Clinical Advisor7h
FDA Approves Freeze-Dried Formulation of Mpox, Smallpox Vaccine
The live vaccine is produced from the strain Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN), an attenuated, non-replicating orthopoxvirus.
MedCity News1d
Ouster of Peter Marks & Mass FDA Layoffs Have Biotech Sector Bracing for Regulatory Disruptions
As the FDA’s top biologics official, Peter Marks oversaw regulation of cell and gene therapies. The departure of Marks and mass layoffs throughout the FDA raise concerns about the agency’s ability to ...
CIDRAP2d
HHS begins layoffs, reassignments, including NIAID director
Jynneos was the first smallpox vaccine developed under Project BioShield, a program created by Congress in 2004 to accelerate ...
CIDRAP2d
FDA approves freeze-dried version of Jynneos mpox vaccine
Yesterday the US Food and Drug Administration (FDA) approved a freeze-dried formulation of Bavarian Nordic's mpox vaccine, ...
Bavarian Nordic’s Jynneos highlights unmet need for mpox prevention in HIV patients
This recent safety and effectiveness data regarding mpox vaccination with Jynneos is important and timely given the ongoing ...
FDA approves Bavarian Nordic’s freeze-dried mpox and smallpox vaccine
The formulation allows for greater stockpiling, with Bavarian Nordic already working with the US Government to add to vaccine ...
US FDA approves freeze-dried version of Bavarian Nordic's mpox, smallpox vaccine
Denmark's Bavarian Nordic said on Monday the U.S. Food and Drug Administration has approved a freeze-dried formulation of its ...
Bavarian Nordic Receives U.S. FDA Approval of Freeze-Dried Smallpox and Mpox Vaccine
The Company has been contracted by the U.S Biomedical Advanced Research and Development Authority (BARDA) to develop and supply a freeze-dried version of JYNNEOS for stockpiling. Manufacturing under ...
Emergent BioSolutions: I See Further Downside Ahead In This Value Trap
Emergent BioSolutions struggles with declining revenues, rising competition, and weak growth prospects. Read why I rate EBS ...
Single vaccine dose shows 84% effectiveness against mpox, but insufficient for HIV patients
Universitätsmedizin Berlin has found that a single dose of the Imvanex vaccine provides protection against mpox with 84% ...
Factbox-Widely used drugs on US imports list from Europe
Widely used prescription medicines could get caught up in the Trump administration's tariff trade wars and EU retaliation. The following is a list of major prescription drugs whose ingredients or ...