App to help enrol COVID-19 patients into clinical trials developed
A new software has been developed, made to help find and enrol COVID-19 positive patients to accelerate clinical trials for new drugs and vaccines.
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FDA grants Fast Track Designation to Moderna’s COVID-19 vaccine
The US FDA has given Fast Track Designation to Moderna's mRNA vaccine candidate, mRNA-1273, designed to protect against COVID-19.
Doubt cast over Avigan (favipiravir) and DAS181 potential to fight COVID-19
A new report has highlighted that the early successes of Avigan (favipiravir) and DAS181 do not guarantee their efficacy against COVID-19.
Mylan partners with Gilead to manufacture remdesivir, potential COVID-19 treatment
According to a new agreement between Mylan and Gilead, the former has the rights to manufacture and distribute remdesivir in 127 countries, a drug being tested to combat COVID-19.
Scientific leaders call for harmonised COVID-19 vaccine R&D
Experts from the US National Institutes of Health have written a commentary to promote a collaborative approach for the testing, scale-up and distribution of COVID-19 vaccine candidates.
FDA new drug approvals down 16 percent in 2019, impacting outsourcing
A new report has found that in 2019 the FDA approved 119 new drugs and biologics, but that this is down from 137 in 2018, impacting contract manufacturing organisations.
Programme to develop sustainable cold chain delivery for COVID-19 vaccine initiated
Researchers have begun research to find how sustainable cold chain delivery systems for a COVID-19 vaccine can be established in resource-poor countries.
ICU Medical recalls one lot of Lactated Ringer’s Injection in US
The US FDA has announced ICU Medical is recalling a lot of Lactated Ringer's Injection due to iron oxide particulates being found by a consumer.
CEPI invests $384m in Novavax COVID-19 vaccine candidate
CEPI has announced that its funding for the Novavax COVID-19 vaccine candidate will go towards Phase I and Phase II trials as well as manufacturing costs.
FTC accepts proposal for AbbVie to acquire Allergan for $63 billion
AbbVie and Allergan have announced the Federal Trade Commission has accepted AbbVie's pending acquisition of Allergan for $63 billion.
Triple antiviral drug combination shows early promise for treating COVID-19 in Phase II trial
A Phase II clinical trial has shown that a two-week course of interferon beta-1b plus lopinavir-ritonavir and ribavirin, started within seven days of showing COVID-19 symptoms, is safe and effective.
FDA approves Tabrecta for treatment of metastatic non-small cell lung cancer
The FDA has approved Tabrecta (capmatinib) for patients with metastatic non-small cell lung cancer whose tumours have a mutation that leads to MET exon 14 skipping.
Multi-arm, multi-stage clinical trials the way forward for Parkinson’s research, says study
According to a new review, multi-arm and multi-stage clinical trials should be used to evaluate potential Parkinson's treatments.
EMA to fast-track development of COVID-19 vaccines and therapeutics
The EMA has announced new regulatory changes that will help potential COVID-19 vaccines and therapeutics accelerate through development.
CEPI calls for proposals to apply for COVID-19 vaccine funding
CEPI has announced it is urging organisations to apply for funding for the development and manufacturing of potential COVID-19 vaccines.
