JB Ashtin’s Post

Attention Pharmaceutical Drug Developers- Clinical Research for Liver Disease is about to get easier... with the latest innovations in non-invasive liver imaging from E-Scopics and the #Hepatoscope. We are excited to announce that #Hepatoscope is now being utilized at California Liver Research Institute. E-Scopics is proud to partner with CLRI and Dr. Edward Mena, to support MASH drug studies and accelerate screening #Hepatoscope.

This segment features .Laxminarayan Bhat, Ph.D., CEO of Reviva Pharmaceuticals (NASDAQ: RVPH) and Senior Life Sciences Analyst John Vandermosten. We cover a number of subjects related to schizophrenia medication and treatment. Starting with a review of biomarkers in development by others, we then look at biomarkers that will be used in the upcoming RECOVER 2 trial. The guests look at some of the methods of administration used for neuropsychiatric medicines. Other topics explored include treatment resistant patients, patent cliffs, pharma's search for new products, options for commercialization and expected timeline for RECOVER 2. https://lnkd.in/gxcHnN5v

Important lesson in development of the PDL-1 inhibitor just came in. China-developed PD-L1 inhibitor called #Envafolimab in-licensed by #Biotech TRACON Pharmaceuticals for North America announced negative results for its subcutaneous PD-L1 inhibitor #Envafolimab, in patients with undifferentiated pleomorphic sarcoma (UPS) or myxofibrosarcoma (MFS) (NCT 04480502). Envafolimab administration resulted in responses in four out of 82 patients so number was below the 11% response rate the phase 2 trial was targeting as its primary endpoint. Tracon is stopping further development of Envafolimab including planned combination with #Ipilimumab https://lnkd.in/em32DnTy. Envafolimab has Chinese approval in advanced microsatellite instability-high (#MSI-H) or mismatch repair-deficient (#dMMR) solid tumors received in 2021 and is developed by #China-based #3DMedicines and #Alphamab Oncology. With this latest development US based access of Envafolimab is likely not in the future. What comes as somewhat surprising is a choice of sarcoma as indication targeted for Phase II development. Sarcomas have been reported with very variable PDL-1 expression depending on different reports/methodologies and with limited efficacy of PD(L)-1 inhibitors either in mono therapy or in combos depending on histology and with small numbers of patients reported in studies rising high uncertainty of results in terms of larger population even within limited histology (informative recent reviews https://lnkd.in/eHZW-ZR8, https://lnkd.in/efefcrrj). #PD-1 inhibitor #sarcoma #Biotech #clinical oncology #immunotherapy #Phase 2

in the INBUILD trial sponsored by Boehringer patients with rheumatoid arthritis and progressive pulmonary fibrosis, nintedanib reduced the rate of decline in forced vital capacity (mL/year) over 52 weeks by 59% compared with placebo. The adverse event profile of nintedanib was consistent with that previously observed in patients with pulmonary fibrosis, characterised mainly by diarrhoea. I think academic research supported by Pharmaceutical Industry (not only with finance but also with support on patient recruitment and study design, dos and don'ts), can find why Nintedanib causes the side effect of diarrhoea. I write this with the hope that the industry will encourage academic research and contribute to improve the research at the fundamental level.

OTO-313 failed as a cure for tinnitus. Here’s why: It was a pharmaceutical drug developed by Otonomy, a San Diego-based biopharmaceutical company. OTO-313 was a liquid compound administered via needle injection, past the eardrum, near the cochlea. (The cochlea is known as the ‘hearing organ’ — its corresponding cochlear nerve carries bio-electric signals up to the auditory cortex, which is how the brain processes sound.) Now, more specifically… OTO-313 is a compound by the name of gacyclidine. Otonomy researchers believed gacyclidine could reduce the severity of tinnitus-related symptoms by strengthening the auditory nerve fibers within the cochlea. So, the drug was promising. But after going through multiple clinical trials, it failed. Trial #1 took place during July of 2020. It included participants with moderate-to-severe unilateral tinnitus (tinnitus in one ear). The trial produced a positive clinical response via the Tinnitus Functional Index (TFI). The TFI is what we use to measure progress (or lack thereof) in treatments, such as loudness and annoyance. The first research trial showed promise, with a positive clinical response to many participants after only a single injection. Trial #2 continued in August of 2022, which unfortunately ended in failure. In other words, there was an insufficient percentage of those reporting reduced symptoms vs the placebo. So, the study was shut down. Still, I applaud the researchers’ efforts. And while this wasn’t an outright success… It did help expand our knowledge as to what is and isn’t working. Especially as it pertains to studies using a placebo. So many research studies in tinnitus, including my own, have not utilized a true double-blind study design, which makes it hard to come to a clear yes-no decision on whether a treatment works or not. That’s why there’s a long history of tinnitus treatment companies slowly fading away, and eventually ending production of their product. Thank you to the researchers for Otonomy for giving this treatment a shot. And thanks to the scientific method for allowing us to put this one to rest. ______________________________________ I'm Ben Thompson, AuD, leading tinnitus specialist, YouTuber and Founder of Treble Health. ➡️ Follow me for: ✔ the latest news and tinnitus-related developments ✔ tips for tinnitus prevention, management and treatment ✔ stories and advice from a telehealth company founder

