FDA
The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
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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EyeOP1 is an high-intensity focused ultrasound device that is the first non-invasive treatment for glaucoma in China.
Tianjin CanSino Biologics announced CFDA approval of its Ebola virus vaccine for China.
Alexion is set to secure even more revenue from its blockbuster drug Soliris, the most expensive drug in the world.
Big pharmas are having a good year so far in terms of FDA approvals.
A look at how the gene therapy approvals may end up confusing payers, lawmakers, and the general public at a time when the industry desperately needs clarity.
An advisory panel with the FDA gave a near unanimous support to Novo Nordisk’s diabetes drug semaglutide, a long-acting GLP-1 analogue.
Maybe timing is everything. On Aug. 28, 2017, Gilead acquired Kite for about $11.9B.
Officially, there have been four new chemical entities have been approved since our last issue.
