This week we highlight a series of moves by the Food and Drug Administration related to COVID-19 treatments, Alzheimer’s and CBD. We also look at contract research organizations and a robotics manufacturing partnership in cell and gene therapy, as well as sentiment in the biotech funding space. Each week we highlight five things you need to know about in the life sciences industry. Here’s the latest.
Pfizer and FDA disagree on Paxlovid treatment course
Some patients experienced a relapse of COVID-19 symptoms after taking Pfizer’s antiviral Paxlovid. While the company has indicated a second course of the antiviral is appropriate in this situation, the FDA has rebuked this claim. “There is no evidence of benefit at this time for a longer course of treatment … or repeating a treatment course of Paxlovid in patients with recurrent COVID-19 symptoms following completion of a treatment course,” said John Farley, M.D., director of the Office of Infectious Diseases. Pfizer is forecasting $22 billion in sales of Paxlovid in 2022.
FDA permits marketing of in vitro test to diagnose Alzheimer’s
The FDA has permitted the marketing of a new test to improve diagnosis of Alzheimer’s. Following a series of disappointing outcomes related to the drug Aduhelm, Alzheimer’s research needs a new win. The new treatment is the first in vitro diagnostic test for early detection of amyloid plaques associated with Alzheimer’s. It can potentially eliminate the need for PET scans.
FDA cracks down on companies illegally marketing CBD and delta-8 THC products
The FDA is cracking down on companies illegally marketing CBD and delta-8 THC products. Per the FDA, its warning letters address the illegal marketing of unapproved delta-8 THC products by companies as treatments for various medical conditions or for other therapeutic uses. There are no FDA-approved drugs containing delta-8 THC. Any delta-8 THC product claiming to diagnose, cure, mitigate, treat or prevent diseases is considered an unapproved new drug.
Prominent CROs partner with robotics manufacturing firm on cell and gene therapies
Multiply Labs, a robotics manufacturing company, is seeing continued success in its cell therapy production process after enrolling two prominent CROs, Thermo Fisher and Charles River Labs. Fred Parietti, co-founder and CEO of Multiply Labs explained, “There is a gigantic mismatch between demand and supply in cell therapy. Manufacturing processes for currently approved cell therapies like CAR-Ts already struggle to keep up, and, with hundreds more clinical prospects moving through trials, it’s clear that you need a new technology. We just believe that robotics technology is both faster and more efficient.”
Mixed sentiment on M&A as biotech valuations fall
As biotech valuations drop, big pharma isn’t immediately snapping up small biotechs. While there has been some activity, such as GSK’s $1.9 billion acquisition of Sierra Oncology, there is yet to be a significant uptick. Many big pharma companies are focused on emerging technologies and the right fit, which may or may not correspond with small biotechs that are cash strapped.
