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While we recognize CMS intent to strengthen program integrity and reduce fraud, we are deeply concerned that several provisions in this rule will create obstacles to coverage, increase out-of-pocket costs, and disproportionately impact vulnerable populations.
Today, display campaigns can be personalized based on geography, prescription behavior, specialty, and even insurancecoverage. For example, a campaign for Trulicity may display formulary-specific messages to endocrinologists based on state Medicaid coverage. Pharma marketers no longer guess who’s seeing their messages.
On the global stage, AI and Machine Learning (ML) drove drug discovery and process optimisation, especially as large-scale pharma companies adopted AI for precision medicine. Building sophisticated laboratories, recruiting scientific talent, and collaborating with global research institutions are essential steps in this process.
It provides evidence-based recommendations on the use of vaccines for children and adults, informs decisions about insurancecoverage, and helps determine eligibility for publicly funded programs such as Vaccines for Children (VFC). ACIP plays a foundational role in shaping immunization policy in the US.
Community pharmacies, as trusted vaccination providers, must stay informed about ACIP proceedings and public discussions to address emerging patient inquiries effectively. ACIP's recommendations are increasingly significant for pharmacies, influencing vaccination planning, billing, and patient care activities.
The MHRA has recognised that some practices are better with more flexibility, and that in a technology-enabled world which allows better training, information and communication, flexibility can be enabled without compromising safety. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
Artificial intelligence addresses key limitations of traditional health technology assessments—such as data gaps and time-intensive processes—through automation, real-time data integration, and advanced predictive modeling, leading to faster and more informed decisions.
It will also negatively affect access to coverage and care for people that obtain their health coverage through the ACA Marketplace and Medicare. The proposed reconciliation bill heightens the risk that millions of Americans will lose access to care and coverage by shifting even more Medicaid costs to the states.
Most MTM platforms use health plan adjudication data, allowing pharmacists to see any medication billed through the patient’s insurance, even if it was not filled at their pharmacy. Because documentation of medication lists is a key component of MTM, pharmacists are well positioned to incorporate this into transitions of care.”
These third-party administrators act as intermediaries between drug manufacturers, pharmacies, and insurance companies. PBMs negotiate prices, establish formularies, and process claims, while also creating preferred networks of pharmacies. Additionally, the role of pharmacy benefit managers (PBMs) cannot be overlooked.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. For more information relating to our privacy practices, we invite you to review our privacy policy. In 2024, Otsuka announced the acquisition of US-based Jnana Therapeutics in a deal worth up to $1.1bn. Sign up for our daily news round-up!
By incorporating a cell line from AvenCell into good manufacturing practice processes, ViroCell met the challenge of delivering a high-yield vector within the required timeframe. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. Topic sponsors are not involved in the creation of editorial content.
First-generation oral cephalosporins (ie, cephalexin and cefadroxil) have excellent coverage of methicillin-susceptible S aureus and Streptococcus spp, making them ideal agents for treatment. Typically, empiric coverage for UTIs includes Escherichia coli and Klebsiella pneumoniae.
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The first one was introduced on September 13, 2020, near the end of Trump’s first term, but was shut down by a federal judge due to the administration’s failure to comply with the proper implementation processes. Second, it does not address the core issues of higher prices, such as the use of rebates by insurers.
Drug tracking data, purchasing information, and usage trends can all be meaningfully applied to build models that generate actionable insights that enhance efficiency, ensure that therapies are available when and where they are needed, enable smarter inventory control, and improve predictive analytics.
Porton Advanced will apply its knowledge in viral vector technology and CAR-T cell therapy process development to enhance EVA Pharma’s mission to provide safe, effective, and scalable cancer treatments. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. Sign up for our daily news round-up!
These platforms are designed for safe drug production while allowing scaleable manufacturing processes. mRNA vaccine coverage on Pharmaceutical Technology (or Clinical Trials Arena) is supported by Trilink. The trial data indicated dose-dependent protein production at the site without systemic bioavailability. “By
Rilonacept therapy management involves carefully evaluating patient disease stability, flare risks, and potential for discontinuation through a shared decision-making process. In an interview with Pharmacy Times ®, Allan L.
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14 This is in the midst of various companies—such as Regeneron, Roche, Merck, and ThermoFisher—reshoring production to the United States in order to avoid paying these hefty tariffs—a process that can take years if the proper infrastructure is not already put in place. Subscribe Now!
With ongoing policy uncertainty, hubs must prioritize adaptable, resilient designs—focusing on process speed, modularity, data tracking, and selecting partners who can evolve with regulatory change. Future-Proofing Hubs is a Must.
