Clinical

Image: Shutterstock (Shutterstock)An extra dose of vitamin D probably won’t make the average person’s bones any stronger. New research from a large-scale, placebo-controlled, and randomized clinical trial out Wednesday has found no evidence that taking vitamin D supplements reduces the risk of bone fractures in healthy older adults.The study comes from researchers at the Brigham and Women’s Hospital, an affiliate of Harvard Medical School in Massachusetts. The team looked through data from an existing research project:…

Image: Shutterstock (Shutterstock)A novel nasal spray treatment appears to show promise in quickly clearing the coronavirus that causes covid-19 from our nostrils. In a recent Phase III trial in India, the spray was found to significantly reduce people’s nasal viral load within days and at a faster rate than those who receiveda placebo. Treated people also tested negative for the virus on a swab test faster than the placebo group.The potential treatment is being primarily developed by the Canadian company SaNOtize, with…

SAN JOSE, Calif.—A federal jury convicted Ramesh “ Sunny” Balwani, the former top lieutenant to Theranos Inc. founder Elizabeth Holmes, on all 12 charges that he helped perpetuate a yearslong fraud scheme at the blood-testing startup.The verdict is the second conviction against Theranos leadership and comes six months after a jury found Ms. Holmes guilty of fraud; it secures another major victory for the U.S. government, which brought the case against the pair…

SAN JOSE, Calif.—A federal jury convicted Ramesh “ Sunny” Balwani, the former top lieutenant to Theranos Inc. founder Elizabeth Holmes, on all 12 charges that he helped perpetuate a yearslong fraud scheme at the blood-testing startup.The verdict is the second conviction against Theranos leadership and comes six months after a jury found Ms. Holmes guilty of fraud, securing another major victory for the U.S. government, which brought the case against the pair in…

Doctors in some countries are frequently prescribing a Covid-19 antiviral from Merck & Co., as safety concerns about a more effective pill from PfizerInc. mixing with other medications take on greater importance than elsewhere. Merck’s drug, which it developed with Ridgeback Biotherapeutics LP, has been administered to patients more than Pfizer’s Paxlovid in Australia, Japan and Italy, despite research showing Paxlovid to be much better at keeping people out of hospitals. Doctors in some countries are frequently…

Future COVID-19 vaccine boosters won’t have to go through a traditional, lengthy clinical trial process to attain emergency use authorization in the U.S., according to a report in Reuters. An agency official, speaking to the publication today, said that the U.S. Food and Drug Administration (FDA) will instead rely on data from trials on shots developed earlier in the pandemic to combat specific virus variants as well as manufacturing data in considering whether to clear boosters for…

A official said vaccine makers won't need to carry out fresh clinical trials to receive approval for booster shots they're updating for newer Omicron variants. Dr. Peter Marks, who runs the FDA's Center for Biologics Evaluation and Research, told the agency will use data from trials for vaccines that target BA.1 — the Omicron variant that caused a huge surge in infections last winter — as well as manufacturing data to assess the vaccines. Safety data and preclinical data from animal studies may also be used.  This…

COVID-19 vaccine manufacturers won’t need to conduct new clinical trials as they develop booster shots targeting the most recent variants of the virus, a Food and Drug Administration official told Reuters. The agency will use clinical trials of variant-specific boosters developed earlier in the pandemic, manufacturing data, and animal studies to evaluate the shots. The omicron variant of the virus has developed into multiple lineages. Right now, the BA.4 and BA.5 variants are the most widespread in the United States.…

A gentle introduction to the growing field of clinical data sciencePhoto by Owen Beard on UnsplashIn this article and other series to follow, I’ll be digging deep into the nitty-gritty of clinical data science.The major points discussed in this series are outlined below;Introduction to clinical data scienceClinical data science and related fieldsSources of clinical dataRegulatory constraintsWhat is clinical data scienceClinical data science is a domain that focuses on applying data science to healthcare with the goal of…

The fate of Ramesh “Sunny” Balwaniis now in the hands of a dozen jurors after a federal judge on Friday handed them the criminal-fraud case with instructions to decide whether the former Theranos Inc. president deceived investors and patients in a high-profile Silicon Valley saga.The conclusion of testimony and arguments in the white-collar case follows a marathon four days of closing arguments. Mr. Balwani’s defense spent more than 11 hours making its case to the jury that Mr. Balwani, who was the longtime chief…