STAT+: Pharmalittle: We’re reading about FDA warnings on CAR-T drugs, a Sanofi deal, and more
The FDA is requiring manufacturers of CAR-T cancer therapies to add a serious warning on the prescribing information about the risk of T-cell malignancies.
Good morning, everyone, and how are you today? We are doing just fine, thank you, despite some cloudy skies hovering overhead. Given that a much-welcomed thaw, of sorts, is under way, there is no need to complain. Of course, some subscribe to the notion that to live is to complain, but we will ignore the philosophers today. Instead, we will reach for another delicious cup of stimulation to brighten our mood. Our choice today is crème brûlée. Please feel free to join. Meanwhile, we have assembled the latest list of interesting items for you to peruse. We hope you have a simply smashing day, and do keep in touch. We have adjusted our settings to accept postcards and telegrams. …
In a bid to expand its pipeline of inflammation-targeting drugs, Sanofi is acquiring Inhibrx in a deal worth up to $2.2 billion, STAT writes. The core of the deal is an experimental therapy for AATD, a disease that progressively damages the lungs and liver. The medicine is designed to reduce inflammation and stave off further damage to the tissue. The acquisition comes as Sanofi seeks to bolster its stable of drug candidates and convince investors it is on the right track. In October, chief executive officer Paul Hudson announced Sanofi was abandoning future profit guidance and was upping investments in its own research programs, a pivot that sent its stock down about 19% in one day.
The U.S. Food and Drug Administration is requiring several manufacturers of CAR-T cancer therapies to add a serious warning on the prescribing information, Reuters notes. In letters to the companies, the agency explained it had identified adverse events and clinical trial reports describing T-cell malignancies. The FDA said it considered the risks of T-cell malignancy, which refers to a group of blood disorders including lymphoma and leukemia, resulting in hospitalization and death, to be applicable to all therapies in the category. Since 2017, six CAR-T cell therapies have been approved by the FDA.
What's Your Reaction?
