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Latest From Joseph Haas
While a dwindling patient base and pricing pressures are depleting the market opportunity in hepatitis C, Merck's decision also may result from regulatory dialogue potentially delaying the start of a Phase III study.
Instead of helping raise a Series A, the Teva chairman and others acquire the preclinical company, convinced of its synthetic nanotech promise in immuno-oncology. Vifor and ChemoCentryx expand their orphan and renal disease collaboration, while Gilead out-licenses an addiction drug candidate.
Likely candidates for use of Gilead's priority review vouchers include GS-4997, a Phase III candidate for NASH, and bictegravir, its second-generation integrase inhibitor for HIV. The virology specialist previously used a PRV successfully to accelerate approval of Odefsey.
Baxalta's hemophilia franchise immediately becomes Shire's top seller, but the specialty firm enjoyed sales growth across its business areas. Meanwhile, the launch of Xiidra is off to an impressive start in market share and patient access.
Phase II data presented at CROI aren't sufficient to demonstrate statistical superiority over ViiV's Tivicay, but one analyst predicts that a repeat performance in larger Phase III trials could support a superiority claim.
Looking to expand beyond Adcetris, Seattle Genetics pays $250m up front for Immunomedics' Phase I/II ADC for triple-negative breast cancer. Elsewhere in the ADC space, Swiss biotech Novimmune and South Korea's LegoChem are teaming up on a research collaboration.