Biopharma News

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.

Novartis will invest $23 billion during the next five years to expand manufacturing and R&D in the US, which will include seven new facilities and a new research hub.

The Therapeutic Goods Administration (TGA) of Australia confirmed its initial decision to decline approval of the mAb for treating early Alzheimer’s disease.

The committee’s recommendation is based on results from a Phase III trial in which Imfinzi demonstrated a reduced risk of recurrence, progression, or death by 32% compared to neoadjuvant chemotherapy alone.

In an interview with BioPharm International®, Sheryl Johnson from Orbia Fluor & Energy Materials chats about gender diversity, how women are helping to advance innovation, sustainability challenges, and progress in the field of inhaled drugs.

BioPharm International® spoke with Jason Bock, founder and CEO of CTMC, to find out about the newest cancer treatments, specifically developments in tumor-infiltrating lymphocytes.

EMA’s CHMP recommended conditional marketing authorization for linvoseltamab to treat adults with relapsed and refractory multiple myeloma.

The approval provides greater access to insulin treatment options.

The European Commission has approved Biocon Biologics’ YESINTEK, a biosimilar referencing Janssen Biotech’s Stelara (ustekinumab).

Co-led by Andera Partners and Bpifrance, the Series B financing will go toward an ongoing Phase Ib/IIa clinical study for EG 427’s lead candidate and to advance the company’s genetic medicines platform.

Vector Bioscience Cambridge is developing highly porous nanomaterials that can help reduce toxicities due to the small amount of vehicle material.