PENBRAYA combines components from two meningococcal vaccines, Trumenba and Nimenrix.
Quality/GMPs
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Digitalization of QbD Risk Assessments
The digital transformation of quality-by-design assessment workflows can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem.
Subjectivity in Quality Risk Management
The authors discuss subjectivity in the ICH Q9 (R1) guidance document.
Phase-appropriate Compliance for Cell and Gene Therapies
Understanding how to apply phase-appropriate GMPs is crucial for achieving successful regulatory approval.
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The agency’s solidarity mechanism allows Member States to support each other when there is a shortage of a critical medicines.
The final guidance document was issued to assist bio/pharma companies in the clinical development and licensure of COVID-19 vaccines.
The agency recommended conditional marketing authorization for Elrexfio (elranatamab) as a monotherapy for adult patients with relapsed and refractory multiple myeloma.
The recommended medicines include treatments for Duchenne muscular dystrophy, relapsed or refractory multiple myeloma, hyperargininemia, invasive candidiasis, menopause symptoms, and diagnostic medicines for characterizing lesions.
The new Digital Health Advisory Committee will advise the agency on issues related to technologies such as AI, virtual reality, and machine learning.
Eli Lilly and Company has received a complete response letter from FDA for its anti-dermatitis biologic therapeutic, lebrikizumab.
The commission’s membership will help facilitate reach and impact for standards harmonization.
Laks Pernenkil, principal and practice leader, US Life Sciences Product & Supply Operations, Deloitte, discusses the impact that digitalization is having on data generation and data integrity in bio/pharma manufacturing.
The program will allow sponsors of certain CBER and/or CDER-regulated products more frequent communication with FDA staff.
Government provides a spoonful of sugar, and genuine leadership, for good medicines.
Glycosylation analysis can provide a deep and nuanced understanding of immune cell phenotype and function.
The European Commission has granted approval for Tyruko (natalizumab), a biosimilar developed by Polpharma Biologics for treating multiple sclerosis.
The agency will be reorganizing field force and compliance functions.
Maintaining compliance to compendial requirements should be straightforward, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.
The tools, originally utilized during the COVID-19 pandemic, are now intended to work alongside FDA’s standard procedures.
What impact will EMA’s decision to phase out COVID-19 regulatory flexibilities have on the pharma industry?
Leaders at CDER and CBER give update on organizational changes at FDA.
The agency’s work with EUnetHTA 21 helped it to prepare the EU for implementation of the regulation.
Experts discussed how to transform companies into learning organizations at the 2023 PDA/FDA Joint Regulatory Conference.
The EMA’s Committee for Medicinal Products for Human Use has given a positive opinion on Sandoz’ biosimilar trastuzumab for breast and gastric cancer.
The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public Health Service Act.
Scientists are leveraging ddPCR technology to get an accurate read on viral titer and vector copy number.
As more novel therapy approvals trend towards biologics, it is important to take stock of what treatments are shaping the future of the market.
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