Tower Mains Weekly Newsletter
We have been published in the August issue of QUASAR, the Research Quality Association (RQA)’s renowned membership magazine. Check out our article on how some of the Tower Mains team made the transition to QA consultancy, here.
FDA grants accelerated approval to Enhertu for HER2-mutant non-small cell lung cancer
On 11th August, the FDA granted accelerated approval to AstraZeneca’s Enhertu for adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumours have activating human epidermal growth factor receptor 2 HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received prior systemic therapy. This is the first approved therapy targeted to patients with the HER2-low breast cancer subtype, which is a newly defined subset of HER2-negative breast cancer. The FDA also approved Oncomine™ Dx Target Test and Guardant360® CDx as companion diagnostics for Enhertu. If no mutation is detected in a plasma specimen, the tumour tissue should be evaluated.
FDA posts safety communication regarding monkeypox
On 12th August, the FDA posted a safety communication to provide information to blood establishments regarding the monkeypox virus and blood donations. Worldwide, there have been no reports of transmission of the monkeypox virus through blood transfusion and the risk of transfusion-transmission remains theoretical. The communication explains that existing safeguards for blood safety are likely to identify individuals who present to donate who are diagnosed with monkeypox virus or who are currently at the greatest risk for infection with monkeypox virus.
MHRA: Paxlovid information updated to reflect extension of shelf life
On 12th August, the Medicines and Healthcare products Regulatory Agency (MHRA) updated the Summary of Product Characteristics (SmPC) to reflect the extension of the shelf life of Paxlovid from 12 to 18 months from initial manufacture.
FDA publishes Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products
On 15th August, the US Food and Drug Administration (FDA) published guidance to assist parties in electronically submitting individual case safety reports (ICSRs) and ICSR attachments to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The document describes FDA’s technical approach for submitting ICSRs, incorporating its regionally controlled terminology, and includes information on adding FDA Adverse Event Reporting System (FAERS) regional data elements that are not addressed in the International Conference on Harmonisation’s (ICH) E2B (R3) Implementation Guideline (IG) for the following FDA-regulated products:
- Drug products marketed for human use with approved new drug applications (NDAs) and abbreviated new drug applications (ANDAs)
- Prescription drug products marketed for human use without an approved application
- Non-prescription (over-the-counter human drug products marketed without an approved application)
- Biological products marketed for human use with approved biologic license applications (BLAs).
ICH: Addendum to S1B reaches Step 4 of the ICH Process
On 15th August, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) announced that the addendum to the ICH S1B Guideline has reached Step 4 of the ICH process on 4 August 2022 and is being integrated with the original guideline and published as ICH S1B(R1) Testing for Carcinogenicity of Pharmaceuticals. It expands the evaluation process for assessing the human carcinogenic risk of pharmaceuticals by introducing an additional approach that is not described in the original S1B Guideline. The application of this integrative approach reduces the use of animals by the 3R (reduce/refine/replace) principles and shifts resources to focus on generating more scientific mechanism-based carcinogenicity assessments while continuing to promote the safe and ethical development of new pharmaceuticals. Further information can be found on the S1B(R1) page, including the Step 4 Informational Presentation for download.
First bivalent COVID-19 booster vaccine approved by MHRA
On 15th August, the MHRA announced it has approved a dual-strain COVID-19 booster vaccine. The bivalent medicine, made by Moderna, targets two different coronavirus variants – the original virus from 2020 and the Omicron variant. In each dose of the vaccine, half of the vaccine (25 micrograms) targets the original virus strain, and the other half (25 micrograms) targets Omicron. Safety monitoring showed that the side effects observed were the same as those for the original Moderna booster dose and were typically mild and self-resolving, and no serious safety concerns were identified. The MHRA has also published further information for healthcare professionals and the public.
FDA launches Operation Lascar website
On 15th August, the FDA launched a new external webpage to highlight Operation Lascar. The operation is the FDA’s first bilateral initiative focused on the movement of illicit FDA-regulated products to the US from and through the UK. The site provides a history of the Initiative, key milestones, and a look ahead at the upcoming two-day symposium in September. This symposium will bring together leaders from industry, government, and the international community to explore regulatory and legal weaknesses and identify multinational solutions.
MHRA: Pfizer/BioNTech COVID-19 updates
On 16th August, the Medicines and Healthcare products Regulatory Agency (MHRA) updated the SmPC and Patient Information Leaflet (PIL) to include information on receiving a heterologous booster dose in individuals aged 18 years and over. The agency also updated the SmPC and PIL for the purple cap product to include updates to shelf life and transportation storage time information.
Issue Number: WN00074
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