Tower Mains Weekly Newsletter
Thank you to those who attended our Lunch and Learn on Wednesday, 1st June, and for those who missed it, the full version is available to view here.
FDA and HHS/ASPR announce extension to the shelf-life for Eli Lilly monoclonal antibody
The Assistant Secretary for Preparedness and Response (ASPR) and the Food and Drug Administration (FDA) have authorised an extension to the shelf-life from 12 months to 18 months for specific lots of the refrigerated Eli Lilly monoclonal antibody, bebtelovimab, which is currently authorised for emergency use. FDA granted this extension following a thorough review of data submitted by Eli Lilly. This extension applies to all unopened vials of bebtelovimab that have been held per storage conditions detailed in the authorised Fact Sheet for Health Care Providers and the EUA Letter of Authorisation for bebtelovimab.
European Commission issues Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746
On 25th May, the European Commission (EC) issued a Q&A clarifying certain interfaces between the Regulation (EU) No 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)1. It was developed by clinical trials experts from Clinical Trials Facilitation and Coordination Group (CTFG) and in vitro diagnostics experts from the IVD sub-group of the Medical Device Coordination Group (MDCG)2.
New safety warnings on risk of insulin leakage from Roche Accu-Chek Insight Insulin pumps
On 26th May, the Medicines and Healthcare products Regulatory Agency (MHRA) issued a national patient safety alert for the NovoRapid PumpCart prefilled insulin cartridge and the Roche Accu-Chek Insight Insulin pump system following concerns raised about cracked cartridges and insulin leaks. Patients are being asked to check the pre-filled glass insulin cartridge for cracks before use, and health care professionals are being advised to contact patients over the next six months using the device to discuss their individual needs and source an alternative pump where appropriate.
EAMS scientific opinion issued to argenx BV for efgartigimod
On 27th May, the MHRA published its early access to medicines scheme (EAMS) scientific opinion issued to argenx BV for the treatment of adults with generalised Myasthenia Gravis (gMG), an autoimmune disease that causes muscle weakness.
Developing gonadotropin-releasing hormone analogues guidance for industry
On 27th May, the FDA issued guidance describing its current recommendations regarding the overall development program to establish the effectiveness and safety of gonadotropin-releasing hormone (GnRH) analogues for treating advanced prostate cancer.
European Commission issues Regulation (EU) 536/2014 guidance
On 30th May, the EC issued a Q&A on Regulation (EU) 536/2014 Q&A providing general guidance on the implementation of the CTR and should be read in combination with the CTIS online training modules, and more specific documents published on EudraLex 10.
FDA: Regulatory Education for Industry Annual Conference 2022
On 31st May, the FDA’s Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), and Center for Biologics Evaluation and Research (CBER) announced its free, virtual Regulatory Education for Industry (REdI) Annual Conference 2022 which will be held on the 6th-10th June 2022. This course is designed to provide participants with a basic foundation in the FDA’s regulatory requirements and will offer a total of 32.5 contact hours of continuing education for physicians, pharmacists, and nurses.
EMA appoints Chief Medical Officer
On 1st June 2022, the EMA announced it had appointed Professor Steffen Thirstrup as Chief Medical Officer. Steffen is a medical doctor with a PhD in pharmacology and broad clinical experience in general internal medicine. He has a track record of working with the EU regulatory network and previously led the Division for Medicines Assessment and Clinical Trials at the Danish Health and Medicines Authority and was the Danish member of EMA’s human medicines committee (CHMP). He was also a member of EMA’s Committee for Advanced Therapies (CAT), the Chairperson of the CHMP’s Respiratory Drafting Group, and Co-Chair of the European Commission Working Group on Market Access of Biosimilars.
Issue Number: WN00063