With the U.S. FDA’s approval of Enflonsia (clesrovimab) to prevent respiratory syncytial virus (RSV) infection lower respiratory tract disease in newborns and infants, Merck & Co. Inc. steps into a space of competition and regulatory shifts. The preventive, long-acting monoclonal antibody (MAb) will take its place in the market alongside the blockbuster Beyfortus (nirsevimab) from Sanofi SA and Astrazeneca plc. The MAb for pediatric use brought in about $1.77 billion in 2024. Read More

Despite the June 9 gutting of the U.S. CDC’s Advisory Committee for Immunization Practices, the Department of Health and Human Services said the committee’s June 25-27 meeting will continue as scheduled. But a new panel has yet to be named, and typically ACIP members have a lot of behind-the-scenes work to do before a meeting. Read More

Insmed Inc.’s chair and CEO, Will Lewis, called the phase IIb trial of TPIP in pulmonary arterial hypertension a “clear and unequivocal success,” with analysts and investors wholeheartedly agreeing, as the company’s shares surged 28.7% June 10. Read More

Aribio Co. Ltd. signed a $600 million license deal with Acino International AG, an Arcera Life Sciences subsidiary, granting the latter commercial rights to its oral Alzheimer’s disease therapy, AR-1001, in select countries including the Middle East. Read More

Is fecal microbiota transplant effective? Is it really safe? And is it really all the same? Scientists at the University of Chicago have investigated the regional differences in gut environments to question these interventions to analyze the microbiome differences and their effects after transplantation form different intestine areas. The results show how host-microbe mismatches after these interventions could affect gut health. Read More

New hires and promotions in the biopharma industry, including: Abcuro, Beacon, Fable, Innospera, Modex, Seed, Torl. Read More

Biopharmas raising money in public or private financings, including: Mosanna, Rakovina, Trevi. Read More

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Ascendis, Avidity, Everest, In8bio, Merck, Metsera, Newamsterdam, Polypid, Regeneron, Sanofi, Vertex. Read More

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Beone, Compedica, Concentra, Elevation, Formosa, Harrow, Neowise, Nipro, Portage, Samsung Bioepis. Read More

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alnylam, Axsome, George Medicines, Italfarmaco, Lipocine, Tuhura, Verity. Read More