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FDA sends warning letter to KVK-Tech manufacturing facility
A warning letter has been sent by the US FDA to KVK-Tech regarding cGMP violations at their drug manufacturing site, including for data integrity.
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Victoria Rees (European Pharmaceutical Review)
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The current and future landscape of HIV treatments and vaccines
Dr Caroline Forkin from ICON discusses the current status of HIV treatments and potential for researchers to develop a vaccine.
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NICE recommends treatment for non-squamous, non-small cell lung cancer
Pembrolizumab with pemetrexed and platinum chemotherapy has been recommended by NICE to treat non-squamous, non-small cell lung cancer.
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J&J submits COVID-19 vaccine data to FDA for emergency authorisation
J&J have submitted Phase III trial data in their application to the FDA for emergency authorisation of their COVID-19 vaccine candidate.
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Intranasal influenza vaccine produces strong immune response, Phase I study shows
A Phase I clinical trial has shown that Ad4-H5-VTN, a single-dose, intranasal influenza vaccine, was safe and produced an immune response.
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UK launches trial to study alternating COVID-19 vaccines for different doses
The UK Government has given £7 million of funding for a clinical trial which will investigate whether patients can be given different COVID-19 vaccines for each dose.
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Is intranasal drug delivery the best way to administer COVID-19 therapeutics?
In this article, we investigate three of the latest developments in COVID-19 therapeutics that are delivered intranasally.
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NICE recommends Beovu (brolucizumab) for treatment of wet AMD
NICE has issued final guidance recommending Beovu (brolucizumab) to treat wet age-related macular degeneration in adults.
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Phase III trial shows Sputnik V COVID-19 vaccine is 91.6 percent effective
An interim analysis from a Phase III trial of the Sputnik V vaccine has shown it is effective against symptomatic COVID-19.
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COVID-19 clinical trials have risen by 639 percent, says report
New findings have shown that there are currently over 4,000 clinical trials taking place investigating potential COVID-19 therapies.
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EMA initiates rolling review of Regeneron’s COVID-19 mAb
The EMA's CHMP has begun a rolling review of REGN-COV2, Regeneron's COVID-19 antibody candidate, after successful pre-clinical trials.
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J&J COVID-19 vaccine shows success in interim analysis of Phase III trial
An interim analysis has shown that the COVID-19 vaccine developed by J&J is safe and effective at preventing the coronavirus in adults.
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AstraZeneca to provide EU with extra nine million doses of COVID-19 vaccine following dispute
After manufacturing delays, AstraZeneca will now provide the EU with the 40 million COVID-19 vaccine doses it originally agreed to supply.
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UK Government orders 100 million doses of Valneva COVID-19 vaccine
The UK Government has ordered a further 40 million doses of Valneva’s COVID-19 vaccine candidate, to be manufactured in Scotland.
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CEPI offers $140 million to support research on COVID-19 vaccines
CEPI has opened a new funding opportunity, providing up to $140 million to support additional clinical research on COVID-19 vaccines.
