Therapeutic-Specific Areas

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

The agency says Novartis drug is the first PI3K inhibitor to be approved for treating breast cancer.

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.

The companies announced a collaboration to jointly discover and develop treatments to address unmet medical needs in a specific neurological disease.

The new facility, located at the company’s headquarters in Pittsburgh, PA, is expected to meet all clinical and commercial development needs of the company’s lead gene therapy program.

While allogeneic therapies can use existing regulatory and quality frameworks, autologous treatments will require pharma’s adoption of true just-in-time and right-first-time concepts, says consultant James Blackwell.

The approval expands use of the drug, Egaten (triclabendazole), which has been by the WHO since 2005 for treating liver fluke infestation.

The approval expands the indications for Sprycel (dasatinib) in Europe.

The partners will collaborate on the development and commercialization of a B-cell maturation antigen-targeting immunotherapeutic for treating multiple myeloma.

The companies will jointly develop and commercialize an investigational bifunctional fusion protein immunotherapy currently in clinical development for cancer treatment.

Horizon and Rutgers University will partner to develop and commercialize new gene editing technology for therapeutic and research applications.

Taconic Biosciences, a provider of genetically engineered rodent model solutions, sent mice into space to advance research on new therapies for aging-related disease processes.

The agency revised draft guidance to enable more efficient and successful drug development programs for the treatment or prevention of rare diseases.

A new gene therapy can turn certain brain glial cells into functioning neurons, which could help repair the brain after a stroke or during neurological disorders like Alzheimer’s or Parkinson’s diseases, according to researchers at Penn State.

Researchers at the University of Delaware have made a step forward in gene therapy by engineering microparticles that deliver gene-regulating material to hematopoietic stem and progenitor cells, which live deep in bone marrow and direct the formation of blood cells.

AbbVie and immunotherapy company Tizona Therapeutics will join forces to develop and commercialize CD39-targeted therapeutics to treat cancer.

The companies will join forces to develop and commercialize an oncology drug to treat hematological cancers.