Pfizer Inc.’s bivalent prefusion vaccine for protecting newborns from severe respiratory syncytial virus (RSV) hit one of its two primary endpoints in its phase III study, which was good enough for the company to stop enrollment and plan to submit a BLA to the U.S. FDA by year-end. PF-06928316 is one of six RSV vaccines in active phase III development globally, which includes an Astrazeneca plc-Sanofi SA collaboration plus one from GSK plc. Pfizer’s is the only one developed for infants by way of maternal immunization and for older adults. Read More
Human Immunology Biosciences (HI-Bio) Inc., a company developing targeted therapies for severe immune-mediated diseases, has secured $120 million in financing. Its initial pipeline is built around two clinical-stage immunology assets in-licensed from Morphosys AG in June 2022. The funds will help the company move through key inflection points over the coming years, in both in its ongoing clinical and discovery programs, where it's currently focused on the role of mast cells as a cellular driver of disease. Read More
Shanghai’s State Medical Products Administration announced that GSK plc has been banned from participating in volume-based procurement tenders until April 29, 2024, after failing a good manufacturing practices (GMP) inspection at a contract manufacturing plant in Poland that makes products for China. Read More
Reflecting statutory and regulatory requirements added over the past five years, the U.S. FDA is issuing a revised draft question-and-answer (Q&A) guidance on expanded access to investigational drugs. One of several guidances recently issued, the 40-page draft incorporates requirements from the 21st Century Cures Act and the 2017 FDA Reauthorization Act that took effect after the current final Q&A guidance was updated in 2017. It also answers new questions sponsors have raised over the past few years. Read More
“Big genomics” specialist Replay Holdings LLC has unveiled the first of four satellite genomic medicine companies it is forming to apply its high capacity herpes simplex viral (HSV) vector to next generation gene therapies. Eudora Therapeutics will specialize in inherited retinal eye diseases. It arrives on the scene with programs targeted at retinitis pigmentosa, Stargardt disease and Usher syndrome type 1B. Read More
Despite a busy September, U.S. FDA approvals and global regulatory news fell in October to the lowest point this year. So far in 2022, the FDA has approved 127 drugs and biologics, including supplemental filings. This is 25% less than each of the last two years, which had 170 approvals in 2021 and 169 approvals in 2020 through the end of October. The last time approvals were lower than this year was 2016 when there were 121. Read More
New hires and promotions in the biopharma industry, including: ADC, Cymabay, Eupraxia, Immunogen, Kala, Kalivir, Lava, Myriad Genetics, Sage, Shuttle. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acelrx, Actinium, Akeso, BMS, Cerecin, Disc, Essa, First Wave, Innocare, Innovent, Instil, Kalvista, Merck & Co., Nicox, Pharmazz, Scancell, Senhwa, United Therapeutics, Vaccitech, Verge. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biocytogen, Dragonfly, Eucure, Gilead, Isu, Ligand, Memo, Merck, Mosaic, Ono, Orsobio, Pharmather, Scilex. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alzamend, Amicus, Antengene, Ardelyx, Cytodyn, Dyne, Santhera, TurnstoneAlzamend, Amicus, Antengene, Ardelyx, Cytodyn, Dyne, Kyowa Kirin, Santhera and Turnstone. Read More
