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.
Today’s BioPharm Brief covers positive Phase 3 data for Akeso’s ivonescimab in biliary tract cancer, FDA Fast Track designation for CytomX’s Varseta-M in colorectal cancer, and positive Phase 3 results for Tezspire in eosinophilic esophagitis.
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.
Amgen and AstraZeneca's tezepelumab (Tezspire) eased swallowing and cut esophagus inflammation in a 368-patient trial through week 52.
Today’s BioPharm Brief covers FDA approval of daraxonrasib for metastatic pancreatic cancer, the first patient dosed in HaemaLogiX’s KMCAR CAR-T trial, and a new collaboration to advance cell-free synthetic DNA for viral vector manufacturing.
FDA's 2025–2026 guidance changes would substantially streamline biosimilar development, including by reducing comparative efficacy and switching-study requirements. Here's what's confirmed, what industry has criticized about the existing pathway, and what's still unresolved.
The FDA has cleared daraxonrasib, the first RAS(ON) tri-complex inhibitor to reach approval, validating a mechanism-driven platform approach to a historically undruggable oncogene family in pancreatic cancer.
HaemaLogiX has dosed the first patient in its Phase 1 KOALA trial of KMCAR T-cell therapy, a novel CAR-T designed to selectively target kappa-restricted multiple myeloma cells while sparing healthy immune cells, with the treatment reported as well tolerated and a second patient enrolling at a higher dose.
4basebio and Genezen have entered an expanded, non-exclusive collaboration giving drug developers access to 4basebio's hpDNA cell-free synthetic DNA technology within Genezen's viral vector development and manufacturing services, aiming to streamline gene and cell therapy programs from early development through commercial manufacturing.
A retrospective cohort study published in Diabetes, Obesity and Metabolism found that sustained Zepbound (tirzepatide) use in adults over 55 with obesity was associated with lower monthly healthcare costs and fewer hospital admissions and emergency department visits compared with untreated matched controls.
Biopharma mergers and acquisitions aren’t one-size-fits-all—this FAQ breaks down how deal type shapes premium pricing, deal protection, and IND sponsorship obligations.
Welcome to The BioPharm Brief, your daily snapshot of developments shaping the biopharmaceutical industry. It’s a busy day for FDA action, with two approvals and a new designation spanning cancer, autoimmune disease, and rare disease. Here’s what we have today.
The FDA has approved two zanidatamab-hrii-containing regimens for first-line treatment of HER2-positive advanced gastroesophageal adenocarcinoma, based on Phase 3 HERIZON-GEA-01 data showing a median overall survival of more than two years, marking the second FDA approval for the bispecific antibody in under two years.
The FDA has granted Rare Pediatric Disease Designation to Mahzi Therapeutics' MZ-1866, an investigational AAV9-TCF4 gene replacement therapy for Pitt Hopkins syndrome, as the Phase 1/2 UNITE study surpasses 50% enrollment.
The FDA has approved IMAAVY (nipocalimab-aahu), an FcRn-blocking antibody from Johnson & Johnson, as the first therapy specifically approved for warm autoimmune hemolytic anemia (wAIHA), based on Phase 2/3 ENERGY trial data showing durable hemoglobin response and reduced fatigue versus placebo.
Today’s BioPharm Brief covers FDA priority review for GSK’s Jemperli in locally advanced rectal cancer, Genentech’s $2.3 billion deal for Hanmi’s investigational obesity drug, and an extended FDA review of Capricor’s deramiocel for Duchenne muscular dystrophy.
Vanda's single-dose antibody was shown to clear severe pustular flares within weeks and is now recognized as a priority treatment across 3 continents.
The FDA has extended the PDUFA target action date for Capricor Therapeutics' deramiocel BLA from August 22 to November 22, 2026, after the company submitted 24-month HOPE-3 open-label extension data supporting a refined indication focused on upper limb function.
The FDA has accepted for priority review GSK's sBLA for Jemperli (dostarlimab) in previously untreated stage II/III dMMR/MSI-H locally advanced rectal cancer, based on AZUR-1 data, with a PDUFA date of February 2027 and eligibility for the National Priority Voucher program.
Genentech is betting up to $2.3 billion on an obesity drug designed to build muscle while cutting fat, addressing a GLP-1 side effect.
Today’s BioPharm Brief covers promising early-stage lung cancer data from AbbVie, an NMPA-accepted NDA for Leads Biolabs’ opamtistomig in rare neuroendocrine cancer, and a first-in-human trial of a brain-penetrant bispecific T-cell engager for glioblastoma.
The company's first-in-class immune-boosting antibody could become the first approved treatment for a cancer with no existing options.
Amplitude Therapeutics has entered a strategic research collaboration and licensing agreement with Eli Lilly and Company to discover and develop trans-amplifying RNA (taRNA) vaccine candidates for infectious diseases with high unmet need, with Lilly holding an option to add up to two additional targets.
AbbVie's bispecific antibody posted a 90% response rate in squamous NSCLC, headlining the company's expanding lung cancer pipeline data.
Adaptin Bio has opened enrollment in a first-in-human Phase 1 trial of APTN-101, a bispecific T-cell engager built on the company's BRiTE platform designed to cross the blood-brain barrier and target EGFRvIII-positive glioblastoma. The trial, conducted with Duke University, will enroll up to 15 adult patients with WHO Grade IV malignant glioma.
A defensible AI quality framework links intended use, patient and product risk, evidence, human accountability, and lifecycle control, without forcing every use case into the same validation model.
This edition of The BioPharm Brief covers FDA approvals for Pasatru in fibrodysplasia ossificans progressiva and Genglycos in glycogen storage disease type Ia, along with a new bispecific CAR-T entering clinical development for large B-cell lymphoma.
