As chair of BIO's Workforce Development, Diversity & Inclusion initiative, Halozyme CEO Helen Torley says she is confident that member companies will strive to diversify at the top because data show a positive correlation between diversity and business success. Torley said BIO is developing tools to help member companies set up sponsorship and mentorship programs, and implement best practices.
Angelika Amon, a professor at Massachusetts Institute of Technology and an investigator at the Howard Hughes Medical Institute, won one of seven $3 million Breakthrough prizes for her research on aneuploidy, which she hopes will lead to new cancer therapies. Xiaowei Zhuang, a professor at Harvard University and also a Howard Hughes Medical Institute investigator, also won a Breakthrough Prize for developing a super-high-resolution imaging system that enabled deeper study of cell structures.
Nearly $2 million in funding has been given to Robert Gordon University in Scotland for studies of microbes and industrial waste. Christine Edwards will lead a consortium of researchers studying cyanobacteria and creating a toxins field test for shellfish growers.
Aspiring astrophysicist Julie Sage, 14, has already taken college-level courses, won awards and designed experiments used by NASA; has a YouTube channel on which she documents her experiments and explains science to her peers; and is now a Marvel Comics hero in the latest edition of Unstoppable Wasp. Sage says she considers scientists "rock stars" and hopes the comic will give girls confidence in scientific pursuits.
A draft guidance has been issued by the FDA in hopes of improving cybersecurity protection for medical devices through the update of recommendations for device design, labeling and documentation, as well as the enhancement of the premarket review process. The guidance, which replaces the first one released by the agency four years ago, covers de novo requests, premarket notifications, product development protocols, premarket approval applications and humanitarian device exemption applications.
Axsome Therapeutics' narcolepsy candidate AXS-12 was given orphan drug status by the FDA. The company intends to launch a midstage trial of the drug in the fourth quarter and expects top-line data next year.
The FDA granted breakthrough therapy designation to Kadmon Holdings' KD025, which is being developed to treat chronic graft-versus-host disease in patients who do not respond to at least two prior lines of systemic therapy. The company is currently recruiting patients for a midstage study of the drug.
Albireo Pharma's late-stage A4250, developed to treat patients with progressive familial intrahepatic cholestasis, was granted fast-track status by the FDA. The candidate also has rare pediatric disease and orphan drug designations for said indication.
One lot of dietary supplement Zero Xtreme capsules, which is intended for weight loss, has been recalled by Fat Burners Zone because it contains appetite suppressant sibutramine, making the supplement an unapproved drug. The recalled product has the lot number 1220062085, expiration date of 03/2020 and was sold across the country and over the internet.
A New Drug Application was submitted by Daiichi Sankyo with Japan's Ministry of Health, Labor and Welfare to obtain marketing approval for its drug quizartinib, indicated to treat adults with relapsed/refractory FLT3-ITD acute myeloid leukemia. Data from a midstage study of quizartinib in Japan, which was ended prematurely because the endpoints were met, were presented at the 80th Annual Meeting of the Japanese Society of Hematology.