You probably know some of the classic concussion signs to watch for: Did the person lose consciousness? Appear dazed or confused? Have a change in mood? Research published this morning (like just now at 6 am ET) in Diagnostics has identified a new potential signal: “the spontaneous headshake after a kinematic event,” or SHAAKE. 

You’ve seen people do this — it’s quick, like they’re shaking sand off their head. The study surveyed almost 350 people from a concussion database, showed them videos of athletes doing this, and asked: “Do you remember ever making this type of head motion after a collision?” Most participants were in their mid-twenties, responding about incidents that happened in high school or college. Of course, this isn’t the most rigorous study model — more research will be needed to see how accurately the movement signals a concussion. But in the study, 69% of respondents reported a SHAAKE, and 93% of those reported one in association with concussion at least once.

Novo escalates its fight against compounders

Novo Nordisk has asked the FDA to bar compounding pharmacies from making copies of its blockbuster drugs semaglutide, arguing that the medication is too complex for the pharmacies to safely make.

Some patients have turned to compounded products as the branded drugs have been in shortage and remain financially out of their reach. Novo’s request to the FDA is an escalation of its attempt to stem the wave of compounding that’s arisen, after filing lawsuits against compounders and telehealth companies.

The move comes as Eli Lilly is also engaged in a heated fight of its own against compounders that make copies of tirzepatide.

biotech

First patient dosed with in-vivo CAR-T therapy

From my colleague Jason Mast: Interius BioTherapeutics said it has dosed the first ever patient with an in-vivo CAR-T treatment, beating out several competitors. The treatment, which is being tested first in Australia, is designed as a more tolerable and more scalable version of the cell therapies that have transformed treatment for several blood cancers over the last decade.

Traditional, so-called ex-vivo, treatments require researchers to remove a patient’s immune cells, strap them in the lab with a cancer-homing GPS, and then re-infuse the treatments. It’s expensive and requires patients to receive high doses of chemotherapy to clear out old cells and make room for the old ones. Patients also have to wait for the treatment to be manufactured.

The hope is that, with in-vivo CAR-T treatments, researchers can transform a patient’s cells into cancer-fighting drones while they remain nestled safely in the patient’s body. Interius uses a heavily neutered and modified HIV virus, delivered via IV infusion. Umoja Biopharma, which also recently received clearance to start a trial, uses a similar technology, as does Kelonia. Some companies are also trying to use lipid nanoparticles, the bubbles of fat used in Covid vaccines and CRISPR treatments.

Although Interius’s preclinical data has generated excitement, experts caution the technology remains a long way from market. Another alternative, more scalable version of CAR-T  — called allogeneic or off-the-shelf CAR-T — generated significant hope years ago, before delivering mixed results in clinical trials.