FDA
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for December 22, 2020.
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A week into his tenure as head of the FDA’s Center for Drug Evaluation and Research, experts agree that Rick Pazdur is the “ideal fit” to stabilize the agency. And, according to one ex-FDA official, if his CBER counterpart Vinay Prasad tries to supersede Pazdur’s authority, “there will be hell to pay.”
Priority voucher awardees and regulators could feel pressure to “meet the moment” as FDA watchers question the intent and feasibility of the Commissioner’s National Priority Voucher program.
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
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The U.S. Food and Drug Administration (FDA) approved New York-based Progenics Pharmaceuticals’ New Drug Application (NDA) for Azedra for adult and pediatric patients 12 years and older with iobenguane scan positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy. It is the first and only therapy approved for these indications.
The U.S. Food and Drug Administration (FDA) approved Indivior’s Perseris for schizophrenia.
Bristol-Myers Squibb reported a strong second quarter, with total revenues of $5.7 billion, up 11 percent from the same quarter in 2017, when it reported $5.144 billion. Sales were driven by Eliquis (apixaban) and Opdivo (nivolumab).
Shares of AbbVie are up slightly this morning after the company announced that it finally received regulatory approval for its endometriosis drug elagolix. The approval marks the first new approved oral treatment for endometriosis-associated pain in more than 10 years.
GlaxoSmithKline continues to make headway in the development of two-drug regimens to benefit HIV patients – even those who have high levels of the virus.
Shares of Eli Lilly jumped in premarket trading after the company reported total revenue of $6.35 billion for the second quarter, a 9 percent increase in revenue over the same period last year.
Shares of Agios Pharmaceuticals jumped this morning after the company said the FDA approved its oral leukemia treatment Tibsovo (ivosidenib). It’s the second approval for the company in less than a year.
The U.S. Food and Drug Administration is looking to address supply chain threats by potentially importing foreign drugs under a narrow scope.
In a speech given at the Brookings Institution preceding the release of the U.S. Food and Drug Administration (FDA)’s Biosimilars Action Plan, FDA Commissioner Scott Gottlieb unloaded on big pharma.
In 2012, the U.S. Food and Drug Administration (FDA) created Breakthrough Therapy designation. The Washington Post reports on a new study conducted by Yale School of Medicine researchers and published in the Journal of the American Medical Association that looks at the designation and the drugs that received it.