October 27, 2021
FDLI SmartBrief
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Drugs & Biologics
An FDA advisory panel voted on Tuesday to recommend emergency use authorization of a reduced dose of Pfizer/BioNTech's COVID-19 vaccine for children ages 5 to 11. The FDA could make a decision within days, and the CDC's vaccination advisers are scheduled to meet on Nov. 2 to discuss vaccination of younger children.
Full Story: National Public Radio (10/26),  HealthDay News (10/26) 
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The CDC said in updated guidelines that certain people with weakened immune systems who have received three doses of an mRNA COVID-19 vaccine may be candidates for a fourth dose at least six months after receiving the third shot. The statement applies to moderately to severely immunocompromised adults, including those with untreated or advanced HIV, people who are undergoing treatment for tumors or blood cancers, those who have received certain transplants, and patients who take high doses of immunosuppressants.
Full Story: CNN (10/27) 
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Novartis said it received a subpoena from the Department of Justice last month requesting documents involving the pricing and marketing of its heart failure drug Entresto. The Justice Department also requested records of remuneration offered to health care professionals as part of a "civil investigative demand."
Full Story: FiercePharma (10/26) 
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Judge: Eli Lilly must pay 2% insulin sales to Ariz. firm
(Pixabay)
A federal judge has ordered Eli Lilly to pay 2% of its insulin sales to Arizona firm Research Corp. Technologies because they signed a royalty deal in 1992 that allowed Lilly to use a specific yeast strain to make its insulin products. "Lilly breached its reporting and royalty payment obligations by failing to pay the 2% royalty owed for the net sales value of the diabetes drugs, so RCT is entitled to judgment as a matter of law as to liability," District Judge Scott Rash argued in his ruling.
Full Story: FDAnews (10/26) 
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Raegan McDonald-Mosley, M.D., chief medical adviser for the Contraceptive Access Initiative, wants the Biden Administration to select a new FDA commissioner who will tackle systemic bias in health care and focus on evidence-based science and advancing health equity. The next commissioner must understand the inequities and disparities in the current system and address those issues, McDonald-Mosley writes.
Full Story: The Hill (10/24) 
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Medical Devices
The FDA has given 510(k) clearance to Sibel Health for its Anne One wireless vital signs monitoring platform. The system is able to monitor multiple vital signs in health care settings.
Full Story: FDAnews (10/27) 
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Claritas HealthTech's iRAD, which helps health care providers interpret CT, X-ray and MR scans by enhancing the images, has been cleared by the FDA.
Full Story: Radiology Business (10/26) 
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A request for emergency use authorization has been submitted by Applied DNA Sciences to the FDA for its Linea SARS-CoV-2 Mutation Panel.
Full Story: Seeking Alpha (free registration) (10/25) 
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European regulators have given CE mark certification to Sorrento Therapeutics for its Covistix COVID-19 virus rapid antigen detection test. Based on the results of a large study conducted in Mexico, the test had 81% sensitivity.
Full Story: FDAnews (10/25) 
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Food and Drug Law Institute (FDLI) Highlights
Food and Drug Law Journal 2021 Symposium: The Path Forward: Seeking Racial Equity in Food and Drug Law | November 4-5 | Virtual Event
Join your peers at this year's academic Symposium, where you'll have the chance to listen to and discuss articles that address racial equity in food and drug law and regulation. Registration is complimentary for members. Register Now
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Savings End Soon: Introduction to Drug Law and Regulation | November 9-10 | Virtual Course
Register by 10/29 and SAVE
Early registration ends Friday for November's drug law and regulation course. During this course, you will learn about patent and exclusivity issues, Rx to OTC switches, Good Manufacturing Practices (GMP), advertising and promotion, compliance, enforcement, and related issues. Register Now and SAVE
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