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Health data company Truveta said Monday it’s partnering with health systems and drugmakers to launch the Truveta Genome Project , a database of genetic data that is expected to accelerate personalized medicine and help discover new drugs.
The gathering brought together senior representatives from hospitals, pharmaceutical companies, policymakers, and ESG leaders, including Fortis, Apollo, Quadria Capital, and Tata Capital Healthcare Fund. The report was released at an event held in New Delhi, supported by Quadria Capital and HealthQuad.
Historically, the FDA has required preclinical testing in animals to obtain safety and efficacy data for investigational new drugs (INDs) before they can begin clinical testing in humans. The FDA plan seeks to leverage existing new technology in drugdevelopment. 3,6 REFERENCES FDA drug approval process infographic (horizontal).
CMS is issuing unique J-codes for 505(b)(2) drugs, classifying them as sole-source products if not therapeutically equivalent. This pathway reduces submission denial risk, accelerates drugdevelopment, and offers potential market exclusivity for up to 7 years. That has changed based upon the [recent] CMS ruling.”
And those are sites, sometimes those are hospitals, sometimes they’re physician’s offices, there’s for-profit, clinical research sites out there. And then the operations piece, that’s really the logistics, it’s called the logistic engine that runs these trials.
While large hospitals may have dedicated reimbursement departments and billing vendors with direct access to CMS updates, smaller or rural practices often depend on Medicare Administrative Contractors (MACs) and third-party systems for claims processing guidance. 15 Inflation Reduction Act of 2022 , Pub. 117–169, 136 Stat. 1818 (2022).
Personalized drug selection can lead to faster symptom control, fewer hospitalizations, and improved adherence—all of which contribute to better outcomes and a more streamlined care process. Pharmacogenetics and drugdevelopment: the path to safer and more effective drugs. Accessed July 21, 2025. link] Roses AD.
June 18, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook GATC’s MAT platform identifies potential new drugs and provides comprehensive analytic reports. Lisata Therapeutics has formed a strategic partnership with GATC Health to advance AI-driven drug discovery and development.
SHOW MORE With robust pipelines, cell therapy remains the major driver for drugdevelopment. The field is expanding into autoimmune diseases, with nononcology trials representing 51% of the pipeline by late 2024.
Further, they say the balance attempted between encouraging innovation and improving access instead could be contradictory for drugdevelopers and investors, in a way that is emblematic of a fragmented EU. Industry reactions have been mixed. Give your business an edge with our leading industry insights.
The first drugdeveloped employing this technology has received approval in Japan for treating a lysosomal storage disorder. It is applied across therapeutic modalities including antibodies, gene and cell therapies, enzymes, oligonucleotides, lipid nanoparticles, peptides and decoy receptors.
This is the online version of STAT’s email newsletter Health Care Inc., delivered to your inbox every Monday. Sign up here. Boy, last week was a doozy. More government layoffs, a national security leak, and everyone’s mad about The Bachelor’s pick. Let’s catch you up.
The present clinical trial ecosystem is not equipped nor projected to have the capacity to satisfy this demand, and as a result the ecosystem is facing a potential slowdown in drugdevelopment. This is despite the majority of patients being treated at community hospitals and clinics.
Fabian Gerlinghaus, CEO of Cellares; Alexander Seyf, co-founder and CEO of Autolomous; and Knut Steffensen, director of the Karolinska Institutet and University Hospital ATMP Center, offer their perspectives on the urgent need for better integration across the therapeutic value chain. References 1. April 14, 2025, LinkedIn Post.
Prices for hospitalizations, surgeries, checkups, devices, and drugs remain higher here than in the rest of the world. The machine chugs along The health care industry has feasted on the public regardless of who is in the White House. It gobbles up the savings, wages, and tax dollars of patients and workers everywhere.
FDA Commissioner Marty Makary stated: “For far too long, drugdevelopers have been playing a guessing game when navigating the FDA. Drugdevelopers and capital markets alike want predictability. Information on additional clinical trials for safety or efficacy requested by the FDA was undisclosed almost 40% of the time.
Initiatives such as Project Optimus emerged from the need for more rigorous dose-finding studies early in drugdevelopment. Find out more “There had been a lot of accelerated approvals in oncology, but a small percentage of them did not translate into clinical benefit when confirmatory trials read out,” Arora explained.
Specifically, it removes so-called “Risk Evaluation and Mitigation Strategies” from the drugs’ labeling, which are used to help manage serious side effects of treatment. Dive Insight: Since the FDA’s approval of Novartis’ Kymriah for leukemia in 2017, six more CAR-T therapies have reached market.
Cooper was joiend by Scott Whitaker , President and CEO, AdvaMed®, Juan Espinoza, MD , Chief Research Informatics Officer, Stanley Manne Children’s Research Institute, Lurie Children’s Hospital, and Christine Waggoner , CEO & Co-foundor of Cure GM1 Foundation.
Actio Biosciences CEO and co-founder David Goldstein stated: “We have made tremendous progress across our pipeline – executing a precision medicine strategy that targets the root causes of disease through genetically informed drugdevelopment. Give your business an edge with our leading industry insights.
Kisunla and Leqembi were touted as the most promising treatments to emerge from Alzheimer’s drugdevelopment in recent times. However, side effects from the drugs can be serious, and their high cost has been a barrier to reimbursement. Give your business an edge with our leading industry insights.
June 20, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The treatments can be accessed through facilities such as Royal Prince Alfred Hospital, Westmead Hospital and the Sydney Children’s Hospitals Network. Credit: Bohbeh creations/Shutterstock. Give your business an edge with our leading industry insights.
In the future, a number of hospitals, clinics, and other healthcare organizations will leverage the combination of business intelligence and artificial intelligence to analyze data and make the right decision based on the analysis. It can benefit individual healthcare providers just as much as whole hospitals and other facilities.
Achieving good oral bioavailability for TPDs Rebecca Coutts is Senior Director of Pharmaceutical Development at PCI Pharma Services, a world leading CDMO providing integrated end-to-end drugdevelopment.
A month and a half after winding operations and laying off almost all its staff, Vor Bio has emerged from the brink with a licensing deal potentially rising to $4bn for an autoimmune drugdeveloped by Chinese biotech RemeGen. Give your business an edge with our leading industry insights.
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