R&D,Bioprocess,Clinical Development,Weekly Roundups

Weekly News Round-up – 24/4/20

Proventa International Weekly News 4 years ago By Josh Neil
Proventa International Weekly News

This week saw a slight slowdown of the big news we’ve come to expect over the last few months, with only minor changes to the ever-shifting coronavirus front. That said, two of the Covid-19 treatment forerunners saw big announcements as trials continue. Gilead’s Remdesivir allegedly provides no benefit for Covid-19 patients, a leaked WHO document suggests. Meanwhile hydrocychloroquine has begun large-scale trials even as new information suggests it could raise death rates in Covid patients. In other news, the FDA has sped up Kymriah’s development; and suspicion of aducanumab for FDA approval has been delayed due to Covid-19. 

REMDESIVIR GIVES NO BENEFIT FOR CORONAVIRUS PATIENTS – Gilead’s antiviral medicine has no impact on Covid-19, leaked documents have shown. A draft manuscript accidentally posted to the WHO’s website noted that the drug neither improved patients’ conditions nor prevented them from dying. Gilead has since claimed that the study did show a ‘potential benefit’, and that the WHO post included ‘inappropriate characterisation of the study’. It should be noted, however, that the study was terminated prematurely, and the manuscript lacks context. Additionally, no peer-review was conducted on the paper. 

FDA SPEEDS UP KYMRIAH DEVELOPMENT IN FOLLICULAR LYMPHOMA – the FDA is providing extra support to Novartis in the creation of its CAR-T cell therapy Kymriah. The follicular lymphoma drug has been labelled an advanced regenerative medicine, possibly seeing a faster six-month FDA review. The support was granted based on preliminary evidence from a phase 2 trial determining drug efficacy and safety. 

LARGE-SCALE TRIAL OF HYDROXYCHLOROQUINE PLANNED – Novartis is set to begin a large-scale trial of Covid-19 drug hydroxychloroquine after smaller trials failed to produce conclusive results about its efficacy. It was also recently revealed that the drug could in fact increase chance of death in patients. The new trial will involve around 440 patients, with intellectual property to be made available to support broad access to the drug should it prove efficacious. 

In other news: 

R&D

Roche creates new Covid-19 antibody test

Clinical Trials

Submission of Alzheimer drug aducanumab delayed due to Covid-19

MHRA approves Covid-18 vaccine trials in just one working week

That’s all for now. See you next week!

Joshua Neil, Editor
Proventa International

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