Moderna, Merck personalized mRNA cancer vaccine cuts melanoma recurrence or death risk 42% in Phase 3
The intismeran autogene results, presented at ESMO and published in NEJM, mark the first late-stage win for a personalized mRNA cancer vaccine even as Moderna s
Biopharmadive · +15 outlets
Artiva shuts down after two patient deaths in autoimmune NK cell therapy trial
Artiva becomes the third company recently to report a fatal event in an autoimmune cell therapy trial, following Novartis and Bristol Myers Squibb.
STAT · +6 outlets
Bristol Myers Squibb reports patient death in MS CAR-T trial, seeks to resume program
The death of a patient 44 days after receiving zola-cel adds to safety questions about applying CAR-T approaches to autoimmune disease.
Biopharmadive · +14 outlets
Merck, Kelun sac-TMT cuts death risk by one-third in advanced endometrial cancer, wins priority review
The Phase 3 data support an FDA filing for the targeted ADC developed with China's Kelun-Biotech.
STAT · +12 outlets
Ferring to acquire IVF startup Gameto for up to $1.4B
The deal gives Ferring rights to technology aimed at simplifying the in vitro fertilization process.
Biopharmadive · +4 outlets
FDA offers new details on faster approval pathway for personalized gene therapies
The guidance on individualized therapies drew praise from rare disease advocates seeking quicker access.
STAT · +14 outlets
Judge rejects Novo Nordisk bid to block Lilly obesity drug ads
The court found Novo failed to show Lilly's superiority claims for Zepbound meaningfully harmed Wegovy sales.
Biopharmadive · +14 outlets
Roche's KRAS drug divarasib posts strong lung cancer data at ESMO
The divarasib dataset was among the more impressive presented at this year's ESMO meeting.
STAT · +11 outlets
Incyte says pancreatic cancer drug induces lasting tumor responses at ESMO
Incyte positions its KRAS G12D candidate as competitive with Revolution Medicines in the pancreatic cancer race.
STAT · +3 outlets
GSK, Hansoh B7-H3 ADC cuts cancer risk 67% in Phase 3 China lung cancer trial
The data support GSK's effort to rebuild an oncology portfolio after a decade largely out of cancer.
STAT · +10 outlets
Nonprofit resurrects shelved gene therapy after UK startup Bloomsbury shuts down
Bloomsbury Genetic Therapies had dosed just one patient before closing; a nonprofit is now reviving its lead program.
STAT · +1 outlets
Missouri AG warns Lilly to stop requiring data from hospitals seeking 340B discounts
The warning signals growing state pushback against drugmaker conditions on the 340B program.
STAT · +3 outlets
FDA approves Pfizer's Talzenna plus Xtandi for earlier metastatic prostate cancer
The approval expands the combination into an earlier treatment setting for metastatic prostate cancer.
Business Wire · +14 outlets
Corxel to go public via SPAC with $300M and two obesity drug candidates
Corxel becomes the latest weight loss focused company to list publicly, armed with GLP-1 and amylin-targeting medicines.
Biopharmadive · +3 outlets
FDA approves breakthrough drug for advanced pancreatic cancer
The approval adds a new option for patients with advanced pancreatic cancer.
University of Colorado Anschutz · +13 outlets
Bristol Myers touts five positive Phase 3 trials for bispecific ADC iza-bren at ESMO
The company's CMO highlighted the breadth of late-stage data for the bispecific antibody-drug conjugate.
Fierce Pharma · +1 outlets
BioNTech, DualityBio report modest benefit for HER2-low breast cancer ADC
The companies said the treatment had limited impact in a setting where AstraZeneca and Daiichi's Enhertu set a high bar.
Biopharmadive · +6 outlets
Kelun-Biotech sac-TMT extends lung cancer survival by 8.5 months in final Phase 3 analysis
The final overall survival analysis adds to the dataset for Kelun-Biotech's TROP2-directed ADC.
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