Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Bioarctic, Eisai, Huahui, Imviva, Intellia, Innovent, Otsuka, Quoin.
Biopharma happenings, including deals and partnerships, and other news in brief: Baseline, Boehringer, Genenta, Hetero, Insilico, Ixcells, Lisata, Mesoblast, MS Pharma, Qilu, Rosebud, Simcere.
Rolling out guidance to help pharma manufacturers provide direct-to-consumer drugs at lower prices, the U.S. Department of Health and Human Services (HHS) clarified ways to eliminate the middlemen while still abiding by the federal anti-kickback statute.
Boehringer Ingelheim International GmbH signed a €1.058 billion (US$1.26 billion) deal with Simcere Pharmaceutical Group Ltd. to license select rights to SIM-0709, a preclinical TL1A/IL-23p19-directed bispecific antibody targeting inflammatory bowel disease (IBD).
With the PDUFA date fast approaching for Regenxbio Inc.’s gene therapy RGX-121, the U.S. FDA placed the drug on clinical hold along with another, RGX-111, after preliminary analysis of a single case of neoplasm (specifically, an intraventricular central nervous system tumor) in a participant treated in the phase I/II study with the latter treatment.
Heeding the recommendation of an independent data monitoring committee, Calcimedica Inc. said it is discontinuing the phase II study testing calcium release-activated calcium channel inhibitor Auxora in patients with acute kidney injury with associated acute hypoxemic respiratory failure.
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