February 2, 2024
Via: PharmaphorumIf 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
February 1, 2024
Via: Biopharm InternationalOn 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 […]
Cell and Gene Therapy, Industry
January 31, 2024
Via: Biopharm InternationalFDA published a final guidance document, Human Gene Therapy Products Incorporating Human Genome Editing, on Jan. 30, 2024. The document provides recommendations for developing gene therapy products incorporating genome editing (GE) of human somatic cells. Recommendations include information needed in […]
January 31, 2024
Via: Biopharm InternationalRevolo Biotherapeutics announced on Jan. 30, 2024 that FDA has granted Orphan Drug Designation to ‘1104, a first-in-class immune-resetting peptide being developed as a potential treatment for eosinophilic esophagitis (EoE). Revolo focuses on developing therapies that reset the immune system […]
Cell and Gene Therapy, Industry
January 30, 2024
Via: Biopharma DiveThe clue came, as they often do, from an unexpected source. Some sixteen months ago, a small study of five people in Germany pointed to a new direction for the high-profile field of cell therapy. The study showed a cellular […]
Cell and Gene Therapy, Industry
January 30, 2024
Via: Biopharma DiveRegeneron Pharmaceuticals is expanding its cell therapy research, announcing a deal Tuesday to acquire the drug pipeline of 2seventy Bio and bring on many of the smaller biotechnology company’s employees. The experimental cell therapies Regeneron acquires will be housed in […]
Cell and Gene Therapy, Industry
January 29, 2024
Via: Biopharma DiveThe Food and Drug Administration could soon decide on whether to make AstraZeneca and Daiichi Sankyo’s drug Enhertu available for any solid tumor with a specific genetic signature. The partners on Monday said the FDA is reviewing their request to […]
Cell and Gene Therapy, Industry
January 26, 2024
Via: Biopharma DiveIf cleared by the European Commission, Abecma would be available for third-line use in the EU’s 27 member countries, a needed boost for a medicine that’s losing ground to Johnson & Johnson’s rival therapy Carvykti. Both medicines are part of […]
Cell and Gene Therapy, Industry
January 25, 2024
Via: Drugs.comFive of six Chinese children born deaf due to a rare genetic defect now have the ability to hear, thanks to an experimental gene therapy. The therapy involved a hollowed-out virus loaded with a healthy version of the gene responsible […]
Cell and Gene Therapy, Industry
January 24, 2024
Via: Biopharma DiveAn 11-year-old boy who was born deaf can hear after receiving an experimental gene therapy, developer Eli Lilly reported on Tuesday. The boy, identified as Aissam Dam by The New York Times, was the first participant treated in a small […]
January 24, 2024
Via: Biopharma DiveCancer drug developer CG Oncology has raised $380 million in an initial public offering than was larger than it expected, a positive sign for a sector that’s struggled to generate demand from Wall Street investors recently. The company on Wednesday […]
Cell and Gene Therapy, Industry
January 23, 2024
Via: Biopharma DiveThe CAR-T therapies — Abecma and Breyanzi from Bristol Myers Squibb, Carvykti from Johnson & Johnson and Legend Biotech, Kymriah from Novartis, and Tecartus and Yescarta from Gilead — can drive deep and durable responses in patients with lymphoma, leukemia […]
Cell and Gene Therapy, Industry
January 18, 2024
Via: Biopharma DiveJaguar Gene Therapy is spinning out a new company to handle the specialized work of manufacturing cell and gene therapies, launching Wednesday a wholly owned subsidiary called Advanced Medicine Partners. The spinout, which is backed by investors Deerfield Management, Arch […]
January 17, 2024
Via: Biopharma DiveMore than two years after the bottom fell out for biotech stocks, the market for IPOs is showing early signs of life, though investors are generally looking for more well-established companies than in the past. Four of the five companies […]
Cell and Gene Therapy, Industry
January 17, 2024
Via: PharmaphorumCasgevy (exagamglogene autotemcel or exa-cel) became the first drug based on the CRISPR/Cas9 gene-editing technology to be approved towards the end of last year, when it was cleared by the FDA for sickle cell disease (SCD). The UK was the […]
January 16, 2024
Via: Biopharm InternationalCellVoyant—an artificial intelligence (AI) first biotechnology company spun out of the University of Bristol—has raised £7.6 million in seed funding to speed up the development of novel cell therapies. According to a Jan. 16, 2024 press release, the funding was […]
Cell and Gene Therapy, Industry
January 12, 2024
Via: PharmaphorumThe new GenePHIT study is enrolling patients with non-ischaemic cardiomyopathy and New York Heart Association (NYHA) class III heart failure who have been medically stable for at least 4 weeks. People with this stage of CHF will have a marked […]
January 5, 2024
Via: Biopharma DiveA California-based company has raised tens of millions of dollars to support its mission of bringing an ecstasy-based therapy to patients with post-traumatic stress disorder. MAPS Public Benefit Corp. formed a decade ago as a subsidiary of the Multidisciplinary Association […]
Cell and Gene Therapy, Industry
January 4, 2024
Via: PharmaphorumGermany’s Merck KGaA is paying $45 million upfront for rights to a potentially first-in-class drug for colorectal cancer (CRC) being developed by New York biotech Inspirna. The agreement gives Merck exclusive ex-US rights to ompenaclid – an oral inhibitor of […]
Cell and Gene Therapy, Industry
January 3, 2024
Via: Biopharma DiveHemophilia and other blood disorders like sickle cell disease and beta thalassemia have drawn intense investment from genetic medicine developers. in December, the FDA approved two such treatments for sickle cell, clearing Vertex Pharmaceuticals’ gene editing drug Casgevy and Bluebird […]