Biopharma News

invoX Pharma has made a second tranche of investment in pHion Therapeutics to support further development of next-generation mRNA vaccines.

Paxlovid is not approved or authorized for use as a pre-exposure or post-exposure prophylaxis for prevention of COVID-19.

Hope is on the horizon as novel solutions and improvements aimed at benefitting the drug development process with the right framework are coming to the fore.

The start of production of US engineering batches of NXC-201, a CAR-T cell therapy candidate in early clinical development, is the first step in transferring Nexcella’s existing manufacturing process to the United States.

Sandoz’s marketing authorization applications for a proposed biosimilar to denosumab are supported by a comprehensive analytical and clinical data package.

The $87.5 million purchase grants Novartis rights to an investigational gene therapy program intended for treatment of cystinosis.

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.

Astellas and Sony will collaborate to discover a novel ADC platform for use in 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.