The Food and Drug Administration announced it is investigating whether CAR-T therapy, which uses genetically modified white blood cells to attack tumors, can in rare cases cause lymphoma, a blood cancer. “Although the overall benefits of these products continue to outweigh their potential risks for their approved uses, FDA is investigating the identified risk of T cell malignancy with serious outcomes, including hospitalization and death, and is evaluating the need for regulatory action,” the agency said in a statement. (Seeking Alpha)
The Biden administration urged drugmakers like Sanofi and AstraZeneca to ramp up manufacturing of RSV vaccines to meet demand for the winter season. With RSV cases rising since mid-October, White House officials are hoping to increase vaccinations as well. (Reuters)
Oncology company Novocure said it is laying off 13% of its staff, or around 200 employees, as it cuts $60 million in operating expenses. As part of its refocusing, it will also home in on three trials, TRIDENT, KEYNOTE D58 and LUNAR-2, which are investigating its Tumor Treating Fields therapy. (Endpoints News)
Novavax’s protein-based COVID-19 vaccine has been granted emergency-use listing by the World Health Organization. The move means that all 194 of the agency’s member states can use the Novavax vaccine to protect against COVID in individuals 12 and older. (MarketWatch)
An opinion piece argued that drugmakers need to be more open about a dangerous Alzheimer’s drug side effect. “I am especially worried about drugmakers’ lack of transparency in fully reporting all details of clinical outcomes related to ARIA,” wrote Madhav Thambisetty. (STAT News)
