UCB SA agreed to pay $2 billion up front to acquire bispecific T-cell engager (TCE)-maker Candid Therapeutics Inc. and lead BCMA/CD3 TCE asset cizutamig (CND-106), continuing big pharma’s spree for China-made autoimmune assets in 2026. Read More
Entering what Mirum Pharmaceuticals Inc. CEO Chris Peetz called “a new phase of growth and value creation,” the company plans to submit an NDA to the U.S. FDA in the second half of this year, based on phase IIb data from the Vistas trial with oral ileal bile acid transporter (IBAT) inhibitor volixibat in primary sclerosing cholangitis (PSC). Read More
For the first time in 13 years, the U.S. Trade Representative (USTR) singled out one of the U.S. trading partners as the worst of the worst when it named Vietnam as a Priority Foreign Country (PFC) in its newly released Special 301 Report. Read More
As Celcuity Inc. awaits a U.S. FDA approval decision for gedatolisib in HER-positive, HER2-negative, PIK3CA wild-type advanced breast cancer, the company already is setting its sights on a supplemental NDA filing, based on a top-line readout of the multi-target PAM inhibitor in a PIK3CA-mutant breast cancer cohort. Read More
Regulatory uncertainty that dominated the life science sector in 2025 is transitioning into an execution framework for biotechnology companies, provided companies can tailor regulatory strategies early, and across the entire development cycle. Read More
A new vaccination strategy designed to induce antibodies that recognize the apex of the HIV Env protein uses Env trimers displayed on liposomes to increase their density and orient them correctly. This presentation enhanced apex-focused antibody responses in macaques, and the monoclonal antibodies isolated after immunization showed binding modes and structural features resembling human broadly neutralizing antibodies (bNAbs), indicating that the vaccine can steer the antibody response toward this vulnerable site. Read More
Biopharma and med-tech companies raising money in public or private financings, including: Cue, Oberland, Rein, Senseonics, Stoked Bio, Techcyte. Read More
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Ascendant Health Sciences, Cue, Esperion, Eton, J&J, Noxopharm. Read More
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Arrowhead, Astrazeneca, Axsome, MRM, Orchestra, Rhythm, Royal Philips, Taewoong, Telix. Read More
