Policy
An inconsistent boom-and-bust cycle funding environment for early-stage biotech innovations and burdensome regulation threaten the U.S.’s half-century-long dominance in the biotech sector.
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Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
The record-setting government shutdown was just the latest blow to the U.S. biopharma industry. When science funding becomes a casualty of political gridlock, we lose valuable talent, erode public trust and jeopardize our position as a global leader in innovation.
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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.