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Vera Therapeutics pushes IgAN to full approval
Vera Therapeutics said final two-year Phase 3 results for its kidney drug Trutakna (approved under accelerated approval for IgA nephropathy) showed continued stabilization of kidney function and...
Pivotal turns for multiple CNS and rare-disease programs
Scholar Rock’s apitegromab-mstn (Isembyld) won FDA approval for spinal muscular atrophy in a label supporting use alongside existing SMN-targeted therapies for adults and children age 2 and...
Phase 3 pressure in oral SERD breast cancer
AstraZeneca reported that camizestrant (Etcamah) did not meet the primary endpoint in the Phase 3 Serena-4 trial, testing the oral selective estrogen receptor degrader (SERD) in first-line...
Small-cell lung cancer: B7-H3 ADC survival signal in China
Two China-based Phase 3 trials for B7-H3-directed antibody-drug conjugates (ADCs) in relapsed small-cell lung cancer met overall survival endpoints, adding momentum to the B7-H3 ADC pipeline...
CNS and dataset infrastructure for AI in biology
OpenAI Foundation will fund Ruxandra Teslo’s proposal for using “biotech’s lost archive” — detailed materials from failed companies, including regulatory filings and safety data — to train medical...
Precision diagnostics: Telix gets first glioma FET-PET authorization in the U.S.
Telix Pharmaceuticals said the U.S. FDA approved Pixclara (floretyrosine F-18, 18F-FET), positioned as the first FDA-approved FET-PET imaging agent for glioma and the first U.S.-approved PET...
Biopharma manufacturing expansion in Europe
Evonik broke ground on a biotechnology expansion at its Fermas site in Slovakia as part of an approximately EUR 80 million investment. The company said the project will add downstream fermentation...
CRO consolidation for discovery-to-validation assays
Single Cell Discoveries (SCD) completed its acquisition of TATAA Biocenter, combining discovery transcriptomics with GLP/GCLP-compliant bioanalysis, including qPCR and dPCR, and molecular assay...
Immunology venture: Nobel-winning Treg work enters clinic
RegCell, the nearly 50-year project of Shimon Sakaguchi’s regulatory T cell research lineage, raised a $44 million Series A as it prepares to advance Tregs into clinical development. The...
Regulatory updates: psychedelics at the FDA and real-world safeguards
The FDA is moving toward earlier access to psychedelic medicines, but agency officials and mental health experts pressed for concrete safety guardrails around dosing, monitoring, and provider...
Rare disease approvals: Scholar Rock wins SMA go-ahead for muscle-targeted therapy
The FDA cleared Scholar Rock’s myostatin inhibitor apitegromab (Isembyld) for spinal muscular atrophy, authorizing use alongside existing SMN-targeted therapies in eligible adults and children age...
Oncology: ivonescimab’s latest Phase 3 readouts aim to narrow the argument vs Keytruda
Akeso and Summit Therapeutics used late-stage results at the World Conference on Lung Cancer to press a case for ivonescimab, a dual-acting PD-1/VEGF antibody, in previously treated lung cancer....
Oncology: Roche partner MediLink reports Phase 3 OS benefit for B7-H3 ADC in relapsed SCLC
MediLink reported Phase 3 interim results for tambotatug pelitecan (Tam-Peli), a B7-H3-targeted antibody-drug conjugate, in Chinese patients with relapsed small-cell lung cancer. In the...
Women’s health oncology: AstraZeneca’s Etcamah fails first-line expansion effort in Phase 3
AstraZeneca’s oral SERD camizestrant (Etcamah) missed key efficacy in a Phase 3 study designed to expand its breast cancer use into a first-line setting. In the Serena-4 trial, Etcamah plus...
Oncology pipeline: Az’s camizestrant setback sharpens ESR1 focus for oral SERDs
A second Phase 3 setback this year for an oral selective estrogen receptor degrader underscored how strongly trial outcomes may depend on patient biology. Coverage of Serena-4 indicated that...
Biopharma dealmaking in Asia: Solstice’s $225M Series A and GLP-1 licensing for bofanglutide
Solstice Oncology emerged from stealth with a $225 million Series A to advance porustobart, a second-generation Fc-enhanced CTLA-4 antibody, into a Phase II setting for microsatellite-stable (MSS)...
Manufacturing and CRO services: Single Cell Discoveries buys TATAA Biocenter to close validation gap
Single Cell Discoveries (SCD) completed its acquisition of TATAA Biocenter, bringing together discovery transcriptomics with assay validation capabilities spanning qPCR/dPCR and GLP/GCLP-compliant...
AI for regulatory submissions: nPhase targets faster clinical-trial paperwork conversion
nPhase launched an AI platform aimed at converting raw clinical study data into submission-ready documentation for regulatory filings. The company claims its workflow can accelerate regulatory...
Biopharma economics and policy: pediatric FDA priority review vouchers near record level as fees drop
The U.S. issued additional FDA priority review vouchers for pediatric rare disease indications, keeping the pediatric PRV count near a recent record. Coverage noted that three new U.S. pediatric...
Cancer immunotherapy financing and next trial launch
Solstice Oncology emerged from stealth with a $225 million Series A to advance porustobart, a second-generation, Fc-enhanced CTLA-4 antibody licensed from Harbour BioMed. The company is pairing...