The FDA has finalized guidance on submission of field alert reports for potentially defective drugs. According to the document, FARs must be submitted by drug firms seeking new drug applications or abbreviated new drug applications within three working days after being informed that there's a mistake in the drug product or its labeling, as well as when they obtain information on bacterial contamination, any significant physical and chemical change or deterioration in the distributed product, or any failure of a distributed batch to meet established specifications.
Dana Seidel went from "traipsing around rural Alberta, following herds of elk" to collecting and analyzing data from radiotransmitter collars and is now the lead data scientist at an indoor vertical farming startup called Plenty. Seidel holds a weekly machine learning and data science workshop for women and says, "Many young students, especially women, don't realize how much they already know."
Katalin Kariko may not be a household name outside biomedical circles, but her invention -- BioNTech's messenger RNA COVID-19 vaccine -- is. Kariko did not win one NIH R01 grant for the first four decades of her career, but she never gave up, and she equates science to rowing, a sport in which the athlete doesn't see the finish line but senses it.
Few resources exist for women approaching perimenopause -- the period before menopause when estrogen production begins to slow -- and few physicians talk to their female patients about it, says obstetrician-gynecologist and integrative health physician Arianna Sholes-Douglas. Perimenopause starts when women are in their 30s or 40s and can drag on for a decade, pregnancy remains possible, symptoms are vague and wide-ranging, and finding support and care can be difficult, but information is available and active support communities are growing.
Women hold fewer biomedical patents than men do, and the result is a lack of inventions aimed at menopause, breast cancer, postpartum depression, preeclampsia, or fibromyalgia, according to a study published in the journal Science. While the patent gap is far from closed, it has narrowed, and some 250 women's health ventures brought in $1.68 billion in funding last year.
The COVID-19 pandemic has both worsened and drawn attention to the challenges women in academic medicine face every day: discrimination, bias, sexual harassment, misogyny, unequal pay, and unequal opportunity for advancement. Many talented women leave academic medicine, potentially taking unrealized medical miracles with them, writes Jennifer Grandis.
This year's Odile Bain Memorial Prizes were awarded to Goylette Chami, an infectious disease epidemiologist at the University of Oxford's Big Data Institute and Clinical Trial Service Unit and Epidemiological Studies Unit, and Barbora Pafco, a junior researcher at the Czech Academy of Sciences and the University of Veterinary Sciences in Brno, Czech Republic. Chami is in the early stages of leading her own research group on schistosomiasis, and Pafco is leading research on strongylid nematodes in mountain gorillas and cattle.
Albireo Pharma's Bylvay, or odevixibat, gained the FDA's approval to treat pruritus for patients ages 3 months and older who have progressive familial intrahepatic cholestasis. Approval of the oral reversible inhibitor was backed by results from two late-stage studies.
The European Commission approved the gene therapy Skysona, or elivaldogene autotemcel, developed by Bluebird Bio to treat neurological disease cerebral adrenoleukodystrophy, a rare inherited disease, for those younger than age 18 who have an ABCD1 gene mutation and no siblings that match as blood stem-cell donors.