Cell Therapies
Seven weeks before its action date, Capricor got an FDA complete response for cell therapy deramiocel in DMD-related cardiomyopathy. It has a Phase III study nearing readout, though.
The Kevin Tang-led firm will pay $4.38 per share for Cargo, which laid off most of its workforce following the failure of a Phase II CAR-T trial.
Relaxing CAR-T restrictions may not be an access panacea because of patient fragility and lack of payer incentive. Conversely, the ACIP’s recent recommendation on Thiomersal-containing flu vaccines is probably the thin edge of a more restrictive wedge.
The drugmaker will spend up to $2.1bn to acquire the privately held biotech firm and its targeted lipid nanoparticle technology platform, with an anti-CD19 asset in the clinic.
The FDA eliminated REMS requirements for approved CAR-T cell therapies that have limited their availability, a move that could enable increased use in the community setting.
With financial help from the founder of Uniqlo, Japan’s leading facility for induced pluripotent stem cells is aiming to automate production to slash costs and kick-start R&D in the field.
A partnership with Germfree Laboratories will bring a new facility to boost Saudi Arabia’s biotech sector as the world’s largest oil exporter tries to establish itself as a global biotech hub by 2040.
The off-the-shelf stem cell therapy shows sustained glycemic control and a high rate of insulin independence.
The drugmaker presented data at a lymphoma meeting showing strong efficacy for the CAR-T in marginal zone lymphoma, the second most common indolent lymphoma.
The company presented Phase I data for CART-EGFR-IL13Rα2, showing patient responses in the notoriously hard-to-treat and deadly brain cancer.
Gilead’s Kite division presented Phase I data for its next-generation CAR-T therapy KITE-363 in patients with B-cell lymphomas.
The biotech believes its logic-gated cell therapies can get round the need for ‘clean targets’ which limit CAR-Ts and ADCs.
In first confirmatory randomized controlled trial of any CAR-T therapy in solid tumors, CARsgen’s Claudin 18.2-targeting satri-cel reduced risk of death or disease progression by 63% in Chinese patients with gastric/gastroesophageal junction cancer.
Vaccine and accelerated approvals are expected to face greater scrutiny under new CBER leader Vinay Prasad, but he has promised “no light switch change” to policy, giving some reassurance to companies whose share prices have been battered.
The biotech said it will have a type A meeting with the agency to resubmit for the cell therapy’s approval in EBV+ PTLD.
While CAR-NKs have pivoted towards autoimmune disease, the Norwegian biotech believes its unique platform can deliver in oncology
Sales of the company’s approved cancer therapies were weaker or down, but Trodelvy is likely to see a label expansion and cell therapies are making progress.
BriaCell announced its cell therapy Bria-IMT plus checkpoint inhibitors bested Gilead’s Trodelvy in a Phase II trial in HR+ breast cancer; a Phase III trial is enrolling.
The company announced positive Phase IIb data for Descartes-08 in myasthenia gravis, with especially strong efficacy among patients without prior biologic treatment.
Bharat Biotech is the latest entrant in India’s cell and gene therapy space, joining majors like Intas Pharma, Sun Pharma, Cipla and Dr. Reddy’s. An indigenously developed CAR-T cell therapy launched last year, what is driving growing interest and success in cell and gene therapies?