HHS Orders 2.5 Million More Doses of JYNNEOS Vaccine For Monkeypox Preparedness

Order will bring federal government’s rapidly available supply to more than 4 million vaccines

The U.S. Department of Health and Human Services (HHS) today ordered an additional 2.5 million doses of Bavarian Nordic’s JYNNEOS, an FDA-licensed vaccine indicated for prevention of smallpox and monkeypox, for use in responding to current or future monkeypox outbreaks and as part of U.S.

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Brown, Colleagues Urge Department of Hea

WASHINGTON, D.C. —U.S. Senator Sherrod Brown (D-OH) joined U.S. Senators Elizabeth Warren (D-MA) and Angus King (I-ME) as well as U.S. Representatives Lloyd Doggett (D-TX), Joaquin Castro (D-TX), Sara Jacobs (D-CA), Katie Porter (D-CA), and 100 of their Senate and House colleagues in urging Health and Human Services (HHS) Secretary Xavier Becerra to swiftly act and use his existing authorities to lower prices on critical prescription drugs.… Read full story

FDA Infant Formula Update: June 30, 2022

Today, the U.S. Food and Drug Administration is providing an update on additional steps it has taken that will lead to more infant formula available in the U.S. under the agency’s recent increased flexibilities.

Company (Product Origin): Danone (New Zealand)

Product(s): Aptamil Gold Plus

Type of Formula: General

Estimated Quantity: 555,000 cans (about 1.1 million pounds or about 16.5 million full-size, 8-ounce bottles)

Availability: Likely to start in August.… Read full story

Biden-Harris Administration Catalyzes Private Health Sector Commitments to Reduce Climate Impacts and Protect Public Health

(Washington, D.C.) – Today, the Biden-Harris Administration is announcing how President Biden’s leadership on climate change is catalyzing private health sector commitments to reduce greenhouse gas emissions, strengthen climate resilience, and protect public health. At a White House event with the U.S.

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NIH-Funded Project Offers Efficient Approach When Tracking SARS-CoV-2 Variants

An interdisciplinary research team has developed a fast, cost-effective method to detect the circulation of SARS-CoV-2 variants. SARS-CoV-2 is the virus that causes COVID-19. The team, funded by the National Institutes of Health’s Rapid Acceleration of Diagnostics (RADx®) Tech program, adopted a customizable genotyping approach to identify known variants and subvariants.… Read full story

HHS Announces Enhanced Strategy to Vaccinate and Protect At-Risk Individuals from the Current Monkeypox Outbreak

 

June 28, 2022 – The U.S. Department of Health and Human Services (HHS) today announced an enhanced nationwide vaccination strategy to mitigate the spread of monkeypox.  The strategy will vaccinate and protect those at-risk of monkeypox, prioritize vaccines for areas with the highest numbers of cases, and provide guidance to state, territorial, tribal, and local health officials to aide their planning and response efforts.

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FDA Introduces Innovative Proposal to Advance Consumer Access to Nonprescription Drugs

 

Proposed rule is intended to increase options for the development of safe and effective nonprescription drugs

Today, the U.S. Food and Drug Administration issued a proposed rule titled, “Nonprescription Drug Product with an Additional Condition for Nonprescription Use,” which is intended to broaden the range of marketed nonprescription drugs available to consumers, empowering them to self-treat certain common conditions and improving public health.… Read full story

FDA Infant Formula Update: June 27, 2022

 

Today, the U.S. Food and Drug Administration is providing an update on additional steps it has taken that will lead to more infant formula available in the U.S. under the agency’s recent increased flexibilities.

Company: Bellamy’s Organic (Australia)

Product(s): Bellamy’s Organic Organic Infant Formula Step 1 (0-6 months) and Bellamy’s Organic Organic Follow-On Formula Step 2 (6-12 months)

Type of Formula: General

Estimated Quantity: 696,000 cans (about 1.4 million pounds or about 21 million full-size, 8-ounce bottles)

Availability: Early July and over the next several months.… Read full story