Ruchila Fating’s Post

Pain, essentially is a natural experience with evolutional significance. Pain relief is not just a removal of an emotional stimulus with negative valance but also functions as the behavioral manifestation of the neurobiological basis of reward and reinforcement. A drug may not be able to show “pain relief” if it’s restrictedly functioning at peripheral region. As a “peripherally restricted” candidate, you can not have it both ways, safety vs potency: peripheral vs central. A pain relief drug is much more than an analgesic.

👁️ PolyActiva is thrilled to report our latest clinical data from our Phase 2a trial testing PA5108, a 6-month sustained-release ocular implant for patients suffering from glaucoma. PA5108 has successfully met the safety and efficacy endpoints in the repeat-dose cohort, demonstrating a statistically significant change from baseline in intraocular pressure (IOP) at weeks 12, 21, 33 and 42 (p<0.0001). Clinically meaningful IOP reductions of 26-35% were observed over 48 weeks. Most importantly to us, the implant was found to be safe and generally well tolerated by trial participants following repeat-dosing over 48 weeks of monitoring! These results demonstrate that PA5108 could be used to treat patients' glaucoma long-term over multiple doses without the compliance and dosing issues that come with drop therapy. PolyActiva is scaling up our manufacturing capabilities to support the commencement of late-stage clinical trials in early 2025, with trials to be conducted under an IND submission to the FDA. Read the full statement here: https://lnkd.in/gvB4QRhW #Glaucoma #DrugDelivery #Biotechnology #Innovation

Hair loss treatment just got easier. Convenient treatment for the second most common form of Alopecia is available now. 💊 A new treatment for Alopecia Areata, Litfulo (ritlecitinib, Pfizer), has been approved by the FDA, EMA, and NHS.     These tablets may replace the use of corticosteroids which have limitations, especially for extensive hair loss that in some cases requires local injections 💉 🔬The Janus kinase (JAK) signaling pathway plays a role in the initiation and progression of Alopecia Areata. 🩺 Current clinical trials have also focused on inhibiting this signaling 🛑 Baricitinib (NCT03570749)  Deucravacitinib (NCT05556265) EQ101(NCT05589610) 📈 According to analysts, this market size is forecasted to be worth $ 5B by 2030. #alopeciaareata Sources: https://lnkd.in/gDZ-_9ny https://lnkd.in/gp4-9Q_5 doi:10.1001/jamanetworkopen.2023.20351 https://lnkd.in/gauxmUb2 — If you like this post, please share ♻️ Follow me for more 💡 #lifesciences #healthcare — Disclaimer:  This poster represents my personal view and does not reflect those of any past, present, or future employer.

Thank you Amber Tong, Senior Editor at Endpoints News, for highlighting Rezolute, Inc. in your newsletter about the recent release of topline results for the RZ402 program, a plasma kallikrein inhibitor that is being investigated as a potential oral treatment for diabetic macular edema (#DME). The current standard of care for DME is an intravitral injection, which has been providing relief to millions of patients since its approval more than 15 years back. But a significant number of patients do not do well with the injections, while some other patients are not compliant to regular injections. Both of which can lead to significant visual impairment. In addition, early stage disease patients usually do not get an injection as the vision may be good in these patients for them to be considered for an injection. A safe oral drug with a different mechanism of action can potentially change the treatment paradigm in these scenarios. #RZ402 is still an investigational drug and some ways away from a possible approval, but having an oral drug that can reduce treatment burden for the clinics and for patients is definitely something that will be welcomed by both. https://bit.ly/4buJrEP

