FDA and CMS outline streamlined approval path for individualized gene editing therapies
The joint FDA/CMS framework would let a single approval cover multiple personalized gene-editing treatments for rare diseases and pairs it with expanded access,
Endpoints News · +7 outlets
Lilly says retatrutide beat Ozempic, delivering roughly double the weight loss in a head-to-head trial
The Phase 3 readout positions retatrutide as potentially the strongest obesity drug developed to date, intensifying competition in the GLP-1 market.
ABC7 Chicago · +13 outlets
Genmab's $8B Merus bet pays off as bispecific combo halves risk of death in Phase 3 head and neck cancer trial
The findings suggest the recently acquired medicine could become a new standard for a form of head and neck cancer, lifting Genmab shares to record highs.
Biopharmadive · +2 outlets
HHS will let compounders make six unapproved peptides, despite FDA scientist objections
The policy temporarily bars enforcement on six peptides that won a contested outside-adviser recommendation, a boost to the peptide craze that drew objections f
Biopharmadive · +14 outlets
Labor Department finalizes PBM disclosure rule requiring fee and compensation data sharing
Starting in 2027 pharmacy benefit managers must share fee and compensation data with self-funded employer clients, drawing praise from employers and overreach c
Biopharmadive · +14 outlets
FDA approves GSK's functional cure for hepatitis B
The approval adds a functional cure option for chronic hepatitis B, a large and long-underserved patient population.
Drug Discovery News · +14 outlets
China's cheap, rapid human trials upend global drug development
Faster and cheaper clinical testing in China is reshaping where multinational drugmakers run trials and how quickly assets reach the clinic.
Bloomberg.com · +1 outlets
Merck and Moderna's mRNA cancer vaccine data assessed at ESMO; melanoma trial shows improved recurrence-free survival
Positive personalized mRNA cancer vaccine data in melanoma and a kidney cancer test ahead suggest the platform is moving toward broader oncology use.
STAT · +9 outlets
Iovance adds biomarker selection to lifileucel lung cancer trial as shares crash on surprise twist
The change to the lung cancer study followed an unexpected result, sending the biotech stock sharply lower.
The Clinical Trial Vanguard · +5 outlets
Beam's base editor for glycogen storage disorder shows efficacy in early data
Early results support the base-editing approach in an inherited metabolic disease, a key test for in vivo gene editing.
GenomeWeb · +1 outlets
FDA enforces long-awaited clinical trial result transparency requirements
The move compels sponsors to post trial results, a years-long push by transparency advocates.
Undark Magazine · +4 outlets
Vertex kidney disease drug scrutinized for infection risk ahead of Nov 30 FDA decision
Safety questions about the drug could weigh on its pending approval for a kidney disease indication.
STAT · +1 outlets
Lilly posts better-than-expected results; Novartis rebounds and GSK faces investor angst in Q3 earnings
Strong Lilly results eased GLP-1 pricing concerns for now, while Novartis weathered a turbulent quarter and GSK wrestled with investor unease.
Biopharmadive · +1 outlets
AstraZeneca launches three-year cost-cutting program targeting $1.5B annual savings for R&D
The savings will be reinvested in research and development as the company restructures spending.
STAT · +5 outlets
Flagship merges three biotech startups into new AI-aided drugmaker Etcelera
Etiome, Cellarity and Empress Therapeutics are being combined into one company claiming better prediction of how new medicines will perform in humans.
Biopharmadive · +2 outlets
Dren Bio raises $350M to push rare blood cancer therapy toward market
The financing supports late-stage development of a therapy aimed at a rare blood cancer.
BioSpace · +1 outlets
Aspen raises $141M IPO for cell therapy aimed at Parkinson's
The San Diego startup is among several firms pursuing a technique with potential to slow or halt the neurodegenerative condition.
Biopharmadive · +1 outlets
FDA approves first-ever drug for a rare neurological disorder after 30 years
The approval marks the first treatment option for a long-unaddressed rare neurological condition.
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