Morning Briefing
Summaries of health policy coverage from major news organizations
Ovarian Cancer Is A Misnomer And Could Be Easily Prevented
Kira Wynn will do almost anything to avoid ovarian cancer, which killed her mother. “My mom thought she’d pulled a muscle in her side,” Ms. Wynn said. Her mother’s doctor, she added, “told her to do physical therapy.” As is often the case with ovarian cancer, Ms. Wynn’s mother’s disease was already at an advanced stage when she was diagnosed. She died 10 months later. (Kolata, 7/28)
Regulators at the Food and Drug Administration have reiterated concerns that Replimune does not have adequate data to support an approval of its investigational skin cancer treatment, as the biotech tries for the third time to seek clearance for its highly controversial drug. (Chen and Herper, 7/28)
Another attempt to win accelerated approval for RP1 (vusolimogene oderparepvec) -- a melanoma drug candidate that's already been rejected twice by the FDA -- could face tough going at a meeting of FDA's outside experts this week. In a briefing document published in advance of Thursday's meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee, FDA staff wrote that the phase II single-arm IGNYTE study -- submitted by Replimune to support accelerated approval of RP1 in combination with nivolumab (Opdivo) for the treatment of advanced melanoma -- was not "an adequate and well-controlled investigation that demonstrates substantial evidence of effectiveness." (Bassett, 7/28)
On ALS, graft loss, diabetes, and cardiovascular risks —
A discovery in the blood could bring researchers one step closer to a long-sought goal in the fight against amyotrophic lateral sclerosis (ALS). Scientists have identified a group of proteins that begin to change months—or even years—before symptoms of the neurodegenerative disease appear, raising hopes that people at risk could one day be treated before irreversible nerve damage occurs. (Notarantonio, 7/28)
Kidney transplant recipients with COVID-19 who received remdesivir (Veklury) early had a lower risk of graft loss, a target trial emulation study found. (Monaco, 7/28)
Initiation of antipsychotic medications, even for short durations, was linked to an increase in the prevalence of pharmacologically treated type 2 diabetes in youths, according to a Dutch cohort study. (Firth, 7/28)
Incidental coronary artery calcium (CAC) scores extracted from nongated chest CT scans accurately predicted cardiovascular risks, a cohort study showed. (Lou, 7/28)