April 25th 2025 Fast-Tracking the Future Nicholas Saraceno, Editor Don Tracy, Associate Editor Claire Riches highlights inefficiencies in the current drug approval process, while outlining the role of payers and insurers in shifting toward data-driven approval framework. References 1. 1 Deadline Loomed. July 28, 2025.
I'll explain why this "gold rush" is fraught with peril, from a risk management and insurance perspective. The elephant in the room: The critical absence of FDA approval The fundamental issue with compounded GLP-1s lies in their sidestepping of the rigorous FDA approval process.
This alliance seeks to bolster clinical trial capabilities through improved regulatory processes and data governance. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. For more information relating to our privacy practices, we invite you to review our privacy policy.
2 The following cases underscore the importance of diligence and vigilance in our procurement processes. That is the risk of acquiring medicines and healthcare products from the secondary or gray market, particularly through unauthorized sellers and channels. April 14, 2025.
Someone ended up donating a car, and they used the money to buy tires and insurance. It seems to streamline the process,” Loy-Helm said. Bridging Gaps in Pharmacy Access Newsletter Stay informed on drug updates, treatment guidelines, and pharmacy practice trends—subscribe to Pharmacy Times for weekly clinical insights.
The approval process for cell and gene therapy candidates is tricky, however, given their high-cost and oft-debated benefit-risk ratio. RFK Jr did not question their importance, and acknowledged panellists’ calls for faster regulatory processes. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
For the second year in a row, patients with chronic conditions rated health plan access a “D,” with nearly half facing insurance-related barriers like high cost-sharing, formulary restrictions, and prior authorization. Nearly one in three adults (32%) report encountering insurance-related barriers more frequently in 2025 compared to 2024.
Many companies have already been in the process of reshoring manufacturing to the United States to avoid the impending tariffs, including AstraZeneca, who plans to invest $50 billion by 2030 in US-based drug manufacturing and R&D, marking its largest single manufacturing investment globally.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. For more information relating to our privacy practices, we invite you to review our privacy policy. Editorial content is independently produced and follows the highest standards of journalistic integrity. Sign up for our daily news round-up!
The agency said that safety information can be adequately conveyed using drug product labelling. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. For more information relating to our privacy practices, we invite you to review our privacy policy. Sign up for our daily news round-up!
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. For more information relating to our privacy practices, we invite you to review our privacy policy. Editorial content is independently produced and follows the highest standards of journalistic integrity. Sign up for our daily news round-up!
Insurancecoverage for GLP-1 medications can be a barrier, as they are often not covered for non-diabetic uses, necessitating pharmacist guidance. 1 It is important to remember that insurancecoverage for GLP-1 medications can be a barrier for patients, particularly amid shortages and changes in medications that are being covered.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. For more information relating to our privacy practices, we invite you to review our privacy policy. IZCARGO is the first drug developed with this technology and approved in Japan for treating a lysosomal storage disorder.
Robert Barrie July 14, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Broader label coverages for Pfizer and Moderna’s vaccines mean they have made in-roads into GSK’s RSV dominant market share. MAXSHOT.PL via Shutterstock. Give your business an edge with our leading industry insights.
Fast-Tracking the Future Nicholas Saraceno, Editor ; Don Tracy, Associate Editor April 25th 2025 Podcast Claire Riches highlights inefficiencies in the current drug approval process, while outlining the role of payers and insurers in shifting toward data-driven approval framework.
It is important for the patients we serve that Sarepta maintains a productive and positive working relationship with FDA, and it became obvious that maintaining that productive working relationship required this temporary suspension while we address any questions that FDA may have and complete the Elevidys label supplement process.”
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. For more information relating to our privacy practices, we invite you to review our privacy policy. Despite being a different drug, it is built on the same viral vector as Elevidys, a recombinant adeno-associated viral vector (AAV) called AAVrh74.
The company is confident that these concerns, which pertain to facilities and processes rather than product quality, can be promptly addressed. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. For more information relating to our privacy practices, we invite you to review our privacy policy.
1 There are specific diseases—including hemophilia and sickle cell disease (SCD)—that are more widespread in groups enrolled in Medicaid than commercially insured individuals, due to the program’s concentration on children, disabled adults, and those families financially impacted by treatment costs. of average manufacturer price.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. For more information relating to our privacy practices, we invite you to review our privacy policy. GlobalData is the parent company of Clinical Trials Arena. Topic sponsors are not involved in the creation of editorial content.
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