Moderna, Merck personalized mRNA cancer vaccine cuts melanoma recurrence in Phase 2 data
Interim INTerpath-001 results presented at ESMO showed improved recurrence-free survival for melanoma patients, boosting hopes for individualized mRNA cancer va
STAT · +14 outlets
Pancreatic cancer vaccine triggers immune response in 99% of patients in early trial
Early-stage data showing near-universal immune activation in pancreatic cancer patients adds to momentum for mRNA-based cancer vaccines.
ScienceAlert · +10 outlets
FDA grants accelerated approval to Inovio DNA immunotherapy Voceryq for recurrent respiratory papillomatosis
The approval makes Voceryq the first DNA-based immunotherapy cleared for the HPV-driven condition, while Precigen shares fell 27% after hours.
HCPLive · +4 outlets
Genmab shares hit record high as head and neck cancer antibody succeeds in Phase 3
Positive trial results added more than $7 billion in market value and revived retail interest in oncology biotech stocks.
Biopharmadive · +7 outlets
FDA proposes streamlined approvals letting one decision cover multiple personalized gene editing therapies
The draft guidance aims to cut regulatory burden for bespoke rare disease treatments, with CMS expanding a related access model.
AllSci · +3 outlets
Lilly says retatrutide delivers roughly double the weight loss of Ozempic
The next-generation obesity drug candidate could intensify competition in the fast-growing GLP-1 market.
ABC7 New York · +5 outlets
Iovance stock crashes after surprise lung cancer trial setback
The cell therapy developer, one of the top-performing biotech stocks, lost ground on unexpected clinical news in lung cancer.
Investor's Business Daily · +2 outlets
Acumen scraps its only drug after Alzheimer's failure, shares plunge 80%
The clinical failure leaves the company without a pipeline asset and wipes out most of its market value.
BioSpace
China upends global drug development with cheaper, faster human trials
The shift is reshaping where multinationals run studies and how quickly they can generate clinical data.
Bloomberg · +2 outlets
Gilead discloses partial clinical hold on two CAR-T cell therapy trials
The hold adds to regulatory scrutiny of cell therapies and could delay development timelines for the programs involved.
Fierce Biotech
Labor Department finalizes sweeping PBM disclosure rule
Starting in 2027 pharmacy benefit managers must share fee and compensation data with self-funded employer clients, a move PBMs call overreach.
Biopharmadive · +3 outlets
Lilly leads Q3 earnings roundup as Novartis rebounds and GSK faces investor doubts
Better-than-expected results eased concerns over GLP-1 pricing pressure, while peers reported mixed quarters.
Biopharmadive
HHS lets compounders make six unapproved peptides, over FDA staff objections
RFK Jr.'s policy gives a regulatory boost to the peptide craze despite concerns from FDA career scientists.
Biopharmadive · +7 outlets
AstraZeneca launches three-year cost-cutting program targeting $1.5B a year for R&D
The savings plan reflects broader pressure on large pharma to fund pipeline investment amid patent cliffs.
STAT · +5 outlets
FDA begins enforcing clinical trial result transparency rules
The long-awaited enforcement step aims to make trial results publicly reported as required by law.
Undark Magazine · +14 outlets
Flagship combines three biotech startups into AI-aided drugmaker Etcelera
Etiome, Cellarity and Empress Therapeutics merge into a single company claiming better prediction of how medicines perform in humans.
Biopharmadive · +2 outlets
FDA approves first-ever drug for a rare neurological disorder after 30 years
The clearance marks the first treatment option for a condition that has gone without an approved therapy for decades.
ScienceAlert
Dren Bio raises $350M to push rare blood cancer therapy toward market
The large financing underscores continued investor appetite for late-stage oncology assets.
BioSpace · +1 outlets