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First person enrolled in Phase I oncolytic virus trial
The Phase I/IIa trial of BT-001 will assess the safety and efficacy of the virus’ dual mode of action in solid tumours.
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FDA approves the Janssen COVID-19 Vaccine for emergency use
The FDA has issued an Emergency Use Authorization for the single-dose Janssen COVID-19 Vaccine, making it the third COVID-19 vaccine available for use in the US.
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EMA recommends six medications for approval in February meeting
The EMA’s committee adopted positive opinions of six medications, including two orphan drugs, and concluded its review of the use of REGN-COV2 – an investigational antibody therapy for COVID-19.
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EMA issues its requirements for adapting COVID-19 vaccines for viral variants
The European Medicines Agency has set out its guidelines for vaccine manufacturers adapting their approved COVID-19 vaccines to combat viral variants.
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Leukine® significantly improves lung function in hospitalised COVID-19 patients
In the trial Leukine® (sargramostim, rhuGM-CSF) improved oxygenation in COVID-19 patients with acute respiratory failure by at least a third in over half of those treated.
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EMA COVID-19 treatment evaluations update
The EMA has begun a rolling review of Celltrion’s regdanvimab (CT-P59) antibody for COVID-19 and assessing new data on Veklury (remdesivir).
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FDA approves more flexible transportation conditions for Pfizer-BioNTech COVID-19 vaccine
Based on new stability data, the US regulator will allow COMIRNATY® to be transported and stored at standard pharmaceutical freezer temperatures for up to two weeks.
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New variant-specific mRNA COVID-19 vaccine to enter clinical trials
Moderna has shipped the trial material for its mRNA-1273.351 vaccine candidate to the US National Institutes of Health for Phase I trials.
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FDA grants Priority Review to Pfizer’s tick-borne encephalitis vaccine TicoVac™
If approved, TicoVac would be the first vaccine in the US to help protect adults and children from tick-borne encephalitis.
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Sanofi and GSK start Phase II study of their COVID-19 vaccine candidate
The dose finding study will assess the safety, reactogenicity and immunogenicity of the companies’ investigational COVID-19 vaccine in 720 participants.
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Patient dosed with first Lassa fever vaccine to reach human trials
The first trial participant has been given INO-4500 in Ghana - INO-4500 is a DNA vaccine candidate being developed to protect against Lassa fever.
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EMA’s transformative treatments of 2020
In this article, we summarise the trial findings for the European Medicines Agency’s 13 most transformative therapies of 2020.
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Janssen submits for WHO Emergency Use Listing of COVID-19 vaccine
If granted Emergency Use Listing by the World Health Organization (WHO), up to 500 million doses of Janssen’s single-dose COVID-19 vaccine could be distributed under COVAX.
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EU doubles its COVAX contribution, promising €1bn for safe and effective COVID-19 vaccines
The addition of €500 million to the EU’s existing COVAX Facility pledge was announced at the G7 summit virtual leaders' meeting.
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IMU-838 shows some clinical benefit in moderate COVID-19 patients
The oral treatment slightly shortened time to clinical improvement and recovery in a Phase II trial, with greatest benefits in high-risk and elderly COVID-19 patients.
