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Novavax's partners Sanofi and Takeda have received regulatory approvals for an XFG variant-adapted formulation of Nuvaxovid, the company's protein-based, non-mRNA COVID-19 vaccine, across the US, EU, and Japan for the 2026-2027 vaccination season, positioning Novavax to continue earning royalties without maintaining its own commercial infrastructure.

PharmaEssentia's ropeginterferon alfa-2b-njft (Besremi) cut ET response rates to 43% versus 6% for anagrelide, backing a first-in-decades FDA nod for a new rare blood cancer treatment.

LIlly reports that Taltz plus Zepbound helped 30.6% of psoriasis patients clear skin and lose 10%+ weight at 1 year, versus 4.4% on Taltz alone.

BioNTech has terminated the Phase 2 BNT122-01 trial of autogene cevumeran as an adjuvant monotherapy in ctDNA-positive resected colorectal cancer, following a DSMB recommendation citing a numerical imbalance in overall survival, while the drug's separate pancreatic cancer trial continues unaffected.

Today’s BioPharm Brief looks at a new cardiovascular indication for Mounjaro, a billion-dollar ADC deal, and a potential new biosimilar competitor for Kadcyla.

Eron Kelly, CEO of ConcertAI, and Shaalan Beg, MD, chief medical officer, oncology, ConcertAI, discuss how artificial intelligence (AI) can accelerate clinical trial design, patient identification, and site selection while maintaining trust in clinical data.

TSY-110 could become the first biosimilar rival to Roche's ado-trastuzumab emtansine (Kadcyla), a $2.5 billion HER2 breast cancer therapy.

DualityBio's DUP5 payload shrank tumors resistant to topoisomerase inhibitor ADCs, backing its new $1 billion-plus deal with Genentech.

The FDA has approved Lilly's tirzepatide (Mounjaro) to reduce major adverse cardiovascular events in adults with type 2 diabetes at high risk, based on the head-to-head SURPASS-CVOT trial showing non-inferiority to dulaglutide (Trulicity), making it the first GIP/GLP-1 receptor agonist with this indication.

Celularity has entered a US manufacturing collaboration with MuseCell Innovations to produce Dezawa MuseCells and related exosome and secretome products at Celularity's Florham Park, New Jersey facility, a relationship that could generate more than $300 million in aggregate purchases over five years.

Mayo Clinic’s Dr Keith L. Knutson and CellxLife’s Dr. von Hofe discuss why cancer vaccines may succeed where checkpoint inhibitors fall short in 60 to 70% of patients.

Akeso's PD-1/VEGF bispecific antibody ivonescimab met its primary endpoint of overall survival against durvalumab plus chemotherapy in the phase 3 HARMONi-GI1 trial for first-line advanced biliary tract cancer, marking the first phase 3 readout for ivonescimab outside non-small cell lung cancer.

Varsetatug masetecan (Varseta-M) posted a 32% response rate in colorectal cancer, backing its new FDA fast track designation.