The hold is the second the agency has placed on the trial due to safety concerns. While the company has deprioritized development of the ACTR087 construct, an analyst wrote that the hold adds to concerns about the company's ACTR platform.
The German drugmaker plans to submit its data package for FDA approval by the end of the year, with potential approval next year. The package will include a synthetic control arm comprising real-world data.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
A spokesperson for the company noted that patients in the Phase II L-MIND trial of the CD19-targeting drug tafasitamab would be too old and frail to be candidates for CAR-T therapies.
The agency set an August PDUFA date for entrectinib, which it gave priority review. It did the same for another Roche drug, polatuzumab vedotin, for high-grade lymphoma.
The Phase I study is planned to enroll 24 patients with relapsed/refractory diffuse large B-cell lymphoma and follicular lymphoma and will be run under Allogene's collaboration with Servier.
The agency approved Truxima for three lymphoma indications, whereas European regulators approved it last year for all the same indications as the reference product, Roche's Rituxan.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Along with Boston Scientific's Watchman in the technology category, Novartis and Gilead's Kite shared the biotechnology award for CAR-T therapy, while Celgene/Agios's Idhifa won the pharmaceutical prize.
A manufacturing error during a clinical trial of Kymriah, now marketed by Novartis, is less likely today, but could be an issue as CAR-Ts move into earlier therapy lines.
The deal will bring the CAR-T therapy to China's burgeoning market, but it faces competition from Gilead's Yescarta - manufactured under a JV with Fosun - and also homegrown products.
CMS could run trials of CAR-Ts in lymphoma if unsure of their similarity on benefit to patients and ancillary service costs, Dr. Peter Bach writes.
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Latest round of venture capital funding brings total amount raised to $175 million since 2003.
The clinical trial of the CAR-T - a potential competitor to bluebird bio's - will start enrolling patients later this year.
Training the immune system to fight a unique marker of B-cell lymphoma, with the hope of treating the cancer without chemotherapy, has netted a California biopharmaceutical company more than $1 million in preclinical investment. Bullet Biotechnology’s active immunotherapy is directed at a specific idotype protein expressed on B-cells. It uses directed conjugation to attach copies […]