Manufacturing

BIIE CEO Dr Stephen Wilson outlines rapid growth plans and a multidisciplinary technology stack targeting global clinical translation.

Dazodalibep hit its phase 3 primary endpoint at week 48, building on phase 2 data showing a 6.3-point ESSDAI reduction versus placebo.

Made Scientific's new 85,000-sq.-ft. facility, with 145 prior GMP batches, adds clinical- to commercial-scale cell therapy capacity.

Novo Nordisk reports that CagriSema outperformed tirzepatide with 12.4% weight loss versus 9.1% in a phase 3 trial in adults with type 2 diabetes.

Vironexis Biotherapeutics reported that the first three antibody-naive patients with relapsed/refractory acute lymphoblastic leukemia treated with its one-time in vivo immunotherapy VNX-101 all achieved MRD-negative complete responses, with durability tracked through at least nine months.

New data show risk-based and centralized monitoring shifts effort across roles, sites, and timelines, reshaping how sponsors plan CRA capacity needs.

Laru-zova helped 31% of high-dose patients gain 15+ letters of vision, representing the first pivotal trial to succeed in treating XLRP.

Athenecia Faggins of Minaris Advanced Therapies discusses raw material qualification, supplier management, testing, and risk control for advanced therapy manufacturing.

Panelists from FDA, Genentech, and Minaris discussed raw material risk, supplier oversight, and at-risk release strategies for advanced therapies at the PDA/FDA Joint Regulatory Conference.

Sanofi's Dr Jack Prior detailed a data maturity framework for biologics manufacturing, while FDA and Gilead panelists debated risk-based AI validation.

FDA's consumer safety officer, Jason Chancey, detailed real inspection findings, such as taped gaskets and delayed retesting, behind sterile facility deficiencies.

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.

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.

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.

BIIE CEO Dr Stephen Wilson explains why Basel's condensed innovation ecosystem was chosen for the institute’s translational research mission.

Single-partner platforms promise to replace fragmented prescription hubs with one connected, data-driven journey for manufacturers and patients alike.

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.

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.

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.