Policy
The current state of political affairs in the U.S. does not bode well for the direction of that turn. The country is at real risk of losing its long-held lead in biotech innovation.
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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After roaring into February with positive data in five different indications, Regeneron and Sanofi announced today a late-stage Dupixent trial has been halted due to futility.
Bayer is heading back to the FDA to seek approval for a new indication of its prostate cancer drug Nubeqa, following positive Phase III results.
GlaxoSmithKline has voluntarily paused activities in its Phase III GRACE trial on a candidate maternal vaccine for respiratory syncytial virus.
While the president temporarily shores up leadership at the OSTP, the NIH is losing another long-time career researcher, John R. Mascola.
By the end of the CREDIT-1 study, patients experienced a significant reduction in low-density lipoprotein cholesterol compared to the placebo group.
It’s not clear if the recent deaths reported in FAERS resulted from the patients taking Aduhelm. This article takes a deep dive into this controversy.
In April 2021, the U.S. Food and Drug Administration issued Acadia a Complete Response Letter (CRL) related to its previous attempt to expand the approved indication for Nuplazid.
At this time, 73% of Americans are immune to Omicron, and it could rise to 80% by mid-March. For that and more COVID-19 news, continue reading.
BioNTech is opening one of the largest mRNA vaccines manufacturing facilities in the world to expand the availability of the COVID-19 vaccine.
With the Omicron surge waning, at least in the U.S., there is speculation that the COVID-19 pandemic may be in its end stages. Some experts, however, warn that this could be premature.