FDA flags four deaths in Newron schizophrenia drug studies
The deaths prompted FDA safety concerns about a novel schizophrenia drug in Newron's clinical program.
Reuters · +4 outlets
Argenx plunges as Phase 3 Sjogren's trial fails, celiac data offers offset
A monitoring board halted the Sjogren's study for futility, removing a blockbuster expansion path for Vyvgart even as celiac results advanced.
Biopharmadive · +5 outlets
Caribou Biosciences to shut down, halt CAR-T work and cut staff
The Doudna co-founded cell therapy developer is pursuing strategic alternatives after failing to secure funding, making it a reverse merger candidate.
Biopharmadive · +9 outlets
Viatris to acquire Pacira in $1.7B deal for non-opioid pain drugs
The deal hands Viatris two non-opioid pain treatments with nearly $700 million in 2025 sales that face coming patent losses.
Biopharmadive · +4 outlets
Roche inks drug discovery deal with Chinese biotech Defand Therapeutics
The partnership focuses on molecular glue medicines and goes beyond a standard licensing arrangement.
STAT · +2 outlets
Trump administration investigates 9 universities for alleged J-1 visa fraud
The inquiry targets a visa category commonly used by postdoctoral researchers, a core part of the U.S. biomedical workforce.
STAT · +14 outlets
Ultragenyx to sell rare pediatric disease priority review voucher for $210M
The Genglycos-derived voucher sale provides non-dilutive funding to the rare disease developer.
Seeking Alpha · +13 outlets
PhRMA sues Trump administration; small biotechs frustrated by tariffs
Industry is challenging the administration in court while smaller companies struggle to win exemptions from imported drug tariffs.
STAT · +1 outlets
Cerevance Phase 3 win rescues Parkinson's drug, paves path to FDA
The Takeda spinout's solengepras shortened off time in late-stage testing, and the company plans to meet with the FDA on next steps.
Biopharmadive · +3 outlets
FDA approves first-line maintenance Tukysa combo for HER2-positive metastatic breast cancer
The approval adds Tukysa plus trastuzumab and pertuzumab as a first-line maintenance regimen.
Pharmaceutical Executive · +14 outlets
FDA approves Fayuvi, first gene therapy for Sanfilippo syndrome type A
The approval marks a first for the rare lysosomal storage disorder.
Denkstrom · +14 outlets
FDA approves daraxonrasib for advanced pancreatic cancer
The RAS-targeted therapy is being framed as a turning point in pancreatic cancer care, with a related pan-RAS inhibitor also winning FDA clinical clearance.
Bioengineer.org · +13 outlets
uniQure plans FDA licensing application for Huntington's gene therapy AMT-130
The company is moving toward a regulatory submission for the experimental Huntington's disease treatment.
HDBuzz · +14 outlets
Optogenetics restores some vision in retinitis pigmentosa trial
About half of patients regained photosensitivity, highlighting optogenetics promise for retinal disease.
STAT · +14 outlets
Tempus expands multi-year cancer vaccine collaboration with Moderna and Merck
The extended partnership deepens work on personalized cancer vaccine development.
Business Wire · +8 outlets
SeaStar Medical wins FDA breakthrough designation for sepsis hyperinflammation therapy
Sepsis contributes to nearly one in three U.S. hospital deaths, underscoring the unmet need.
The Manila Times · +4 outlets
MimiVax cancer vaccine misses Phase 2 endpoint in glioblastoma
The trial failed its primary endpoint though the CEO called the data inspiring; a separate experimental vaccine showed promise.
Fierce Biotech
Halozyme wins patent fight; Dutch court bars Merck's subcutaneous Keytruda in Europe
The ruling restricts Merck's sale of subcutaneous Keytruda in several European countries.
Biopharmadive · +1 outlets