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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children should initiate first-in-human clinical trials in adults before undertaking pediatric trials, according to new draft guidance the FDA released last week.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The FDA has released a draft guidance on investigational new drug (IND) submissions by developers of individualized gene therapies that use antisense oligonucleotides (ASO), as part of the agency’s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
China announced that it has granted conditional authorization for one of Sinopharm’s inactivated COVID-19 vaccines, a shot that the state-owned pharma company claimed is 79.3 percent effective according to an interim analysis of its phase 3 trial. Questions remain, however, due to a lack of details from the company. Read More
“Our data clearly show that C21 can restore lung function on top of steroids and normalize gas exchange,” said Vicore CEO Carl-Johan Dalsgaard. Read More
Novavax has launched a phase 3 study in the U.S. and Mexico to evaluate its COVID-19 vaccine candidate, NVX-CoV2373, after deferring the trial for two months because of holdups in securing doses. Read More
The FDA rapped California-based drug manufacturer Sky Systems in a Form 483 with a dozen observations after an inspection revealed the firm lacked a quality control unit. Read More
In 2020, messenger RNA (mRNA), the technology behind Pfizer’s and Moderna’s COVID-19 vaccine, practically became a household word. Now the gate is open for more mRNA vaccines to flood the space. Read More
Swedish drugmaker Vicore Pharma has reported positive results from a phase 2 study evaluating its oral therapy for treating respiratory infection in hospitalized COVID-19 patients. Read More