The European Medicines Agency (EMA) has accepted the marketing authorisation application for Evrysdi™ (risdiplam) as a treatment of spinal muscular atrophy (SMA).
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Abingdon Health's COVID-19 rapid antibody test has been registered with the UK's Medicines and Healthcare products Regulatory Agency.
Tofersen reduced expression of the SOD1 gene known to cause amyotrophic lateral sclerosis (ALS) and slowed clinical decline in the Phase I/II trial.
A pharmaceutical formulation of the human angiotensin peptide, TXA127, will enter Phase II trials in hospitalised COVID-19 patients not in intensive care.
The first patient has been dosed in the Chinese Phase I trial of JS016 in healthy people who do not have a COVID-19 diagnosis.
Coating the tetanus portion of the DTP vaccine in silica rendered it thermally stable up to 100°C and able to be distributed without refrigeration.
Treating COVID-19 patients with respiratory distress with acalabrutinib, a Bruton tyrosine kinase (BTK) inhibitor reduced inflammation and improved their breathing within three days.
Researchers reveal their experimental test can detect the presence of COVID-19 RNA in a sample in 10 minutes, and in a way that does not require trained personnel to interpret.
Advent announced it has manufactured and delivered the first 4,000 doses of the AZD1222 vaccine candidate for the University of Oxford clinical trial.
The adenovirus type 5 vectored COVID-19 (Ad5-nCoV) vaccine candidate safely induced T cell and antibody responses in 108 adults.
Clinical trials testing potential malaria vaccines report the vaccines were well tolerated and demonstrated some efficacy, delaying Plasmodium falciparum infection.
Researchers have used CRISPR-Cas to edit the genes of contaminating proteins in mammalian cells used to produce recombinant-protein drugs, which could reduce costs and strengthen quality.
Scientists have developed a protocol for encapsulating antibodies in an ultrasound-sensitive drug carrier for targeted drug delivery.
QA/QC & Analytical Techniques In-Depth Focus 2020 with a special focus on Chromatography & Microbiology
This in-depth focus highlights how liquid chromatography coupled to mass spectrometry (LC-MS) can be used to characterise proteins, what to do to improve regulatory compliance when using chromatography and the risks posed by underestimating bacterial contaminants in cleanrooms.
This issue focuses on the regulatory challenges associated with increased ventilator demand during COVID-19, as well as articles investigating the use of LC-MS for protein characterisation, improving efficiency with continuous processing and the risks posed by cleanroom contaminants. Other features discuss the continual evolution of solid dosage forms and the…