Policy
An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it didn’t follow the regulator’s recommendations in testing its mRNA flu vaccine.
FEATURED STORIES
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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The Committee for Medicinal Products for Human Use of the European Medicines Agency issued a negative trend vote on the company’s Marketing Authorization Application for Aduhelm.
While COVID-19 appears to be surging again in the U.S. and Europe, the government is spending billions to acquire antibody and antiviral therapies and edging toward vaccination boosters.
Pfizer’s oral antiviral treatment for COVID-19 is making its way through regulatory hurdles. The company is working with global manufacturers to ensure a steady supply of the medication.
Thanks partly to Biogen’s pricey new Alzheimer’s drug, Medicare enrollees will be burdened with higher monthly premiums for their Part B coverage.
President Joe Biden has nominated former U.S. Food and Drug Administration Commissioner Robert Califf to reprise his role at the agency’s helm.
Moderna responded to claims that the government should be co-patent owners of the mRNA vaccine developed by the company and said its mRNA sequence was exclusively selected by Moderna scientists.
Houston-based money manager Alan Eisenman testified in the ongoing Elizabeth Holmes fraud trial that he sought “straight answers” about the company’s work for several years.
Between January 4, 2020 and October 30, 2021, COVID-19 accounted for 576 deaths among children 17 and younger, compared to 189 from influenza, according to the CDC.
Pfizer and BioNTech requested the FDA authorize booster shots for their COVID-19 vaccine for all adults 18 years and older, presenting data not available in September.
Public Citizen urged NIH director Dr. Francis Collins to clarify the NIH’s role in Moderna’s vaccine publicly and explain what he plans to ensure that federal scientists are credited for their work.