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NIH halts COVID-19 convalescent plasma trial
The trial evaluating COVID-19 convalescent plasma as a treatment for COVID-19 patients with mild to moderate symptoms was stopped due to ineffectiveness.
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Biologics
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Merck to manufacture Janssen’s COVID-19 vaccine
Merck has entered into multiple agreements to support the expansion of the supply of COVID-19 medicines and vaccines.
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Application sheet: Mobile testing LabPODs
Readily deployable, fully integrated mobile testing labs for fast-track delivery of diagnostic and analytical lab capability where and when needed.
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Whitepaper: Transmissible disease defense unit
The use of flexible mobile biocontainment and test units to prevent the spread of transmissible diseases.
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Case study: Oxygen monitoring during shelf life
A stability study that provides an opportunity to extend the product shelf life, by optimising the formulation and/or product packaging.
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COVID-19 treatments update: hydroxychloroquine and tocilizumab
Find out what the WHO has to say about the use of hydroxychloroquine in COVID-19 prevention and the results of a severe COVID-19 pneumonia trial with tocilizumab.
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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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Tezepelumab significantly reduces exacerbations of severe asthma
In a Phase III trial, tezepelumab was shown to meaningfully reduce annualised asthma exacerbation rates in a range of patients with severe, uncontrolled asthma.
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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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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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Ide-cel provides lasting remissions in multiply-relapsed myeloma
BMS and bluebird bio have applied to the FDA for approval of ide-cel as a standard therapy for relapsed or refractory multiple myeloma based on positive Phase II trial results.
