As health care spending claims an ever bigger chunk of the U.S. economy, federal lawmakers continue to hope for a disruptive player while they sit on the sidelines, trying to get the big picture by examining the sector play by play through their legislative binoculars. Read More
The Alltrials campaign is launching an online tracker to name and shame clinical trial sponsors who do not report the results as required, and to cause embarrassment to the FDA if the agency does not enforce reporting requirements. Read More
AUSTIN, Texas – Organs on a chip that recreate living human biology are poised to move into mainstream drug discovery and development, complementing, and eventually superseding, cell culture and animal models in preclinical safety and efficacy studies. Read More
The race to relief for peanut allergy sufferers pounded onward Tuesday, with Aimmune Therapeutics Inc. delivering endpoint-meeting outcomes from a pivotal phase III test of its oral immunotherapy, AR-101. The 499-participant trial found that about 67 percent of evaluable people treated with AR-101 tolerated a single highest dose of at least 600 mg of peanut protein with no more than mild symptoms vs. 4 percent of those given a placebo. Read More
AUSTIN, Texas – The advent of gene editing and induced pluripotent stem cells has revived the fortunes of xenotransplantation – and given it a new twist. Read More
Dynavax Technologies Corp., of Berkeley, Calif., said it closed on a $175 million nondilutive term loan agreement with CRG LP, a health care-focused investment firm. Read More
Zealand Pharma A/S, of Copenhagen, Denmark, and Brisbane, Australia-based Uniquest, the commercialization arm of The University of Queensland, have agreed to work together to identify new peptide therapies inspired by venoms as potential new treatments for gastrointestinal diseases. Read More
Athenex Inc., of Buffalo, N.Y., reported phase II data at the American Academy of Dermatology meeting in San Diego, showing that KX2-391, a dual Src kinase and tubulin polymerization inhibitor, achieved a higher overall 100 percent clearance of actinic keratosis lesions at day 57 in the five-day treatment cohort vs. the three-day treatment cohort (43 percent vs. 32 percent). Read More
Arkansas could become the first state in the U.S. to put additional regulatory requirements on pharmacy benefit managers (PBMs), which negotiate drug prices and formulary placement with biopharma companies. Read More