The company’s original plan was to not apply to regulators until 2023, but now, it plans to submit the drug to the FDA in the next few months, with plans to launch the drug in mid-2023.
BioSpaceIn a perplexing social paradox, diseases that disproportionately affect people of color are frequently also ones that receive less attention from the medical world. Compounding the problem, diseases that affect people across all races often have fewer people of color in clinical trials for new treatments. The reasons for the problem are widely speculated.
Monkeypox outbreaks in Africa are not concentrated among gay men, unlike in other parts of the world, experts from the World Health Organization (WHO) and the Africa CDC said on Thursday.
Novo Nordisk sought to soothe concerns about supplies of its new obesity drug Wegovy on Thursday, saying there was nothing unusual about a slight delay in its availability.
Roche signed a $6 billion-plus collaboration deal with Poseida Therapeutics on blood cancers, while its Alzheimer’s partner, AC Immune, parsed failed data on an Alzheimer’s drug to suggest a positive spin.
Merck’s Keytruda (pembrolizumab) has taken another hit after the drug failed to meet dual primary endpoints in the Phase III KEYNOTE-921 trial for metastatic castration-resistant prostate cancer (mCRPC).
Researchers have found that decay of tissues after death can be halted and cell functions restored based on early experiments in pigs that may eventually help increase the number of transplantable human organs.
BioSpace, GettyWhen Theranos was formed in 2003, it promised to be the end-all and be-all of medical testing, a one-stop diagnostic shop from a single finger-prick of blood. What it actually did, as the world now knows, was perpetrate fraud on a massive scale, fooling its board of directors, investors and – worst of all – the physicians and patients who trusted the company to deliver accurate test results.
Gilead’s total revenue for Q2 increased 1% to $6.3 billion compared to Q2 in 2021. Overall, the company exceeded both its own expectations and the predictions of market analysts for the second quarter.
The Omicron variant may be more efficient at infecting children through the nose than previous versions of the coronavirus, a small study suggests.