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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THE LATEST
January has been a largely quiet month for PDUFA dates on the U.S. Food and Drug Administration (FDA)’s calendar. There were two dates for the entire month, and one of those has been moved back to April. Here’s a look.
Pazdur, along with the FDA’s R. Angelo de Claro and Gautam Mehta from the Center for Drug Evaluation and Research, penned an opinion piece published Thursday in JAMA Oncology.
Public health officials churn out a lot of statistics related to COVID-19, but it can often be difficult to determine just how accurate they are because there are just so many unreported test results.
Laurence F. Doud III, the former chief executive officer of Rochester Drug Co-Operative, Inc. (RDC), one of the 10 largest pharmaceutical distributors in the United States, ignored what U.S. prosecutors have called “serious red flags” surrounding the sale of opioid drugs.
Dr. Anthony Fauci expects the FDA will authorize the Pfizer-BioNTech vaccine for children under the age of five in the next month.
Gilead Sciences reported that about $250 million of counterfeit versions of its HIV drugs, Biktarvy and Descovy, were sold to pharmacies over two years.
The extensions are due to the FDA’s requiring more time to review additional clinical data it had requested from bluebird.
While many of these scams targeted the public at large, scammers also turned their sights to those sources that would naturally be on the spot as the result of demand.
Martin Shkreli and his former company, Vyera Pharmaceuticals, earned a 5,000% increase on the toxoplasmosis drug, Daraprim.
As the COVID-19 pandemic moves into its third year, at least some people think we might be seeing the light at the end of the tunnel as the disease progresses from a pandemic to an endemic stage.