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Latest From Joseph Haas
Once suspended due to safety issues, bardoxolone now has completed a Phase II study that showed kidney function benefit in four rare types of CKD. A pivotal study is underway, with another planned and more possible.
A week after Gilead missed its primary endpoint in the first Phase III NASH trial, Intercept shows a statistically significant fibrosis benefit in Phase III with OCA. It plans to file for approval later this year.
BioMarin’s focus on rare diseases and gene therapies and expected financial growth make it a logical acquisition target for almost any large pharma, though Biogen, Amgen and Regeneron also offer a beneficial fit for many.
Already having launched several portfolio companies, Roivant goes a step further by spinning out CNS specialist Arvelle from Axovant. BI and IBM will incorporate blockchain technology in clinical trials, while AbbVie licenses multiple myeloma candidate from TeneoBio.
Funded entirely by grants and partnerships to date, Affinivax’s pneumococcal vaccine candidate has begun a Phase I/II study less than five year’s after the biotech’s founding. Firm thinks its technology may eventually apply to immuno-oncology as well.
Gilead took a risky approach with selonsertib in NASH, pursuing a tough liver fibrosis benefit and failing, continuing a trend of disappointments outside of its antiviral franchises. Analysts don’t expect the second Phase III study in less-sick patients to succeed either.