Another major milestone in medical advancement was made last night! The FDA has granted accelerated approval to the first drug ever to treat moderate to advanced NASH, a condition that can lead to extensive and irreversible liver scarring and damage and ultimately death. The approved drug, resmetirom tablet, now branded as Rezdiffra, developed by Madrigal Pharmaceuticals, has demonstrated impressive results in the pivotal Phase 3 program. >80% of moderate to advanced NASH patients treated with Rezdiffra achieved fibrosis reversal or no fibrosis progression. What's more, the FDA has given Rezdiffra, a once-daily pill, a fantastic label that requires no biopsy for determining the stage of disease, has no contraindications, no boxed warning, and no monitoring requirements beyond the standard of care. With this approval, doctors will now at last have an effective and safe tool to treat the ca. half a million patients in the U.S. diagnosed with moderate to advanced NASH who would otherwise face a bleak future. Madrigal has furthermore priced Rezdiffra within the cost-effectiveness threshold range, as suggested by the independent organization ICER, which should facilitate broad insurance coverage. This is a huge win for medical science and the patients who have been waiting for a solution for so long. #nash, #liverdisease, #fattyliverdisease, #medicaladvancements

Developing advanced sustained-release dosage forms ensures consistent therapeutic effects, enhanced patient compliance, and optimized drug delivery. These systems are especially impactful in managing chronic conditions like cardiovascular diseases, where controlled, precise drug release can improve outcomes and quality of life. SmaBio Labs leverages cutting-edge formulation techniques and innovative release mechanisms to design solutions tailored to your molecule's unique properties. From concept to commercialization, we ensure efficiency and precision at every stage of development. Curious about the science behind sustained-release formulations and their role in cardiovascular therapies? Visit smabiolabs.com to explore the details. #SustainedRelease #DrugDelivery #CDMO #Innovation #SmaBioLabs #cardiovascularmedication

Modern treatments depend heavily on the development of sophisticated sustained-release dosage forms, which offer consistent drug delivery, lower dosage frequency, and enhance patient adherence to treatment plans. For chronic disorders like cardiovascular diseases, where stable plasma medication levels might avoid oscillations that result in negative events, these developments are especially revolutionary. These formulations, which incorporate cutting-edge technologies and creative excipients, not only improve therapeutic results but also tackle issues like reducing side effects and customizing drug release to suit patient requirements and lifestyles.

Diabetic Foot Ulcers Pipeline Update 2024: FDA Approvals, Therapeutic Advancements, and Key Companies involved by DelveInsight | Medline, B. Braun, Organogenesis, 3M, Smith & Nephew, Molnlycke Health: (Las Vegas, Nevada, United States) As per DelveInsight’s assessment, globally, Diabetic Foot Ulcers pipeline constitutes 30+ key companies continuously working towards developing 34+ Diabetic Foot Ulcers treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and … Continue reading → #Business #HealthMedicine #MarketingSales #PharmaceuticalsBiotech

A recent consensus from an international task force highlights the urgent need for clinical trials focusing on alcohol use and its impact on liver disease. The expert recommendations, published by UT Southwestern Medical Center in Nature, stress the importance of addressing the stigma associated with alcohol use disorder (AUD) and alcohol-related liver disease (ALD). These insights align with Adial Pharmaceuticals (NASDAQ: ADIL) and their commitment to developing innovative treatments for AUD, reinforcing the need for collaborative and stigma-free research efforts. For more: https://bit.ly/3zB0Pd4 #AUD #ClinicalTrials #HealthcareInnovation #HealthResearch

#ESMOGynae24: The recent approval by the US FDA of pembrolizumab combined with chemoradiotherapy (CRT) for high-risk #CervicalCancer marks a significant advancement in treatment. But how applicable is this combination for low- and middle-income countries, where most of the global burden of #CervicalCancer lies? A subgroup analysis of the phase III ENGOT-cx11/GOG-3047/KEYNOTE-A18 trial revealed that adding pembrolizumab to CRT reduced the risk of progression or death by 45% in East Asian patients. Despite these promising results, the cost of this combination therapy poses a significant challenge, with expenses varying widely between countries. 👇Read Ilaria Colombo's insights in the latest #ESMODailyReporter article https://ow.ly/Mwve50SmkGp