Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3B, Alloy, Artbio, Beigene, Beone, Flashpoint, Slingshot, Syncona.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Global Institute of Stem Cell Therapy, Kondrion, Leo Pharma, Nurexone, PTC.
While women’s health has slid under the research radar for decades, large biopharma companies and venture capital firms are beginning to take notice of the untapped market potential. More companies are wandering into the space and exploring avenues of science that were largely ignored for years. A BioWorld analysis of biopharma companies working on women’s health solutions found that while many efforts to improve the well-being of women exist, the proportion of funding and partnering for this emerging sector of medicine still represents only a small slice of the industry’s overall activity.
Biontech SE is extending its relationship with Biotheus Inc. from a licensing deal to a full-scale acquisition, agreeing to pay $800 million cash and up to $150 million in milestone payments for the Chinese oncology specialist.
While women make up half the world’s population and own two out of every five businesses, there are substantial knowledge gaps about conditions affecting their health – mostly due to decades of research excluding women from clinical trials and investment decisions.
PTC Therapeutics Inc.’s accelerated go-ahead from the U.S. FDA for Kebilidi (eladocagene exuparvovec-tneq), a recombinant adeno-associated virus serotype 2-based gene therapy to treat aromatic L-amino acid decarboxylase (AADC) deficiency, came with a priority review voucher (PRV) that the company intends to monetize.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adaptimmune, Aileron, Biorestorative, Creative Medical, Syros.