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Syngene builds peptide lab, ramps automation — CRDMO scale‑up
India’s Syngene International completed site upgrades to add a dedicated peptide laboratory in Bengaluru and introduced advanced automation across DMPK and direct‑to‑biology (D2B) workflows. The...
India court allows generic Evrysdi — Roche faces pricing blow
India’s Supreme Court dismissed Roche’s petition and allowed Natco Pharma to sell a lower‑cost generic version of Evrysdi (risdiplam) in India, a decision described in coverage as weighing public...
Enhertu pushes earlier — Phase 3 signals curative potential
AstraZeneca and Daiichi Sankyo presented Phase 3 data at ESMO showing Enhertu improves outcomes when used earlier in breast cancer treatment. The companies reported results indicating meaningful...
Datroway vs Trodelvy: Head‑to‑head ESMO readouts sharpen choice
Two antibody‑drug conjugates—AstraZeneca/Daiichi Sankyo’s Datroway and Gilead’s Trodelvy—delivered competing Phase 3 results at ESMO that both showed benefits versus chemotherapy in first‑line...
Padcev–Keytruda combo extends survival — Phase 3 bladder data
New Phase 3 data presented at ESMO show that the Padcev (enfortumab vedotin) plus Keytruda (pembrolizumab) combination extends overall survival in locally advanced or metastatic bladder cancer....
Grail’s Galleri improves accuracy — PATHFINDER 2 readout alters filing narrative
Grail published PATHFINDER 2 results showing improved positive predictive value (PPV) and a sensitivity of 40.4% for its Galleri multi‑cancer screening test in nearly 36,000 adults over age 50....
BioNTech halts late‑stage melanoma vaccine
BioNTech announced it will not advance a cancer vaccine program in late‑stage melanoma, according to reporting from Endpoints News at ESMO. The company said it remains undecided about studying the...
mRNA COVID shots amplify immunotherapy response — MD Anderson analysis
Data presented at ESMO and analyses from MD Anderson reported that patients who received mRNA COVID‑19 vaccines within 100 days before starting immune checkpoint inhibitors lived longer than...
Tubulis clinical win backs hefty financing — investors take notice
Tubulis reported an overall response rate (ORR) of 59% for its TUB‑040 ADC in early‑phase trials, data the company presented at ESMO. The clinical signal arrived just after Tubulis closed a $361...
VT3989 demonstrates early activity in refractory mesothelioma
The University of Texas MD Anderson Cancer Center reported promising early outcomes from trials of VT3989, a first‑in‑class YAP‑TEAD inhibitor, in refractory mesothelioma and other solid tumors....
Syngene builds automated peptide lab to speed discovery
India‑based Syngene International completed site upgrades, opening a dedicated peptide laboratory in Bengaluru and deploying advanced automation across DMPK and Direct‑to‑Biology (D2B) workflows....
FDA exodus and voucher program scrutiny reshape regulatory backdrop
BioCentury analysis quantified a recent staffing drain at the FDA—reporting that one in seven CBER and one in eight CDER employees exited in fiscal Q4—raising concerns about the agency’s capacity...
Grail’s Galleri improves accuracy: FDA filing nears
New large-study data show improvements in Grail’s Galleri multi-cancer screening test as the company moves toward broader regulatory review. Results from the PATHFINDER 2 U.S. study—presented at...
FDA unveils nine 'national priority' picks — review clock shortens
The FDA has selected the first nine products for its Commissioner’s National Priority Review Voucher pilot, a program designed to compress review timelines for candidates that address national...
Sophia Genetics launches Digital Twins: AI models simulate cancer patients
Sophia Genetics unveiled Sophia DDM Digital Twins at the ESMO conference, an AI-driven module that builds computational replicas of individual cancer patients using multimodal clinical, genomic...
New mesothelioma agents show activity: YAP‑TEAD inhibitor and Vivace readouts
Two separate midstage programs reported activity in treatment-resistant mesothelioma. Researchers at MD Anderson disclosed early results for VT3989, a first-in-class YAP‑TEAD inhibitor that...
ADCs encroach on first‑line TNBC: head‑to‑head presentations shift treatment choices
At ESMO, competing antibody‑drug conjugates (ADCs) from AstraZeneca/Daiichi Sankyo and Gilead were presented back-to-back with positive Phase 3 data in metastatic triple‑negative breast cancer...
Tubulis clinical win follows big funding: investor thesis validated
Tubulis reported first‑in‑human data for its next‑generation ADC TUB‑040 with an overall response rate of 59% across dose cohorts in heavily pretreated patients, data the company released shortly...
mRNA COVID shots linked to better checkpoint immunotherapy outcomes
Clinical teams reported independent observations that receipt of mRNA COVID‑19 vaccines near the time of checkpoint inhibitor therapy coincided with improved outcomes in advanced cancer patients....
Tumor‑infiltrating Fusobacterium induces quiescence and blunts chemotherapy
MD Anderson researchers described a mechanism by which tumor‑infiltrating bacteria—chiefly Fusobacterium nucleatum—physically surround epithelial tumor cells, disrupt cell‑cell communication and...