Novartis Pharmaceuticals and Folia Health Partner on Innovative App-Based Study to Assess Real-World Experience of IgA Nephropathy
BOSTON, March 13, 2025 (GLOBE NEWSWIRE) -- Today, Folia Health and Novartis Pharmaceuticals, Inc. proudly announce their collaboration on an innovative, at-home observational real-world evidence initiative supporting individuals with IgA nephropathy. This ground-breaking study will leverage Folia's cutting-edge technology platform, allowing participants to track changes and quality of life impacts based on the symptoms most relevant to them- whether commonly associated with IgAN or not- alongside their individual treatment plan during an initial six-month observational period. By enabling participants to self-select and define what's most relevant to them, rather than relying solely on pre-specified patient-reported outcomes (PROs), this approach provides a comprehensive and nuanced understanding of the lived experiences of IgAN.
This study is the first real-world data program designed to capture the at-home experiences of individuals and caregivers managing IgAN. Developed in collaboration with IgAN patients themselves, it directly measures patient-defined burden and evaluates the impact of various treatments on quality of life. As new therapies for IgAN become available, these insights will provide a timely and valuable understanding of real-world day-to-day experiences and treatment outcomes in this population.
Through the Folia platform, IgAN patients and caregivers can actively engage with their own study observations, gaining deeper insights into their symptom burden, treatment effects, and acute health events. The Folia app can generate tracking summary reports, allowing users to easily visualize their changes over time- such as symptom severity trends, frequency of flare-ups, and treatment responses. Folia can also overlay treatment usage with symptom severity and patients can export visual reports to share with their care teams.
This study is entirely remote, eliminating the need for clinic visits while still enabling participants to use their tracked data during medical appointments, ensuring that real-world insights can directly inform their care.
'The point of Folia is to provide a tool to help people with chronic conditions take more control over their care, and understand how their treatment plan is working for them. We're excited to bring these capabilities to kidney disease with this IgAN program, and look forward to the insights on treatment effectiveness and living with IgAN that our participants share with our research teams," said Nell Meosky Luo, the CEO & Founder of Folia Health.
'Advancing IgAN research requires more precise, real-world data captured directly from patients over time. This program enables the collection of granular, home-reported outcomes for the first time in this population, offering a richer, more accurate view of disease progression and treatment impact in everyday life,' said Briana Ndife, Director, HEOR, Nephrology at Novartis Pharmaceuticals.
About Folia Health:
Folia Health is the founder of home-reported outcomes (HROs), the next generation of patient health data that transforms lived experiences outside the clinic into valuable insights for better research and care. Through an innovative platform backed by expert analysis and support from a compassionate team, we help life science partners develop effective therapies with demonstrated, real-world value for complex, chronic conditions. Folia's wealth of longitudinal data and proprietary analytics play a vital role in establishing a home-centered, data-driven healthcare ecosystem. To explore the transformative potential of patient and caregiver knowledge, visit www.foliahealth.com.
About Novartis Pharmaceuticals:
Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.
