UK conditionally approves Lilly’s Retsevmo® for RET-driven lung and thyroid cancers
The conditional marketing authorisation of Retsevmo® (selpercatinib) was based on positive results from the LIBRETTO-001 Phase I/II trial.
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Novavax’s COVID-19 vaccine is effective against emerging SARS-CoV-2 variants
New trial data shows Novavax’s COVID-19 vaccine, NVX–CoV2373, is effective against both the B.1.1.7 UK and the B1.351 South African variants.
Danish, Norwegian and Icelandic authorities suspend use of COVID-19 Vaccine AstraZeneca
Several countries have temporarily stopped the use of the vaccine while reports of blood clots are investigated by the EMA’s pharmacovigilance committee and other authorities.
![Lines of vials labelled 'COVID-19 Vaccines' [Credit: Dimitris Barletis/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Covid-19-vaccines-2-1-300x278.jpg)
![Lines of vials labelled 'COVID-19 Vaccines' [Credit: Dimitris Barletis/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Covid-19-vaccines-2-1-e1614176959561.jpg)
A single vaccine dose is sufficient for immunity in COVID-19 survivors, finds study
New research shows a second COVID-19 vaccine dose may be unnecessary in individuals previously infected with SARS-CoV-2 and needlessly exposes individuals to higher rates of adverse effects.
Proxalutamide reduces COVID-19 mortality risk by 92 percent
In a Phase III trial, Proxalutamide reduced mortality and expedited recovery of hospitalised COVID-19 patients in Brazil.
First patients receive Moderna’s modified COVID-19 vaccine candidates
Moderna has begun testing two new mRNA COVID-19 vaccines, one specifically targeting the B.1.351 variant and the other a multivalent candidate.
Bamlanivimab and etesevimab prevent COVID-19 related deaths
In a high-risk patient cohort, treatment with the combination of bamlanivimab and etesevimab reduces COVID-19 related hospitalisation and death by 87 percent.
Biotechs to test feasibility of a shelf-stable, powder mRNA COVID-19 vaccine
The collaborators hope to make mRNA COVID-19 vaccines accessible to all by creating a shelf-stable, reconstitutable powder formulation.
Maturation inhibitor shown to be safe and effective in Phase II HIV trial
The highest doses of the novel maturation inhibitor, GSK3640254, had the greatest antiviral activity and were shown to be safe in 34 treatment-naïve adults with HIV.
New Finnish company to develop a nasal spray vaccine for COVID-19
The spin-out from the Universities of Helsinki and Eastern Finland will leverage years of research to test and bring to market a nasal spray vaccine against COVID-19.
FDA grants Emergency Use Authorisation to Abott’s SARS-CoV-2, influenza and RSV test
The PCR based Alinity™ m Resp-4-Plex molecular assay can detect and differentiate SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus (RSV).
ASC40 meaningfully reduces liver fat in Phase II NASH trial
ASC40 reduced liver fat and significantly lowered an enzyme associated with liver inflammation in nonalcoholic steatohepatitis (NASH) patients.
NICE approves gene therapy for spinal muscular atrophy
Zolgensma, a one-off, potentially curative treatment for type 1 spinal muscular atrophy, is set to become the most expensive drug ever approved for use on the UK’s NHS.
COVID-19 T cell test submitted for emergency use authorisation
In clinical testing, the T-SPOT.COVID test was found to agree with PCR test results in over 96 percent of samples taken within first 60 days of infection.
India’s Covaxin® 81 percent effective against COVID-19
An interim analysis reveals the Covaxin® (BBV152) vaccine was relatively safe and 81 percent effective in preventing symptomatic COVID-19.
