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 >
FDA
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 >
5 things to know in life sciences: Week of November 15
This week we look at the Food and Drug Administration’s approval of a virtual reality system to treat chronic lower back pain. We also explore a new round of anti-amyloid drugs seeking FDA approval to treat Alzheimer’s disease, a sustainable method to manufacture pharmaceuticals, another deal to license ... READ MORE >
5 things to know in life sciences: Week of November 1
The life sciences industry saw the first meaningful activity around drug pricing reform as Democratic lawmakers included language in their domestic spending package. At the same time, innovation and investment continue to exemplify the life sciences ecosystem. By the way, we’re a little late in getting ... READ MORE >
5 things to know in life sciences: Week of September 27
Telehealth has been one of the big developments in health care brought on by the COVID-19 pandemic. It both promises to make care easier for patients to fit into their busy lives and holds the potential of allowing trials and new treatments to reach people far from the research hospitals in city centers. ... READ MORE >