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Vertex kidney drug hits Phase 3 goal – best‑in‑class hopes rise
Vertex reported positive late‑stage results for a drug it acquired, showing a roughly 50% reduction in a key biomarker for IgA nephropathy in a Phase 3 study. The company said the data match or...
Xenon’s epilepsy pill crushes Phase 3 target: seizure rates halved
Xenon Pharmaceuticals announced Phase 3 X‑Tole2 results for azetukalner showing a 53.2% placebo‑adjusted reduction in focal onset seizure frequency at the 25 mg dose and strong tolerability at the...
Bristol Myers’ CELMoD mezigdomide clears Phase 3 — multiple myeloma PFS improves
Bristol Myers Squibb reported that mezigdomide, an oral CELMoD acquired through past transactions, met its primary endpoint in a late‑stage study of relapsed or refractory multiple myeloma,...
Ipsen pulls Tazverik after safety signals — market withdrawal and trial halts
Ipsen announced an immediate withdrawal of tazemetostat (Tazverik) from the U.S. market and suspension of ongoing clinical studies after an independent data monitoring committee identified cases...
Roche’s giredestrant flunks PersevERA — first‑line oral SERD setback
Roche reported that giredestrant missed the primary progression‑free survival endpoint in the PersevERA Phase 3 trial as a first‑line therapy for ER‑positive, HER2‑negative advanced breast cancer....
Agilent snaps up Biocare for $950M to expand pathology reach
Agilent Technologies agreed to acquire Biocare Medical for $950 million in cash to broaden its pathology portfolio with immunohistochemistry (IHC), in situ hybridization (ISH), FISH assays and...
FDA updates biosimilar Q&As: reissues guidance and posts revised draft — clarity on BPCI Act
The U.S. Food and Drug Administration issued a pair of documents clarifying its interpretation of the Biologics Price Competition and Innovation Act (BPCI Act). The agency reissued its final...
Ferritin 'FACE' platform boosts CAR‑T avidity without re‑engineering receptors
Researchers at the Institute of Process Engineering (Chinese Academy of Sciences) published a Cell paper introducing the ferritin aggregation cell engager (FACE), a biomimetic, ferritin‑based...
Verily and Samsung team to feed Galaxy smartwatch data into clinical trials
Verily and Samsung announced a partnership to integrate Galaxy smartwatch sensor data into Verily’s Pre platform to support clinical trials. The collaboration aims to create an end‑to‑end system...
DocTr AI matches doctors to trials with 58% higher accuracy — trial site selection gets smarter
A Nature Health study introduced DocTr, an AI system that recommends investigators and sites for clinical trials by analyzing patient encounter data, unstructured protocol documents, and...
Azetukalner cuts focal seizures 53% – Xenon aims Q3 filing
Xenon Pharmaceuticals reported Phase 3 X‑Tole2 results showing azetukalner reduced focal onset seizure frequency by 53.2% at the 25 mg dose and 34.5% at 15 mg versus placebo. The company said the...
Vertex’s acquired drug halves IgA marker – late‑stage win
Vertex reported that the drug it acquired in a multibillion‑dollar deal met its primary endpoint in a Phase 3 study for IgA nephropathy, cutting a key disease marker by roughly 50%. The company...
Mezigdomide improves PFS – BMS de‑risks CELMoD slate
Bristol Myers Squibb announced that mezigdomide, an oral targeted protein degrader from its CELMoD platform, produced a statistically significant and clinically meaningful improvement in...
Ipsen pulls Tazverik after safety monitors flag secondary cancers
Ipsen voluntarily withdrew tazemetostat (Tazverik) from the market and halted ongoing studies after an independent data monitoring committee detected cases of secondary hematologic malignancies in...
Ferritin engager boosts CAR‑T avidity…less cells, less CRS
Researchers at the Institute of Process Engineering (Chinese Academy of Sciences) introduced a ferritin aggregation cell engager (FACE) that links CAR‑T cells and leukemia cells via CD71,...
In‑vivo CAR‑T bets accelerate – delivery and safety still central
A field review mapped the accelerating investment and M&A activity around in‑vivo CAR‑T platforms, which aim to convert off‑the‑shelf delivery into patient T‑cell reprogramming inside the body....
Gene‑edited probiotic shows safety gains in preclinical tests
An international research team engineered Saccharomyces boulardii to remove virulence features and demonstrated reduced infection risk in animal models, addressing safety concerns for probiotic...
Verily and Samsung link Galaxy data to trial platform – wearables go mainstream
Verily and Samsung announced a partnership to integrate Galaxy smartwatch data into Verily’s Pre platform, creating an end‑to‑end solution for deploying wearables in clinical trials and analyzing...
Sartorius unveils CHO host with up to 3× productivity – manufacturing edge
Sartorius launched a rationally designed CHO host cell line developed via proteomic profiling and targeted genome editing that delivered up to two‑fold higher expression titers and up to...
Agilent buys Biocare for $950M – beefs up pathology reagent portfolio
Agilent Technologies agreed to acquire Biocare Medical for $950 million in cash to expand its pathology product set, adding immunohistochemistry (IHC), in situ hybridization (ISH/FISH) assays, and...