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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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Read our takes on the biggest stories happening in the industry.
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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Jefferies analysts envision a steady launch curve that could ultimately drive meaningful sales from people who are dissatisfied with existing treatments.
Both companies received agency requests for more evidence of the effectiveness of their therapies.
Four of this year’s biggest acquisitions topped 11-figure figures. One was 2025’s messiest bidding war.
Despite the definitive failure of Novo Nordisk’s semaglutide in Alzheimer’s, biotech executives, analysts and other industry experts see potential in more testing of GLP-1s for the neurodegenerative disease, particularly in a combination approach.
Analysts called the approval a much-needed win for Novo Nordisk, but warned that the company could struggle to grow sales once rival drugs come to market.
Analysts said the outcome is disappointing because there are no approved treatments for dyskinetic cerebral palsy, but the setback had little impact on Neurocrine’s valuation.
The banker allegedly shared details of a series of multibillion-dollar buyouts by companies including AbbVie, GSK and Pfizer.
The patient, who died on December 14, was originally enrolled in a Phase III study in 2022 and transitioned into an extension phase in 2023.
A push to reshore some drug production and progress in advanced manufacturing technologies have been prominent trends this year, industry leaders say.
Of all the stories we published this year, these deep dives by BioSpace editors stand out as relevant re-reads going into the New Year.