Expanded access for compassionate use of remestemcel-L in COVID-19 infected children
US expands access to remestemcel-L for compassionate use in COVID-19 infected children with complications of multisystem inflammatory syndrome.
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FDA approves new heart rhythm devices featuring Bluetooth connectivity and continuous remote monitoring
Abbott’s Gallant™ implantable cardioverter defibrillator (ICD) and cardiac resynchronisation therapy defibrillator (CRT-D) devices are given approval.
Sustainable biomedical device promising for regenerative medicine, say researchers
The sustainable device, consisting of food industry by-products, had excellent biocompatibility both in vitro and in vivo.
New next-generation research platform launched by Genomics England
The genomic research platform will initially be used to help fast-track COVID-19 drug research and development, before being leveraged against other diseases, such as cancer.
US trial testing Kevzara® (sarilumab) as a COVID-19 treatment stopped
Companies leading trial announce Kevzara failed to meet primary and secondary endpoints in critically ill COVID-19 patients, so the trial has been halted.
European Pharmacopoeia publishes new chapter regarding BET testing
The new chapter describes a method for bacterial endotoxins (BET) testing using recombinant factor C (rFC) instead of limulus amoebocyte lysate (LAL).
EMA recommends Idefirix (imlinfidase) is granted marketing authorisation
The European Medicines Agency (EMA) recommended Idefirix is granted conditional marketing authorisation for highly sensitised patients awaiting kidney transplant.
CHMP recommends cystic fibrosis treatment Kaftrio is granted marketing authorisation
The European Medicines Agency's human medicines committee (CHMP) said the treatment would offer a therapeutic option for certain cystic fibrosis phenotypes that are currently untreatable.
Further billions pledged to ensure equitable access to COVID-19 treatments
The European Investment Bank (EIB), in partnership with the European Commission (EC), have pledged an additional €4.9 billion for use in the global coronavirus response funds.
First COVID-19 vaccine given green light for Phase I trial in China
CanSino Biologics' Ad5-nCoV vaccine, a potential COVID-19 prophylactic, has been approved for study in a Phase I clinical trial in China.
CBD could reduce behavioural problems in children with intellectual disability
A new study has shown that in children and adolescents with an intellectual disability, cannabidiol (CBD) reduced severe behavioural problems.
Gilead prices remdesivir at $2,340 per patient for developed countries
Gilead has announced that the potential COVID-19 drug remdesivir will cost $390 per vial for developed countries, with treatment courses costing $2,340 per patient.
FDA approves new administration route for Phesgo to treat breast cancer
The FDA has given approval to Phesgo for injection under the skin to treat HER2-positive breast cancer, meaning it can be administered at home by a healthcare professional.
First COVID-19 vaccine clinical trial approved in India
Indian authorities have given the green light to test Bharat Biotech's COVID-19 vaccine in Phase I and Phase II clinical trials.
Common cancer treatments do not worsen COVID-19 infection, study finds
A study has found that chemotherapy and surgery do not correlate with worse COVID-19 outcomes for cancer patients, whereas taking immune checkpoint inhibitors does.
