Regulatory

STA Pharmaceutical Co., Ltd., – a subsidiary of WuXi AppTec – announced today that its Jinshan manufacturing facility in Shanghai, China has successfully passed an inspection by the European Medicines Agency with no critical and no major findings.
Arcutis Also Announces Enrollment of Last Patient in 52-Week Long-term Safety Study of ARQ-151 Cream as a Potential Topical Treatment for Plaque Psoriasis
In its announcement on Thursday, the FDA said its preliminary tests of alternative antacid treatments such as Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole), and Prilosec (omeprazole) currently show no NDMA at this time based on testing.
CELLINK publishes the quarterly report for the period 1st of June 2019 – 31st of August 2019 and for the full year of operations 2018-2019.
BioArctic and Eisai presented new data regarding BAN2401 at the Alzheimer’s Association International Conference® (AAIC®) in July that confirmed BAN2401’s unique characteristics and was consistent with previously presented results
First academic bridge partnership in Israel aims to translate early-stage research from the Hebrew University (“HU”) of jerusalem into industrial drug development projects
MONROVIA, Calif., October 22, 2019 – AcuraStem, a biotechnology company advancing neuroscience through patient-based drug discovery, announced today that the company has triggered Phase II funding worth $3 million from its Fast Track Small Business Innovation Research grant awarded by the National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health *[Award Number R44NS105156].
Partnership in iABC project will accelerate Alaxia’s development of promising antimicrobial therapy for cystic fibrosis
Calls for increased transparency in clinical trials have been growing and now many medical journals are requiring authors of submitted papers to disclose whether or not they will be sharing clinical trial results.
The decision was based on new analysis run by Biogen in consultation with the FDA of a larger dataset from the trials halted in March.
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