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FDA crosshairs and post-approval disputes for rare disease therapy
Amgen is asking for an independent review as the FDA weighs whether to withdraw the approval of Tavneos (avacopan), according to the company’s response strategy. The dispute stems from FDA...
Clinical-stage readouts: psoriasis head-to-head and durability
Takeda says its oral TYK2 inhibitor zasocitinib (TAK-279) demonstrated statistical superiority over Bristol Myers Squibb’s Sotyktu (deucravacitinib) in a Phase 3 head-to-head psoriasis readout...
Company financing: large biotech Series B for ultrasound-mediated genetics
SonoThera raised an oversubscribed $125 million in a Series B financing to advance ultrasound-mediated delivery of genetic medicines toward clinical testing. The funding round, led by Vida...
Public market signals: major oncology CAR T moves and next-stage advancement
Oricell Therapeutics says its GPC3-targeted autologous CAR T, Ori-C101, is entering a confirmatory registration-directed Phase 2 trial in patients with GPC3-positive advanced hepatocellular...
Non-viral immunotherapy and preclinical potency: precision oncolytic virus retargeting
Researchers unveiled an engineered vesicular stomatitis virus variant, ErbB-OSV, designed to selectively target and kill metastatic ovarian cancer cells via rewired signaling while sparing normal...
Regulatory diagnostics: FDA clears at-home STI specimen kit with Roche workflow
OraSure Technologies received 510(k) clearance from the FDA for an at-home urine collection kit that supports molecular STI testing using Roche automated systems. The Colli-Pee kit is designed for...
Diagnostics and MRD testing rebrand and indication expansion planning
Roche’s Foundation Medicine rebranded Saga Diagnostics’ minimal residual disease test after the $595 million acquisition, renaming the assay to FoundationOne MRD and signaling a push into...
Genetic medicine strategy: non-viral DMD mRNA delivery using targeted extracellular vesicles
A new preclinical and translational package reports systemic delivery of full-length Duchenne muscular dystrophy mRNA using skeletal-muscle-targeted extracellular vesicles (EVs). In the study,...
Abridge and clinical trial recruitment: strategic expansion backed by Lilly
Abridge received investment from Eli Lilly as it expands from clinical documentation into clinical trial recruitment workflows. Lilly’s venture arm is backing the startup as it broadens its...
Regulatory approvals and FDA decisions in oncology
Merck’s Welireg–Keytruda combination won FDA approval as an adjuvant treatment for kidney cancer patients after surgery to remove all or part of the organ, extending the checkpoint-VEGFR/HIF axis...
Late-stage inflammatory disease efficacy readouts
Takeda reported a top-line Phase III win for oral TYK2 inhibitor zasocitinib (TAK-279) in moderate-to-severe plaque psoriasis, beating Bristol Myers Squibb’s Sotyktu (deucravacitinib) in the...
Cardiovascular pipeline funding via IPO roadshows
Kardigan filed for a Nasdaq IPO to raise about $320 million, targeting cardiovascular indications spanning genetic dilated cardiomyopathy and calcific aortic valve stenosis. The company plans to...
Ultra-rare gene therapy safety and feasibility in ophthalmology
A Chinese team published clinical findings in the New England Journal of Medicine supporting a subretinal gene therapy approach for X-linked retinoschisis (XLRS), using an AAV8 vector delivering a...
Biopharma financing: ultrasound-mediated genetic medicines
SonoThera secured an oversubscribed $125 million Series B financing round to advance its ultrasound-mediated delivery platform toward clinical testing. The company plans to fund lead programs in...
Oncology companion diagnostics: FDA CDx clears Guardant360
Guardant Health said the FDA approved its Guardant360 CDx assay as a companion diagnostic for Boehringer Ingelheim’s HER2-mutant lung cancer drug Hernexeos (zongertinib). The liquid biopsy test...
Cell therapy development milestones: confirmatory CAR T approach
Oricell said its GPC3-targeted autologous CAR T therapy, Ori-C101, is moving into a confirmatory registration Phase II trial for patients with GPC3-positive advanced hepatocellular carcinoma. The...
Rare disease regulatory policy: MHRA pressure for incentives
A rare-disease biotech CEO urged the MHRA to extend beyond its draft rare disease therapy framework, arguing that incentives comparable to the FDA’s Priority Review Voucher (PRV) scheme are...
Clinical AI and recruitment: Lilly expands investment in Abridge
Eli Lilly invested in Abridge as the health tech startup expands into clinical trial recruitment and broadens its reach across life sciences. The investment, made through Lilly’s venture arm, is...
Dealmaking: Roche rebrands Saga MRD test and targets new uses
Roche and Foundation Medicine rebranded Saga Diagnostics’ minimal residual disease test after Roche’s $595 million acquisition earlier this year, renaming Pathlight MRD to FoundationOne MRD and...
Precision oncology diagnostics
Roche’s Foundation Medicine rebranded Saga Diagnostics’ minimal residual disease test after the $595 million acquisition earlier this year, positioning the assay for new indications beyond breast...