All Drug Development articles – Page 55
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NewsCHMP 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.
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NewsMonoclonal 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.
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NewsEnhertu 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.
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NewsFirst 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.
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NewsEMA 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.
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NewsLargest 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.
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NewsTakeda to license potential treatment for colorectal cancer
Takeda and HUTCHMED have entered into an exclusive licensing agreement, to develop tyrosine kinase inhibitor fruquintinib for colorectal cancer outside China.
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NewsOnivyde® improves survival in Phase III pancreatic cancer trial
Onivyde® (irinotecan liposome injection) treatment regimen significantly improved survival in a Phase III trial compared to nab-paclitaxel plus gemcitabine.
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NewsPersonalised cancer immunotherapy granted fast track designation
The FDA has granted fast track designation for Evaxion’s personalised cancer vaccine in combination Keytruda® for patients with metastatic melanoma.
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NewsFDA issues complete response letter for donanemab
A complete response letter for Eli Lilly's accelerated approval submission of donanemab for early Alzheimer's has been issued by the US Food and Drug Administration (FDA).
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NewsMHRA authorises BRUKINSA® in Great Britain for two cancers
BRUKINSA® (zanubrutinib) has been authorised by the MHRA for chronic lymphocytic leukaemia and marginal zone lymphoma in Great Britain.
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NewsClinical trial-first for liver cancer immunotherapy combo
IMbrave050 is the first Phase III study to show a cancer immunotherapy combo reduced risk of disease recurrence for early-stage hepatocellular carcinoma.
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NewsAmgen commits $8m to clinical trial diversity programme
The Robert A. Winn Diversity in Clinical Trials Award Program has been pledged $8 million over the next four years by Amgen.
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NewsNICE recommends all-oral treatment for multiple myeloma
Ninlaro® (ixazomib) plus lenalidomide and dexamethasone has been recommended by NICE for relapsed/refractory multiple myeloma patients who have had two or three lines of therapy.
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NewsmRNA vaccine trial shows efficiency in older adults with RSV
Moderna's mRNA vaccine targeting respiratory syncytial virus (RSV) in older adults demonstrated promising efficacy in a Phase III trial.
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NewsUK medical cannabis manufacturer granted GMP registration
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted a UK manufacturing facility good manufacturing practice (GMP) registration for its cannabis API.
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NewsUK ATMP clinical trials report 2022 published
T cells were revealed as the most commonly investigated cell type continuing to increase, found CGT Catapult's 2022 UK ATMP clinical trials report.
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NewsMHRA approves biosimilar for vision disorders in Great Britain
A marketing authorization for Ximluci® biosimilar referencing Lucentis® (ranibizumab) in Great Britain has been issued by the Medicines and Healthcare products Regulatory Agency (MHRA).
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NewsPotential treatment identified for septic patients
CER-001 is a potentially game-changing treatment for septic patients at high risk of acute kidney injury, suggested a ABIONYX Pharma VP.
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NewsModerna joins the Association of the British Pharmaceutical Industry
To support the UK’s investments in manufacturing and R&D, Moderna has joined the Association of the British Pharmaceutical Industry (ABPI).