ArriVent's phase 3 lung cancer trial fails; stock collapses over 48% to all-time low
The readout for furmonertinib in EGFR-mutant lung cancer appears to erase ArriVent's chance to compete with Johnson & Johnson and other rivals, wiping out more
Biopharmadive · +7 outlets
Vaxcyte's pneumococcal vaccine hits Phase 3 endpoints, setting up Pfizer and Merck competition
The next-generation shot matched the effectiveness of Pfizer's and Merck's vaccines on nearly all bacterial strains in the first of three Phase 3 trials.
STAT · +6 outlets
Eli Lilly's Jaypirca wins FDA approval as first-line CLL therapy
The expanded clearance makes the BTK inhibitor an option for previously untreated chronic lymphocytic leukemia and small lymphocytic lymphoma patients.
STAT · +14 outlets
Lilly's Jaypirca wins FDA approval as first-line CLL therapy
The approval makes Jaypirca an option for previously untreated CLL and SLL patients.
STAT · +9 outlets
Forbion raises $2.6B for a pair of venture funds in its largest fundraise to date
The raise provides a lift for a European biotech industry that has fallen further behind counterparts in the U.S. and China.
Biopharmadive · +2 outlets
GE HealthCare to acquire Sofie Biosciences for $945M
The purchase expands GE HealthCare's radiopharmaceutical capabilities for manufacturing and distributing time-sensitive PET imaging drugs.
Biopharmadive · +14 outlets
AbbVie and Genmab's Epkinly scores in frontline lymphoma trial
Better-than-expected results could make Epkinly the new standard in newly diagnosed DLBCL, according to one analyst.
Biopharmadive · +10 outlets
Lilly and Novo say weight-loss drugs show signs of slowing biological aging
Readouts from molecular aging clocks suggest GLP-1 drugs may affect more than weight, though the claim remains early and contested.
MIT Technology Review · +12 outlets
Shionogi pays $2B to acquire rare disease startup IntraBio
The deal adds a marketed treatment for two inherited conditions to Shionogi's growing rare disease business.
Biopharmadive · +4 outlets
AstraZeneca opens $1B Boston R&D site in Kendall Square
The investment underscores AstraZeneca's commitment to the unsettled center of U.S. biotechnology amid a wave of Chinese dealmaking.
STAT · +4 outlets
AstraZeneca CEO says Summit drug could drive next generation of cancer combinations after $2B investment
The comments follow AstraZeneca's sizable bet on Summit Therapeutics' experimental cancer therapy.
CNBC · +14 outlets
FDA seeks public input on early-phase ibogaine trial design as first psychedelic approval nears
The Trump administration is advancing the first government-funded clinical trials of ibogaine for opioid addiction and PTSD while regulators weigh how to overse
Applied Clinical Trials · +9 outlets
Novo's once-monthly hemophilia A drug Denecimig delayed over manufacturing site issues, not trial results
The FDA decision was pushed back because of problems at a manufacturing site rather than the clinical data.
Medical Daily · +10 outlets
STAT+: FDA spells out 2027 AI guidance plans as new AI office takes shape
The agency is signaling how it will regulate artificial intelligence in health products while its newly created AI office works out implementation.
STAT · +2 outlets
Genentech marks 50 years of biotech with The Impossible Bet documentary
The film traces the company's half-century of biotech breakthroughs.
Medical Marketing and Media · +2 outlets
Moderna surges on optimism over full melanoma vaccine readout with Merck
Investors are betting on the next data drop from Moderna and Merck's personalized mRNA cancer vaccine program.
24/7 Wall St.
FDA backs single-trial pathway for Wave Life Sciences' AATD RNA editor
The regulatory alignment could speed development of Wave's RNA editing therapy for alpha-1 antitrypsin deficiency.
CRISPR Medicine News · +1 outlets
Divergent trial results on cancer vaccines leave the field grappling with hard questions
Mixed outcomes across cancer vaccine studies have researchers debating which approaches and patient populations can succeed.
STAT