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Tag: cell therapy


Cell and Gene Therapy, Industry

Cure Ventures backs a cell therapy startup targeting Parkinson’s

February 29, 2024

Via: Biopharma Dive

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 […]


Cell and Gene Therapy, Industry

Bayer receives U.S. FDA Breakthrough Therapy designation for BAY 2927088 for non-small cell lung cancer harboring HER2 activating mutations

February 27, 2024

Via: World Pharma News

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, […]


FDA, Regulations

FDA approves Alvotech and Teva’s Simlandi as interchangeable Humira biosimilar

February 26, 2024

Via: PMLiVE

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 […]


News

NGM to go private through deal with investment firm

February 26, 2024

Via: Biopharma Dive

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 […]


Cell and Gene Therapy, Industry

BioMarin preaches patience amid slow sales for hemophilia gene therapy

February 23, 2024

Via: Biopharma Dive

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 […]


Cell and Gene Therapy, Industry

Johnson & Johnson’s Tecvayli receives FDA approval for reduced dosing in multiple myeloma patients

February 23, 2024

Via: PMLiVE

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 […]


FDA, Regulations

FDA’s Drug Safety Priorities for 2023

February 21, 2024

Via: Biopharm International

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 […]


Cell and Gene Therapy, Industry

NEJM paper fills in details on ‘remarkable’ CAR-T result in autoimmune disease

February 21, 2024

Via: Biopharma Dive

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, […]


Cell and Gene Therapy, Industry

AstraZeneca gets new Tagrisso OK as drug succeeds in another trial

February 20, 2024

Via: Biopharma Dive

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 […]


Cell and Gene Therapy, Industry

FDA Approves Amtagvi, First Cell Therapy for Skin Cancer

February 20, 2024

Via: Biopharm International

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 […]


Cell and Gene Therapy, Industry

Tagrisso-chemo cleared in US as 1st-line lung cancer therapy

February 19, 2024

Via: Pharmaphorum

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 […]


Biotech, Industry

Hunting a non-opioid painkiller, a biotech reveals plans to chase Vertex

February 14, 2024

Via: Biopharma Dive

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 […]


FDA, Regulations

Ipsen drug approved by FDA for early pancreatic cancer

February 14, 2024

Via: Biopharma Dive

Pancreatic cancer remains one of the most difficult tumors to treat, with few good options after cancerous cells have spread more widely. More than 60,000 people are diagnosed with the adenocarcinoma form each year, according to Ipsen, often after metastases. […]


Cell and Gene Therapy, Industry

BioNTech and Autolus enter CAR-T cell therapy collaboration worth over $250m

February 13, 2024

Via: PMLiVE

Both companies have entered into a license and option agreement, as well as a securities purchase agreement, in connection with the collaboration. Under the terms of the agreement, BioNTech will purchase $200m of Autolus’ US depositary shares in a private […]


Cell and Gene Therapy, Industry

Scientists develop micofluidic chip to make cell therapy safer

February 12, 2024

Via: Pharma Times

Researchers from the Massachusetts Institute of Technology (MIT) and the Singapore-MIT Alliance for Research and Technology have developed a plastic microfluidic chip to improve the safety and effectiveness of cell therapy treatments for patients living with spinal cord injuries. In […]


Cell and Gene Therapy, Industry

FDA fast-tracks GSK’s chronic hep B therapy bepirovirsen

February 12, 2024

Via: Pharmaphorum

The fast-track designation from the US regulator recognises that bepirovirsen is the only single agent in phase 3 that has shown the potential to achieve a “functional cure” when combined with standard CHB therapies based on oral nucleoside or nucleotide […]


Cell and Gene Therapy, Industry

AstraZeneca to invest $300M in US cell therapy plant

February 7, 2024

Via: Biopharma Dive

AstraZeneca is ramping up in cell therapy after a late entrance to the field. In 2022, it made its first significant acquisition in the area, buying up privately held Neogene Therapeutics. And the follow year, it formed a partnership with […]


Cell and Gene Therapy, Industry

4DMT gene therapy cuts need for Eylea in wet AMD trial

February 5, 2024

Via: Pharmaphorum

On the strength of the results, 4DMT is planning to start a phase 3 trial of the gene therapy by the end of the first quarter of 2025. The data from the phase 2 PRISM study comes from a cohort […]


News

FDA sets date for Adaptimmune’s sarcoma drug verdict

February 2, 2024

Via: Pharmaphorum

If the biologics license application (BLA) is approved, afami-cel will become the first engineered T-cell therapy for solid tumours and the first effective treatment option for advanced synovial sarcoma in more than a decade, according to the Anglo-American company. Synovial […]


Cell and Gene Therapy, Industry

Regeneron Forms R&D Cell Therapy Unit from 2seventy bio Platform Acquisition

February 1, 2024

Via: Biopharm International

On Jan. 30, 2024, Regeneron Pharmaceuticals (Regeneron) announced the formation of a new R&D unit, Regeneron Cell Medicines, founded on an agreement with 2seventy bio, a US-based immuno-oncology cell therapy company. Under the agreement, Regeneron acquires full development and commercialization […]