FDA
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
FEATURED STORIES
The Senate failed to pass a massive spending bill on Thursday—which includes the rare pediatric PRV program but also funding for the Immigration and Customs Enforcement’s large-scale crackdown in Minnesota and other states.
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.
Together with robust data-driven modeling, rethinking regulation and data use could push forward a notoriously challenging field.
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During this webinar BioSpace sits down with former FDA Chief Information Officer Vid Desai to discuss the potential advantages and pitfalls of deregulation stemming from one of President Donald Trump’s first executive orders. Together, they uncover what this shift means for drugmakers, compliance and patient safety.
After the FDA revoked Sarepta Therapeutics’ platform designation in July, Krystal Biotech is “poised to be the first major beneficiary” of this program, according to analysts at William Blair.
Elecsys’ approval could help boost the uptake of currently approved Alzheimer’s disease therapies, including Biogen’s Eisai-partnered Leqembi, with CEO Chris Viehbacher recently noting that such biomarker-based tests could “remove some of the bottlenecks” in uptake.
While a new facility setup program aimed at encouraging onshoring received a positive reception at a recent meeting, industry representatives said the current rules on existing production plants are the main regulatory issues facing manufacturing teams.
Heading into the final quarter of a year that has seen dramatic upheaval at the FDA—from the exodus of numerous senior leaders to unclear policy changes and a safety saga that engulfed the gene therapy space—drug approvals appear roughly on par with recent years.
New analysis from Jefferies shows that rare disease and cancer drugs granted the status are especially likely to be approved.
In the Phase III FIBRONEER-IPF study, Jascayd demonstrated significant lung capacity improvements over placebo.
Six months after his controversial departure from the top spot at the FDA’s biologics division, Peter Marks has landed at Eli Lilly, joining former colleague Rachael Anatol, who was ousted from the agency not long after Marks.
The hold was placed earlier this year when the FDA asked for more preclinical data, but the agency was slow to respond due to ‘strain’ on its capacity, according to Neurizon.
This latest FDA program aims to provide speedier reviews for generic drugmakers who produce their products in the U.S.