Tower Mains Weekly Newsletter
Regulatory Updates
MHRA guidance updates
- Register medical devices to place on the market. On 1st December, the Medicines and Healthcare products Regulatory Agency (MHRA) provided clarification concerning fees and actions required to change the legislation of a registered device. Click to view source
- The Innovative Devices Access Pathway (IDAP). On 1st December, updated the guidance to aannounce that the IDAP Pilot is closed for applications. Click to view source
- Medicines: apply for a parallel import licence. On 5th December, the MR-DC product list (applicable from 1 December 2023) was updated. Click to view source
Animal generic drug user fees and fee waivers and reductions
On 4th December, the Food and Drug Administration (FDA) published final guidance on the types of fees the FDA is authorised to collect under AGDUFA and how to request a waiver or a reduction of these fees. This guidance describes the types of fees; the FDA’s current thinking on how it intends to implement the generic new animal drug user fee provision of AGDUFA; the type of fee waiver or reduction available; what information the FDA recommends you submit in support of a request for a fee waiver or reduction; how to submit such a request; and FDA’s process for reviewing requests.
Industry Updates
First-of-its-kind molecular communication system developed by King’s engineers
On 29th November, Kings College London (KCL) announced its researchers from the Department of Engineering have created a novel system for biologically compatible molecular communication which could serve as the foundation for new applications, from new forms of computation to drug delivery.
Queen’s University and Almac Discovery to establish state-of-the-art Chemoproteomics facility
On 29th November, Queen’s University Belfast and Almac Discovery announced a five-year project to develop a new Chemoproteomics Centre of Excellence for drug discovery. Chemoproteomics is a way to find new starting points for creating biological tools and first-of-their-kind drugs, particularly for diseases that currently have no effective treatments. The multi-million-pound facility, which is jointly funded by Almac Discovery and a BBSRC Prosperity Partnership award, is a first of its kind in Northern Ireland.
Precautionary action taken to amend incorrect expiry dates of flu nasal spray vaccines
On 30th November, the MHRA announced that AstraZeneca has informed the agency that the printed expiry date for a limited number of batches of Fluenz Tetra nasal spray vaccines is incorrect. Following routine testing, AstraZeneca observed that certain batches of Fluenz nasal spray vaccines dropped in potency faster than predicted once thawed, and the manufacturer has since revised the expiry dates for all affected batches as a precautionary measure. These batches are safe to use and fully effective within the amended expiry date.
Registration for FDA’s Rare Disease Day 2024
On 1st December, the FDA opened the registration for its virtual Rare Disease Day on Friday, 1st March 2024. This year’s Rare Disease Day is dedicated to patients and healthcare professionals and will discuss efforts to address the unique challenges of developing treatments for rare diseases, as well as the FDA’s efforts to promote new medical products for patients with rare diseases.
EU medicines agencies reflect on lessons learned from COVID-19
On 1st December, a joint report was issued by the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) on the network’s response to the COVID-19 emergency and to highlight the main learnings for any future health crisis.
FDA grants accelerated approval to pirtobrutinib for lymphocytic leukaemia and small lymphocytic lymphoma
On 1st December, the FDA granted accelerated approval to pirtobrutinib for adults with chronic lymphocytic leukaemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.
NIHR-funded researchers help influence WHO guidelines for people living with HIV
On 1st December, it was announced that the World Health Organisation (WHO) has updated its guidelines based on findings from the AMBITION-cm study, led by the National Institute for Health and Care Research’s Global Research Professor Joe Jarvis. The study recommends a new treatment which is simpler, safer, and more cost-effective for people living with HIV.
Novartis gains FDA approval for blood disorder drug
On 6th December, Novartis announced the FDA approval of Fabhalta® (iptacopan) as the first oral monotherapy for the treatment of adults with paroxysmal nocturnal haemoglobinuria (PNH). Fabhalta is a Factor B inhibitor that acts proximally in the alternative complement pathway of the immune system, providing comprehensive control of red blood cell (RBC) destruction within and outside the blood vessels (intra- and extravascular haemolysis [IVH and EVH]).
Issue Number: WN00141
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