Biopharma News

FDA has approved the first topical gene therapy product for treating wounds in patients with dystrophic epidermolysis bullosa.

FDA has approved AbbVie’s EPKINLY (epcoritamab-bysp), a bispecific antibody for treating relapsed or refractory diffuse large B-cell lymphoma.

The current lack of standardization within the industry can be attributed to the recent rapid growth of the cell therapy market and the associated drive to improve the efficiency and cost-effectiveness of production.

With $73 million in financing from investment firms, Myeloid Therapeutics plans to accelerate its lead clinical candidate into Phase I/II development for treating solid tumors.

The pin-point system is completely modular, allowing for different components to be selected for optimal performance specific to the gene targets.

ProBioGen’s Lenti.RiGHT is a lentivirus production platform for use in gene transfer applications.

Sania Therapeutics has emerged from stealth mode and launched its technology platforms for enabling the development of novel therapeutics to treat neural circuit dysfunction.

Biotech firm Lumen Bioscience has received fast track designation from FDA for its oral biologic drug candidate for treating C. difficile infection.

Gilead Sciences and Arcus Biosciences have expanded their research collaboration to include inflammatory diseases in addition to oncology.

Avirmax’s new gene therapy facility in Hayward, Calif., will specialize in AAV gene therapy research and development.

Under the collaboration, BiOneCure Therapeutics and Nanjing Leads Biolabs intend to develop a range of innovative antibody-drug conjugates for treating solid tumors.

In a deal potentially worth more than $530 million, Amgen will use TScan Therapeutics’ target discovery platform to home in on novel targets for Crohn’s disease treatment.

The new partnership between Sandoz, a Novartis division, and Just – Evotec Biologics will aim to develop and manufacture multiple biosimilars.

Private investors from Advent International and Warburg Pincus will operate the assets as an independent CDMO.

FDA’s Division of Applied Regulatory Science’s (DARS) computational toxicology and pharmacology research has been focused on the development of highly curated data sets and QSAR models for endpoints of regulatory interest.

New therapeutic opportunities are offering significant promise for the bio/pharma industry and patients.

Aspect Biosystems and Novo Nordisk A/S have announced a collaboration, development, and license agreement to develop bioprinted tissue therapeutics.

SAB Biotherapeutics has received both breakthrough and fast track designations from FDA for its lead antibody drug candidate for treating influenza.

Merck will acquire Prometheus Biosciences, a clinical-stage biotechnology company specializing in immune-mediated diseases, at a total equity valuation of $10.8 billion.

Gamida Cell’s therapy is meant to reduce the risk of infection following stem cell transplantation.

FDA has granted fast track designation to Caribou Biosciences for its allogeneic CAR-T cell therapy for relapsed or refractory multiple myeloma.

Under this partnership, the two companies will develop bioprinted tissue therapeutics for diabetes and obesity.

Forecyte Bio has opened a new GMP facility in Shanghai just two months after its sister site in the United States.

If approved, Johnson & Johnson would pay $8.9 billion to resolve all current and future claims in its ongoing talc litigation.

Lonza and ABL Bio are collaborating on the development and manufacture of bispecific antibody product.

Sartorius’ acquisition of Polyplus is designed to strengthen its cell and gene therapy capabilities.

Takeda received approval in Japan for a subcutaneous injection formulation of Entyvio (vedolizumab) for treating ulcerative colitis.

Takeda plans to build a new facility in Osaka, Japan, for the manufacture of plasma-derived therapies.