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FDA approves first-of-its-kind regulatory T cell therapy for HSCT
The FDA has approved Orca Bio’s cell therapy Tregzi (Tregzi/Treg-based therapy) for patients undergoing matched-donor allogeneic HSCT after myeloablative conditioning, aiming to improve chronic...
Merck pulls an Alzheimer’s phase 2 program with Neuphoria
Merck has terminated a phase 2 Alzheimer’s trial testing MK-1167, an oral asset developed with partner Neuphoria Therapeutics, after an interim analysis failed to meet expectations. The...
HIF-2α inhibition lights up biomarker story in kidney cancer
Arcus Biosciences reported new Nature-published data linking suppression of circulating erythropoietin to treatment response in metastatic clear cell renal cell carcinoma (ccRCC) patients...
Sustained coverage for liquid biopsy CRC screening test
UnitedHealthcare’s coverage decision for Guardant Health’s Shield colorectal cancer screening test triggered a sharp market reaction, with the test moving into first-line use for average-risk...
Ipsen expands rare-disease kidney franchise with Memo acquisition
Ipsen agreed to acquire Memo Therapeutics for €700 million upfront, adding potravitug, a phase 2-ready antibody targeting BK virus-associated infections and nephropathy in immune-compromised...
FDA Precheck pilot takes first step with seven manufacturing-select companies
The FDA cleared the first flight of its PreCheck pilot, selecting seven companies for an early regulatory manufacturing assessment framework designed to increase predictability and support...
Beeline extends funding for immune pipeline built on BMS-licensed assets
Beeline Medicines secured an additional $126.3 million, bringing its total Series A commitment to $426.3 million to advance afimetoran and other immune-focused programs. The funds are earmarked...
CAR-T design expands with GPNMB tumor–myeloid dual targeting
Researchers reported preclinical efficacy for GPNMB-targeted CAR-T cells that attack both tumor cells and myeloid cells within a humanized glioblastoma setting. The dual targeting strategy aims...
Caidya and Simbec-Orion combine into a specialty clinical CRO platform
Caidya announced it combined with Simbec-Orion to form a specialty clinical CRO platform spanning Europe, the Americas, APAC and China, with operations anchored by early-phase clinical...
FDA/industry scrutiny sharpens after China trial retractions
China-led and China-based clinical trial data has faced renewed scrutiny after retractions of high-profile studies, spotlighting gaps in data transparency and validation systems. The reporting...
FDA approval of next-gen precision cell therapy for HSCT
The FDA has approved Orca Bio’s personalized T-cell therapy for matched-donor allogeneic HSCT patients with hematologic malignancies, bringing the company’s precision-engineered cell therapy...
Ipsen expands rare disease and immunosuppression infection pipeline with Memo deal
Ipsen announced it will acquire Memo Therapeutics for about €700 million, adding potravitug, an antibody in Phase III-ready development targeting BK virus-associated infections and nephropathy in...
Oncology diagnostics move: FDA breakthrough designation for melanoma gene expression test
The FDA granted breakthrough device designation to SkylineDx’s Merlin CP-GEP assay, a clinical-pathologic gene expression profiling test for risk assessment in early-stage cutaneous melanoma. The...
Merck exits mid-stage Alzheimer’s asset with Neuphoria
Merck terminated a Phase 2 trial of its oral Alzheimer’s disease candidate MK-1167, dealing another setback to its partner Neuphoria Therapeutics. Merck’s decision followed an interim analysis in...
U.S. biotech manufacturing regulation shift: FDA PreCheck pilot kicks off
The FDA launched the first wave of its PreCheck Pilot Program for onshoring and improved regulatory predictability in drug manufacturing. The agency selected seven biopharma manufacturers,...
FDA leadership change in cell and gene therapy oversight
Vijay Kumar, the FDA’s acting director of CBER’s Office of Therapeutic Products overseeing cell and gene therapies, announced he is stepping down from the role. Kumar said the agency mutually...
Orca-T / Tregzi pipeline context in FDA review calendar
The FDA’s July calendar includes at least 10 drug and biologics decision dates, including a cell therapy with an action date pushed back from April. Orca Therapeutics is among companies signaling...
CAR-T and immune cell manufacturing: new SRV2 envelope tech for efficient CAR immune cell production
Researchers at Korea’s KRICT identified a novel SRV2 envelope protein intended to improve viral vector efficiency for producing CAR immune cells. The group said the approach targets manufacturing...
Can-Fite Phase 2a PDAC update boosts sentiment on namodenoson durability and safety
Can-Fite Biopharma reported Phase 2a results for namodenoson in advanced pancreatic ductal adenocarcinoma, pushing investor focus toward the drug’s safety profile and durability of overall...
Checkpoint for clinical evidence integrity: China trial retractions spotlight transparency
China-led clinical trial evidence is drawing heightened scrutiny after retractions of high-profile studies, raising questions about validation systems across journals, regulators, and developers....