FDA grants priority review to uniQure's Huntington's gene therapy AMT-130, PDUFA set for May 1, 2027
The FDA accepted uniQure's BLA for its Huntington's disease gene therapy with an accelerated review path and a May 2027 decision date, sending shares higher.
TOKENPOST · +14 outlets
FDA grants accelerated approval to Inovio's DNA immunotherapy Voceryq for recurrent respiratory papillomatosis
Inovio's plasmid DNA-based treatment for the wart-like airway disease becomes its first commercial product, lifting shares sharply and unsettling rival Precigen
Pharmacy Times · +14 outlets
Person in Washington state dies from bird flu after exposure to infected cattle, first US death in a year
The death marks the first US fatality from H5N1 in a year and follows the virus's spread into dairy herds.
STAT · +14 outlets
Karyopharm files Chapter 11 and lines up Ayrmid as lead bidder in planned merger
The indebted biotech is selling itself through a court-supervised auction, with the parent of cell therapy maker Gamida Cell positioned as lead bidder.
Biopharmadive · +2 outlets
FDA approves generic version of HIV prevention shot, widening access for lower-income countries
The approval of a generic lenacapavir shot is a key step toward broader access in dozens of lower-income countries.
STAT · +6 outlets
Hyderabad startup PopVax uses AI to build personalized mRNA cancer vaccines, targets 100+ in 12 months
The Indian biotech's RNA foundry effort highlights a broadening global push into individualized mRNA cancer vaccines.
Startup Pedia · +6 outlets
FDA places partial clinical hold on Bright Minds Biosciences' BMB-101 seizure trial over mouse toxicity
The regulator's action dims the company's outlook for its planned seizure study pending resolution of toxicity findings in mice.
Mugglehead Investment Magazine · +13 outlets
FDA issues draft guidance on cell and gene therapy development, gene editing shares jump
New FDA guidance on cell and gene therapy development, described as a plug-and-play vision, lifted gene editing stocks.
The Pharma Letter · +14 outlets
Keytruda biosimilars approach but face an uphill battle for market share
Merck's flagship blockbuster nears a patent cliff, yet analysts see headwinds for biosimilar uptake and note South Korea trailing China and India in approvals.
Biopharmadive · +3 outlets
Setara launches with $90M to pursue rare disease genetics at scale after Actio's collapse
The new biotech emerges from the ashes of Actio with funding to chase rare disease genetic targets.
BioXconomy · +3 outlets
Four drugmakers allegedly paid tens of millions to Russian middlemen to supply medicines to government entities
The reported payments raise questions about pharma supply chains and sanctions compliance in Russia.
STAT · +3 outlets
Kymera eczema trial readout looms as high-stakes test of a proposed Dupixent rival
Investors and physicians await mid-stage results for Kymera's experimental therapy positioned against Dupixent.
STAT
FDA delays PDUFA action on Agios' mitapivat sNDA for sickle cell disease
The regulator pushed back its decision date on Agios' supplemental application for the sickle cell indication.
Genetic Engineering and Biotechnology Ne · +6 outlets
AstraZeneca plans cost cuts as Alnylam slumps and Regeneron posts record quarter in Q3 earnings
The earnings roundup captures divergent fortunes across large-cap biopharma amid restructuring and pipeline concerns.
Biopharmadive · +3 outlets
BioSpace: cell therapy investment grows as CAR T safety events rankle Big Pharma's autoimmune push
Rising safety concerns are complicating pharma's expansion of CAR T into autoimmune disease even as investment increases.
BioSpace
New polymer technology could improve mRNA medicine delivery, UCL researchers say
The research points to a potential delivery advance for mRNA-based medicines.
UCL · +1 outlets
Psilocybin's lasting benefits prove elusive in mice across five Bay Area labs
A multi-lab comparison found limited lasting effects of psilocybin on anxiety and depression-like behavior in mice.
STAT · +1 outlets
Drugmakers rush to partner with Summit's ivonescimab ahead of a key verdict
Pharma companies are lining up collaborations around Summit's bispecific antibody before pivotal results.
BioSpace · +1 outlets