Covering Food and Drug Commerce and Safety
Double Trouble for Cancer Tumors: The Dual-Action Immunotherapy Breakthrough
A new molecule, ABBV-CLS-484, developed by TIDE, AbbVie, and Calico Life Sciences, offers a unique dual-action approach against cancer by enhancing tumor susceptibility and boosting immune cell potency,
Diversity in Early-Phase Cancer Trials Improved Since 2000
The researchers found that the proportion of patients aged 40 to 64 years at enrollment decreased from 59.8 percent in 2000-2003 to 47.5 percent in 2020-2022, with simultaneous increases in ages 65 to 74 years
Predictions of the effect of drugs on individual cells are now possible
Experts from ETH Zurich, the University of Zurich, and the University Hospital Zurich have used machine learning to jointly create an innovative method to predict how individual cells react to specific treatments
ALX Oncology (ALXO) Up 56% on Upbeat Gastric Cancer Study Data
Data from the study showed that patients in the evorpacept-combination treatment arm confirmed an overall response rate (“ORR”) of 52%, compared to the 22% ORR achieved in the control group arm.
Celltrion's Humira biosimilar receives FDA approval for new doses
Yuflyma is a copycat version of AbbVie’s blockbuster drug Humira, used to treat many inflammatory conditions in adults such as rheumatoid arthritis and psoriatic arthritis.
Eton Pharmaceuticals Announces Acquisition of FDA-Approved Ultra-Rare Disease Product Nitisinone
Nitisinone market estimated to be more than $50 million annually
Inhibikase Therapeutics Receives FDA Orphan Drug Designation for Risvodetinib for the Treatment of Multiple System Atrophy
There are currently no approved symptomatic or disease-modifying therapies for MSA on the market. MSA is an aggressive form of Parkinsonism
Pixel 8 Pro Thermometer works on objects, under FDA review for people
Google has submitted the Pixel 8 Pro Thermometer to the U.S. Food and Drug Administration (FDA) to take body readings and will add that capability to the app once approved.
BioXcel shares jump 9% following update on FDA meetings, patents
The biotech company planned to meet with the FDA to discuss filing for expanded approvals of its anti-agitation drug BCX501, also known as Igalmi or dexmedetomidine.
CAR-NK: Can natural killer cell therapy pick up from where CAR-T left off?
Riding on the success of CAR-T cell therapy, a breakthrough in the treatment of blood cancers, CAR-NK therapies are an emerging field in therapeutic research that aim to boost an even stronger immune response against cancer.