This week we look at comments from acting Food and Drug Administration commissioner Janet Woodcock on perceptions that the agency is getting tougher on drug companies during the approval process. We also highlight new uses of CRISPR to control gene expression, venture funds focused on life sciences, newly approved remote monitoring devices and a $17 billion dollar clinical research organization acquisition.
Each week, we highlight five things you need to know about in the life sciences industry. Here’s the latest.
1. Acting FDA commissioner states that the agency is not getting tougher on approvals
Despite comments from investment bank SVB Leerink to the contrary, FDA acting commissioner Janet Woodcock expressed that she does not feel that the FDA is being tougher on approval decisions and stressed weighing the needs of patients against the risks of easing approvals. She also talked about challenges facing the agency as it works through a backlog of over 1,000 inspections that were delayed because of the pandemic.
2. Using CRISPR to switch genes on and off without editing the underlying DNA
CRISPR-Cas9 is a technology that has dramatically simplified gene editing, opened up new avenues for genetic therapies and won two inventors the 2020 Nobel Prize in chemistry. As scientists look for new uses of the technology and for ways to leverage it more safely, they have made a number of important new discoveries. This article looks at new research from MIT and UCSF that used CRISPR to turn genes on and off without needing to edit the underlying DNA.
3. New $100 million venture fund focuses solely on early stage life sciences companies
Building off the success and investor base of its first $25 million investment vehicle, Rapha Capital Management announced last week their first venture fund with a goal of raising $100 million. The fund will lead early stage investments focused on revolutionizing medicine, health care and biotech sectors. The announcement provides a strong tailwind for continued growth in the startup life sciences industry after a record year of investment.
4. FDA approves two remote patient monitoring devices
The FDA recently announced the approval of two remote patient monitoring devices from Masimo and MyHomeDoc, this Fierce Biotech piece explains. Masimo’s device is designed to be used in a hospital and allows for the continuous monitoring of CO2 levels as the patient moves throughout the hospital. MyHomeDoc’s is a handheld device equipped with an array of sensors, designed to be used by patients at home to examine various parts of the body, body temperature and oxygen saturation levels. Both devices are a step toward more affordable and easy-to-use remote patient monitoring.
5. CRO PPD gets a $17.4 billion valuation as it is acquired by Thermo Fisher
Thermo Fisher Scientific has announced that it will acquire clinical research organization PPD for $17.4 billion. This acquisition will be a complement to its acquisition of drug manufacturer Patheon NV in 2017 and enables Thermo Fisher to support all stages of drug development.