Folia Health Contact:Connie Zhang+1 617-306-1282connie@foliahealth.com
Novartis Contact:Briana Ndifebriana.ndife@novartis.com

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Business Upturn
an hour ago
- Business Upturn
Novartis Pluvicto™ demonstrates statistically significant and clinically meaningful rPFS benefit in patients with PSMA-positive metastatic hormone-sensitive prostate cancer
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The trial met its primary endpoint with a statistically significant and clinically meaningful benefit in radiographic progression-free survival (rPFS) with a positive trend in overall survival (OS) in patients with prostate-specific membrane antigen (PSMA)-positive metastatic hormone-sensitive prostate cancer (mHSPC) treated with radioligand therapy (RLT), Pluvicto™ (lutetium (177Lu) vipivotide tetraxetan), in combination with standard of care (SoC) versus SoC alone1. In PSMAddition, the SoC is a combination of androgen receptor pathway inhibitor (ARPI) therapy and androgen deprivation therapy (ADT)3. Almost all mHSPC patients ultimately progress to metastatic castration-resistant prostate cancer (mCRPC)4. There is a need for additional treatment options with novel mechanisms of action that further delay progression, prolong OS and improve disease control compared to the current SoC, while showing a favorable safety and tolerability profile. 'The progression from metastatic hormone-sensitive prostate cancer to castration-resistant disease remains a formidable challenge that can profoundly impact the survival of patients,' said Shreeram Aradhye, M.D., President, Development and Chief Medical Officer at Novartis. 'These results further strengthen our confidence in Pluvicto as a PSMA-targeted radioligand therapy. Following the recent FDA approval based on the PSMAfore trial in metastatic castration-resistant prostate cancer, these data suggest using it in an earlier disease setting could advance care and address a significant unmet need for hormone-sensitive prostate cancer patients.' This is the third positive read-out for Pluvicto in a Phase III trial, following the VISION and PSMAfore studies5,6. Results from PSMAddition in mHSPC show potential for treatment in an earlier setting with Pluvicto, which was recently granted US Food and Drug Administration (FDA) approval for earlier use in mCRPC, based on results from PSMAfore1,2. Novartis is harnessing the innovation of world-class scientists, strategic partnerships and one of the industry's most competitive pipelines to explore the potential of new, targeted therapies and precision medicine platforms to address the greatest unmet needs in prostate cancer. Data will be presented at an upcoming medical meeting and, based on FDA feedback, will be submitted for regulatory review in the second half of the year. About PSMAddition study PSMAddition (NCT04720157) is a Phase III, open-label, prospective, 1:1 randomized study comparing the efficacy and safety of Pluvicto in combination with SoC (ARPI + ADT) vs. SoC alone in adult patients with PSMA-positive mHSPC3. Patients randomized to the SoC alone arm are allowed to crossover to receive Pluvicto, upon confirmation of radiographic progression by blinded independent review committee (BIRC) and per the discretion of the treating physician3. The primary endpoint is rPFS, defined as the time to radiographic progression by PCWG3-modified RECIST V1.1 (as assessed by BIRC) or death3. The key secondary endpoint of OS is defined as time to death due to any cause3. About Pluvicto™ (INN: lutetium (177Lu) vipivotide tetraxetan) Pluvicto is an intravenous RLT that combines a targeting compound (a ligand) with a therapeutic radionuclide (a radioactive particle, in this case lutetium-177)5,7. After administration into the bloodstream, Pluvicto binds to PSMA-expressing target cells, including prostate cancer cells that express PSMA, a transmembrane protein5,7. Once bound, energy emissions from the radioisotope damage the target cells and nearby cells, disrupting their ability to replicate and/or triggering cell death7. Pluvicto is the only PSMA-targeted agent approved for PSMA-positive mCRPC and is the first targeted RLT to demonstrate a clinical benefit for patients with PSMA-positive mHSPC1. Novartis is investigating Pluvicto in earlier stages of disease, including oligometastatic prostate cancer (PSMA-DC, NCT05939414). Novartis and radioligand therapy (RLT) Novartis is reimagining cancer care with RLT for patients with advanced cancers. By harnessing the power of targeted radiation and applying it to advanced cancers, RLT is designed to deliver treatment directly to target cells, anywhere in the body8,9. Novartis is investigating a broad portfolio of RLTs, exploring new isotopes, ligands and combination therapies to look beyond gastroenteropancreatic neuroendocrine tumors (GEP-NETs) and prostate cancer and into breast, colon, lung and pancreatic cancer. Novartis has established global expertise, with specialized supply chain and manufacturing capabilities across its network of RLT production sites. To support growing demand for RLTs, we have expanded production capabilities in Millburn (NJ), Zaragoza (Spain), Ivrea (Italy) and a state-of-the-art facility in Indianapolis (IN). In Carlsbad (CA), Novartis is establishing its third US-based RLT manufacturing site to support expanded use of RLTs, create resiliency in its manufacturing network and optimize the delivery of medicines to patients on the West Coast. Disclaimer This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as 'potential,' 'can,' 'will,' 'may,' 'could,' 'trend,' 'potentially,' 'upcoming,' 'progression,' 'progress,' 'investigating,' 'investing,' 'look beyond,' or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for Pluvicto, or regarding potential future revenues from Pluvicto. