Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Henlius.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aadi, Allovir, Cargo, Kalaris, Purdue, Whitehawk.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acumen, Benitec, Hutchmed, Immunovant, Innovent, Maat, Novartis, Regenxbio, Roivant, Satellos, Tvardi, UCB.
Taimed Biologics Inc.’s TMB-365/TMB-380 long-acting combination of broadly neutralizing antibodies regimen for HIV maintenance could reshape HIV treatment management, offering a viable alternative to daily combination antiretroviral therapy (cART), the Taipei-based company said after reporting on phase IIa results.
Pharma companies in the U.K. said the rebate they are required to make on drug sales is making the country “un-investible,” prompting staff cuts and leading clinical research partnerships to be unwound. Rather than the 15.3% rebate on branded drugs companies expected to pay this year, the rate has leapt to 22.9%. That has left the Voluntary Scheme for Branded Medicine Pricing and Access “in crisis,” according to the Association of the British Pharmaceutical Industries.
Elevation Oncology Inc. has nixed its lead pipeline product, a claudin 18.2 antibody-drug conjugate (ADC) called EO-3021, on disappointing phase I data, sending shares tumbling by 42% and placing its preclinical HER3 ADC to the forefront of development.
Sanofi SA is getting deeper into oncology and immunology therapy development through buying Dren Bio Inc.’s myeloid cell engager for deep B-cell depletion, DR-0201. The deal could reach as high as $1.9 billion for privately held Dren. Sanofi is paying a hefty $600 million up front, and milestone payments to come could add up to $1.3 billion.
Researchers at the German Cancer Research Center Deutsches Krebsforschungszentrum (DKFZ) and their collaborators have cast new light on the mechanisms by which hepatic stellate cells control liver metabolism and regeneration. The work builds on the concept of angiocrine signaling, established 15 years ago.
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