This week we highlight a Food and Drug Administration approval for an alternative to LASIK, promising results for a less invasive brain interface device and a precision biotech who has recently raised an additional $100 million in funding. Finally, we look at additional FDA approvals for a wearable ... READ MORE >
FDA
5 things to know in life sciences: Week of March 7, 2022
This week we highlight changes in drug exclusivity, international mRNA manufacturing expansion, clinical trial challenges in Russia, and recent Food and Drug Administration activities. Each week we highlight five things you need to know about in the life sciences industry. Here’s the latest. Top 10 ... READ MORE >
5 things to know in life sciences: Week of Feb. 28, 2022
This week we highlight clinical holds on cell and gene therapies, clinical trials and patient experience, artificial intelligence and identifying bone fractures, and more. Each week we highlight five things you need to know about in the life sciences industry. Here’s the latest. Cell and gene therapies ... READ MORE >
5 things to know in life sciences: Week of Feb. 14, 2022
This week, we highlight Moderna’s contract extension with Rovi, a recent report that indicates the global contract development and manufacturing organization (CDMO) market is expected to grow by over $8.65 billion by 2026, Robert Califf’s return as Food and Drug Administration commissioner, an artificial ... READ MORE >
5 things to know in life sciences: Week of Feb. 7, 2022
This week we highlight regulatory challenges for the United States and China; a softening of guidelines in the prescription of opioids; and record-breaking sales figures for Pfizer as it sees a more than 600% increase in vaccine revenue. Finally, we look at a new cartilage implant inspired by spiders and ... READ MORE >
Biopharma business outlook: Spring 2022
Drug approvals in 2021 continued at a pace consistent with prior years, but a large backlog of inspections is slowing some approvals. Cell and gene therapies investment is growing rapidly and promises substantial revenue growth in the coming years. Read about other sectors 2021 FDA approvals ... READ MORE >
The need for regulatory framework modernization: Spring 2022 medtech outlook
Having a well-defined pathway to quickly review and provide clearance for low-risk devices will help alleviate the backlog and shift resources to more critical and high-risk device applications. As the pace of innovation increases and the number of novel devices brought to market continues to grow, ... READ MORE >
5 things to know in life sciences: Week of Jan. 31, 2022
This week, we highlight a breakthrough tubeless insulin pump which received Food and Drug Administration clearance. We also look at a telehealth pharmacy booming during the pandemic, potential breakthroughs in neurovascular research, the disparity of Asian scientists’ contributions and recognition in ... READ MORE >
5 things to know in life sciences: Week of Jan. 17, 2022
This week, we look at antimicrobial-resistant diseases, their toll on health systems globally and the need for new treatments. We also feature the continued delays in Food and Drug Administration inspections, the demand for decentralized trials, as well as medtech's initial public offerings and their ... READ MORE >
5 things to know in life sciences: Week of Jan. 3
This week we explore a partnership between a large biopharma and a machine learning startup. In addition, we look at a non-commercial approach to address the global COVID-19 vaccine shortage, a major mRNA-focused acquisition, a temporary pause on factory inspections, and finally, 55 new drug approvals in ... READ MORE >