Given that Novavax Inc.’s COVID-19 vaccine will be a latecomer to the U.S. scene if it gets FDA authorization, it’s been cast in a supporting role to the lead being played by the mRNA vaccines from Moderna Inc. and Pfizer Inc.-Biontech SE. But the data presented at the June 28 Vaccines and Related Biologic Products Advisory Committee meeting suggest the Novavax adjuvanted protein vaccine may have the chops to take on a larger role in taming the pandemic. Read More
Shares in Ipsen SA edged higher June 29 after the firm announced it had refiled its palovarotene NDA with the U.S. FDA for the ultra-rare disease fibrodysplasia ossificans progressiva. The regulator granted a six-month priority review for the drug, which was once written off and had its FDA filing pulled in 2021 after officials asked for further analyses and data.
Trevi Therapeutics Inc. took its place among several late-stage contenders by scoring a win in prurigo nodularis in the form of positive data from the 360-participant, phase IIb/III Pruritus Relief through Itch-Scratch Modulation, or PRISM, trial with oral Haduvio (nalbuphine extended release). Read More
Mirobio Ltd. is poised to take two checkpoint agonists into the clinic in the treatment of autoimmune diseases, after closing a $97 million series B round. The most advanced program, MB-272, is an agonist of the B and T lymphocyte attenuator receptor that relays inhibitory signals to suppress the immune response. Mirobio says activating it has a “far reaching” regulatory effect, restoring self-tolerance across several major autoimmune diseases, including lupus. Read More
Immuno-oncology company Imugene Ltd. reported median overall survival for patients receiving HER-Vaxx plus chemotherapy was 13.9 months compared to 8.3 months in patients treated with chemotherapy alone in its phase II study in HER2/neu overexpressing advanced gastric cancer. Read More
Novartis AG is making good on its plan to streamline the company so it can save $1 billion by 2024. The Basel, Switzerland-based company told BioWorld the restructuring that’s underway could impact 8,000 positions around the world, with 1,400 of them in Switzerland. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ideaya, GSK, Panbela, Merck, Neurotrauma Sciences, Transcenta, Transgene, XNK. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bavarian Nordic, Gilead, Kite, MRM, Sanofi, Schrödinger, Soligenix, Verrica. Read More
