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The current state of political affairs in the U.S. does not bode well for the direction of that turn. The country is at real risk of losing its long-held lead in biotech innovation.
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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.
The rare disease drugmaker is facing potential competitors for achondroplasia drug Voxzogo. Is a big M&A deal with two approved assets enough to maintain investor interest?
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.
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Novo Nordisk and Eli Lilly have been battling head-to-head in an exploding obesity market. They should never have been compared apples to apples.
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Elisa Cascade, CPO at Advarra explains why addressing the challenges faced by clinical research sites is vital for improving patient trust and the overall viability of clinical trials.
The FDA is mired in uncertainty with some staffers losing their jobs over the weekend and more potentially to come, vaccines and psychedelic therapies could be facing very different futures under newly confirmed HHS Secretary Robert F. Kennedy, Jr., Moderna continues its downward revenue slide and Merck, Regeneron, BMS and more face strong patent headwinds.
The partnership splits the rights to Stoke’s epilepsy antisense oligonucleotide, with up to $385 million in potential payments due to Stoke.
Back in 2023, Novo Nordisk committed up to $1.3 billion for a hypertension and kidney disease drug from KBP Biosciences. Now, the pharma giant claims to have been misled by the biotech’s founder—and a judge seems to agree.
AlgoTherapeutix blames a “strong placebo effect” for the mid-stage failure for its pain gel ATX01, but the company still believes in the promise of its candidate as Vertex Pharmaceuticals’ first-in-class drug Journavx opens up the non-opioid space.
In the first podcast in a special series focused on BioSpace’s NextGen Class of 2025, Senior Editor Annalee Armstrong speaks with Dannielle Appelhans, CEO of COUR.
Casdatifan’s progression-free survival benefits could help differentiate it from Merck’s Welireg in the kidney cancer arena, according to analysts at Truist Securities.
COUR Pharmaceuticals has been around a while, but not until last year did the company solidify behind its ultimate mission with a series A raise.
The hammer came down on an unspecified number of FDA employees this weekend, days after Robert F. Kennedy Jr. was confirmed as HHS Secretary.
The approvals come as Robert F. Kennedy Jr.—who has been critical of vaccines—takes leadership of the Department of Health and Human Services.