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Nader Pourhassan, who led CytoDyn for nearly 10 years, was convicted in December 2024 of misleading investors regarding the biotech’s investigational COVID-19 and HIV drug, which artificially inflated its share price.
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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.
From opening new therapeutic mechanisms to repairing neuronal damage, investigational molecules from Ventyx Therapeutics, AC Immune, Gain Therapeutics and more could shape the future of Parkinson’s disease treatment.
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The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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Takeda on Monday said it is paying AC Immune $100 million upfront for an option on a Phase Ib/II Alzheimer’s disease candidate that could activate the immune system to clear amyloid beta plaques.
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.