Tag: gene therapy

Biotech, Cell and Gene Therapy, Industry

HitGen and BioAge Announce Research Progress in DNA-Encoded Library Based Drug Discovery Research Collaboration

April 6, 2021

Via: BioSpace

Shanghai Stock Exchange listed biotech company HitGen Inc. (“HitGen”) announced important research progress in a collaboration with BioAge Labs, Inc. (“BioAge”), a private biotechnology company developing targeted small molecules for the treatment of diseases of aging. The companies have conducted […]

Cell and Gene Therapy, FDA, Industry, Regulations

How to gear up for more stringent gene and cell therapy regulations

April 1, 2021

Via: EPM Magazine

In January 2020, the US Food and Drug Administration (FDA) published a series of seven guidances regarding cell and gene therapy. These have not come too soon, given some much-publicised regulatory rejections. For example, the FDA turning down the Biologics […]

Cell and Gene Therapy, Industry

How Cancer Immunotherapy Gets a STING

March 29, 2021

Via: Genetic Engineering and Biotechnology News

The innate immune system scans for signs—such as misplaced genetic material—that a pathogen or dangerous mutation could cause disease. When DNA is found in areas of the cell other than the nucleus, which can occur due to viruses or cancer, […]

Cell and Gene Therapy, Industry

Krystal Biotech Launches Spinoff for Gene-Based Anti-Wrinkle Products

March 25, 2021

Via: BioSpace

On the back of a $135 million public offering in February, rare disease gene therapy company Krystal Biotech has launched subsidiary Jeune Inc. to promote its gene therapies for aesthetic skin conditions. In conjunction with the launch, Jeune announced positive […]

Cell and Gene Therapy, Industry

Drugmakers flock to Vineti’s fix for a cell, gene therapy problem

March 24, 2021

Via: Biopharma Dive

The cell and gene therapy field hit major milestones over the last few years. In the summer of 2017, the Food and Drug Administration approved a first-of-its-kind cellular medicine from Novartis for a hard-to-treat form of leukemia. Less than two […]

Cell and Gene Therapy, Clinical Trials, Industry, Research and Development

Novel cancer-fighting gene therapy enters phase I clinical trial

March 18, 2021

Via: Medical News

Researchers from the MDC and Charité have developed a new gene therapy based around a special T-cell receptor that helps the immune system effectively recognize and fight cancer cells. The safety of the novel therapy is now being tested on […]

Cell and Gene Therapy, Industry

Sio Gene Therapies Provides Update on Cash Position and Major Upcoming GM1 Gangliosidosis Program Milestones

March 15, 2021

Via: BioSpace

Sio Gene Therapies Inc. (NASDAQ: SIOX), a clinical-stage company focused on developing gene therapies to radically transform the lives of patients with neurodegenerative diseases, today announced that it had $120.9 million in cash and cash equivalents as of March 12, […]

FDA, Regulations

Alkermes Announces FDA Orphan Drug Designation for Nemvaleukin Alfa for Treatment of Mucosal Melanoma

March 11, 2021

Via: BioSpace

Alkermes plc (Nasdaq: ALKS) today announced that nemvaleukin alfa (“nemvaleukin”, formerly referred to as ALKS 4230), the company’s investigational engineered interleukin-2 (IL-2) variant immunotherapy, has been granted orphan drug designation for the treatment of mucosal melanoma by the U.S. Food […]


Agena Bioscience Signs Exclusive Distribution Agreement with AGBL Group of Companies

March 10, 2021

Via: BioSpace

Agena Bioscience, the global manufacturer of the MassARRAY System for targeted genetic analysis, announced an exclusive distribution agreement with Alliance Global, the AGBL Group of companies, to bring the MassARRAY technology to many emerging markets across the Middle East, Africa, […]

Cell and Gene Therapy, Industry, News

Cytovance Biologics now offering Licensing for Plasmid DNA Manufacturing

March 8, 2021

Via: BioSpace

Cytovance® Biologics, a leading biopharmaceutical contract development and manufacturing organization (CDMO) of mammalian, microbial biologics and gene therapy plasmid DNA (pDNA), announces a licensing opportunity for pDNA manufacturing. The Keystone Expression System pDNA platform is an end-to-end solution for manufacturing […]

FDA, Regulations

FDA Accepts Dupixent (dupilumab) for Review in Children with Moderate-to-severe Asthma

March 4, 2021

Via: BioSpace

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) as an add-on treatment for children aged 6 to 11 […]

FDA, Regulations

U.S. FDA Expands Approval of Pfizer’s LORBRENA as First-Line Treatment for ALK-Positive Metastatic Lung Cancer

March 4, 2021

Via: BioSpace

The U.S. Food and Drug Administration (FDA) approved Pfizer Inc.’s (NYSE: PFE) supplemental New Drug Application (sNDA) for LORBRENA (lorlatinib), expanding the indication to include first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). LORBRENA […]