As expected, the EMA is recommending withdrawal of the mpox indication for Siga Technologies Inc.’s tecovirimat, whilst maintaining its approval as a treatment for smallpox, cowpox and adverse reactions to vaccinia vaccines.
Chaos continues at the U.S. CDC and its Advisory Committee on Immunization Practices (ACIP) with the resignation of ACIP member Robert Malone and the impending deadline for the president to nominate a new CDC director following the dramatic exit last year of Susan Monarez and months of acting directors.
Overall, results from the phase III Valor trial testing Lyme disease vaccine PF-07307405 “strengthen confidence” in the candidate, according to partners Pfizer Inc. and Valneva SE, with the big pharma now looking toward regulatory submissions. Investors, however, focused on the fact that the study, which demonstrated more than 70% efficacy in preventing Lyme disease in individuals, ages 5 and older, failed to hit the statistical criterion for the first prespecified analysis.
In one fell swoop March 16, a U.S. federal judge stayed the CDC’s January memo revising the childhood vaccine schedule and the Advisory Committee on Immunization Practices (ACIP) as reconstituted by Health and Human Services Secretary Robert Kennedy, along with everything that committee has done since early June.
Twelve years on from the World Health Organization formally raising the alarm, antimicrobial resistance continues to grow, and despite numerous public and private incentives and initiatives, the pipeline of antibiotics in development is thinner than ever.
In what it says could be the largest disclosed patent settlement in the pharmaceutical industry, Roivant Sciences Ltd. has reached a potential $2.25 billion settlement with Moderna Inc. over the use of its lipid nanoparticle delivery technology in the Spikevax COVID-19 vaccine.
The U.S. CDC’s Advisory Committee on Immunization Practices (ACIP) has two new members, bringing its total membership to 15. As he has done since dismissing the entire ACIP panel last June, Health and Human Services Secretary Robert Kennedy named the new members, Angelina Farella and Sean Downing, barely two weeks before the next ACIP meeting, March 18-19.
The EMA’s Committee for Medicinal Products for Human Use recommended approval of Moderna Inc.’s Mcombriax (mRNA-1083), positioning it to potentially become the world’s first combination vaccine for both seasonal influenza and COVID-19.
In an all-cash transaction valued at €780 million (US$920 million), Asahi Kasei Corp. offered to buy Aicuris Anti-infective Cures AG, expanding its infectious disease portfolio with a marketed cytomegalovirus product and a herpes treatment nearing an NDA.
The effects of aging pose an additional challenge for people with HIV due to the neurological and psychological consequences that persist despite antiretroviral therapy. At the Conference on Retroviruses and Opportunistic Infections (CROI) held Feb. 22-25, 2026, in Denver, the scientific community examined how the virus affects the brain, how the reservoir is established in the CNS, and which genetic, immunological or treatment-related factors influence cognitive health.
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