LONDON – Conflicting data from around the world on the extent to which the Delta variant of SARS-CoV-2 is reducing the effectiveness of vaccines is generating uncertainty over the need, or not, for booster programs.
The Biden administration’s plan to roll out COVID-19 boosters by Sept. 20 could get pushed back – pending the outcome of an FDA advisory committee meeting and how quickly the FDA acts on the adcom’s recommendation. Peter Marks, director of the FDA's Center for Biologics Research and Evaluation, announced Sept. 1 that the agency will convene its Vaccines and Related Biological Products Advisory Committee for a virtual meeting Sept. 17.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Coherus, Entos, Harbour, Innovative Cellular, Janssen, Junshi, Medincell, Merck, Neuren, Teva.
Ventura Capital has led a $60 million series A investment round into consumer genetic testing company Dnanudge Ltd. It is the first major fundraising round for the London-based company, which will be used to accelerate deployment of its DNA testing service worldwide. Dnanudge is aiming to tap into the lucrative consumer DNA testing market with Dnaband, a wearable device that stores digital DNA and helps users make healthier choices by personalizing shopping behaviors. The company is also planning a service for personalized skincare shopping.
A look at the COVID-19 cases and deaths globally and on a weekly basis suggest that the world is not doing any better than it was this time last year, even though numerous vaccines are now authorized and approved.
LONDON – One in seven children and young people who have COVID-19 go on to develop symptoms of Long COVID, according to the first cut of data from a large national study involving 6,804 participants ages 11 to 17 who had PCR tests between January and March this year.
The race to develop better antivirals for COVID-19 is heating up after Pfizer Inc. and Merck & Co. Inc. pushed ahead with clinical development of late-stage candidates, while Rigel Pharmaceuticals Inc. announced encouraging midstage data.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: AC Immune, Adial, Amarin, Axerovision, Bayer, Curevac, Genentech, Gennova, Gensight, GSK, HDT, J&J, Nocion, Pharmaxis, Poseida, Roche, Senhwa, SK Bioscience, Tauriga.
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