Tower Mains Weekly Newsletter
Regulatory Updates
MHRA updates
Annual conflicts of interest report. On 25th July, the Medicines and Healthcare products Regulatory Agency (MHRA) published its 2022 annual conflict of interest compliance report. This outlines the potential conflicts of interest (COI) arising from the operation of the three centres of the MHRA (the agency) – the MHRA Regulator (the Regulator), the National Institute of Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). Click to view source
FDA guidance updates
FDA’s Voluntary Qualified Importer Program. On 21st July, the US Food and Drug Administration (FDA) published final guidance describing the FDA’s policy regarding participation in the agency’s Voluntary Qualified Importer Program (VQIP) by food importers for humans or animals. This document provides guidance on the benefits VQIP importers can expect to receive; the eligibility criteria for VQIP participation; instructions for completing a VQIP application; conditions that may result in revocation of participation in VQIP; and criteria for VQIP reinstatement following revocation. Click to view source
M7(R2) assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk. On 25th July, final guidance was published to harmonise the considerations for assessing and controlling DNA reactive (mutagenic) impurities. Click to view source
Industry Updates
CatalYm highlights GDF-15 as main anti-PD-1 resistance factor
On 20th July, CatalYm announced the publication of preclinical data in Nature Communications under the title “Tumor-derived GDF-15 blocks LFA-1 dependent T cell recruitment and suppresses responses to anti-PD-1 treatment”. The study reveals a central role of GDF-15 in the resistance of tumours to current immunotherapy. These findings further highlight the therapeutic significance of CatalYm’s proprietary anti-GDF-15 antibody candidate, visugromab, currently in advanced Phase 2 clinical studies.
EMA issues latest CHMP meeting highlights
On 21st July, the EMA issued meeting highlights from its Committee for Medicinal Products for Human Use (CHMP) held on the 17th-20th of July 2023. This covered 14 new medicines recommended for approval, withdrawals of applications and the latest CHMP statistics.
First RSV vaccine to protect infants up to 6 months of age and older adults
On 21st July, the European Medicines Agency (EMA) announced it has recommended granting a marketing authorisation in the EU for Abrysvo, a vaccine to protect against disease caused by the respiratory syncytial virus (RSV). Abrysvo is the first RSV vaccine indicated for passive immunisation of infants from birth through six months of age following administration of the vaccine to the mother during pregnancy, and it is also indicated for active immunisation of adults aged 60 years and older.
Stent approval for treatment of PAS in paediatric patients
On 21st July, the FDA approved the Cordis Palmaz Mullins XD Pulmonary Stent for paediatric patients receiving treatment for pulmonary artery stenosis (PAS). The stent is placed in the pulmonary artery through a catheter inserted through the patient’s blood vessel and addresses the critical narrowing of the pulmonary artery and keeps the pulmonary artery open, decreasing the pressure load on the right ventricle of the heart while improving blood flow to the lungs. This approval marks the first device of its kind approved to treat PAS in paediatric patients that offers an additional treatment option for patients.
ViiV Healthcare’s cabotegravir for HIV prevention receives positive CHMP opinion
On 24th July, ViiV Healthcare, the global specialist HIV company majority owned by GSK, recieved a positive opinion by the EMA’S CHMP recommending marketing authorisation for cabotegravir long-acting (LA) injectable and tablets for HIV prevention. Cabotegravir is recommended to reduce the risk of sexually acquired HIV-1 infection in high-risk adults and adolescents weighing at least 35 kg.
MHRA launches public consultation on the proposal to reclassify codeine linctus to a prescription-only medicine.
On 24th July, the MHRA announced it has launched a public consultation on the proposal to reclassify codeine linctus to a prescription-only medicine. The agency is asking healthcare professionals and all members of the public their views on whether cough medicines containing the opioid codeine should become prescription-only or should remain available to purchase over the counter in pharmacies.
MHRA publishes latest Drug Safety Update newsletter
On 24th July, the MHRA published the July edition of the Drug Safety Update newsletter from the MHRA and its independent advisor, the Commission on Human Medicines
Paving the way towards coordinated clinical trials in public health emergencies in the EU
On 25th July, the EMA issued a report from a workshop that collected insights and suggestions for possible EU-level actions to improve the way clinical trials are set up and conducted in the EU during public health emergencies. The actions presented in the report aim to holistically address the barriers and challenges experienced during the COVID-19 pandemic and the outbreak of m-pox disease in setting up adequately sized clinical trials across multiple Member States that enable the swift gathering of high-quality evidence to support robust decision-making by health authorities across the EU.
Vantage Biosciences launched to treat diabetic eye disease
On 26th July, Vantage Biosciences, a new company launched by ALSA Ventures which invests in novel therapeutics for unmet medical needs, announced the acquisition of lead asset VX-01, an oral therapy targeting diabetic eye diseases, set to enter Phase 2 clinical development in mid-2024. If successful, VX-01 could emerge as a game-changing therapy, offering a more convenient and effective alternative to existing treatments.
Issue Number: WN00122
Would you like a personal copy of the Tower Mains Weekly Newsletter directly to your mailbox each month? Just send an email to info@towermains.com with the subject “Weekly Newsletter Please.”