Biologic Drugs in Development

New routes to cancer treatment can be found with the help of tumor-infiltrating lymphocyte (TIL) therapies.

Eli Lilly and Company has received a complete response letter from FDA for its anti-dermatitis biologic therapeutic, lebrikizumab.

The program will allow sponsors of certain CBER and/or CDER-regulated products more frequent communication with FDA staff.

Biologics formulation comes with a unique set of challenges, which can be overcome through innovative strategies and good partnerships.

Tumour-infiltrating lymphocyte (TIL) therapies offer a new route to target cancer.

The EMA’s Committee for Medicinal Products for Human Use has given a positive opinion on Sandoz’ biosimilar trastuzumab for breast and gastric cancer.

Despite the successes that have already been achieved with emerging therapy development and manufacturing, companies are still facing numerous challenges.

Seagen will be responsible for conjugating these degraders to antibodies to make DACs and advancing these DAC drug candidates through preclinical and clinical development and commercialization.

Image analysis algorithms coupled with microscopy techniques can be used to characterize aggregates of therapeutic proteins.

FDA has halted enrollment in clinical studies for Gilead Sciences’ magrolimab, a biologic treatment in development for acute myeloid leukemia.

Teva Pharmaceuticals and Alvotech will expand their partnership for the development and commercialization of biosimilar candidates.

Janssen has received a positive opinion from the EMA for two novel bispecific antibodies, TALVEY (talquetamab) and TECVAYLI (teclistamab), which the company is developing to treat blood cancer.

Newly launched Crossbow Therapeutics will work to advance a novel class of antibody therapies for treating cancers.

Exploring new fields can bring novel antibody candidates to the pipeline.

Chime Biologics, Leads Biolabs, and BeiGene have formed a three-way collaboration to advance the development and global manufacturing of Leads Biolabs’ lead mAb candidate, LBL-007.

Image analysis algorithms coupled with microscopy techniques can be used to characterize aggregates of therapeutic proteins.

There are various challenges associated with the development of CAR-T therapies for solid tumor cancers.

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

New fields are being explored to bring novel antibody candidates to the pipeline.

Compliance with GMP standards remains an integral focus in bulk mAb manufacturing.

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 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.

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