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Tag: cell therapy


Cell and Gene Therapy, Industry

Germany approves legislation to improve cell & gene therapy availability

June 15, 2021

Via: EPM Magazine

The parliament advocated for an increase in the number of NUB inquiries that can take place each year. NUB inquiries are used by hospitals to gain short term reimbursement for innovative treatment and diagnostic methods, supplementing the standard Diagnosis Related […]


Cell and Gene Therapy, Industry

Biogen’s inherited eye disease gene therapy misses the mark in late-stage trial

June 15, 2021

Via: Pharma Times

The Phase III STAR study enrolled 169 adult males with a genetically confirmed diagnosis of choroideremia. It evaluated the safety and efficacy of a single subretinal injection of the investigational gene therapy. The primary endpoint was the proportion of patients […]


Cell and Gene Therapy, Industry

Beigene expands into cancer cell therapy with Shoreline pact

June 9, 2021

Via: Biopharma Dive

Beigene has quickly become a force in cancer drug development, earning approvals in the U.S. and China for its targeted therapy Brukinsa and immunotherapy tislelizumab. The biotech is developing a slate of small molecule and antibody drugs aimed at several […]


Cell and Gene Therapy, Industry

Quality considerations for a growing gene therapy field

June 7, 2021

Via: Biopharma Dive

The approvals of Roche’s Luxturna (2017) for inherited retinal disease and Novartis’ Zolgensma (2019) for spinal muscular atrophy are indicative of a resurgence in the gene therapy field after a decline due to the death of a patient in 1999. […]


Cell and Gene Therapy, Industry, News, Pharma

Iksuda Therapeutics raises $47m to progress ADC pipeline

June 7, 2021

Via: Pharma Times

This includes the company’s lead pre-clinical ADC candidate IKS03, a potentially ‘best-in-class’ CD19-targeted asset for B-cell cancers. Iksuda will use the funds to support the progression of IKS03 into first-in-human Phase I clinical trials, and will also be used to […]


Cell and Gene Therapy, Industry, Mergers and Acquisitions

Novo Nordisk partners with Heartseed on heart failure cell therapy

June 1, 2021

Via: PMLiVE

HS-001, Heartseed’s lead asset, is an investigational cell therapy using purified cardiomyocytes derived from induced pluripotent stem cells (iPSC). The therapy is currently being developed as a treatment for heart failure. Heartseed is already planning to launch a phase 1/2 […]


Cell and Gene Therapy, Industry, News

Allogene set to disrupt CAR-T market with pivotal trial of ‘off the shelf’ therapy

May 21, 2021

Via: Pharmaphorum

Data announced ahead of this year’s American Society of Clinical Oncology (ASCO) conference suggest that Gilead and CAR-T rivals Bristol-Myers Squibb and Novartis better watch their backs as Allogene announced plans for a pivotal study this year. Allogeneic or “off […]


Cell and Gene Therapy, Industry

Biogen gene therapy misses goal in eye disease study

May 14, 2021

Via: Biopharma Dive

Biogen’s acquisition of Nightstar signaled the biotech company’s commitment to gene therapy research, an investment it’s expanded upon with subsequent deals like a January collaboration with Germany’s ViGeneron and another earlier this week with Capsigen. The Nightstar deal bought Biogen […]


Cell and Gene Therapy, Industry, Mergers and Acquisitions

Two biotechs team up to bring CRISPR to ‘natural killer’ cell therapy

May 6, 2021

Via: Biopharma Dive

Two biotechs aim to broaden the reach of cancer immunotherapy by applying gene editing tools to an emerging form of cell therapy through a wide-ranging collaboration. The agreement, between CRISPR Therapeutics and Nkarta, includes three components. The biotechs will first […]


Cell and Gene Therapy, Industry

Resource Links Gene Variants with Immune System Regulation and Immune-Mediated Diseases

April 30, 2021

Via: Genetic Engineering and Biotechnology News

University of Tokyo researchers and colleagues at the RIKEN Research Institute have compiled a first-of-its-kind genetic database for autoimmune and autoinflammatory diseases. It’s hoped that the resource will offer up new insights into how immune disorders develop, and potentially aid […]


Cell and Gene Therapy, Industry, News

Gene Therapy CDMO Forges Ahead with $120M Series B Financing

April 29, 2021

Via: Genetic Engineering and Biotechnology News

Gene therapy-focused CDMO Forge Biologics has closed on a $120 million Series B financing, saying the proceeds will accelerate its planned expansion of adeno-associated virus (AAV) manufacturing capabilities. The company operates a 175,000-square-foot cGMP facility in Columbus, OH, dedicated to […]


Clinical Trials, News, Research and Development

Avillion/Merck psoriasis nanobody hits the mark in phase 2

April 26, 2021

Via: Pharmaphorum

The IL-17A and IL-17F inhibitor hit all its objectives in the phase 2 trial, which has now been published in The Lancet, and showed that it was significantly more effective than placebo at clearing up skin lesions in patients with […]