though, as the recent post below from the Muscular Dystrophy Association points out, advances for people with type 2 or 3 has lagged.   New research from the laboratory of Albert La Spada [UC Irvine] ], however, shows that their mouse model of X-linked spinal and bulbar muscular atrophy [Kennedy’s disease] displays prominent #cardiac disease phenotypes, which resemble abnormalities detected in human SBMA patients (1). The ECGenie readily provides #digitalbiomarkers of #cardiac disturbances in awake laboratory mice from birth through old age. ECGenie: Getting to the heart of matters! https://lnkd.in/edigRK2r.   Their publication underscores the need to evaluate human SBMA patients for signs of…heart disease and recommends that “…therapies being developed to treat patients should be delivered peripherally” (1).   #health #wellness #crispr #aav #drugdiscovery #drugdevelopment References: 1.    Anastasia  Gromova et al. X-linked SBMA model mice display relevant non-neurological phenotypes and their expression of mutant androgen receptor protein in motor neurons is not required for neuromuscular disease. Acta Neuropathol Commun. 2023 Jun 2;11(1):90. Link to publication: https://lnkd.in/eCZimKYp

Glioblastoma Pipeline Drugs and Companies Insight, 2023 Updates: Analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments by DelveInsight #Business #HealthMedicine #MarketingSales #PharmaceuticalsBiotech

Structure Therapeutics reported its oral GLP-1 drug led to #weightloss in two studies. In a 12-week Phase 2a study, the daily capsule formulation led to 6.2% placebo-adjusted weight loss. In a separate 12-week study, a new tablet formulation, called GSBR-1290 led to placebo-adjusted weight loss of up to 6.9%. Results suggest it is competitive with a once-daily GLP-1 drug currently being developed by Eli Lilly, orforglipron, an oral alternative to the company’s injectable Zepbound or to Novo Nordisk’s injectable Wegovy. Structure plans on initiating a 36-week Phase 2b global #obesity study in Q4 of 2024.

Madrigal Pharmaceuticals’ resmetirom, soon available as Rezdiffra, has achieved the milestone of becoming the primary therapy for NASH to receive FDA clearance, after a protracted journey through drug development. Rezdiffra marked a significant milestone as the first medication to achieve both NASH resolution and improvement in fibrosis during a phase III trial. While Rezdiffra benefits from being the first to enter the NASH treatment market, other treatments have shown encouraging early clinical results, aiming to capture a significant portion of the NASH treatment market. To know more about the emerging treatment options in the NASH market, visit: https://lnkd.in/gzYBPRM7 #NASH #NASHtherapies #therapies #madrigalpharmaceuticals #resmetirom

Ipsen's Sohonos Capsules Gain FDA Approval for Fibrodysplasia Ossificans Progressiva After a tumultuous journey, Ipsen's drug Sohonos (formerly palovarotene) gains FDA approval as the first therapy for fibrodysplasia ossificans progressiva (FOP), an ultra-rare bone disease. Overcoming clinical holds, setbacks, and regulatory rejections, Sohonos curbs abnormal bone growth by 54%. However, caution is advised due to potential risks, including premature growth plate closure. Priced at $624,000 annually, competition from Regeneron looms. Ipsen gains a priority review voucher with approval and a path opens after approval in Canada. The FOP community celebrates, but the long, tumultuous journey raises questions about the future landscape of rare disease treatments. If you're interested in continuing to read the full story and want to stay updated with the Latest Pharma News in USA, visit Pharmtales. #pharma #pharmaceutical #pharmtales #latestnews #pharmanews #pharmaceuticalindustry #fdaapproval #fda #drug https://lnkd.in/dn2fmcFe