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Decentralising manufacturing has previously been seen as an “up-and-coming development” in the cell and gene therapy sector due to high costs associated with setting up these processes. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. Give your business an edge with our leading industry insights.
Transition to NDC-12 codes will significantly impact the pharmaceutical supply chain, affecting manufacturing, distribution, and reimbursement processes. Increased regulatory engagement highlights the importance of updating SOPs to ensure compliance and effective documentation of processes. 27, 2026, respectively.
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.
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. A decision by the FDA is expected in H1 2026. MAXSHOT.PL via Shutterstock.
The financial impact of this agreement on JCR’s consolidated results for the fiscal year ending 31 March 2026 has already been included in the current earnings forecast. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. JUST-AAV is a proprietary platform technology that employs modified AAV vectors.
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. Despite being a different drug, it is built on the same viral vector as Elevidys, a recombinant adeno-associated viral vector (AAV) called AAVrh74. Editorial content is independently produced and follows the highest standards of journalistic integrity.
The company is confident that these concerns, which pertain to facilities and processes rather than product quality, can be promptly addressed. While the CRL will delay the potential approval of UX111 to 2026, we are working with urgency to respond and resubmit.” Efforts are underway to work with the FDA to resolve them.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. GlobalData is the parent company of Clinical Trials Arena. Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.
to find out one specific way each of them has redesigned a process or care model in the past year to serve more patients — without adding staff. To meet this challenge, Infirmary Health redesigned its clinical documentation integrity process without adding staff. Alaska Mikal Canfield.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. His exit raises critical questions: which evidence standards will prevail: traditional or accelerated?” commented Cynthia Pussinen, CEO of Owl Bio Advisors, a life sciences consultancy group. Give your business an edge with our leading industry insights.
Health insurers covering more than 250 million Americans have unveiled a sweeping plan to streamline and reduce prior authorization requirements — a long-standing source of frustration and burnout for providers and patients. I don’t believe that it will substantially decrease denials but might just speed up the denial process.
Sarepta Therapeutics is set to cut 500 jobs as part of its restructuring and pipeline prioritisation plan, which is expected to result in annual cash cost savings of $120m in 2026. With its pipeline reprioritisation, the company anticipates delivering $300m in annual non-personnel cost savings from 2026.
By GlobalData Learn more about Strategic Intelligence Moderna said it plans to have mRESVIA available for both both younger adults and older adults in the US in time for the 2025-2026 respiratory virus season. mRNA vaccine coverage on Pharmaceutical Technology (or Clinical Trials Arena) is supported by Trilink.
Prior authorization has been popular with the insurance industry because it works. This is known as the sentinel effect, and in the initial stages, providers accommodated the process without much complaint. The health insurance industry didn’t have many other tools to suppress demand, so it went with the sentinel effect by default.
The NBPP is a set of rules and guidelines issued annually by CMS that outline the policies and standards for health insurance plans and issuers, primarily focusing on the Health Insurance Marketplace under the Affordable Care Act. These are the rules for the federal health insurance marketplace for the coming year.
We believe that patient-centric engagement is essential to ensure that the negotiation process leads to outcomes that genuinely benefit patients. 1 And we appreciated CMS’ thorough responses to comments for IPAY 2026 and hope the Agency will replicate this for this comment opportunity.
Coverage of Anti-Obesity Medications (AOMs) The NHC applauds CMS for aligning with the medical community and proposing to recognize obesity as a chronic disease and allow Medicare Part D coverage for AOMs. Below, we provide detailed comments and recommendations on key provisions of the proposed rule.
The NHC appreciates CMS’ efforts to gather patient-centered data as part of this ICR and its commitment to making the process more relevant for patients and patient organizations. While we acknowledge these improvements, it is important to note that some aspects of the data collection process may remain challenging.
Making available more specific information about total costs and coverage will ensure that all consumers have comprehensive information to help them make smart health care decisions. These resources should aim to clarify insurance terms and concepts, aiding consumers in navigating the complexities of selecting a health plan.
Under the new Manufacturer Discount Program, manufacturers will be required to provide discounts on applicable drugs during the initial coverage phase and catastrophic phase of the defined standard Part D drug benefit.
Congress left Medicare drug pricing to the drug manufacturers, pharmacies, and insurance plan sponsors to determine, and expressly prohibited the government from “interfering” in those private price negotiations under the so-called “Non-Interference Clause” of the Medicare Modernization Act of 2003.
. – Considering that the government promotes companies to “Make in India”, we request that the time limit for commencing manufacturing or production be further extended to 31 March 2026. Therefore, the sunset period should be extended for borrowings in foreign currency up to 31 March 2026; this would support the vision of “Make in India”.
General Support for CMS Proposals The NHC commends CMS for its ongoing commitment to advancing health equity, improving access to care, ensuring program integrity, and maintaining affordability through Marketplace coverage. Copay Assistance and Drug Coverage in Large Group Plans Accumulator Adjustment Programs and Cost Sharing.
Overarching Comments The NHC acknowledges CMS efforts to implement meaningful policy updates in CY 2026 to advance equity, affordability, and access to high-value care for Medicare beneficiaries. 3 Establishing a feedback loop with stakeholders during this monitoring process will provide additional safeguards against adverse effects.
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