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.
FEATURED STORIES
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.
Subscribe to BioPharm Executive
Market insights and trending stories for biopharma leaders, in your inbox every Wednesday
THE LATEST
Move in line with ‘National Program for the Combat of Obesity in Children and Adolescents 2021'
The vaccine, Vaxelis, was approved to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenza type b.
President Trump’s new trade deal, now called the U.S.-Mexico-Canada Agreement, is wending its way before Congress. With that, the details are coming to light, and many critics of the biopharmaceutical industry and generic drug policy aren’t happy.
The battle of the bulge is ongoing and it appears that Americans are losing, according to a report from the U.S. Centers for Disease Control and Prevention. The report shows that Americans are losing height and gaining girth.
As 2018 comes to a close, analysts, journalists, investors and industry-watchers are studying their crystal balls to see what trends to watch in the upcoming year. Here are 7 trends most likely to be hitting the news cycle.
In a December 17, Washington Post op-ed, Senator Elizabeth Warren (D-MA), proposed The Affordable Drug Manufacturing Act, which would allow the Department of Health and Human Services (HHS) to manufacture or contract out the manufacture of generic drugs.
Alexion Pharmaceuticals and Stemline Therapeutics both secured FDA approval for their drugs.
Companies closed out the year with a number of appointments and hires to strengthen their leadership teams, including changes at the FDA, Melinta, CLSA, Virion, and more.
According to the U.S. Centers for Disease Control and Prevention (CDC), 12 people in three states were hospitalized for infections caused by bacterial contamination of stem cell products.
-- Golodirsen has been studied for the treatment of exon 53 amenable patients, approximately eight percent of patients with Duchenne --