Shobana Narayanan’s Post

Leading the future

Curious about the latest EU pharmaceutical reforms?🩺💊 Our latest article by Phillipus Putter explores the European Commission’s proposed reforms for the regulation of paediatric medicinal products. Since our initial coverage in July 2023 and following the Parliament’s first reading in April 2024, several key changes have been introduced. This update is crucial for stakeholders in the pharmaceutical industry, especially those focused on paediatric medicines. To understand the full impact of these changes and stay ahead in the industry, read the full article here: https://2bird.ly/48sef8C

Significant Progress in the Pharmaceutical Sector: FDA-Approved First Therapy for MASH! ✌ On 14th March 2024, FDA approved Madrigal Pharmaceuticals' Rezdiffra, the first treatment for steatohepatitis associated with metabolic dysfunction (MASH), signaling the end of the protracted search for a feasible remedy. Rezdiffra provides new hope for patients who were previously without targeted treatment options by treating patients with MASH, which is characterized by moderate to severe liver scarring. Rezdiffra approval establishes a ground-breaking precedent for future treatments in a field that is estimated to affect approximately 5% of adult Americans. Recently, potential competitors to Madrigal's (MDGL) treatment have also shown improvement. The news last week that Akero Therapeutics Inc.'s (AKRO) experimental treatment for MASH, efruxifermin, was showing encouraging results from a mid-stage trial caused its stock price to soar. Additionally, MASH patients will now be able to participate in 89bio Inc.'s (ET)(N)(B) phase 3 trial for Pegozafermin, an investigational medication. Rezdiffra is expected to have peak global sales of $5.5 billion, so this approval not only fills a significant gap in the MASH treatment market but also represents a sizable opportunity. #MadrigalPharmaceuticals #fdaapproval #Rezdiffra #mash #competitiveintelligence

Interstitial Cystitis Market Growth Anticipated by 2032 | Companies includes Merck, Teva Pharmaceutical, Lipella Pharmaceuticals, Seikagaku Corporation: Interstitial Cystitis Market The therapeutic landscape for Interstitial Cystitis in the United States is shaped by existing treatment practices and the anticipated introduction of new therapies. In the market landscape of Interstitial Cystitis, an impressive surge is expected during the … Continue reading → #Business #Europe #HealthMedicine #PharmaceuticalsBiotech #US

To my international network: Do you have a national pharmaceutical strategy in your country? Let me know in the comments! In Sweden, the first national pharmaceutical strategy was released in 2011 and has been revised three times. The current strategy, that the Swedish government has released, is valid between 2024-2026 and covers three focus areas: - availability of new and old medicines - pharmaceutical treatment and medicine handling - development of new medicines and clinical trials

📣FEBRUARY'S FDA ROUNDUP - EYP-1901: Wet Age-Related Macular Degeneration US-based pharmaceutical company EyePoint Pharmaceuticals has reported positive topline data from the Phase II DAVIO 2 clinical trial of EYP-1901, which is an investigational therapy being trialed for the treatment of wet age-related macular degeneration (wet AMD).3 According to the report, “EYP-1901 also demonstrated a favourable safety profile without any treatment-associated ocular or systemic serious adverse events being reported.”3 EyePoint Pharmaceuticals president and CEO Jay Duker said: “The 32-week topline DAVIO 2 data strongly supports our planned Phase III noninferiority design, consistent with the FDA’s recent guidance for wet AMD clinical trials.” 3 ⭐The FDA Roundup is bringing you up to speed with the latest announcements and approvals in #Ophthalmology. Read here ➡️: https://brnw.ch/21wHc6V #DAVIO2 #EYP1901 #WetAMD #wAMD #AgeRelatedMacularDegeneration #Ophthalmologist #ClinicalTrial #EyeHealth

This reflect a crucial aspect of pharmaceutical pricing and access to medicine. In any society, the affordability of medicine is intricately linked to the income levels of its citizens, particularly non-skilled workers who often face financial constraints. Price controls play a vital role in ensuring that essential and nonessential medications remain accessible to all, regardless of economic status. Without proper regulation, the pharmaceutical industry in a capitalist society could prioritize profit over public health, leading to exorbitant prices that effectively exclude the most vulnerable populations from accessing life-saving treatments. As you rightly pointed out, fatal diseases do not discriminate based on wealth or social status. Removing price controls without adequate safeguards could exacerbate inequalities in accessing medicines, leaving disadvantaged patients at the mercy of market forces. It's imperative for regulatory bodies and policymakers to prioritize the protection of poor patients by implementing measures that promote affordability and equitable access to essential medications. Otherwise, the consequences could be dire, with lives hanging in the balance due to the inability to afford vital treatments.

CREATION identified 7,135 eHCP mentions of pharmaceutical companies in March 2024, which was 14% fewer than the previous month. There were three Pharma initiatives that garnered a lot of HCP attention: 1. An Oncologists tutorial on X for #TumorBoardTuesday discussing data revealed at #ESMO2023 gained particular attention by HCPs 2. Dr. Michael Gibson shared the “big news” of Novo Nordisk, Wegovy receiving an expanded label approval from the FDA. The post was shared by 9 HCPs. 3. Six HCPs shared an article diving into the potential of Gilead Sciences’s antiviral treatment “obeldesivir” against Ebola. (Link in the comments) #pharma #healthcare

Six “Antimicrobial Resistance (AMR) Roadmaps”, one for each of the World Health Organization regions, that define and prioritise major milestones towards mitigating AMR for the period 2024 to 2028, are published by FIP today. The roadmaps were developed by FIP in collaboration with its regional pharmaceutical forums and, for the European Region, with FIP member organisations in Europe as there is no FIP regional pharmaceutical forum in the European region. The new roadmaps have been developed to follow roadmaps for 2020-2024. The new publication also presents various activities against AMR that have been undertaken in countries of each region. Access the roadmaps here www.fip.org/file/6112

Six “Antimicrobial Resistance (AMR) Roadmaps”, one for each of the World Health Organization regions, that define and prioritise major milestones towards mitigating AMR for the period 2024 to 2028, are published by FIP today. The roadmaps were developed by FIP in collaboration with its regional pharmaceutical forums and, for the European Region, with FIP member organisations in Europe as there is no FIP regional pharmaceutical forum in the European region. The new roadmaps have been developed to follow roadmaps for 2020-2024. The new publication also presents various activities against AMR that have been undertaken in countries of each region. Access the roadmaps here www.fip.org/file/6112