First medicine approved in EU for eosinophilic esophagitis
Dupixent® has been approved by European Commission as the first and only targeted medicine indicated for eosinophilic esophagitis.
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Three-year patent strategy for greater medicine access announced
The Medicines Patent Pool's 2023-2025 strategy plans to expand medicine access by improving the availability of innovative medicines in low- and middle-income countries.
Citrate-free HCF of adalimumab biosimilar gets positive opinion
A positive opinion has been adopted by the CHMP for a citrate-free high concentration formulation of its biosimilar Hyrimoz® (adalimumab).
FDA approves first BTK inhibitor for lymphoma
The first BTK inhibitor of any kind approved for mantle cell lymphoma treated with a covalent BTK inhibitor, has been granted FDA approval.
CHMP meeting highlights – January 2023
Four new medicines were recommended for approval at the Committee for Medicinal Products for Human Use (CHMP)’s January meeting, with positive opinions given to two type 2 diabetes drugs.
Monoclonal antibody could prevent malaria, study shows
Based on recent research, a "potential game changer” approach could offer a practical way to use monoclonal antibody therapies for malaria in Africa.
Eli Lilly to help fund cold chain initiative
$1.15m funding from Eli Lilly and Company will support a new cold chain capacity initiative in low- and middle-income countries, to help improve medicine access.
New UK point of care manufacturing regulatory framework
A first-of-its-kind regulatory framework for point of care manufacturing of innovative medicines is set to be introduced in the UK, ensuring these products are as safe as conventional medicines.
Enhertu approved in EU for HER2-low breast cancer
The European Commission has approved Enhertu in the EU as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer.
First CAR T-cell therapy recommended on NHS
NICE’s recommendation of Yescarta® means it is the first time patients will be able to access CAR T-cell therapy long-term on the NHS.
EMA publishes updated Q&A for ICH M10
An updated Q&A document for ICH M10 'Bioanalytical Method Validation and Study Sample Analysis’ has been published by the European Medicines Agency (EMA).
WHO urges supply chain to take action on contaminated medicines
Key stakeholders in the medicine supply chain have been urged by the World Health Organization to take immediate action against recent cases of contaminated medicines.
Major study on DMT shows promise for depression
One of the largest studies for a short-acting psychedelic showed a remission rate of 57 percent for major depressive disorder after a single dose of DMT.
EMA validates first regulatory submission for CRISPR-based medicine
The first regulatory submission for a CRISPR-based therapy has been validated by the European Medicines Agency, to treat sickle cell disease and transfusion-dependent beta thalassemia.
Largest global clinical site hires all-female key leaders in Europe
Three all-female key leaders in Europe have been hired by Velocity Clinical Research, the largest clinical sites business globally.
