Tower Mains takes on Belfast
Last week, some of the team took on Belfast to celebrate Rhona’s 50th birthday… here’s a little snippet of what they got up to. We hope you had a fantastic time celebrating your milestone birthday, Rhona!
Q13 Continuous Manufacturing of Drug Substances and Drug Products
On 1st March, the US Food and Drug Administration (FDA) issued final guidance describing scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM). Building on existing International Council for Harmonisation (ICH) Quality guidances, this guidance provides clarification on CM concepts and describes scientific approaches and regulatory considerations specific to CM of drug substances and drug products.
- On 8th March, the Medicines & Healthcare products Regulatory Agency (MHRA) published updated fee information. Click to view source
- On 8th March, a list of accredited units was added to MHRA guidance on joining its phase I accreditation scheme. Click to view source
FDA issues paper on Artificial Intelligence to prepare for implementation in drug manufacturing
The FDA issued a discussion paper on artificial intelligence (AI) to help prepare for its implementation in drug manufacturing. The agency is asking interested stakeholders to provide input on certain areas of consideration identified in the discussion paper to help inform its evaluation of the existing regulatory framework.
FDA and FTC collaborate to advance competition in the biologic marketplace
On 2nd March, the FDA published the FDA Voices, “FDA and FTC Collaborate to Advance Competition in the Biologic Marketplace,” by Patrizia Cavazzoni, MD, director of the Center for Drug Evaluation and Research. The FDA and the Federal Trade Commission (FTC) have been working to help advance competition for biologics, including biosimilars and interchangeable biosimilars. Together, they have developed an educational resource for consumers about biosimilars and interchangeable biosimilars to help address common misperceptions.
Letters issued to healthcare providers regarding when using certain hemodialysis systems
On 6th March, the FDA issued a letter to healthcare providers about its expanded work to evaluate the potential risk of exposure to toxic compounds when using certain hemodialysis systems. The agency is working with manufacturers to further collect and evaluate data to determine the potential risk of exposure to toxic compounds in patients and develop strategies to address the issue if needed.
Sanofi’s Dupixent accepted for FDA review
On 7th March, Sanofi announced the FDA has accepted, for review, the supplemental Biologics License Application (sBLA) for Dupixent® to treat adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) that is not adequately controlled with the current standard of care. The target action date for the FDA decision is October 22, 2023.
Medical Devices Regulatory Reform update
On 7th March, the MHRA issued an update to the Life Sciences Council Joint Statement on the Medical Devices Regulatory Reform.
Affibody and Chiesi group collaborate to develop and market innovative treatments for respiratory diseases
On 7th March, Affibody AB and Chiesi Farmaceutici S.p.A announced a collaboration and licensing agreement to develop and market innovative treatments for respiratory diseases using Affibody’s proprietary technology. Under the terms of the agreement, the parties will collaborate closely to progress up to three programs based on Affibody® molecules against undisclosed targets for respiratory diseases. Chiesi will fund the discovery, development, and subsequent marketing worldwide, in line with its commitment to providing a best-in-class level of care for people living with respiratory diseases.
MHRA Patient Involvement Strategy: One Year On
On 8th March, the MHRA published an update on the progress of its Patient Involvement Strategy. Between October 2021 and September 2022, the agency has:
- involved patients in the early stages of medicinal product development, and encouraged the wider research landscape to do the same
- included the patient and public perspective in our work to widen access to medicines
- incorporated patient views and lived experience in our benefit-risk reviews of medical products
- integrated the views of over 2,400 members of the public into a new scheme which will help the MHRA understand and reduce the number of harmful side effects caused by medicines
- launched a training programme on patient involvement, specially designed for staff
The agency has concluded that the progress so far gives it a solid base to build upon as it progresses in this journey.
Issue Number: WN00102
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