Top Ten most popular articles on Pharmafile.com this week
pharmafile | April 24, 2020 | News story | Medical Communications | COVID-19, coronavirus, top 10
Hydroxychloroquine is once again a main feature in the news as it fails a coronavirus clinical trial in France, while the FDA and Novartis have agreed to conduct a similar Phase 3 trial with the drug. Meanwhile, experts at the US National Institutes of Health (NIH) have drafted treatment guidelines for the use of hydroxychloroquine in COVID-19 patients, saying it should not be used due to “potential toxicities.”
In other COVID-19 news, the FDA has warned that they may not be able to sustain its current levels of timely reviews and approvals of marketing applications due to staff being reallocated to working on the coronavirus pandemic, while the regulatory body has also granted emergency clearance to the first in-home COVID-19 testing kit.
The clinical benefit of Gilead’s promising antiviral therapy Remdesivir has been touted in the treatment of severe cases of COVID-19 after anecdotal reports of its success were obtained from a trial conducted at the University of Chicago Medicine.
Novartis has pulled back the curtain on five-year data from an extension trial for its sphingosine 1-phosphate receptor modulator Mayzent (siponimod), supporting its use in the treatment of secondary progressive multiple sclerosis (SPMS).
8. US Government’s BARDA to fund Moderna’s coronavirus vaccine by $483m
Moderna has secured $483 million in funding from the Biomedical Advanced Research and Development Authority (BARDA), to drive development and availability of its messenger RNA (mRNA) vaccine candidate against the novel coronavirus.
7. First in-home COVID-19 testing kit approved by the FDA
The US Food and Drug Administration have granted emergency clearance to the first in-home COVID-19 testing kit.
6. National Institutes of Health says COVID-19 patients should not take hydroxychloroquine
Experts at the US National Institutes of Health (NIH) have drafted treatment guidelines for the use of hydroxychloroquine in COVID-19 patients, saying it should not be used due to “potential toxicities.”
5. Novartis to sponsor large clinical trial of hydroxychloroquine in COVID-19 patients
The FDA and Novartis have agreed to move forward with a Phase 3 clinical trial to evaluate the effectiveness of hydroxychloroquine in COVID-19 patients.
4. BARDA director abruptly leaves post, claims he was ousted over pushback to hydroxychloroquine
Rick Bright has claimed that he has been forced out of his position as the Director of the US Biomedical Advanced Research and Development Agency.
3. Gilead’s remdesivir significantly reduces COVID-19 symptoms in rhesus monkeys in NIH trial
A study from the National Institutes of Health has shed more light on the efficacy of Gilead’s promising antiviral therapy remdesivir in the fight against COVID-19, showing that the drug was able to “significantly reduce” clinical disease and lung damage in rhesus macaque monkeys infected with the novel coronavirus SARS-CoV-2.
2. FDA cautions that drug reviews will be slower due to COVID-19
The FDA has warned that they may not be able to sustain its current levels of timely reviews and approvals of marketing applications due to staff being reallocated to working on the COVID-19 coronavirus pandemic.
1. Hydroxychloroquine fails COVID-19 clinical trial in France
The malaria treatment hydroxychloroquine is facing further scrutiny as a coronavirus treatment after failed trials in France.
Conor Kavanagh
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