Passive Immunization: The Expanding Role of Monoclonal Antibodies in Preventive Medicine
For governments and health systems, monoclonal antibodies represent not just another drug class, but a strategic shift toward precision prevention.
For governments and health systems, monoclonal antibodies represent not just another drug class, but a strategic shift toward precision prevention.
Eli Lilly is spending up to $3.8 billion to buy vaccines in development for shingles, staph infections, and Epstein-Barr virus as well as the platform technologies that spawned these programs. The pharmaceutical giant indicated interest in infectious disease last year when it hired Peter Marks, former director of the FDA division that oversees vaccines.
Improving healthcare was a central theme of the latest episode of the Debunked Podcast. The discussion offered perspectives from Louisiana Republican Senator Bill Cassidy, HHS Secretary Robert Kennedy Jr., Devoted Health CEO Ed Park, and Dr. Ezekiel Emanuel, an oncologist and professor with University of Pennsylvania, and Debunked co-hosts Arundhati Parmar and Samir Batra.
The FDA said consolidating safety reporting into a single platform, the Adverse Event Monitoring System (AEMS), will increase transparency and reduce costs. But like the legacy systems it replaces, AEMS reports are unverified so causation and frequency of events cannot be determined.
The FDA’s refuse-to-file letter cited no safety or efficacy concerns for Moderna’s influenza vaccine, mRNA-1010. The company said the agency’s justification for refusing a review is inconsistent with guidance given prior to the start of Phase 3 testing.
A report supporting the CDC’s revisions says the U.S. is an outlier in the number of diseases and the total number of vaccine doses recommended in its pediatric vaccine schedule. But some physician groups say comparisons to other countries can be misguided and removing vaccines from the schedule puts children’s health at risk.
We are taking a look at how health insurers are using AI, defining success, and managing cybersecurity risks. Give us your opinions by completing our brief, anonymous survey.
Dynavax Technologies brings Sanofi a commercialized hepatitis B vaccine and a clinical-stage shingles vaccine, both of which offer differentiation from products marketed by GSK. It's Sanofi’s second billion-dollar vaccines acquisition of 2025.
Recent changes to ACIP leadership and vaccine guidance have raised concerns that longstanding immunization protections are being weakened, potentially leading to lower vaccination rates and more preventable disease.
His longstanding anti-vaccine rhetoric and vocal opposition to science-backed expert consensus has caused widespread concern among public health and medical professionals about the appropriateness of his leadership.
Sanofi’s Vicebio acquisition brings technology for developing vaccine combinations for multiple pathogens, such as RSV and hMPV. The deal complements an existing partnership with Novavax that encompasses R&D of combination vaccines for Covid-19 and flu.
The Trump administration's healthcare policy changes from the gutting of medical research grants to changes on the CDC vaccine board were the focus of the discussion on the latest episode of the Debunked Podcast with MedCity News Editor-in-Chief Arundhati Parmar and Samir Batra, managing partner of Health Innovation Pitch.
Novavax’s partnership with Sanofi allows the pharma giant to explore potential combinations of assets from both companies, and it’s a blueprint for the kinds of alliances the vaccine developer is pursuing. Rather than commercializing vaccines, Novavax aims to turn its research into business development deals, R&D executive Ruxandra Draghia-Akli said.
The Trump administration has cancelled $766 million in contracts to develop mRNA vaccines against potential pandemic flu viruses. In addition, since President Donald Trump took office, at least half of the security council’s staff have been laid off or left. This is dangerous say former health security officials.
In calling for more clinical testing of vaccines in younger people and those who face a low risk of severe disease from Covid-19, the FDA said its policy will compel generation of more evidence for these groups. Our roundup of regulatory news includes notable firsts for Alzheimer’s diagnosis and migraine treatment.
Robert F. Kennedy Jr. testified before the House Committee on Appropriations and the Senate Health, Education, Labor and Pensions Committee on Wednesday. He faced questions on vaccines, HHS cuts and other issues.