EMA initiates rolling review of Moderna’s COVID-19 vaccine
The rolling review will shorten the approval timeframe by evaluating data on the safety, efficacy and quality of the mRNA-1273 vaccine as it becomes available.
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WHO lists first vaccine for emergency use
The nOPV2 vaccine has received emergency use listing and will be used to combat outbreaks of circulating vaccine-derived polio viruses (cVDPVs).
Fluvoxamine may prevent severe COVID-19 onset, suggests trial
Researchers say the promising results warrant larger trials evaluating fluvoxamine as a potential intervention to prevent COVID-19 patients developing severe symptoms.
CHMP recommends five medicines for approval in latest meeting
The European Medicines Agency committee reports its November findings, including five drugs recommended for marketing authorisation.
Moderna’s COVID-19 vaccine is 94.5 percent effective, according to interim analysis
The analysis reveals that mRNA-1273 was generally well tolerated and prevented COVID-19 with an efficacy of 94.5 percent in a Phase III study.
First COVID-19 patient dosed in Phase II trial of Quellor
The first patient has been dosed with Quellor in a Phase II clinical trial, evaluating the drug for the treatment of pulmonary complications from COVID-19.
Hybrid purifier removes host cell proteins during mAb bioprocessing, study shows
Researchers have shown that a hybrid purifier can remove host cell proteins during the downstream processing of monoclonal antibodies.
NICE recommends new chemo-free chronic lymphocytic leukaemia treatment
More than 1,000 people each year could benefit from treatment with a combination of venetoclax and obinutuzumab, according to NICE.
Russia’s Sputnik V COVID-19 vaccine candidate shows promising results, report says
Russia’s Sputnik V, a potential COVID-19 vaccine, was 92 percent effective at protecting people from the coronavirus, interim results have shown.
Calquence fails to prevent respiratory failure in COVID-19 patients
AstraZenaca reveals Calquence (acalabrutinib) did not increase the proportion of hospitalised COVID-19 patients who remained alive and free of respiratory failure.
Packaging initiative to protect COVID-19 medicines against counterfeiting launched
The AlpVision COVID-19 Initiative will provide pharma companies with access to use a crytoglyph on their medicine packaging for free.
Stem cell therapy trial for COVID-19 patients with ARDS advised to continue
The trial’s independent Data Safety Monitoring Board (DSMB) recommended that the Phase III study evaluating remestemcel-L continue based on the second interim analysis.
Novo Nordisk set to acquire Emisphere for $1.8 billion
Following approval by Emisphere shareholders, Novo Nordisk will acquire the company for a total of $1.8 billion.
Pfizer and BioNTech to supply the EU with 200 million doses of BNT162b2 vaccine
Subject to regulatory approval, EU member states will be supplied with the potentially highly effective BNT162b2 COVID-19 vaccine candidate.
FDA grants Fast Track Designation to Novavax COVID-19 vaccine candidate
The FDA has given Fast Track Designation to NVX-CoV2373, Novavax’s COVID-19 vaccine candidate, created using recombinant nanoparticle technology.
