Vaginal microbiome specialist Freya Bioscience ApS has added $11.8 million to its series A, bringing the total for the round to $50 million. Of the additional $11.8 million, $10.4 million comes from the Gates Foundation and is designated for the development of vaginal microbiome-based immunotherapies for treating bacterial vaginosis, a cause of preterm birth and other pregnancy complications.
China’s National Medical Products Administration (NMPA) has accepted Ascentage Pharma Group Corp. Ltd.’s NDA for its in-house-developed Bcl-2 selective inhibitor, lisaftoclax (APG-2575), which could be the first domestically approved Bcl-2 inhibitor in China and the second global approval.
The U.S. FDA issued a complete response letter Nov. 15 for Izervay’s (avacincaptad pegol intravitreal solution, ACP) supplemental NDA, which sought to include positive two-year data for the Astellas Pharma Inc. therapy, previously approved for use in a treatment for geographic atrophy secondary to age-related macular degeneration.
Endometriosis has been woefully under-recognized in the medical community, and consequently, the delay between onset and diagnosis is often quite long, with some women waiting up to 12 years for a diagnosis.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adverum, Alnylam, Anthos, Arbutus, Bridgebio, Cybin, Eli Lilly, Intellia, Neurogene.
New hires and promotions in the biopharma industry, including: Alterity, Byondis, Cancervax, Georgiamune, Kaida, Kuros, Latigo, LB, Mind Medicine, Mirai, Nanovation, Terns.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Aldeyra, Avenzo, HCW, Neurobo, Trogenix, VBI Vaccines, Velavigo, WY Biotech.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aldeyra, Alentis, Alkeus, Arrowhead, Astrazeneca, Biogen, Formycon, Foundation Medicine, Johnson, Klinge, Junshi, Orphelia, Samsung Bioepis, Syndax, Vaderis, Topalliance.
Neurogene Inc.’s stock sank 43% on news that its phase I/II gene therapy, NGN-401, resulted in a serious adverse event in a pediatric Rett syndrome patient receiving the highest dose.
RSS
