FDA approves Tabrecta for treatment of metastatic non-small cell lung cancer
The FDA has approved Tabrecta (capmatinib) for patients with metastatic non-small cell lung cancer whose tumours have a mutation that leads to MET exon 14 skipping.
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Multi-arm, multi-stage clinical trials the way forward for Parkinson’s research, says study
According to a new review, multi-arm and multi-stage clinical trials should be used to evaluate potential Parkinson's treatments.
EMA to fast-track development of COVID-19 vaccines and therapeutics
The EMA has announced new regulatory changes that will help potential COVID-19 vaccines and therapeutics accelerate through development.
CEPI calls for proposals to apply for COVID-19 vaccine funding
CEPI has announced it is urging organisations to apply for funding for the development and manufacturing of potential COVID-19 vaccines.
MRC and LifeArc announce grants for Gene Therapy Innovation Hubs in UK
The UK MRC and LifeArc are making £16 million available as grants to fund the establishment of Gene Therapy Innovation Hubs to improve resources for researchers and manufacturers.
First patient dosed with Pfizer’s potential COVID-19 vaccine in US
Pfizer and BioNTech have initiated Phase I/II trials in the US to determine the safety and optimal dose of four mRNA COVID-19 vaccine candidates.
EMA initiates ‘rolling review’ of remdesivir, potential COVID-19 treatment
The EMA's human medicines committee has announced it has begun a rolling review of remdesivir for the treatment of COVID-19, to examine its safety and effectiveness.
Attenuated diptheria toxin developed by researchers as novel form of drug delivery
A new potential platform for drug delivery has been created by researchers using attentuate diptheria toxin, which can enter cells and escape the endosome.
CEPI and European Investment Bank collaborate to fund vaccine projects
The Coalition for Epidemic Preparedness Innovations (CEPI) and European Investment Bank (EIB) will work together to identify and fund vaccine projects for infectious diseases.
CDMO pledges increased production of hydroxychloroquine sulfate, potential COVID-19 treatment
The CDMO AMRI has said it will boost its production of the malaria drug hydroxychloroquine sulfate, identified as a potential COVID-19 treatment, following an emergency use authorisation from the FDA.
EMA recommends eight drugs for approval from April meeting
The EMA's human medicines committee has adopted a positive opinion for eight medicines, recommending their marketing authorisation.
NICE joins international collaboratives to respond to COVID-19
NICE in the UK has announced it will partner with international collaborations to share its work on COVID-19 and develop guidelines for healthcare professionals.
New standards to help remove foreign particles in bioprocessing
ASTM International says its new standard for single use system manufacturing processes will help to prevent the contamination of biopharmaceuticals with foreign particles.
FDA grants remdesivir emergency use authorisation to treat COVID-19
The US FDA has given emergency use authorisation to remdesivir for the treatment of patients in hospital with severe COVID-19.
Gilead files lawsuit against US federal government over alleged contract breaches
Gilead's complaint alleges five contract breaches by the US Centers for Disease Control and Prevention (CDC) and seeks a declaration of contract breach and damages.