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that Pluvicto will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that Pluvicto will be commercially successful in the future. In particular, our expectations regarding Pluvicto could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. About Novartis Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide. Reimagine medicine with us: Visit us at and connect with us on LinkedIn, Facebook, X/Twitter and Instagram. References Data on file. Pluvicto [prescribing information]. Millburn, NJ: Advanced Accelerator Applications USA, Inc.; 2025. An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With SoC, Versus SoC Alone, in Adult Male Patients With mHSPC (PSMAddition). identifier: NCT04720157. Updated March 5, 2025. Accessed June 2, 2025. Oing C, Bristow RG. Systemic treatment of metastatic hormone-sensitive prostate cancer—upfront triplet versus doublet combination therapy. ESMO Open 2023l doi: 10.1016/ Sartor O, J. de Bono KN, Chi K, et al. Lutetium-177–PSMA-617 for Metastatic Castration-Resistant Prostate Cancer. NEJM 2021; doi: 10.1056/NEJMoa2107322. Morris M, Castellano D, Herrmann K, et al. 177Lu-PSMA-617 versus a change of androgen receptor pathway inhibitor therapy for taxane-naive patients with progressive metastatic castration-resistant prostate cancer (PSMAfore): a phase 3, randomised, controlled trial. The Lancet 2024; doi: 10.1016/S0140-6736(24)01653-2. University of Chicago Medicine. Lutetium-177 PSMA Therapy for Prostate Cancer (Pluvicto). Accessed June 18, 2024. Jadvar H. Targeted Radionuclide Therapy: An Evolution Toward Precision Cancer Treatment [published correction appears in AJR Am J Roentgenol. 2017 Oct;209(4):949. doi: 10.2214/AJR.17.18875]. AJR Am J Roentgenol. 2017;209(2):277-288. doi:10.2214/AJR.17.18264 Jurcic JG, Wong JYC, Knoc SJ, et al. Targeted radionuclide therapy. In: Tepper JE, Foote RE, Michalski JM, eds. Gunderson & Tepper's Clinical Radiation Oncology. 5th ed. Elsevier, Inc. 2021;71(3):209-249 # # # Novartis Media Relations E-mail: [email protected] Novartis Investor RelationsCentral investor relations line: +41 61 324 7944 E-mail: [email protected] Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. GlobeNewswire provides press release distribution services globally, with substantial operations in North America and Europe.
Yahoo
7 hours ago
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HUTCHMED Highlights SACHI Phase III Study Data Presented at the 2025 ASCO Annual Meeting
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SACHI is a Phase III study of the savolitinib and osimertinib combination for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor ('EGFR') mutation-positive non-small cell lung cancer ('NSCLC') with MET amplification after disease progression on first-line EGFR inhibitor therapy ( identifier NCT05015608). Title: Savolitinib combined with osimertinib versus chemotherapy in EGFR-mutant and MET-amplification advanced NSCLC after disease progression on EGFR tyrosine kinase inhibitor: Results from a randomized Phase III SACHI study Lead Author: Shun Lu, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China Session: Oral Abstract Session: Lung Cancer - Non-Small Cell Metastatic Abstract Number: LBA8505 Date & Time: Sunday, June 1, 2025, 8:00 AM Central Daylight Time Location: Arie Crown Theater Prof. Shun Lu, Chief of the Shanghai Lung Cancer Center at Shanghai Chest Hospital, School of Medicine, Shanghai Jiaotong University, and Principal Investigator of the SACHI study, said, 'The results from the SACHI Phase III study represent a significant advancement in the treatment of EGFR mutation-positive NSCLC with MET amplification. The savolitinib and osimertinib combination demonstrates promising efficacy in patients who have progressed on prior EGFR inhibitor therapy. These findings highlight the potential of this novel, chemotherapy-free combination to enable a continued oral regimen, offering a convenient and well-tolerated treatment option that addresses critical unmet needs for patients with this challenging disease.' The event will be held in English and can be accessed via A replay will also be available on the website shortly after the event. As of the interim analysis data cut-off of August 30, 2024, a total of 211 patients were randomized to receive the savolitinib and osimertinib combination or chemotherapy. In the intention to treat (ITT) population, the median progression-free survival ('PFS') assessed