endomyocardial calcification with pulmonary and systemic hypertension in a term neonate with multisystem inflammatory syndrome of newborn mis n

Original title: “Endomyocardial calcification with pulmonary and systemic hypertension in a term neonate with multisystem inflammatory syndrome of newborn (MIS-N).”

Nearly 100 biotechs went public amid the industry’s IPO frenzy in 2021, driven by an influx of pandemic-driven investments. But many of those companies have little to show investors. While supportive of Amylyx’s acquisition of a GLP-1 drug, analysts say the company’s future hinges on key upcoming readouts from multiple products in its pipeline. ... Of all the companies on this list, Invivyd most directly benefited from the influx of pandemic cash, with its $336 million series C in April 2021 promising to fund the development of ADG20, the biotech’s lead candidate being tested for the prevention and treatment of COVID-19. Verve entered the industry with a mission to harness gene and base editing for cardiovascular diseases. While the Massachusetts-based biotech no doubt benefited from the pandemic-induced influx of money, it remained true to its identity, even as many peers pivoted to addressing the virus. In the months leading up to the IPO, Verve worked on its editing technology for lowering LDL cholesterol and a preclinical program for atherosclerotic cardiovascular disease (ASCVD). In late 2020, Bayer led the biotech’s $65 million series A round, while Moderna in 2021 partnered with the startup to advance in vivo therapies for genetic diseases. Both Bayer and Moderna then co-led Metagenomi’s series B round in 2023, bringing in $275 million for the biotech. But the public markets have been hard on Metagenomi, which still does not have a candidate in the clinic. The company’s stock has fallen some 85% since its February 2024 debut. The company’s shares were trading at $1.60 apiece as of Dec. 2, nearly one-tenth of its $15-per-share IPO price. Caribou also pivoted from oncology to autoimmune diseases in September 2024, after its lead asset CB-010 won the FDA’s fast track designation for systemic lupus erythematosus. But immunology would not work out for Caribou either, forcing the biotech in April this year to return to its oncology origins—and lay off 32% in the process.

Original title: “2021 Sparked a Banner Year for Biotech IPOs. Where Are They Now? - BioSpace”

This report describes COVID-19 vaccine effectiveness among children ages 9 months to 17 years.

Original title: “Effectiveness of 2024–2025 COVID-19 Vaccines in Children in the United States — VISION, August 29, 2024–September 2, 2025”

COVID-19 Module Long-term Care Facility Component data on Resident and Staff Impact

Original title: “Nursing Home Data Dashboard”

The Food and Drug Administration (FDA or the Agency) is announcing the issuance of Emergency Use Authorizations (EUA) (the Authorizations) for certain medical devices related to Coronavirus Disease 2019 (COVID-19). FDA has issued the Authorizations listed in this document under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under the FD&C Act, FDA is required to publish in the Federal Register a notice of each authorization, and each termination or revocation of an authorization, and an ex

Original title: “Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability”

The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Pfizer Inc. for the Lucira by Pfizer COVID-19 & Flu Test and Lucira by Pfizer COVID-19 & Flu Home Test. FDA revoked the Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization holder. The revocations, which include an explanation of the reasons for each revocation, are reprinted at the end of this document

Original title: “Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability”

This direct final rule (DFR) removes the requirement that Head Start programs have a COVID-19 mitigation policy. This requirement was included in the final rule titled "Mitigating the Spread of COVID-19 in Head Start Programs," which ACF published on January 6, 2023. Specifically, this rescission removes the requirement from the Head Start Program Performance Standards (Performance Standards) that Head Start programs have a COVID-19 mitigation policy developed in consultation with their Health a

Original title: “COVID-19 Mitigation Policy Requirement in Head Start Programs; Recission”