Policy
Incoming PhRMA Chair Paul Hudson, a day before the White House announcement, pledged to work with the administration as the president turns to insurers as a source of cost savings for prescription medicines.
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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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The CDC supported the FDA’s approval of mixing and matching vaccines, where eligible populations can take a booster shot from another brand different from their initial series.
The upcoming changes will be less disruptive but will have far-reaching consequences throughout the pharmaceutical supply chain.
An experimental AstraZeneca cancer drug trial has been placed on hold due to safety concerns. This news comes two years after Amgen was also forced to pause a study of a drug within the same class.
A subtype of the Delta variant might be rising, although it’s not yet clear if it’s more transmissible or lethal than the original Delta variant. Read on for that and more COVID-19 news.
The experimental drug, NTLA-2001, is being developed for the treatment of transthyretin (ATTR) amyloidosis.
More than $170 million was paid out for drugs that manufacturers voluntarily withdrew from the market after subsequent trials showed no benefit in overall survival.
With expectations that the U.S. FDA will announce a decision about booster shots for the Moderna and Johnson & Johnson vaccines this week, there is plenty of COVID-19-related news. Here’s a look.
Flu season is here and overall viral activity is up 23% across the United States, even as respiratory syncytial virus and COVID-19 infections continue to sweep across parts of the nation.
The concern relates to the risk of two rare heart inflammation conditions, myocarditis and pericarditis, that have been linked to the Pfizer and Moderna mRNA vaccines.
The U.S. Food and Drug Administration has a few PDUFA dates on its calendar for this week. Here’s a look.