Tag: cell therapy

July 1, 2024

Like many of its cell therapy peers, Artiva reshuffled its strategy hoping to ride a recent wave of investor interest in autoimmune disease research. The company is one of a number of biotechs to emerge in recent years to develop […]

June 24, 2024

The new data from Vertex’s phase 1/2 trial of VX-880, presented at the American Diabetes Association (ADA) annual congress in Florida, suggest that the therapy can restore the physiological activity of the insulin-producing islet cells of the pancreas and restore glucose […]

May 16, 2024

To date, the FDA has approved 36 cell and gene therapy products. In the past decade, new cell therapy modalities such as chimeric antigen receptor T-cell (CAR-T) immunotherapies have emerged as promising treatments especially for many types of cancers. There […]

May 1, 2024

Astellas Pharma is betting again on cell therapy, announcing Wednesday a deal with Poseida Therapeutics to develop donor-derived treatments for cancer. Through the partnership, the companies aim to create two allogeneic, or “off-the-shelf,” cell therapies for solid tumors. Astellas will […]

April 23, 2024

The Food and Drug Administration has rejected an experimental cell therapy for a rare skin condition, asking its developer, Abeona Therapeutics, to provide more information about how the treatment is made. Abeona on Monday said the FDA issued a so-called […]

April 22, 2024

CAR-T therapies are personalized treatments made from patients’ own immune cells. Their production is precisely choreographed, as frozen cells are brought to manufacturing hubs where they are engineered and expanded into a cancer-seeking drug product. It’s laborious, time-consuming and costly. […]

April 11, 2024

Drugmakers are moving quickly to study whether cell therapy, already a proven treatment for certain blood cancers, can tamp down autoimmune conditions, too. Lupus, a chronic disease that can cause inflammation and pain across the body, is one of the […]

April 2, 2024

Ginkgo Bioworks is expanding its ability to help other companies make cell and gene therapies, this time by acquiring a startup with tools to improve cell-based treatments. Ginkgo on Tuesday announced it has bought Modulus Therapeutics, a Seattle-based biotechnology startup. […]

February 29, 2024

Kenai Therapeutics, a San Diego-based biotechnology company, has raised $82 million to support its work developing cell therapies for nervous system disorders. Cure Ventures, a new venture capital firm founded by three longtime biotech investors, co-led the Series A round […]

February 27, 2024

Bayer announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for BAY 2927088 for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, […]

February 26, 2024

Simlandi has been approved by the regulator to treat rheumatoid arthritis, idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis. Biosimilars, according to the FDA, are biological products that are highly similar to […]

February 26, 2024

Founded in 2007, NGM took a broad approach to its drug research, assembling a pipeline that spans from solid tumors to retinal diseases to liver and metabolic disorders. NGM raised a few hundred million dollars in private funding before going […]

February 23, 2024

Roctavian’s approval was a scientific milestone, the culmination of years of research developing a genetic medicine for the chronic blood disease hemophilia A. Its launch, which began in Europe in 2022 and the U.S. last year, has been a focus […]

February 23, 2024

The regulator’s decision means that RRMM patients who have achieved a complete response or better for at least six months can receive a 1.5mg/kg dose of the BCMA-targeting bispecific antibody every two weeks. More than 35,000 new cases of multiple […]

February 21, 2024

On Feb. 15, 2024, FDA’s Center for Drug Evaluation and Research (CDER) released its report, Drug Safety Priorities FY23. The report describes the center’s key safety programs and activities involved in promoting and protecting public health and dealing with the […]

February 21, 2024

A new research paper offers the most thorough look yet at a study that sparked the drug industry’s recent experimentation with cell therapy for autoimmune diseases. The paper, which was published in The New England Journal of Medicine on Wednesday, […]

February 20, 2024

Tagrisso is at the center of AstraZeneca’s oncology resurgence. The drug, which first won approval in the U.S. in 2015, is the company’s second highest selling product, after the diabetes and kidney disease treatment Farxiga. It has become a go-to […]

February 20, 2024

On Feb. 16, 2024, FDA announced the approval of Iovance Biotherapeutics’ Amtagvi (lifileucel), which the agency said in a press release is the first cellular therapy indicated for treating adult patients with unresectable or metastatic melanoma that has been previously […]

February 19, 2024

The US regulator has approved the drug after a priority review on the strength of data from the FLAURA 2 study showing that the combination of EGFR inhibitor Tagrisso (osimertinib) and chemo cut the risk of disease progression or death […]

February 14, 2024

A little over four years ago, biotechnology giant Amgen retreated from neuroscience research, halting much of its work developing treatments for diseases of the brain and trimming associated staff. Amgen’s pivot proved a boon for a small startup that was […]