Cell Therapies
With Gilead reporting that both of its approved CAR-Ts saw sales declines as other products saw growth, a mixture of different competitive headwinds seems to be behind the disparities.
The biotech will present data at the upcoming ASH meeting on three patients who achieved PRs or VGPRs with minimal residual disease negativity and no cases of neurotoxicity.
Data presented at the Berlin meeting highlight the potential of the company's cell therapy anzu-cel to redefine the treatment paradigm for uveal melanoma.
The drugmaker is joining the rush to acquire an in vivo CAR-T therapy developer as concerns mount about whether the health care system can accommodate cell therapies’ dramatic growth.
While some big pharma companies have exited cell and gene therapy, Novartis, Astellas, Gilead’s Kite and AstraZeneca’s Alexion are diving back in, executives said at ARM’s Cell and Gene Meeting on the Mesa.
While there may be the beginnings of a turnaround in biopharma capital markets, gains in the cell and gene therapy space may lag the broader sector recovery, noted speakers at ARM’s Cell and Gene Meeting on the Mesa.
It remains to be seen whether the Trump administration’s most favored nation drug pricing policy will trickle down from big pharma to small biotech, but executives said at ARM’s Cell and Gene Meeting on the Mesa that they are preparing strategies now to manage the future.
Speakers at ARM’s Cell and Gene Meeting on the Mesa highlighted challenges of CAR-T’s evolution from niche to mainstream therapy given health care providers’ limited capacity to deliver the complex care associated with the products.
Non-binding offers have come mostly from groups of financial investors rather than biopharma players.
Japan continues to see promise in iPSC and other cell therapies, despite two major firms recently announcing their withdrawal from the area and other setbacks.
Suzhou-based Accuredit Therapeutics led the pack of recent China financings with a $75m series A. Other major funding rounds in the country backed by venture capital and private equity firms included Beijing GRIT Biotechnology's $53.5m series C.
Following a meeting with the FDA, Capricor plans to complete an ongoing Phase III study and refile its BLA in Duchenne muscular dystrophy, but the review timeline is unclear.
The CAR-T specialist is spending $350m to acquire the private Philadelphia-based firm, which is developing in vivo CAR-Ts using lentiviral vectors.
Shanghai-based BRL Medicine is building a novel pipeline led by universal CAR-Ts. Its founder talks to Scrip about the benefits of this approach, China's potential advantages in the field and challenges faced by new ventures.
The quarter saw strong growth overall, but the company now expects sales of Yescarta and Tecartus to fall for the full year 2025 versus 2024 thanks to competition.
Sumitomo Pharma's iPSC therapy for Parkinson's has been filed for approval in Japan after showing safety and efficacy in a Phase I/II trial and may become one of the first such therapies to reach the market in the country, which has invested heavily in the modality.
Aurigene Oncology CEO talks in this audio interview about the tough biotech funding environment, pipeline assets including a CAR-T therapy in Phase II, "hybrid" manufacturing, outcome-based reimbursement and the promise of bispecifics and multispecifics, including Akeso's PD-1/VEGF bispecific.
The company said it will no longer use ALLO-647 after a patient developed a fatal adenovirus infection, and it will pursue further development of its Dagger technology to minimize or eliminate the need for lymphodepletion.
The company is getting just $55m from the sale of Tecelra and a couple of late-stage T-cell therapies to US WorldMeds.
With $216m in initial funding, the newly launched company is aiming to develop a cell therapy-based universal immuno-oncology option for solid tumor indications.