FDA approves Epidyolex for treatment of tuberous sclerosis complex-associated seizures
Epidyolex, a cannabidiol oral solution, has been given approval by the FDA to treat seizures associated with tuberous sclerosis complex (TSC).
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US invests over $240 million into seven new COVID-19 diagnostic tests
The National Institutes of Health in the US has awarded contracts to seven biomedical companies to develop and manufacture COVID-19 diagnostics.
NICE recommends avelumab and axitinib to treat renal cell carcinoma
Bavencio (avelumab) and Inlyta (axitinib) are recommended by NICE for the treatment of advanced renal cell carcinoma, available on the Cancer Drugs Fund.
FDA proposes four APIs for bulk substances list for outsourcing facilities
Four APIs are being considered by the FDA for its bulk drug substances list for potential use by outsourcing facilities when compounding if there is a clinical need.
COVID-19 rapid antibody tests approved for use in UK
Abingdon Health's COVID-19 rapid antibody test has been registered with the UK's Medicines and Healthcare products Regulatory Agency.
Biopharma increasingly factoring sustainability into cold chain decisions
A survey has found that the biopharma industry is taking sustainability into their cold chain considerations more and more, with 66 percent saying it is very important.
Sanofi and GSK to supply UK with 60 million doses of COVID-19 vaccine
Sanofi and GSK have reached an agreement with the UK government to supply up to 60 million doses of their COVID-19 vaccine.
EC approves subcutaneous formulation of Remsima®
The European Commission has granted marketing authorisation to Celltrion's Remsima (infliximab, CT-P13) subcutaneous formulation.
Trade Committee urges UK to ensure drug supply ahead of second COVID-19 wave
According to a new report from the International Trade Committee, the UK's medicine supply chain was able to withstand the challenge of COVID-19, but must be optimised for a potential second wave of the virus.
UKRI announces six research initiatives into COVID-19 and ethnicity
The UKRI and NIHR will fund projects worth £4.3 million to investigate the disproportionate death rate from COVID-19 among people from BAME backgrounds.
PQE Group creates an internal research Task Force to fight fake news in relation to COVID-19
The CEO of PQE Group has formed a task force of employees in the corporate community to research and dispel fake news regarding COVID-19.
Potential COVID-19 treatment LAM-002A to enter Phase II clinical trial
Yale University and AI Therapeutics will collaborate on a Phase II trial to study LAM-002A as a COVID-19 treatment for newly diagnosed patients.
EMA initiates review of dexamethasone for treating COVID-19
The EMA has begun to review dexamethasone to provide an opinion on the results of the RECOVERY study for the treatment of adults admitted to hospital with COVID-19.
Pfizer and BioNTech COVID-19 vaccine candidate enters Phase II/III trials
The BNT162b2 mRNA-based vaccine produced by Pfizer and BioNTech will enter Phase have II/III clinical trials to test its safety and efficacy against COVID-19.
Sandoz and Austrian government to invest in European antibiotic manufacturing
Sandoz plans to invest €150 million and the Austrian government €50 million into integrated antibiotic manufacturing operations at Kundl.
