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Latest From Emily Hayes
Results from the first Phase III study – LEAP 1 – of the antibiotic lefamulin are positive, and Nabriva still has one trial to go. But the firm believes that regardless of that result, the totality of data could be used to support regulatory filings.
Bayer's PI3 kinase inhibitor copanlisib now has accelerated approval in a common type of non-Hodgkin lymphoma, but the drug's competitive profile still awaits Phase III data.
An 'imperfect biomarker' – that's how a New England Journal of Medicine editorial describes the eosinophil count used in METREX and METREO studies.
Bristol's Opdivo and Novartis/GlaxoSmithKline's Tafinlar/Mekinist combo both performed well in early, post-surgical treatment of advanced melanoma in trials reported at ESMO, promising yet another revolution in the standard of care, but leaving Roche's Zelboraf/Cotellic in the dust.
Analysts had already been doubtful about the prospects for success in the Spectri study. A second Phase III trial is ongoing, but the candidate is already being removed from revenue models.
Company has priced its Factor Xa anticoagulant at $15 per capsule, on par with competitors, and is gearing up for a launch, but it first must resolve manufacturing issues with FDA as it scales up to commercial capacity.