The FDA has released final guidance offering details on how drugmakers and sponsors should prepare and submit pediatric study plans. According to the guidance, sponsors required to submit initial pediatric study plans must do so within 60 calendar days after the end-of-Phase 2 meeting, or at a time agreed on by the company and the FDA.
Eli Lilly and Co. has launched a late-stage trial to evaluate whether its investigational antibody drug can prevent coronavirus infections or COVID-19 in staff or residents of nursing homes exposed to someone with COVID-19. The novel trial will be conducted with the help of the NIH through its COVID-19 Prevention Network.
The Svalbard Global Seed Vault in Germany is launching a 100-year seed experiment that will involve storage of experimental seed samples from five gene banks in liquid nitrogen at minus 196 Celsius to impede the ageing process for barley, cabbage, lettuce, pea and wheat. "This experiment is one of its kind. It will provide future generations with valuable information about seed viability and more precise knowledge of how often seeds need to be regenerated," said Asmund Asdal, seed vault coordinator for Nordic Genetic Resource Center, the gene bank managing the project.
The FDA has developed regulations that allow pharmaceutical companies to use advanced manufacturing techniques to expedite production of COVID-19 treatments and vaccines, according to Commissioner Stephan Hahn and Deputy Commissioner for Medical and Scientific Affairs Anand Shah. The regulations focus on using new technology in public health emergencies, examining technical concerns when manufacturing gene therapies and helping companies develop control processes for continuous manufacturing before drugs are submitted for approval.
The Canadian government has signed supply deals with Moderna and Pfizer and its partner BioNTech for the delivery of millions of doses of their companies' experimental coronavirus vaccines as part of the country's push to obtain vaccines. Canada has also funded projects such as the vaccine candidate of Quebec's Medicago while also approving a trial to be conducted locally for China's CanSino Biologics, although all vaccine candidates will still require regulatory approval from Health Canada.
A vaccine based on a modified Ad26 virus prevented SARS-CoV-2 infection in monkeys, and Johnson & Johnson is testing it in safety trials in the US and Europe. None of the six monkeys given a single dose of the vaccine developed lung disease when subsequently exposed to the virus, and nasal swabs were clear in five, researchers reported in Nature.
Protection from SARS-CoV-2 lasted for at least 13 weeks in rhesus monkeys given a two doses of a vaccine four weeks apart. The vaccine, developed by Inovio Pharmaceuticals, also reduced viral load in the monkeys' lower lungs and nasal passages, the company reported.
Elevated oxytocin levels have been found in memory-related areas of the brains of people who had Alzheimer's disease, but a study in mice showed that the hormone could help prevent memory loss associated with Alzheimer's. Male mouse brain samples treated with both toxic beta-amyloid and oxytocin did not lose synaptic plasticity, but oxytocin alone did not improve synaptic plasticity.