This week we spotlight the Food and Drug Administration’s improved decision times on 510(k) submissions. We also delve into a clinical trial that shows the effects of pitavastatin calcium on reducing cardiovascular events in people with HIV, as well as artificial intelligence systems for accurate blood ... READ MORE >
FDA
5 things to know in life sciences: Week of June 19, 2023
This week we spotlight the significant uptick in biotech layoffs in the first quarter as well as the European Commission's strategic postponement of the new Medical Device Regulation. Additionally, we delve into recent groundbreaking approvals encompassing two innovative oral medications for pediatric ... READ MORE >
5 things to know in life sciences: Week of June 12, 2023
This week we're tracking new COVID-19 booster strategies targeting the XBB variant, Moderna's move into mRNA therapies for rare diseases, U. S. Food and Drug Administration guidelines to safeguard tattoo inks, challenges for European medical device startups, and a Scottish startup's pilot telerobot ... READ MORE >
5 things to know in life sciences: Week of May 22, 2023
This week we look at how artificial intelligence is revolutionizing voice banking for patients with conditions like amyotrophic lateral sclerosis, also known as ALS. In addition, we highlight proposed prescription drug transparency in Medicaid and how the Food and Drug Administration has changed its ... READ MORE >
5 things to know in life sciences: Week of May 8, 2023
This week we look at a paper published by the U.S. Food and Drug Administration related to artificial intelligence. We also highlight a statement from the World Health Organization declaring that mpox is no longer a global health emergency, a venture fund focused on blood-related research, and an effort ... READ MORE >
5 things to know in life sciences: Week of April 24, 2023
This week we look at a World Health Organization meeting on mRNA, using artificial intelligence to streamline clinical trials, Food and Drug Administration approval of a new blood cancer treatment and an upcoming Johnson & Johnson spinout. Finally, we highlight the resumption of a phase 2 trial on an ... READ MORE >
5 things to know in life sciences: Week of April 17, 2023
This week we look at a range of topics in the life sciences industry, from drug pricing negotiations and long-COVID-19 treatment to quantum computing in drug development. Each week we highlight five things affecting the life sciences industry. Here's the latest. Drug pricing negotiation policies are ... READ MORE >
5 things to know in life sciences: Week of April 3, 2023
This week we highlight the impact of emerging biopharma on the life sciences industry, a new method for delivering gene therapy, an innovative device to improve safety and sleep quality in infants, and a cutting-edge treatment for vision loss caused by age-related macular degeneration. Finally, we look at ... READ MORE >
5 things to know in life sciences: Week of March 27, 2023
This week we look at new cybersecurity standards for medical devices, a newly identified trigger for mood disorders, an implantable insulin delivery system and the exit of a major player in the race for an RSV vaccine. Finally, we continue to watch developments in diversity considerations for clinical ... READ MORE >
5 things to know in life sciences: Week of March 6, 2023
This week we look at manufacturing investments taking place in life sciences, the Food and Drug Administration’s first Safer Technologies Program approval as well as the agency’s first full approval of a COVID-19 rapid antigen test. Finally, we highlight a story on the thriving canine population of ... READ MORE >