Shares of Aclaris Therapeutics Inc. (NASDAQ:ACRS) rose 64% to $1.80 Tuesday on news that A-101, its topical treatment of verruca vulgaris, or common warts, met both the primary and all secondary efficacy endpoints of the phase III THWART-2 trial, the first of two pivotal studies intended to support an NDA filing for the drug, a high-concentration topical hydrogen peroxide solution. The other trial, THWART-1, is expected to read out in the fourth quarter. Read More
Management's first flush of excitement two years ago in creating new therapies and a new company led also to the creation of Edgewise Therapeutics Inc.'s name. "We were all talking and no one could get a word in edgewise," Kevin Koch, Edgewise's president and CEO, told BioWorld. "It just made sense." Read More
After doing deals with big pharma – Eli Lilly and Co., Merck & Co. Inc., Abbvie Inc. and Bayer AG – Atomwise Inc. announced three partnerships last week with smaller preclinical companies to use its artificial intelligence (AI) platform to develop drugs for their targets. Read More
With the NDA target date of October approaching for roxadustat, Fibrogen Inc.'s hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) for anemia in chronic kidney disease (CKD), watchers of the space are handicapping the prospects for competitor Akebia Therapeutics Inc., developing vadadustat in the same class. Read More
BOGOTA, Colombia – Mylan NV's Ogivri (trastuzumab) has become the first registered biosimilar in Colombia, to be marketed by Strenuus Marketing, a Bogota-based drug distributor. Read More
Bioq Pharma Inc., of San Francisco, entered a development, supply and distribution agreement with Alpharetta, Ga.,-based Avanos Medical Inc. to gain approvals and then commercialize a self-contained, infusible, non-opioid, postoperative pain product in the U.S., Canada and Mexico. Read More
Linnaeus Therapeutics Inc., of Haddonfield, N.J., said it closed a $12 million series B financing led by Kairos Ventures with participation by the Penn Medicine Co-Investment Fund at the University of Pennsylvania. The company intends to use the proceeds to conduct its phase I/II trial of its lead compound, LNS-8801, in patients with advanced cancer. Read More
Concerns about affordability of new drugs will continue to grow as innovation results in more single or short-term transformative therapies (SSTs) that produce benefits beyond what's been seen so far, Steven Pearson, president of the Institute for Clinical and Economic Review (ICER), said Tuesday at an ICER summit on valuing potential cures. Read More
