News|Articles|October 9, 2025

Report - Digital Transformation in Biopharma: The Gap Between Hype and Implementation

Comparing our survey results with recent headlines uncovered biopharma’s digital transformation paradox: high potential vs. low adoption.

As new bio/pharmaceutical manufacturing and development approaches move toward commercialization, traditional industry modalities are under intense pressure (1-7). At the same time, automation, advanced analytics, digital twins, artificial intelligence, and other technologies are evolving quickly and promising to transform how medicines are developed, produced, and delivered.

Related to this article

Close-up of an older person's hands, with the thumb of one hand pressing into the palm of the other, against a blurred teal background. | Image Credit: © eyepark - stock.adobe.com

October 2nd, 2026

Artiva to Present AlloNK Data Showing CAR T-Like B-Cell Depletion in Rheumatologic Diseases at ACR 2026

Artiva Biotherapeutics will present data on AlloNK, an allogeneic, non-genetically modified NK cell therapy given with rituximab, in refractory rheumatoid arthritis, Sjögren disease and systemic sclerosis at ACR Convergence 2026, ahead of a planned phase 3 trial in rheumatoid arthritis.

Brain imaging scan showing a cross-section of the human brain. | Image Credit: © merydolla - stopck.adobe.com

September 29th, 2026

uniQure's AMT-130 Shows Continued Slowing of Huntington's Disease at 48 Months, Though Primary Endpoint Misses Significance

Updated 36-month data in 15 high-dose patients showed 80% slowing on cUHDRS, while the 48-month cUHDRS result did not reach statistical significance. uniQure attributes the gap to attrition in the external control, and the FDA is reviewing a BLA based on the 36-month data.

October 2nd, 2026

The BioPharm Brief: Room Temperature, RNA, and ADCs

CaseBioscience joins an ARPA-H effort to develop room-temperature cell therapy preservation, Novartis licenses an mRNA-encoded T-cell engager from Abogen, and AstraZeneca, Daiichi Sankyo, and Summit plan to combine Datroway with ivonescimab.

3D illustration of three golden spherical nanoparticles, one shown in cross-section to reveal a layered lipid shell, with a blue helical nucleic acid strand winding around them against a black background. | Image Credit: © Love Employee - stock.adobe.com

October 2nd, 2026

Novartis Licenses Abogen's mRNA-Encoded CD19xCD3 T-Cell Engager ABO2203 for Autoimmune Diseases

Novartis has secured an exclusive worldwide license to ABO2203, Abogen's investigational mRNA-encoded CD19xCD3 T-cell engager designed to produce the bispecific inside the body to reset B cells in autoimmune disease. The agreement also includes options on other programs built on Abogen's RNA platform.

Tablet, science team and people learning for cancer cure, help or medical development in laboratory. Training, investigation or research info with scientists in clinical trial for medicine internship | Image credit: © CoetzeeRising/peopleimages.com - © CoetzeeRising/peopleimages.com - stock.adobe.com

October 2nd, 2026

CaseBioscience Joins $7.3 Million ARPA-H Team on Cell Preservation

The 15-month project could let living cell therapies ship and store at room temperature, cutting cold-chain costs that limit patient access.

October 1st, 2026

Former FDA Oncology Reviewer Paz Vellanki on Novel Endpoints and Early FDA Engagement Under CDER's ARC Program

Former FDA oncology reviewer Paz Vellanki, MD, PhD, of Precision for Medicine, discusses how CDER's ARC program supports novel end points such as ctDNA for rare diseases and why sponsors should engage FDA early.

3D illustration of a single-stranded RNA molecule with nucleotide bases extending from a twisting backbone, shown in purple, pink, and yellow against a black background. | Image Credit: © Dr_Microbe - stock.adobe.com

October 1st, 2026

Wave Life Sciences Aligns With FDA on Registrational Path for RNA Editing Therapy WVE-006 in AATD

Following an FDA meeting, Wave Life Sciences plans a single 2-year registrational trial of WVE-006, its GalNAc-conjugated RNA editing oligonucleotide for alpha-1 antitrypsin deficiency, with a 1-year interim analysis that could support accelerated approval based on biomarkers.

FDA - US Food and Drug Administration | Image credit: © gguy - © gguy - stock.adobe.com

October 1st, 2026

FDA Warns Fresenius Kabi Over Sterile Injectable Contamination

Patients suffered pyrogenic reactions before Fresenius Kabi recalled 3 contaminated batches at its 430,000-sq-ft Melrose Park, Ill., biologics plant.