UK recall of Clinigen’s Mexiletine hydrochloride hard capsules
A Class 1 Medicines Recall Notification has been issued for three batches of Mexiletine hydrochloride hard capsules due to potential for under- or overdosing.
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L9LS antibody safe and highly protective against malaria, finds study
Phase I human challenge study shows a single subcutaneous injection of the monoclonal antibody L9LS provides at least short-term protection against malaria.
Pharmacopoeias to further support vaccine development and supply
US and European Pharmacopoeias announce new activities to help promote vaccine development, manufacturing, quality and supply.
Global alliance to end childhood AIDS
New global alliance launched by UNAIDS, UNICEF and WHO aims to overcome “outrageous” disparities in the AIDS response and ultimately end AIDS in children by 2030.
GSK to supply Europe with 85mn pandemic flu vaccines
New agreement reserves million doses of GSK’s pandemic influenza vaccine Adjupanrix to support Europe’s pandemic preparedness.
Litifilimab reduces skin disease activity in CLE trial
Phase II results suggest litifilimab safely and effectively reduces skin disease activity in cutaneous lupus erythematosus (CLE) patients.
ViiV agrees to expand access to long-acting HIV PrEP
Under a new agreement, licenced manufacturers will be able to supply generic versions of ViiV’s long-acting cabotegravir HIV pre-exposure prophylaxis (PrEP) medication to developing nations.
Big Data Steering Group to enhance data quality and discoverability under new workplan
The Group plans to deliver a data quality framework by the end of 2022 and publish a public catalogue of European real-world data by 2025, among other actions.
Microparticles could form self-boosting vaccines
New research suggests microparticles able to release their payloads at different times could form the basis of self-boosting vaccine courses that would require just a single injection.
Bristol Myers Squibb aims to improve disability diversity in clinical trials
Bristol Myers Squibb is collaborating with non-profit organisation Disability Solutions on an initiative to increase diversity in clinical trials.
Regulators commit to collaborating on RWE integration
Global regulators commit to collaborate on the integration of real-world data and real-world evidence (RWE) in regulatory decision-making.
Biohybrid microrobots could be effective cancer drug delivery systems
A new study demonstrates the design and potential of adding artificial components to bacteria to enable tumour targeted drug release and immune activation.
CHMP meeting highlights – July 2022
At its July meeting, the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) recommended 11 medicines for approval and extended the indication of six more, including Imvanex for the prevention of monkeypox.
EU proposes new blood, tissues and cells Regulation
The draft Regulation aims to enhance the protection of donors and recipients of substances of human origin (SoHO) therapies, while facilitating supply and innovation.
NA to NAM ratio as a biomarker for cell therapy sterility
Study shows nicotinic acid (NA) to nicotinamide (NAM) ratio enables detection of early-stage microbial contaminations in cell therapy products.
