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US closes enrolment in two COVID-19 antibody studies due to futility
The sub-studies evaluating VIR-7831 and BRII-196 with BRII-198 have stopped enrolment based on recommendations from the Data and Safety Monitoring Board.
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Biologics
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Experimental immunotherapy significantly delays onset of type 1 diabetes
If approved for use, teplizumab could be the first drug able to delay the onset or completely prevent type 1 diabetes in at-risk groups.
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EMA begins rolling review of Sputnik V COVID-19 vaccine
The EU regulator has begun reviewing preclinical and early trial data for Sputnik V, the COVID-19 vaccine developed by Russia.
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Whitepaper: Early product characterisation mitigates risks in biologics development
Product characterisation facilitates easier process design to ensure the biological drug attains critical product safety, purity, and potency.
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Video series: The champions of iCON: A collaborative discussion on global turnkey solutions (Part 2)
iCON has improved delivery capacity by standardising the infrastructure for a flexible and readily available drug manufacturing facility.
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Video series: The champions of iCON: A collaborative discussion on global turnkey solutions (Part 1)
iCON has improved delivery capacity by standardising the infrastructure for a flexible and readily available drug manufacturing facility.
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On-demand webinar: Key elements of a sterility assurance program
This on-demand webinar will provide aspects of a sterility assurance program for a pharmaceutical product. Sterility assurance begins at the early stages of product development and follows through the entire product lifecycle.
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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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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.
