Despite the higher placebo response than a previous, identically designed experiment turned up, Cara Therapeutics Inc.’s Kalm-2 phase III study Korsuva (CR-845/difelikefalin) for injection handily reached its primary endpoint in hemodialysis patients with moderate to severe chronic kidney disease-associated pruritus (CKD-aP).
Looking ahead to COVID-19 strategies, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), said vaccine studies might be done not in clinics but in the streets. “By definition, we’re probably not going to be able to vaccinate everyone simultaneously,” he noted.
As expected – and well ahead of the Aug. 20 PDUFA date – Bothell, Wash-based Seattle Genetics Inc. (Seagen) won FDA clearance for the oral small-molecule breast cancer therapy tucatinib, a tyrosine kinase inhibitor branded Tukysa.
San Francisco-based RDMD Inc. netted $14 million in series A money fueling an approach designed to generate clinical evidence that will speed drug development in rare diseases.
Arriving at MEI Pharma Inc.’s deal with Kyowa Kirin Co. Ltd., focused on phase II-stage ME-401 for B-cell malignancies, was a competitive process that brought large and midsized pharma bidders to the table, MEI Chief Operating Officer David Urso said, but the terms proposed by suitors tended to “look a lot the same.”
New York-based Immunovant Inc.’s phase IIa results with neonatal Fc receptor (FcRn)-targeting IMVT-1401 in thyroid eye disease (TED), also known as Graves’ ophthalmopathy, prompted renewed speculation about the space, hot since the approval on Jan. 21 of Tepezza (teprotumumab-trbw) from Horizon Therapeutics plc, of Dublin.
Boston-based Pieris Pharmaceuticals Inc., during its March 12 earnings call, talked up gastric cancer prospect PRS-343, a 4-1BB/HER2 bispecific for HER2-positive solid tumors, which has turned up single-agent and checkpoint-combination antitumor activity.
Backers in Tango Therapeutics Inc.’s $60 million series B round represent “a group of really smart crossovers who normally don’t come in quite this early” and “hung in there” during some especially hard times on Wall Street recently, CEO Barbara Weber told BioWorld. “We were about to sign the term sheet the first time the market crashed, which was a little nerve-wracking.”
Evercore ISI assembled a dozen internal specialists for a webinar to talk about COVID-19 from a variety of perspectives, with opinions aplenty on transmission route, up-and-coming treatment prospects, and problems in how testing procedures are understood – or not.
Sage Therapeutics Inc.’s chief business officer, Michael Cloonan, said the firm is “not going to give details around the geographies and the number of sites” that will continue to use Zulresso (brexanolone) for postpartum depression (PPD) after the restructuring of the Cambridge, Mass.-based firm.
