Nearly a full month ahead of the PDUFA date, ADC Therapeutics SA said Friday the FDA has granted accelerated approval for Zynlonta (loncastuximab tesirine), a CD19-targeted antibody-drug conjugate for the single-agent treatment of adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. The approved indication includes the treatment of patients with diffuse large B-cell lymphoma not otherwise specified and those with DLBCL arising from low grade lymphoma and high grade B-cell lymphoma, which ADC's CEO Chris Martin said would be an important point of differentiation for the product.
Advances lately in the genome-editing space include Beam Therapeutics Inc. publication in The CRISPR Journal details of its work with inlaid base editors, which the firm is applying in the BEAM-102 program for sickle cell disease. IBEs’ predictable, shifted editing window lets researchers go after disease-causing mutations that canonical base editors cannot reach, Beam said, and do the job with high efficiency and few off-target effects on the genome. The hottest news due in the near-term future from the sector will spill from Intellia Therapeutics Inc., of Cambridge, Mass., which is due to roll out first-in-human data with a systemic CRISPR-based genome editing therapy, NTLA-2001, in hereditary transthyretin amyloidosis.
As of 2020, the NIH had identified 507 grant recipients who potentially had undisclosed conflicts of interest, with many of those conflicts involving affiliations with foreign governments that may expect the scientists to share or steal NIH-funded research.
DUBLIN – Isotopen Technologien München (ITM) AG raised €90 million (US$108 million) in debt financing to complete phase III development of its lead radiopharmaceutical, solucin, in gastroenteropancreatic-neuroendocrine tumors and to take forward several more preclinical pipeline projects.
DUBLIN – Anavo Therapeutics BV raised €20 million (US$24 million) in seed financing to fund the build-out of a platform that aims to drug the human phosphatome, or the ensemble of phosphatase enzymes that plays a crucial role in maintaining cells’ phosphorylation balance by removing phosphate groups from their target substrates.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Amarin, Henlius, Saniona, Ultragenyx.
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