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The discovery of a tumor in a patient who received REGENXBIO’s gene therapy for Hurler syndrome prompted the FDA to place a hold on that program along with the company’s Hunter syndrome program, which is awaiting an FDA decision on or before Feb. 8.
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With the biopharma industry performing better of late, analysts, executives and other industry watchers are “cautiously optimistic”—a term heard all over the streets of San Francisco at the J.P. Morgan Healthcare Conference earlier this month.
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.
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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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In this episode of Denatured BioSpace’s head of insights Lori Ellis discusses the public health consequences of vaccine hesitancy and the critical distinction between skepticism and cynicism with Paul Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.
Following a similar decision in case the trade group Outsourcing Facilities Association brought against FDA over its decision to declare the end of the shortage of Novo Nordisk’s semaglutide, Judge Mark Pittman agreed that Eli Lilly’s tirzepatide is in sufficient supply, meaning compounding pharmacies can no longer sell the lucrative weight loss drugs.
Gilead will construct three new facilities in the U.S., while upgrading three others. The company claims the investment will produce "$43 billion in value.”
The independent experts will meet on May 22 to discuss updates to the COVID-19 vaccine for the upcoming season.
The UCSF professor and frequent YouTube poster has criticized COVID-19 vaccine mandates as well as the accelerated approval pathway and other FDA practices. Predictions of what his tenure might achieve are scattershot.
The Massachusetts biotech will focus its efforts and resources into cemsidomide, an oral drug candidate being trialed for multiple myeloma and non-Hodgkin lymphoma.
Although the job market did not pick up in April, layoffs were down year over year and month over month, according to BioSpace tallies. Meanwhile, Amgen, Novartis, Regeneron and Roche announced U.S. manufacturing investments that are sparking job creation.
Yes, according to leading vaccine physician Paul Offit, who denounced the new placebo-controlled trial requirements for vaccines and sought greater clarity: “I don’t know what they’re talking about.”
CRISPR Therapeutics’ partner Vertex reported that more than 65 treatment centers have been activated for the gene therapy Casgevy. While Vertex handles the market, CRISPR has been focused on its clinical program.
The FDA in February formally declared the end of the semaglutide shortage, which Novo Nordisk expects will help improve the market position of Wegovy. But Eli Lilly’s Zepbound is quickly gaining ground, with sales just $300 million behind Wegovy in Q1.