LONDON – Biontech SE announced positive preliminary data from the ongoing phase I/II trial of one of the four COVID-19 vaccines it is developing with Pfizer Inc., with participants in each of three dose groups mounting immune responses that were greater than seen in patients who recovered from COVID-19 infections. Read More

Strongly positive histological data from Akero Therapeutics Inc. is being seen as setting a potentially new high bar in treating nonalcoholic steatohepatitis (NASH), but 89bio Inc.’s NASH treatment, on a similar development timeline, is sharing in the success. Read More

Bolt Biotherapeutics Inc.’s $93.5 million series C round “takes us well into the back end of 2021 and into 2022,” CEO Randall Schatzman told BioWorld, with enough money that the firm is “not impeded in terms of the creativity [we’re] bringing to the table.” Read More

Biosimilars referencing Amgen Inc.’s rheumatoid arthritis drug, Enbrel (etanercept), could remain sidelined in the U.S. for nearly another decade, following a Federal Circuit decision Wednesday affirming the validity of two patents protecting etanercept and its manufacturing methods. Read More

CAJICA, Colombia – Aided by federal funds from the Brazilian government, the University of Sao Paulo is moving forward with developing a precision SARS-CoV-2 vaccine that is about to start preclinical trials. Read More

The U.S. Department of Veterans Affairs (VA) is looking for more discounts from prescription drug manufacturers, but it likely will be a few years before the ask becomes reality as it will require congressional action and federal rulemaking. Read More

New hires and promotions in the biopharma industry, including: 4Bio, Akari, Arcturus, Beigene, Cellectar, Codiak, Egenesis, Khondrion, Moderna, Scenic, Sotio, Trevi, Xoma, Zentalis. Read More

Biopharmas raising money in public or private financings, including: Acceleron, Akari, Akouos, Amylyx, Chiasma, Crispr Therapeutics, DFP Healthcare Acquisitions, IMV, Orphazyme, Painreform, Panacea Acquisition, Tela Bio. Read More

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akero, Anavex, Biondvax, Biontech, Context, Corcept, Daiichi, Durect, Eyenovia, Ipsen, Matinas, Oncolys, Pfizer, Polypid, Revance, Timber, Vasopharm. Read More

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Advanced Biodesign, Aligos, Avadel, Binx Health, Bioinvent, Boehringer Ingelheim, Canagen, Celsius, Crestone, Dr. Reddy’s, Eisai, Emollivet, Epicentrx, Exela, Fujifilm, Foresight, G1, Genix, Ginkgo Bioworks, Leo, Liminal, Lipidor, Myneo, Pfizer, Prometic, Quralis, Repurpose.AI, Revolution Medicines, Sciclone, Sherlock Biosciences, Sumitomo Dainippon, Therapix, Thinkcyte, Van Heron Labs. Read More

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bavarian, Blueprint, EMD, Golden, Hangzhou Yuyuan, Isa, Janssen, Medicinova, Mezzion, Pfizer, Revive, Rhythm, Scpharmaceuticals, Sun, TC, Obseva, Ultragenyx, Y-mabs. Read More

The latest global regulatory news, changes and updates affecting biopharma, including: Indivior, Reckitt Benckiser, Glenmark, Apotex, Intercept, Teva. Read More