FDA grants priority review to uniQure's Huntington's gene therapy, with May 2027 decision date
A decision on the one-time therapy would be the first FDA verdict on a gene therapy for Huntington's disease, though the agency appears likely to convene an adv
Biopharmadive · +14 outlets
CVS Health to split into two companies, separating Aetna and Caremark from retail pharmacies
The breakup reverses years of vertical integration and comes amid federal and state scrutiny of combining insurance, pharmacy benefit management and retail oper
Biopharmadive · +14 outlets
Midterms give Democrats control of Congress, sweeping power over health care policy
Democratic majorities now have leverage to push back on the Trump administration's health agenda and shape pending legislation.
STAT · +14 outlets
Wyden and Sanders, both Medicare for All backers, to lead key Senate committees
Their committee gavels could revive debate over government-run insurance and reshape drug pricing oversight.
STAT · +3 outlets
Madrigal's former clinical development head files whistleblower suit alleging Rezdiffra safety cover-up
The lawsuit raises questions about safety disclosure at a company whose liver disease drug is a rare commercial success.
STAT · +3 outlets
BioNTech beats Q3 estimates, keeps focus on mRNA cancer therapies despite trial misses
The company's earnings results and pipeline commentary come as personalized mRNA cancer vaccines draw growing attention from investors and researchers.
GenomeWeb · +3 outlets
FDA approves new drug for advanced pancreatic cancer, and personalized mRNA vaccines show long-term remission in trial
The separate advances cover both a newly cleared therapy and trial evidence for individualized mRNA vaccines in pancreatic cancer.
PravdaReport · +13 outlets
Bernie Sanders poised to hold major sway over FDA funding bill reauthorization
PDUFA reauthorization is a must-pass vehicle that Sanders could use to attach drug industry reforms.
STAT · +1 outlets
Novo Nordisk gets lift as oral Wegovy sales top Wall Street forecasts
The pill's third-quarter numbers widen Novo's early edge over Eli Lilly in the next front of weight loss competition.
Biopharmadive · +4 outlets
Splits emerge on health policy as midterm winners and losers crystallize
Democratic doctors and scientists won seats while the MAHA movement and Trump's health agenda lost ground.
STAT
Sanofi halts development of Nurix-partnered STAT6 degrader, sending Nurix shares lower
The setback fuels analyst debate over the prospects of drugs designed to degrade the hard-to-target STAT6 protein.
Biopharmadive · +8 outlets
Lame duck Congress faces deadlines to fund government and expiring health programs
Before Democrats take control, lawmakers must fund expiring health care programs and confirm HHS nominees.
STAT · +13 outlets
Biopharma stocks expected to climb higher after Democratic 'blue wave,' analysts say
Historical midterm patterns and Democrats' competing priorities are seen as limiting near-term drug pricing action.
Biopharmadive · +5 outlets
Where does MAHA go from here? Three possible futures after GOP midterm losses
Republican defeats leave Robert F. Kennedy Jr.'s movement without its main political tailwind.
STAT · +1 outlets
Ultragenyx to cut about 20% of staff after another rare disease study fails
The layoffs come as the company ends development of two rare disease drugs.
STAT · +7 outlets
Personalized melanoma vaccine cuts risk of recurrence
The result adds to evidence that individualized mRNA cancer vaccines can reduce relapse in high-risk patients.
Lab + Life Scientist · +14 outlets
Servier's $1.55B muscular dystrophy drug fails first major test
The surprise miss hits a form of Becker muscular dystrophy that currently lacks approved treatments.
STAT · +1 outlets
Enrollment holds: Vertex calms investor fears on kidney drug ahead of FDA decision
Executives expressed conviction in the coming launch of a medicine for IgA nephropathy that Wall Street views as key to Vertex's future.
Biopharmadive · +1 outlets