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The limited supply of this common reagent is set to drive drug prices higher, but there are ways for companies to lessen the impact.
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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.
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?
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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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A pre-planned analysis revealed patients receiving the vibostolimab-Keytruda coformulation in a late-stage trial had a high rate of dropouts due to immune-related adverse events, Merck announced Monday.
The major biopharma players have promised to increase their investments in France to help boost their respective global manufacturing and R&D capabilities, with Sanofi committing more than $1 billion.
Results from a Phase I study presented Friday at the ASGCT 2024 annual meeting showed that despite a good safety profile, Excision BioTherapeutics’ HIV gene editor failed to suppress viral activity.
An updated draft of the BIOSECURE Act introduced on Friday would give U.S. drug manufacturers additional leeway for existing contracts with certain Chinese “companies of concern” until 2032.
Two of the five fatalities were found to be unrelated to MacroGenics’ investigational antibody-drug conjugate vobra duo, while the other three are still under investigation.
While these technologies are now a therapeutic reality, the ASGCT 2024 annual meeting this week was a reminder of just how far we are from widespread use.
Anticipating approval for its COPD therapy ensifentrine, Verona has entered into a $650 million financing deal with Oaktree Capital Management and OMERS Life Sciences.
With its $525 million investment, Royalty Pharma will acquire the royalties and milestones for ImmuNext’s anti-CD40 therapy frexalimab, which is currently in Phase III trials for multiple sclerosis.
With 15 patients started across its three gene therapies, bluebird bio claims a 138% year-over-year revenue growth and aims to initiate up to around 100 new patients in the current year.
At a Thursday ASGCT 2024 session, CBER Director Peter Marks made the case for a better, “more convergent” global framework on cell and gene therapies, especially for rare diseases.