Biogen Inc.'s decision to file for approval early next year of beta-amyloid-targeting aducanumab (adu) in Alzheimer's disease (AD) based on fresh analysis of a bigger phase III dataset juiced the stock and induced shock at the same time, as Wall Street pressed company officials for details on their rationale behind the move.
The FDA's Antimicrobial Drugs Advisory Committee last week backed by a large margin cefiderocol for treatment of complicated urinary tract infections (cUTIs), despite the mortality disparity found by Shionogi & Co. Ltd. among critically ill drug-treated patients in the descriptive phase III trial in severe infections called Credible-CR.
Benefit for patients with disease that has spread to the brain put a special shine on top-line data rolled out by Seattle Genetics Inc. (Seagen) from the HER2Climb study, an experiment to test the oral small-molecule tyrosine kinase inhibitor (TKI) tucatinib, designed as highly selective for HER2 without significantly knocking down EGFR.
His parents likely expected Henri Termeer to find his position in the shoe business that the family had run for several hundred years but, after his advanced schooling, Termeer had other ideas. Biotech observers today may wonder who can fill the moccasins of the trailblazer that Termeer became.
CEO Christine Bunt of Verseau Therapeutics Inc. told BioWorld that the company has prepared a "wave" of prospects from its macrophage checkpoint modulator (MCM) platform ready to crash upon the shores of cancer therapy, with 23 novel targets in the hopper.
The pipeline shift made public Thursday by Syros Pharmaceuticals Inc. may have been presaged by analysts, who in August sounded lukewarm about the Cambridge, Mass.-based firm's prospects as they stood then.
The FDA's Antimicrobial Drugs Advisory Committee backed by a large margin cefiderocol for treatment of complicated urinary tract infections (cUTIs), despite the mortality disparity found by Shionogi & Co. Ltd. among critically ill drug-treated patients in the descriptive phase III trial in severe infections called Credible-CR.
Days after going public, Viela Bio Inc. nailed down a deal with Mitsubishi Tanabe Pharma Corp. to develop and commercialize Viela’s humanized anti-CD19 monoclonal antibody, inebilizumab, in nine Asia regions for the rare disease called neuromyelitis optica spectrum disorder (NMOSD), as well as other potential future indications.
Reata Pharmaceuticals Inc.'s surprise victory in the pivotal, second part of the phase II study called Moxie with Nrf2 activator omaveloxolone in patients with Friedreich's ataxia (FA) energized Wall Street and sharpened appetites for data due shortly with another candidate in the class, bardoxolone methyl, in the works for Alport syndrome (AS).
With phase III trial enrollment underway and expected to enroll about 120 patients, South San Francisco-based Principia Biopharma Inc. disclosed positive preliminary data from its phase II open-label trial testing the oral Bruton tyrosine kinase inhibitor PRN-1008 against pemphigus vulgaris (PV).
