American Society of Hematology (ASH) President Kenneth Anderson said that the annual meeting, set for next month in Atlanta, will include plenty more data with chimeric antigen receptor (CAR) T cells, highlighting the approach's much-celebrated ability to build for patients an "autologous immune army." Read More
Cytokinetics Inc. is suspending development of its lead candidate, tirasemtiv, for amyotrophic lateral sclerosis (ALS) after it failed to hit both primary and secondary endpoints in a crucial phase III test. Read More
Estrogen receptor beta (ER-beta) is an important factor that should be considered in the design of new stem cell-based regenerative therapies for neurodegenerative conditions, a new Swedish-American collaborative study has concluded. Read More
LONDON – "For the past year and half we have been living with uncertainty. We can now take practical action to maintain business continuity." So said Guido Rasi, executive director of the EMA, giving his reaction to the political decision to move the agency from London to Amsterdam when the U.K. leaves the EU. Read More
HONG KONG – A year and a half after reports of illegal vaccine sales prompted investigation by China's CFDA, a recent recall involving vaccines of substandard quality has further eroded public trust in the country toward drug safety and raised concerns of the government's loophole-ridden supervision of the space. Read More
Arsanis Inc., of Waltham, Mass., said it closed its IPO of 4.6 million shares of its common stock at $10 each, including 600,000 additional shares of common stock issued upon the exercise in full by the underwriters of their overallotment option. Read More
Menlo Therapeutics Inc., of Redwood City, Calif., said it started enrollment in a phase II trial of serlopitant for the treatment of pruritis associated with psoriasis. Read More
US Worldmeds LLC, of Louisville, Ky., said the FDA accepted and granted priority review of the NDA for lofexidine, an investigational product to mitigate symptoms associated with opioid withdrawal and facilitate completion of opioid discontinuation treatment. A PDUFA date for lofexidine, an oral, selective alpha 2-adrenergic receptor agonist, is expected in the second quarter of 2018. Read More
