Policy
An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it didn’t follow the regulator’s recommendations in testing its mRNA flu vaccine.
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Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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The partial government shutdown has entered day 24 and the pharma and medtech industry is beginning to feel the impact even more, particularly as the U.S. Food and Drug Administration grows more incapable of reviewing some medications for approval.
It didn’t take long for the new leadership structure in the U.S. House of Representatives to take on the pharmaceutical industry. On Monday, the House Committee on Oversight and Reform launched an investigation into prescription drug pricing practices.
Couples can choose the gender of the child based on the UAE rules and regulations
The U.S. Food and Drug Administration (FDA) approved Bridgewater, NJ-based Amneal Pharmaceuticals’ generic version of Novartis’ Exelon Patch (Rivastigmine Transdermal System) for dementia related to Alzheimer’s and Parkinson’s diseases.
Because of the government shutdown, which as of Monday, January 14 is into its fourth week, 40 percent of the U.S. FDA employees were furloughed. However, the two approvals described here should still be on track.
As 2019 gets underway for the biopharma industry, more companies are increasing their reliance on the use of artificial intelligence as part of their drug discovery process.
According to U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, less than two percent of Americans use biologics, but they account for 40 percent of total spending on prescription drugs.
As the partial government shutdown enters its 21st day, tying it for the longest U.S. shutdown in history, the impact is becoming more and more realized within the pharmaceutical industry.
As the Democratic-led House of Representatives begin to file a number of bills aimed at lowering the cost of prescription drugs in the United States, Johnson & Johnson has joined the ranks of pharma companies that started out the new year with a price hike.
In 2010, China launched the “Thousand Talents Plan,” which is aimed at attracting top researchers from across the globe.The government of China is reportedly asking officials to quiet down promotion of the program aimed at recruiting western scientists to work in that country.