by investigator was 8.2 months with savolitinib plus osimertinib, compared to 4.5 months with chemotherapy (hazard ratio ['HR'] 0.34; 95% confidence interval ['CI'] 0.23-0.49; p < 0.0001). The independent review committee ('IRC') assessed median PFS was 7.2 months vs 4.2 months, respectively (HR 0.40; 95% CI 0.28-0.59; p < 0.0001). The investigator-assessed objective response rate (ORR) was 58% in the savolitinib plus osimertinib group compared to 34% for patients in the chemotherapy group. The disease control rate (DCR) was 89% vs 67% and the median duration of response (DoR) was 8.4 months vs 3.2 months, respectively. Overall survival was not mature at the time of the interim analysis. Efficacy outcomes in the third-generation EGFR tyrosine kinase inhibitor ('TKI')–treated patients were comparable with those in the intention-to-treat and third-generation EGFR-TKI–naïve populations. In the third generation EGFR-TKI–treated subgroup, the investigator-assessed and IRC-assessed median PFS were highly consistent, both at 6.9 vs 3.0 months (HR 0.32; p < 0.0001). The safety profile of the savolitinib and osimertinib combination was tolerable and no new safety signals were observed. Treatment-emergent adverse events of Grade 3 or above occurred in 57% of patients in the savolitinib plus osimertinib group compared to 57% for patients in the chemotherapy group, suggesting a favorable safety profile. In January 2025, the Independent Data Monitoring Committee (IDMC) of SACHI has considered that the study has met the pre-defined primary endpoint of PFS in a planned interim analysis and as a result, enrollment into the study has concluded. Supported by data from SACHI, a New Drug Application (NDA) for the combination of savolitinib and osimertinib for the treatment of patients with locally advanced or metastatic EGFR mutation-positive NSCLC with MET amplification after disease progression on first-line EGFR inhibitor therapy has been accepted and granted priority review by the China National Medical Products Administration (NMPA). About Savolitinib Savolitinib is an oral, potent, and highly selective MET TKI that has demonstrated clinical activity in advanced solid tumors. MET is a tyrosine kinase receptor that has an essential role in normal cell development. Savolitinib blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression. MET overexpression and/or amplification can lead to tumor growth and the metastatic progression of cancer cells, and is a known mechanism of acquired resistance to EGFR TKIs. The prevalence of MET depends on the sample type, detection method and assay cut-off used. Savolitinib is approved in China and is marketed under the brand name ORPATHYS® by our partner, AstraZeneca, for the treatment of adult patients with locally advanced or metastatic NSCLC with MET exon 14 skipping alteration, representing the first selective MET inhibitor approved in China. It has been included in the National Reimbursement Drug List of China (NRDL) since March 2023. It is currently under clinical development for multiple tumor types, including lung, kidney, and gastric cancers as a single treatment and in combination with other medicines. About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: or follow us on press release contains forward-looking statements within the meaning of the 'safe harbor' provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED's current expectations regarding future events, including but not limited to its expectations regarding the therapeutic potential of savolitinib, the further clinical development for savolitinib, its expectations as to whether any studies on savolitinib would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates and the timing and availability of subjects meeting a study's inclusion and exclusion criteria; changes to clinical protocols or regulatory requirements; unexpected adverse events or safety issues; the ability of savolitinib, including as combination therapies, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential markets of savolitinib for a targeted indication, and the sufficiency of funding. In addition, as certain studies rely on the use of other drug products such as osimertinib as combination therapeutics, such risks and uncertainties include assumptions regarding their safety, efficacy, supply and continued regulatory approval. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED's filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. CONTACTS Investor Enquiries +852 2121 8200 / ir@ Media Enquiries FTI Consulting – +44 20 3727 1030 / HUTCHMED@ Ben Atwell / Alex Shaw +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) Brunswick – Zhou Yi +852 9783 6894 (Mobile) / HUTCHMED@ Panmure Liberum Nominated Advisor and Joint Broker Atholl Tweedie / Freddy Crossley / Rupert Dearden +44 20 7886 2500 HSBC Joint Broker Simon Alexander / Alina Vaskina / Arnav Kapoor +44 20 7991 8888 Cavendish Joint Broker Geoff Nash / Nigel Birks +44 20 7220 0500


Business Upturn
14 hours ago
- Business Upturn
New Resource from NYC Medical Malpractice Attorney Jonathan C. Reiter Now Available
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