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WHO expert panel advises against use of remdesivir for hospitalised COVID-19 patients
The WHO group concluded there is currently no evidence that remdesivir improves survival when reviewing data from 7000 hospitalised COVID-19 patients.
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Regulation & Legislation
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FDA grants EUA to baricitinib with remdesivir to treat COVID-19
The FDA has issued an Emergency Use Authorization for baricitinib in combination with remdesivir to treat COVID-19 in hospitalised patients.
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Lilly’s Emgality (galcanezumab) recommended by NICE as migraine preventative
The UK's NICE has recommended Emgality (galcanezumab) for the prevention of migraine in adults with episodic and chronic migraine.
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EDQM releases new guidelines for COVID-19 vaccine quality testing
The European Directorate for the Quality of Medicines & Healthcare has announced three new guidelines outlining how to test the quality of COVID-19 vaccines.
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BNT162b2 vaccine is 95 percent effective against COVID-19, finds final efficacy analysis
The concluded Phase III study of BNT162b2 met all primary efficacy endpoints, with a consistent 95 percent efficacy across all patient populations.
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PhRMA announces new principles on clinical trial diversity
New principles on diversity in clinical trials in the US have been released to address systemic issues that deter people from participating in studies.
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EMA releases safety monitoring plan for COVID-19 vaccines
The EMA's safety monitoring plan outlines how new information after authorisation of COVID-19 vaccines will be collected and reviewed.
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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).
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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.
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Interactive PDF: Risk mitigation and quality requirements interactive tool
Risk mitigation interactive tool to guide you through the challenges and quality requirements of your bio-manufacturing process.
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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.
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Whitepaper: BPOG extractables data in single-use systems adoption
An overview on the role of BPOG extractables data in the effective adoption of single-use systems in biomanufacturing
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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.
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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.
