Development

Acepodia's ACE723 delivers 2 cytotoxic payloads to GPC3-positive tumors, clearing FDA review to begin trials in liver cancer.

GMP cleanroom differential pressure control prevents FDA 483 citations and contamination failures through HVAC design and validation.

GSK's up to $1.3 billion deal centers on HUTCHMED's HMPL-A830, which pairs a KRAS inhibitor with an EGFR antibody.

Apazunersen missed its primary endpoint in a phase 3 Angelman syndrome trial, meaning that patient population remains without an approved treatment option.

ArsenalBio is halting all development of its ex vivo CAR T programs for solid tumors and laying off the majority of its workforce as it pivots the company entirely toward in vivo CAR T therapy, joining a fast-growing field that already includes Johnson & Johnson, Eli Lilly, and several other developers.

NewBiologix's Xcell platform aims to replace costly transfection with stable cell lines for Synastra's high-dose DMD gene therapy.

Teva's TEV '408 blocked gluten-induced gut damage in a phase 2a trial, supporting its use for celiac disease, which has no approved drug treatment.

SIM0660's dual CD79a/CD19 targeting aims to deepen B-cell depletion, supporting Roche's up-to-$1.53 billion bet on Simcere Zaiming's TCE platform.

AstraZeneca's Enhertu plus pertuzumab cut progression risk 44%, extending PFS past 3 years as the first new 1st-line HER2+ regimen in 10 years.

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.

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.

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.

Webinar Date/Time: Fri, Sep 18, 2026 11:00 AM EDT

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.

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.

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.

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.

The company's first-in-class immune-boosting antibody could become the first approved treatment for a cancer with no existing options.

AbbVie's bispecific antibody posted a 90% response rate in squamous NSCLC, headlining the company's expanding lung cancer pipeline data.

Avexitide cut severe hypoglycemic events 55% in a pivotal PBH trial, positioning it to become the condition's first approved therapy.

Regeneron Pharmaceuticals' garetosmab-grts has become the first approved therapy to shrink new bone lesions in FOP, cutting them by up to 94% as it targets the disease's root biology directly.

The companies are targeting a protein on glioblastoma's treatment-resistant tumor stem cells, which could open a new path past the blood-brain barrier.