Policy
The US dramatically altered its recommendations for a series of vaccines, which drive billion-dollar earnings for giants like Merck and Pfizer.
FEATURED STORIES
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.
Representatives from companies such as Sanofi and Forge Biologics point to the potential for PreCheck to drive activation of idle production capacity and help companies that are already building plants.
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Industry observers say the Inflation Reduction Act of 2022 could affect the direction of research, and some fear it may lead to further government forays into price control.
The FDA provided briefing documents ahead of Amylyx’s rare second adcomm for AMX0035, an investigational treatment for ALS. The regulator does not appear to be convinced.
The U.S. Food and Drug Administration had a busy week leading up to the Labor Day holiday. Here’s a look at the agency’s recent activities.
The Administrative Law Judge overseeing the FTC’s challenge of Illumina’s acquisition of Grail rejected the regulator’s anti-competition argument, Illumina announced Thursday.
A High Court judge in London granted AstraZeneca an injunction, temporarily blocking a former executive from joining rival pharma GSK.
The problem of intellectual property theft is greater than most biopharma executives realize, but the real issue is that companies are protecting only a fraction of their IP.
The University of Michigan and the University of South Florida have filed a lawsuit against Novartis, alleging the company’s cardiac drug, Entresto, infringes a cocrystal patent held by both universities.
In the wake of the COVID-19 pandemic, several Western nations are investing heavily in rapidly developing drugs to treat populations when new pandemics emerge.
The long-awaited review of problematic opioid prescribing is taking longer than observers had hoped.
The Artemis I space mission hopes to provide researchers with a better understanding of the high levels of radiation on the body for cancer treatment and other applications.