Business Insights, PHARMACY MARKET
PRNewswire | August 09, 2023
Verista, a leading business and technology services company offering specialized solutions for the life sciences industry, is delighted to announce a new partnership with Sware. This collaboration underscores Verista's commitment to its clients to provide advanced and innovative digital validation solutions, helping them realize Pharma 4.0.
By incorporating Sware's Res_Q platform, clients can enhance, streamline, and optimize the flow of content and data, effectively addressing the challenges posed by static documents and disjointed workflows in the validation discipline. Together, Verista services and Res_Q provide a powerful combination, offering customers a comprehensive and efficient risk-based approach to validation processes in the life sciences industry.
"In this partnership, Verista will drive the efficient execution of digital transformations with Res_Q enabling clients to modernize their processes and leverage the latest regulated technologies in compliant ways," says Manny Soman, CEO of Verista. "We are delighted that Verista and Sware share the same goal to reduce and manage validation efforts while helping clients unleash the full potential of digital transformation to bring their products to market more quickly and safely."
"Digitizing the validation process is crucial for compliance-focused life sciences companies to be able to meet stringent global regulatory requirements, but digitizing processes means much more than putting paper processes on glass," says Bryan Ennis, Co-Founder and CEO of Sware. "Our partnership with Verista couples our deep digital technology expertise with robust industry experience to deliver the most comprehensive, intelligent and digital validation solutions on the market today."
Verista is a leading business, technology and compliance company that enables clients to improve health and improve lives. We help clients solve their most critical and complex challenges across the GxP lifecycle, from clinical to commercialization, manufacturing and distribution. Verista's experts continually deliver consistent, safe, and high-quality results across the product development lifecycle in the areas of enterprise and lab solutions, technology solutions, manufacturing solutions, and regulatory compliance and product management.
Sware is changing how the life sciences industry manages validation – helping companies deliver safer therapies through better technology. Sware provides one validation solution crafted specifically for the entire life sciences industry. Res_Q by Sware automates validation – effortlessly navigating through each step of the validation process for both GxP and non-GxP systems.
Views and Analysis
PRNewswire | August 21, 2023
Everest Medicines announced that U.S. Food and Drug Administration (FDA) has accepted the submission for the supplemental New Drug Application (sNDA) for Nefecon® from its partner Calliditas Therapeutics AB and granted Priority Review. The Prescription Drug User Fee Act (PDUFA) goal date is Dec. 20, 2023.
"We congratulate our partner Calliditas for being granted priority review by the FDA for full approval and taking a step closer to offering this first-in-disease therapy to all IgAN patients at risk of progression. It is another testament to Nefecon® as an important, disease-modifying medicine with significant eGFR treatment benefit observed across the entire study population that can substantially delay onset of dialysis for patients at risk," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "As IgAN prevalence in Asia is much higher than the rest of the world, we look forward to receiving NDA decision for Nefecon® in mainland China in the second half year and filing NDAs in other Asian territories as soon as possible."
The sNDA is based on the full data set from the Phase 3 NefIgArd clinical trial, a randomized, double-blind, multicenter study evaluating the efficacy and safety of Nefecon® at a once-daily dose of 16 mg, compared to placebo, in adult patients with primary IgAN on optimized RASi therapy. The full data from the NeflgArd Phase 3 trial was published in The Lancet in August 2023.
The trial demonstrated a statistically significant benefit of Nefecon® over placebo (p-value < 0.0001) in estimated glomerular filtration rate (eGFR) over the two-year study period, which consisted of nine months of treatment with Nefecon® or placebo, followed by a 15-month follow-up period off the study drug. The data reflected treatment benefits across the entire study population, regardless of UPCR baseline, and showed a difference between TARPEYO and placebo in 2-year eGFR total slope of approximately 3mL/min per year using a robust regression method of analysis.
The China National Medical Products Administration (NMPA) accepted Everest's NDA for Nefecon® for the treatment of IgAN in November 2022, with a decision expected in the second half year of 2023. The NMPA has also granted Nefecon® break-through therapy designation and NDA priority review. Nefecon® was the first non-oncology drug to receive break-through therapy designation in China.
