Respiratory vaccines specialist Vicebio Ltd. is to be acquired by Sanofi SA in a $1.6 billion deal, of which $1.15 billion will be paid up front. The acquisition rests on an ongoing phase I trial of the lead asset, VXB-241, a bivalent vaccine that is intended to provide protection against both respiratory syncytial virus and metapneumovirus. The interim analysis of the study showed a favorable safety and tolerability profile in adults, ages 60 and older, and validated the underlying vaccine technology, which is applicable to a wide range of respiratory viruses. Read More
There are a raft of problems the U.S. FDA wants resolved before Replimune Group Inc.’s BLA for RP-1 (vusolimogene oderparepvec) with nivolumab to treat advanced melanoma goes any further, all of which the company said are a surprise. Read More
Following up on the $175 million it raised in September 2023, Avalyn Pharma Inc. secured an additional $100 million in an oversubscribed series D financing round to support development of its inhaled treatments for pulmonary fibrosis. Read More
Livzon Mabpharm Inc.’s anti-IL-17A/F monoclonal antibody, LZM-012, met the primary endpoint in a phase III trial in moderate to severe plaque psoriasis. Conducted at Fudan University’s Huashan Hospital, the phase III multicenter, randomized, double-blind, active-controlled (secukinumab) trial enrolled 926 patients with moderate to severe plaque psoriasis. Read More
We all look different to HIV, a virus that destroys the immune system. The defensive cells record every interaction with foreign agents, infections from viruses and bacteria, but also with mechanisms occurring within the body, such as microbiome metabolism, the effects of aging, or the development of diseases. At a preconference session at the 13th IAS Conference on HIV Science (IAS 2025), scientists explained the interactions of different microorganisms with HIV. Read More
In an about-face, Sarepta Therapeutics Inc. said it would “voluntarily and temporarily” pause all shipments of Duchenne muscular dystrophy gene therapy Elevidys (delandistrogene moxeparvovec) in the U.S. The move comes only a few days after the firm publicly declined a U.S. FDA request to halt shipping of the therapy in the wake of a third patient death, this one linked to a gene therapy using the same adeno-associated virus (AAV) vector as Elevidys. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alkermes, Alzecure, Astrazeneca, Cloudbreak, Cognition, Genentech, Ionis, Revalesio, Urogen. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Azurity, Concentra, Cycle, George, Handa, Iteos. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bayer, Bioxcel, Bristol Myers Squibb, Disc, Genentech, Geovax, Imcheck, Johnson & Johnson, Korro, Nkgen, Orion, Oruka, Promis, Redhill, Springworks. Read More
