Biopharma News

Minimize contamination in cell therapy manufacturing with isolators, staff protocols, sterile materials, and validated suppliers for process integrity.

Genascence’s first-in-class gene therapy blocking interleukin 1, GNSC-001, will enter a Phase IIb/III study in 2026.

Biopharma job cuts surge in 2025, hitting R&D, manufacturing, and commercial roles and causing professionals to face shifting priorities and tighter pipelines.

The company’s gene therapy, AAVB-039, for the treatment of Stargardt disease progresses to a Phase I/II clinical trial.

Northway Biotech will develop and scale production of AATec’s ATL-105 for the treatment of non-CF bronchiectasis.

FDA will review GSK’s application to expand the use of its respiratory syncytial virus vaccine, Arexvy, to adults aged 18–49 who are at increased risk.

The IL-36 inhibitor is being explored for additional inflammatory skin conditions, aiming to expand treatment options for underserved patient groups.

Trump’s tax bill could reshape drug R&D, manufacturing, Medicaid access, clinical trials, and biotech funding, impacting strategy across the bio/pharmaceutical industry.

Once limited to experimental vaccine platforms, messenger RNA (mRNA) is now taking center stage across the entire biotech landscape.

Regulatory shift reflects maturation of CAR-T field and impacts biopharm manufacturing, development, and discovery.

The next-generation monoclonal antibody could potentially be used to prevent and treat active COVID-19 infections, according to its developer, providing a non-vaccine option.

The biotech company urges government action to support newborn genome screening, emphasizing the need for rare disease care, testing, and family resources.

The agency has recommended conditional marketing authorization for Zemcelpro (dorocubicel/unexpanded umbilical cord cells) to treat adults with hematological malignancies (blood cell cancers).

Lilly expands into genetic medicines with Verve's in vivo gene-editing therapies, aiming to replace chronic cardiovascular treatments with single-dose care.

BioPharm International® spoke with Robert Cornog, senior director, Product Development, at Quotient Sciences about how commercial manufacturing and tech transfer impact biopharmaceuticals at the development stage.

First-in-class therapy targets iron deficiency and phosphate imbalance in CKD, offering earlier intervention and simplified treatment for European patients.

The acquisition boosts BioNTech’s mRNA design and manufacturing capabilities, accelerating development of next-gen cancer immunotherapies.

The partnership aims to accelerate late-stage development of a low-cost Shigella vaccine to combat child diarrhea and rising antimicrobial resistance.

The dismissal of all 17 members of the Advisory Committee on Immunization Practices has far-reaching impacts for the industry and beyond.

The rebranding to VeonGen marks a strategic shift to clinical-stage development, reflecting progress from platform innovation to human trials in gene therapy.

BNT327, a bispecific antibody targeting PD-L1 and VEGF-A, enters late-stage trials for lung and breast cancer with joint development by BioNTech and BMS.

Funding will support the company’s efforts to refine its proprietary glycan-engineering platform, expand its scientific and operational team, and advance preclinical studies of its engineered biologics.

Sanofi is acquiring Vigil Neuroscience, a biotech firm focused on novel neurodegenerative disease therapies, to boost its early-stage neurology pipeline.

Mirai Bio and Thermo Fisher partner to integrate AI-driven design with CGMP manufacturing, aiming to streamline development of genetic medicines.

Black Hawk’s subsidiary, BH Merger Sub, will merge with Vesicor as part of the agreement.

The investment agreement will support the company’s ongoing clinical trials for its treatment for the rare genetic condition, spinocerebellar ataxia.

The first patient has been dosed in a Phase II clinical trial for the company’s MB-105 first-in-class CD5-targeted CAR-T cell therapy.

The agency has approved BMS’ Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line treatment for unresectable or metastatic hepatocellular carcinoma.