Therapeutic Specific Areas

The Committee for Medicinal Products for Human Use of the European Medicines Agency has granted a positive opinion recommending marketing authorization for Bavencio (avelumab) in combination with axitinib for treating kidney cancer.

The acquisition will enhance Lundbeck’s brain disease therapy portfolio as well as its antibody process and development capabilities.

The companies aim to integrate glucose sensing with insulin delivery technologies to help change the way diabetes is managed.

Xeris Pharmaceuticals has received FDA approval for GVOKE (glucagon), a liquid glucagon for treating hypoglycemia.

Passage Bio has licensed a sixth gene therapy development program under its partnership with the University of Pennsylvania for the clinical development of a potential treatment for a nerve disorder.

A new report by GlobalData projects 2.9% growth by 2028 for the hemophilia A and B market across the eight major world markets.

In a Phase III trial for advanced small-cell lung cancer, the investigational antibody drug conjugate, Rova-T (rovalpituzumab tesirine), did not demonstrate a survival benefit for patients taking it.

The company has received breakthrough therapy designation for its prophylactic respiratory syncytial virus vaccine candidate for treating adults aged 60 years or older.

Vertex will use the acquisition to develop cell-based treatments for type 1 diabetes.

The partnership aims to establish a virtual R&D center to advance the development of new cancer therapies.

BioPharm International spoke with Cindy Reiss-Clark, vice president, general manager, Biologics at West Pharmaceutical Services Inc., about the growing biologics market, specifically gene therapies, and how West is helping their clients prepare for these new trends.

The companies have signed a strategic multi-year manufacturing agreement for the future commercial production a late-phase investigational cell therapy.

The acquisition will boost Merck’s pipeline for cancer, fibrosis, and autoimmune disease therapeutics.

Research advances have enabled the application of nanotechnology to drug delivery. What does this technology offer in the way of enhancing therapeutic effect?

This article explores the challenges and potential of next-generation therapeutic antibodies.

MilliporeSigma awarded its Advance Biotech Grant to three US companies that are focused on traumatic brain injury, vaccine development, and chronic pain.

The acquisition provides Valby, Denmark-based Lundbeck with a discovery platform and a US-based research hub.

The acquisition will expand Pfizer’s rare disease portfolio with an early pipeline candidate for treating dwarfism.

Harvard University researchers used single-cell sequencing to identify a protein expressed uniquely by insulin-producing beta cells created from stem cells in the laboratory.

Lonza will provide development and manufacturing services to two of Alector’s neurodegeneration drug candidates.

The companies will work together to develop observational research analytics to assess treatment outcomes for areas of unmet need in oncology.

A new facility in Frederick County, MD, will expand the company’s cell therapy manufacturing capabilities.

University of Southern California scientists have made an advancement in chimeric antigen receptor (CAR) T-cell therapy that seems to eliminate its severe side effects, making the treatment safer and potentially available in outpatient settings.

Novartis has announced that FDA has accepted its biologics license application (BLA) for brolucizumab (RTH258) for the treatment of wet age-related macular degeneration (AMD).

The new service offers a flexible, customizable suite of products and services designed to accelerate the clinical and commercial development of gene and cell therapies.

With the spin-off, Alcon will operate as a standalone company, and Novartis will focus on its core innovative medicines.

Adding to an existing $115-million investment, the 700,000-ft2 site in Longmont, CO will expand AveXis’ gene-therapy manufacturing capacity.

The collaboration will apply artificial intelligence and machine learning to the development of drugs for treating a range of cancers.

Worth up to $605 million, the collaboration will focus on studying a preclinical novel target that could lead to potential new treatments for autoimmune diseases.

The companies aim to assess automated CAR-T cell therapy manufacturing at the point-of-care and develop technologies to facilitate patient access to immunotherapies.