Robert Califf's confirmation as the next FDA commissioner is being held hostage – by a Democrat senator who wants the FDA to do something other than talk about the growing opioid problem facing the nation and a presidential candidate who has an issue with the cardiologist's close ties to the drug and medical device industry. Read More
Dosing and new patient enrollment in all cohorts of Akashi Therapeutics Inc.'s phase Ib/IIa study of the FDA fast-tracked experimental Duchenne muscular dystrophy (DMD) medicine HT-100 (halofuginone) are being suspended after one of the patients receiving the highest study dose began experiencing serious, life-threatening health issues. Read More
Finishing its $51 million series A round begun about five months ago, Adicet Bio Inc. is taking over Applied Immune Technologies Ltd. (AIT), and aims to push its universal immune cell therapy platform toward the clinic. Read More
LONDON – Inivata Ltd. has raised £31.5 million (US$42.2 million) in a series A round, to advance the commercialization of its circulating tumor DNA liquid biopsy technology. Read More
SHANGHAI – Glaxosmithkline plc's China problem has taken a new turn. Two employees, both scientists of Chinese heritage, have been indicted by a federal grand jury in Pennsylvania on criminal charges for stealing early stage biologic secrets from GSK. Read More
Chinese researchers have reported the creation of two generations of transgenic macaque monkeys bearing a gene duplication of the MeCP2 gene. In humans, MeCP2 duplication syndrome is a childhood neurological disorder that is part of the autism spectrum, and the monkeys showed some of the behavioral symptoms that are typical of MeCP2 duplication syndrome, though they lacked the cognitive symptoms that are a prominent feature of the disorder in humans. Read More
TOKYO – Japan will lower the prices of 45 drugs in the second quarter as part of a push to reduce spending in health care and encourage the use of generics. Among the drugs most likely to be affected by the move are Gilead Sciences Inc.'s popular hepatitis C virus (HCV) drugs Sovaldi and Harvoni. Read More
Emmaus Life Sciences Inc., of Torrance, Calif., raised about $1.7 million in gross proceeds from the sale of common shares to Korea Biomedical Science Institute (KBMSI), of Seoul, South Korea, as part of a collaboration agreement between the two companies. Read More
The Hereditary Neuropathy Foundation (HNF), of New York, said it entered a partnership with Acetylon Pharmaceuticals Inc., of Boston, a firm developing selective histone deacetylase (HDAC) inhibitors for enhanced therapeutic outcomes. Read More
Cornerstone Pharmaceuticals Inc., of Cranbury, N.J., reported that for 20 patients with stage IV pancreatic adenocarcinoma enrolled in its phase I study of CPI-613 in combination with Folfirinox, there was an objective response rate of 56 percent, higher than what has been reported for Folfirinox alone (31.6 percent). Read More
