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The UK’s National Health Service (NHS) will begin treating adult COVID-19 patients in intensive care with Roche’s and Sanofi’s arthritis medications following positive trial results that showed the drugs were highly effective when given early enough. Read More
Multiple COVID-19 vaccine developers are expected to file for regulatory approval in the coming months as the global pandemic continues its relentless advance. Read More
A study carried out by the University of Texas Medical Branch and Pfizer has found that the drugmaker’s COVID-19 vaccine still protects against a viral mutation that’s raised concerns around the world, though more research is needed. Read More
India’s Bharat Biotech has finalized enrollment for a phase 3 trial of its COVID-19 vaccine, Covaxin, which Indian regulators approved Jan. 3 for emergency use. Read More
A small randomized trial in Argentina has found that the early use of convalescent plasma in COVID-19-infected adults helped to reduce progression to severe disease. Read More
Scientists are closely monitoring the potential impact of mutations of the SARS-CoV-2 virus on the effectiveness of COVID-19 vaccines, but for the moment the new strains don’t appear able to completely evade their protective effect. Read More
Sponsors of human gene therapy (GT) products for neurodegenerative diseases affecting adults and children should initiate first-in-human clinical trials in adults before undertaking pediatric trials, according to new draft guidance the FDA released last week. When pediatric trials must be conducted first, sponsors should provide a rationale for why adult studies are not ethical or feasible, the guidance says. Read More
Regeneron’s CEO stated that “the clinical efficacy data are based on a small data set of events and cannot be viewed as conclusive at this stage.” Read More
The FDA has released a draft guidance on investigational new drug (IND) submissions by developers of individualized gene therapies that use antisense oligonucleotides (ASO), as part of the agency’s ongoing efforts to encourage orphan drugs. Read More
Researchers at China’s Shenzhen Institutes of Advanced Technology have found that pralatrexate, a chemotherapy drug used to treat lymphoma, may hold potential as a COVID-19 treatment and that it outperforms remdesivir in inhibiting the virus. Read More
Regeneron has released positive initial results from an ongoing phase 1/2/3 study evaluating its antibody cocktail, casirivimab and imdevimab, in hospitalized COVID-19 patients who require low-flow oxygen. Read More