Nefecon® is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. The formulation is designed as a delayed release capsule that is enteric coated so that it remains intact until it releases budesonide to the distal ileum. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum where the disease originates, as per the predominant pathogenesis models.
In June 2019, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas, which gives Everest Medicines exclusive rights to develop and commercialize Nefecon® in Mainland China, Hong Kong, Macau, Taiwan and Singapore. The agreement was extended in March 2022 to include South Korea as part of Everest Medicine's territories.
Nefecon® was approved in the United States under accelerated approval based on a reduction in proteinuria. Recently announced topline results from the global, randomized, double-blind, placebo-controlled Phase 3 clinical trial NefIgArd demonstrated a statistically significant benefit for Nefecon® over placebo in estimated glomerular filtration rate (eGFR), a measure of renal function.
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules, many of which are in late-stage clinical development. The Company's therapeutic areas of interest include renal diseases, infectious diseases, mRNA platform and autoimmune disorders.
Businesswire | August 18, 2023
Koneksa, a healthcare technology company pioneering evidence-based digital biomarkers, today announced the first collaboration in the Koneksa Academic Partnership Program for Parkinson’s Disease (KAPP-PD) to incorporate its Neuroscience Toolkit into research programs.
The first collaboration of the KAPP-PD program, with Oregon Health & Science University (OHSU), enables the inclusion of app-and actigraphy-based digital measures and electronic patient reported outcome (ePRO) instruments from Koneksa’s Neuroscience Toolkit into a study comparing short-acting versus long-acting levodopa in Parkinson’s disease. Koneksa’s Neuroscience Toolkit implements a variety of digital assessments that can be combined to collect data for measures of interest.
The OHSU team, led by Dr. Delaram Safarpour, MD, MSCE, FAAN, is investigating changes in the neurophysiological correlates of PD with carbidopa-levodopa immediate release compared to long-acting levodopa (Rytary), as well as changes in gait performance at intervals of 30 minutes for a total of 4 hours during each visit. This research will provide strong support for clinical profiles of short- versus long- acting levodopa in PD corresponding to objective physiological measures.
“We are collaborating with Koneksa to enhance our study’s objectives: We’ll be including smartphone- and actigraphy-based digital measures and electronic patient reported outcome (ePRO) instruments into our study,” said Martina Mancini, Ph.D., co-investigator of the study, director of the Balance Disorders Laboratory, and Associate Professor of Neurology, OHSU School of Medicine. “Our lab uses new technologies to better understand and measure motor impairments, with the goal of learning how to better help patients with these conditions. Novel, objective metrics, like those made possible with Koneksa’s technology and toolkit, allow us to expand upon what we’ve been able to do in the clinic. In particular, digital at-home measures of daily physical activity, gait and mobility, motor functionality, sleep, and ePRO measures of quality of life all have the potential to uniquely complement OHSU’s in-clinic assessments, offering new and real-world-setting patient insights to support the study’s objectives.”
“Koneksa is proud to extend our contribution to critical neuroscience research through KAPP-PD, and we’re delighted to get the program underway with our first collaboration,” said John Wagner, MD, Ph.D., Chief Medical Officer, Koneksa. “These measures will support OHSU in both in-clinic and at-home patient monitoring of critical parameters of interest for this study. We’re committed to helping to get new and better treatments to patients faster, and that’s a vision that OHSU’s Balance Disorders Laboratory shares.”
About the Koneksa Academic Partnership Program – Parkinson’s Disease
The Koneksa Academic Partnership Program – Parkinson’s Disease (KAPP-PD) is a structured collaboration between Koneksa and select academic partners that enables researchers to incorporate Koneksa’s Neuroscience Toolkit into research programs focusing on Parkinson’s disease. Researchers gain access to an array of devices that capture key measures objectively and sensitively, as well as training materials for site coordinators and study subjects, a cloud-based platform for real-time monitoring, and industry-leading analytics and patented algorithms.
Koneksa is a healthcare technology company pioneering evidence-based digital biomarkers to accelerate clinical research and guide decision making in drug development and market strategy. Our evidence-based biomarker solutions enable efficient clinical trial designs to help innovative therapies reach patients faster. Koneksa aims to revolutionize treatment effect detection in clinical research and improve patient outcomes.