BioBusiness

Amgen and AstraZeneca announced that the Phase 3 DeLLphi-305 trial met its primary endpoint, with Imdelltra (tarlatamab) plus Imfinzi (durvalumab) significantly improving overall survival versus durvalumab alone as first-line maintenance therapy for extensive-stage small cell lung cancer — the first phase 3 study of a bispecific T-cell engager to show a survival benefit in this earlier-line setting.

Del-desiran missed its primary endpoint in a phase 3 DM1 trial, though secondary measures showed signs of clinical activity.

HHS announced four senior FDA leadership selections, including Karim Mikhail as permanent Director of the Center for Biologics Evaluation and Research and Michael Davis as Director of the Center for Drug Evaluation and Research, capping more than a year of turnover at both centers.

BrainChild Bio's BCB-276 extended survival to 19.8 months from diagnosis in phase 1, backing its $116 million-funded pivotal DIPG trial.

Moonwalk's $70 million new funding advances MW101, an adipose-targeted siRNA aiming to cut fat while preserving muscle in obesity patients.

Bristol Myers Squibb reported positive topline phase 2 results for arlocabtagene autoleucel, a potential first-in-class GPRC5D-directed CAR T cell therapy, in patients with quadruple-class exposed relapsed and refractory multiple myeloma who had already received a prior BCMA-targeted therapy.

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

Cipla's US subsidiary secured exclusive rights to commercialize QL2107, Qilu Pharmaceutical's phase 3 biosimilar candidate to Keytruda, ahead of the reference biologic's anticipated 2028 patent expiration.

Medicus Pharma secured worldwide rights to PF-08046031 (CD228V), an antibody-drug conjugate targeting melanotransferrin that Pfizer discontinued earlier this year following its $43 billion Seagen acquisition, in a co-development and license agreement that could pay Pfizer more than $1 billion in milestones.

Sebastian Andersen, CEO and founder of ClarityNorth Partners, discusses H1 2026 biopharma M&A, oncology deal activity, Lilly’s strategy, capital deployment, and how transaction structure can help companies manage risk.

TScan Therapeutics is reorganizing to prioritize in vivo-engineered TCR-T therapy for solid tumors, pausing its phase 3 trial and autoimmune program and cutting about 75% of its workforce, even as new phase 1 data showed complete donor chimerism in all tracked heme malignancy patients.

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.

Here's what you need to know about how stability programs assess potency and purity in complex biologics, like bispecific antibodies, under ICH Q5C and FDA guidance.

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.

BeOne Medicines and Jazz Pharmaceuticals announced positive topline overall survival results from the second interim analysis of the Phase 3 HERIZON-GEA-01 trial, reinforcing the benefit of Ziihera-containing regimens just days after their FDA approval in first-line HER2-positive gastroesophageal adenocarcinoma.

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.

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.

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.