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New HER2 ADC posts high response in urothelial cancer – RC48 data
Phase 2 data from the RC48G001 study show the HER2‑targeted antibody‑drug conjugate disitamab vedotin (DV) produced confirmed overall response rates above 50% in previously treated metastatic...
Ultragenyx gene therapy hits primary endpoint in rare metabolic trial
Ultragenyx reported that its gene therapy candidate achieved one of two primary endpoints in a Phase 3 trial for ornithine transcarbamylase (OTC) deficiency, a rare urea cycle disorder. The...
FDA draft guidance loosens rules for biosimilar testing – a market opener
The FDA released draft guidance that, in certain situations, would allow biosimilar developers to rely on comparator data generated outside the U.S., potentially lowering the cost and time...
Evaluate predicts $409B rare‑disease market by 2032 – industry growth forecast
Evaluate’s 2026 Orphan Drugs Report forecasts global annual sales of rare‑disease therapies will exceed $409 billion by 2032, claiming more than 21% of total global prescription sales. The...
AI biotechs advance: Insilico joins Hang Seng; Waiv spins out with $33M
Insilico Medicine secured inclusion in the Hang Seng Composite Index, granting broader market access and eligibility for Stock Connect—an institutional milestone that increases the company’s...
New CAR‑T manufacturing tricks extend persistence – scaffold and cytokine fusions
Two independent academic teams reported manufacturing innovations aimed at prolonging CAR‑T cell efficacy. Researchers at Albert Einstein College of Medicine described a modular protein scaffold...
Vitestro raises $70M to scale robotic phlebotomy ahead of US push
Vitestro closed a $70 million Series B to accelerate global deployment of Aletta, its autonomous robotic phlebotomy device designed to standardize venous access and blood collection. The...
Antibody‑siRNA conjugate reaches muscle in humans – del‑desiran shows promise
Clinical data from the Phase I/II MARINA trial of delpacibart etedesiran (del‑desiran, AOC‑1001), an antibody‑siRNA conjugate targeting DMPK mRNA in myotonic dystrophy type 1 (DM1), demonstrate...
Immutep trial halted for futility – stock collapses
Immutep disclosed that an independent data monitoring committee recommended stopping its Phase III TACTI-004 trial of eftilagimod alfa (efti) in first-line non-small-cell lung cancer for futility,...
FDA tentatively clears Lutathera generic – patent fight ahead
The FDA issued a tentative approval for Lantheus’ ANDA for PNT2003, a generic version of Novartis’ radioligand therapy Lutathera (lutetium Lu 177 dotatate), while Novartis continues active patent...
New HER2 ADC posts robust responses in urothelial cancer
Phase 2 data presented at ASCO Genitourinary show disitamab vedotin (DV), a HER2‑targeting antibody‑drug conjugate, produced confirmed overall response rates above 50% in both HER2‑positive and...
Cadonilimab combo improves outcomes in advanced cervical cancer
COMPASSION‑16 Phase 3 results indicate that adding cadonilimab, a bispecific PD‑1/CTLA‑4 inhibitor, to first‑line chemotherapy with or without bevacizumab improves clinical outcomes in advanced...
Ultragenyx gene therapy clears key Phase 3 bar for OTC deficiency
Ultragenyx announced that its gene therapy candidate for ornithine transcarbamylase (OTC) deficiency met one of two primary endpoints in a Phase 3 study enrolling 37 patients. The result...
Multi‑cytokine scaffold produces longer‑lived CAR‑T cells
Researchers at Albert Einstein College of Medicine reported a manufacturing strategy using an engineered protein scaffold (HCW9206) that fuses IL‑7, IL‑15 and IL‑21 to generate CAR‑T cells...
Genetic code expansion: five noncanonical amino acids in one protein
A synthetic biology group demonstrated simultaneous incorporation of five distinct noncanonical amino acids into a single protein in mammalian cells, significantly expanding the capability to...
AI plus autonomous lab cuts cycle time for biological discovery
OpenAI and Ginkgo Bioworks reported a collaboration showing how AI models integrated with an autonomous laboratory can design and iterate real biology experiments at substantially higher speed....
FDA drafts guidance to ease biosimilar testing — competition could accelerate
The FDA released draft guidance that would, in some cases, lower the data requirements for biosimilar development by allowing use of comparator product data from outside the U.S. The agency said...
Orphan drug market set to surge past $400B by 2032
Evaluate’s 2026 Orphan Drugs Report forecasts global orphan drug sales will exceed $400 billion by 2032, driven by high‑value gene and cell therapies, extended uses of existing orphan brands, and...
Immutep’s phase III shock: efti trial stopped for futility
Immutep’s Phase III TACTI-004 trial of eftilagimod alfa (efti) in first-line non‑small‑cell lung cancer was halted after an independent data monitoring committee recommended stopping for futility....
Ultragenyx gene therapy clears major Phase 3 endpoint in OTC deficiency
Ultragenyx reported that its gene therapy candidate met a key primary endpoint in a Phase 3 trial for ornithine transcarbamylase (OTC) deficiency, a rare urea cycle disorder. The company disclosed...