Policy
Former ACIP vice chair Robert Malone claimed that Andrew Nixon, spokesperson for the Department of Health and Human Services, “trashed” him with the media, adding that he resigned because “I do not like drama.”
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TrumpRX and DTC sales may expand prescription drug access, but they will not solve the affordability crisis by themselves.
Here’s how drug developers can best approach interactions with the agency following last year’s seismic changes to its leadership, workforce and policies.
The CDC’s changes threaten to cut vaccine sales for makers including Pfizer, Moderna, Merck and more, but a legal expert suspects affected manufacturers will stay on the sidelines rather than back a push to declare the revised schedule unlawful.
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The last few months have been tumultuous for the CDC, which has seen the ouster of Director Susan Monarez and all 17 members of the Advisory Committee on Immunization Practices.
A new version of the controversial bill removes the specific company names that were included in a previous iteration but still requires the industry to ditch Chinese biotech contractors in order to receive federal dollars.
The British proposal to increase support for pharma is “clearly positive,” according to analysts at Leerink, who noted that the NHS’ move will improve patient access to treatments.
The CDC’s Advisory Committee on Immunization Practices was scheduled to convene Oct. 22 to 23, but this meeting has been postponed, with no new date specified. The delay comes as the VA published new research showing that COVID-19 shots prevented hospitalizations and death.
The $48 million award, granted through the Advanced Research Projects Agency for Health, will help Kernal take its in vivo mRNA-encoded CAR T therapy forward.
Cell and gene therapy experts question where the FDA designation fits in an environment that features a range of intersecting regulatory perks.
A new group of CDC advisors voted last month to separate the chickenpox vaccine from the measles, mumps, rubella components of the MMRV shot due to concerns over febrile seizures, while recommending a more risk-based approach to COVID-19 immunizations that mirrors recent FDA approvals.
Jeanne Marrazzo, former director of the National Institutes of Allergy and Infectious Disease, was formally terminated Thursday after months on administrative leave, after filing a whistleblower report.
Expanded exemptions for orphan drugs could mean prolonged protections for top-selling drugs like Merck’s Keytruda, which was initially approved under this designation in 2014.
President Donald Trump last week announced that 100% pharma tariffs would come Oct. 1, but a White House official has clarified that that’s when the government will “begin preparing” the levies.