As backers of other drug developers with CAR T cell therapies in the works scrambled to downplay the hitch met by Juno Therapeutics Inc. and gain distance from it, CEO Hans Bishop outlined what he called "a clear path forward" with JCAR015 in acute lymphoblastic leukemia, held up by the FDA because three patients died in phase II trials.
Martin Mackay, global head of R&D for Alexion Pharmaceuticals Inc., told BioWorld Today the firm is "very much in preparation mode" for talks with regulators about complement protein C5 binder Soliris (eculizumab) for refractory generalized myasthenia gravis (MG).
Akari Therapeutics plc CEO Gur Roshwalb told BioWorld Today that his firm "like[s] to think we'll be second to market" with once-daily, self-injected therapy Coversin for paroxysmal nocturnal hemoglobinuria (PNH), behind intravenous (I.V.) Soliris (eculizumab, Alexion Pharmaceuticals Inc.), given every other week.
With new science and true innovation, reimbursement should "take care of itself," Seres Therapeutics Inc.'s chief scientific officer (CSO) David Cook told BioWorld Today, on the brink of phase IIb data with SER-109 for recurrent Clostridium difficile infection (CDI).
Computational-chemistry expert Schrödinger Inc. collaborated with his firm "as a co-founder almost," Morphic Therapeutic Inc. CEO Praveen Tipirneni told BioWorld Today, which should provide "an interesting advantage" in working with crystal structures to design oral integrin-targeting drugs.
Analysts had plenty of questions but Esperion Therapeutics Inc. offered few answers regarding the FDA's stalling on oral, once-daily bempedoic acid (ETC-1002) for lipid lowering, after the agency told company officials it's uncertain about an acceptable endpoint and how the treatment paradigm might transform.
Xencor Inc.'s broadly enabling platform made possible "the calculated trade-off" by Novartis AG that let his bispecific antibody firm hang onto U.S. rights for its pair of lead compounds in a deal that could be worth as much as $2.4 billion-plus, CEO Bassil Dahiyat told BioWorld Today.
Antibiotics development underwent “a bad period, and probably the low point was around 2009,” Melinta Therapeutics Inc. Chief Scientific Officer Erin Duffy told BioWorld Today.