The Affordable Edge: Transforming the Specialty Pharmaceuticals SectorIn the speciality pharmaceuticals sector, striking a balance between profitability and drug affordability is crucial. Conditions like cancer and Alzheimer’s necessitate advanced, targeted therapies, which are initially expensive due to their extensive research and development phases. https://lnkd.in/gmU6cnnA #onlinepharmacy #mrmed #onlinemedicineshop #superspeciltypharmacy #ordermedicineonline

According to DelveInsight Business Research LLP, in the year 2022, the total prevalent cases of Ocular Hypertension were approximately 21 million cases in the 7MM. The US accounted for the highest number of prevalent cases in the 7MM in 2022 which are anticipated to increase further by 2032. Leading pharma and biotech companies such as Nicox, Laboratoires Théa, Glaukos Corporation, DWTI D. Western Therapeutics Institute, AbbVie, TearClear, Ocular Therapeutix, Inc., Perfuse Therapeutics, and others are developing novel Ocular Hypertension drugs to overcome the existing treatment challenges and unmet needs. Get a more detailed analysis, at: https://lnkd.in/gJQZH6ch #healthcare #biotechnology #lifesciences #pharmaceuticalindustry #pharmaceutical #marketresearch #marketforecast #markettrends #consulting #healthcareconsulting #consultingservices #marketforecast

SK Biopharmaceuticals (hereinafter referred to as SK Biopharm) succeeded in exporting technology to transfer the global rights of a non-narcotic pain treatment candidate (SKL22544) to IGNIS Therapeutics in China. The maximum scale of this technology export amounts to around KRW 80 billion (approximately USD 57.8 million). In particular, this technology export is garnering attention as it includes a preferential negotiation right, allowing SK Biopharm to repurchase the U.S. marketing rights once the clinical efficacy of SKL22544 is confirmed. https://lnkd.in/gxCjtdvc

Vamorolone, a Potential Duchenne Muscular Dystrophy Therapy, Undergoes Priority Review in China Sperogenix Therapeutics has applied for approval of vamorolone for the treatment of Duchenne Muscular Dystrophy (DMD) in China. The filing has been accepted by the NMPA, and a decision is expected in the first quarter of next year. The New Drug Application is supported by comprehensive data that has already led to vamorolone's approval in the US, EU, and UK. Sperogenix holds the exclusive rights to develop and market vamorolone in China under a license agreement with Santhera. The potential approval of vamorolone in China would be a significant step forward in treating DMD. For more details please click the link! https://lnkd.in/d5JJxrpX #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical

Exciting developments in treating rare cancers will be unveiled at the 2nd Targeted Radionuclide Pharmaceuticals (TRPs) Supply Chain & Manufacturing Summit in Boston from September 24-26, 2024. With Molecular Targeting Technologies (MTTI) and Brookline Capital Markets at the helm, the conference promises groundbreaking advancements in the radiopharmaceutical market ✅ MTTI's workshop, "Evaluating the Commercial & Pharmaceutical Viability of Radioisotopes to Benchmark Potential," will explore the dynamic world of radioisotopes like actinium-225, lutetium-177, lead-212, and copper-67. Experts will discuss market demand, commercial viability, and the challenges faced in developing these innovative compounds 💡 Chris Pak, CEO of MTTI, emphasized the prowess of MTTI's EB technology, which boasts 8 to 30-fold higher uptake at the target with reduced radiation doses, translating to better efficacy and medical economics. #Radiopharmaceuticals #LifeSciences #HealthcareInnovation #OncologyResearch #ClinicalTrials #ClinicalResearch #LifeScience #ElixirAssociates #StaffingPartner