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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. BIO President and CEO John F.
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.
EU’s Pharma Package falls short of Europe’s goal of global competitiveness Why can’t the US figure out weight loss drug prices? 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. The undisclosed biotech company’s option agreement with Apertura will investigate the potential of TfR1 CapX in conjunction with its payloads aimed at treating CNS disorders. The specific terms of the agreement remain confidential.
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. Meanwhile, wholesalers have until Aug.
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.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. In 2024, Otsuka announced the acquisition of US-based Jnana Therapeutics in a deal worth up to $1.1bn. Editorial content is independently produced and follows the highest standards of journalistic integrity.
Nanotein Technologies co-founder and CEO Curtis Hodge said: “Nanotein’s soluble activators are designed to improve cell therapy expansion by enhancing the quality and quantity of T cells and providing a feeder-free soluble activator for NK cell activation and expansion, addressing critical challenges in the manufacturing process.”
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.
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
All costs and expenses associated with Prize acceptance and use not specified herein as being provided such as reservation fees, taxes, insurance and other expenses incurred by accepting the Prize are the sole responsibility of the Winner.
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!
As of late 2024, Florida, the state that began planning its program in 2020 (and receiving an FDA go-ahead in 2022) had spent millions setting up its process for supplying state agencies, but had yet to deliver any medicine. 2 Colorado, Maine, New Hampshire, and New Mexico are among the states also seeking importation permits.
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. How will RFK Jr’s American dream for vaccines play out? Don’t let policy changes catch you off guard.
Criminal networks exploit forged documentation , fake packaging, and corrupt distributors to infiltrate regulated supply chains with dangerous products. 2 The following cases underscore the importance of diligence and vigilance in our procurement processes. April 14, 2025.
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.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. AbbVie’s purchase comes just a few days after the US Food and Drug Administration (FDA) removed an access barrier for currently approved CAR-T therapies, regarded as a boost to the sector’s outlook.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. This update also suggests we may not see REMS requirements for CD19 and BCMA autologous CAR-T cell therapies in the future,” the research note added. Editorial content is independently produced and follows the highest standards of journalistic integrity.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content. Give your business an edge with our leading industry insights.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. How will RFK Jr’s American dream for vaccines play out? JCR has also developed a proprietary blood-brain barrier-penetrating technology, J-Brain Cargo, to deliver biotherapeutics into the central nervous system.
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. How will RFK Jr’s American dream for vaccines play out? MAXSHOT.PL via Shutterstock.
EU’s Pharma Package falls short of Europe’s goal of global competitiveness Why can’t the US figure out weight loss drug prices? Sarepta confirmed it will work with the FDA to respond to requests for information while advancing the Elevidys safety labelling supplement process. Don’t let policy changes catch you off guard.
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. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. How will RFK Jr’s American dream for vaccines play out?
EU’s Pharma Package falls short of Europe’s goal of global competitiveness Why can’t the US figure out weight loss drug prices? Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. GlobalData is the parent company of Clinical Trials Arena. Give your business an edge with our leading industry insights.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content. Give your business an edge with our leading industry insights.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. Elsewhere in the partnership arena, AstraZeneca outlaid $5.2bn to enlist the services of China-based CSPC Pharmaceuticals. In addition, BMS earmarked $11bn earlier this month to join BioNTech’s development of a bispecific cancer drug.
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.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. How will RFK Jr’s American dream for vaccines play out? Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. Give your business an edge with our leading industry insights. Give your business an edge with our leading industry insights.
mRNA vaccine coverage on Pharmaceutical Technology (or Clinical Trials Arena) is supported by Trilink. GSK also has an FDA-approved vaccine in the form of Arexvy, though its label only covers those at risk in individuals aged between 50 through 59 years , along with the standard indication of ages 60 and over.
mRNA vaccine coverage on Pharmaceutical Technology (or Clinical Trials Arena) is supported by Trilink. Shares of key sector players such as Moderna and BioNTech remain stable, with values reducing by 2.8% and increasing by 0.21% respectively, suggesting that investors still have hope for the modality.
Subscribe Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Give your business an edge with our leading industry insights.
Payer step therapy and restrictive coverage criteria may limit broad adoption of biologics, while high list prices, such as Eohilia’s reported launch price at approximately $5,250, could hinder uptake without robust cost-effectiveness data. Despite the strong growth outlook, the market faces challenges.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. In 2023, SpliceBio signed a licensing agreement with Spark Therapeutics, allowing the latter to use its protein splicing platform and develop a gene therapy for an undisclosed inherited renal disease.
Since it is likely this appropriations package will be one of the last meaningful pieces of legislation before the November elections, other policy priorities may be added to that final legislation as it gets closer to passage. We reiterated these priorities to start the year in January 2024. The House passed H.R.
FDA approval process The FDA regulates both OTC and prescription drugs, but in different ways. Prescription drugs have to go through the New Drug Application (NDA) process. The application includes submitting clinical drug trial data and information about the manufacturing process.
How does the qualification package support more meaningful endpoints and rare disease research as a result? When Aidan’s insurance company denied coverage for EXONDYS, the data she captured overturned the denial in 24 hours without engaging in the appeal process.
Launching a new drug can be a risky business, with regulatory approval no guarantee that private, commercial, and government-funded insurers will reimburse it. Meanwhile, in Germany, the AMNOG process is conducted twelve months after the drug is launched, thus giving freedom to the company to set the drug’s price during this period.
The NHC supports the development and use of processes and tools that enhance beneficiary experience, making interactions with the MPPP smoother and more intuitive for all beneficiaries. Similarly, updating the Explanation of Benefits to include visual aids and examples will clarify MPPP’s impact on cost-sharing and coverage.
The NHC supports the development and use of processes and tools that enhance beneficiary experience, making interactions with the MPPP smoother and more intuitive for all beneficiaries. Similarly, updating the Explanation of Benefits to include visual aids and examples will clarify MPPP’s impact on cost-sharing and coverage.
Personally, I haven't seen this much attention in awhile about pharmacy since PillPack made strip-packaging of medications mainstream three-years ago, and am quite eager to see if this is really going to change the current paradigm of pharmacy services. One issue is that the dispensing process is not a full-proof system at the current time.
Due to the multiplicity of regulatory processes and multiple regulators, undertaking operations become complex and time consuming. IRDAI has included the health insurancecoverage for 12 such modern treatment methods under Chapter V of the Guidelines on “Standardisation of exclusions in health insurance contracts”.
Certification Requirements Here are some of the most important steps to the certification process that pharmacists should know about. Record the NDC and lot number from each medication package dispensed in the patient’s record. One tablet is individually blistered on one blister card that is packaged in an individual package.
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