BioBusiness

Regulatory approvals, trial data, and major licensing deals in 2026 are accelerating subcutaneous biologics, cutting patient burden and reshaping biopharma strategy.

In this exclusive podcast, Bo Watkins (SVP, Sales & Business Management) and Pat Adams (VP, Expansion Operations) of Simtra BioPharma Solutions discuss the company's major manufacturing expansion in Bloomington, Indiana. The conversation covers the new Building H facility and the Park Campus development, and how these investments are designed to expand US sterile injectable and high-potency manufacturing capacity. They also detail the practical benefits for customers, the digital capabilities supporting the buildout, and what the expansion means for Simtra's Bloomington workforce and community.

Insilico's Longevity Vaccines use circular mRNA to arm T cells against aging's earliest culprit cells, starting with immune rejuvenation.

GSK's new trispecific TCE targets 2 tumor antigens plus T cells, aiming to improve on the tolerability of current myeloma therapies.

Tambotatug pelitecan (Tam-Peli), a B7-H3-targeted antibody-drug conjugate, is the second of at least three B7-H3-targeted ADCs to post positive late-stage data in relapsed small-cell lung cancer this year.

Four cell therapy developers have pulled back from ex vivo manufacturing in the past month — ArsenalBio, TScan Therapeutics, and Cellectis all pivoted to in vivo approaches, while Bristol Myers Squibb terminated its manufacturing partnership with automation specialist Cellares after determining its platform couldn't meet requirements for commercial Breyanzi production, triggering layoffs.

Phio's PH-762 posted a 70% response rate in skin cancer, supporting its FDA briefing package for a planned phase 2b trial.

Cellectis is pivoting to in vivo gene editing to advancing its .HEAL-101 and .HEAL-201 candidates for lipid disorders while exiting its CAR T programs.

Samsung Biologics signed a $262 million contract manufacturing agreement with an undisclosed European pharmaceutical company, extending production commitments through 2033 and lifting the CDMO's cumulative contract value past $21.9 billion.

With 15 patients now dosed in its pivotal EMERALD trial, Resolution will build on the 70% 4-year transplant-free survival seen with RTX001 in earlier data.

CordenPharma is expanding its Caponago, Italy site with a €80 million multi-year investment and new aseptic fill-finish lines, aiming to reach 500 million sterile injectable units of annual capacity to meet rising demand across peptide, biologic, LNP, and oligonucleotide-based drug products.

Lundbeck's asedebart, which blocks ACTH signaling at its source, has won FDA orphan status for endogenous Cushingsyndrome.

Solstice Oncology launched with a $225 million Series A financing to advance porustobart, a second-generation, Fc-enhanced CTLA-4 antibody licensed from Harbour BioMed, into neoadjuvant Phase 2 testing for microsatellite-stable colon cancer.

Biora's BioJet capsule aims to deliver adalimumab without a needle, entering human testing after hitting 51.3% preclinical bioavailability.

Satralizumab cut MOGAD relapse risk 68% in a phase 3 trial, positioning it as the first potential treatment for this rare disease.

Encoded Therapeutics closed a $275 million Series F financing to fund pivotal and expansion studies of ETX101, an AAV9-mediated gene regulation therapy for SCN1A-positive Dravet syndrome, alongside commercial-scale buildout of the company's in-house GMP manufacturing.

Ersodetug missed its phase 3 primary endpoint in congenital HI, but FDA is reviewing CGM data showing 50%+ hypoglycemia reductions.

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.