FDA grants accelerated approval to Inovio's Voceryq, first plasmid DNA immunotherapy for RRP
The clearance is the first US approval for a plasmid DNA-based immunotherapy and sent Inovio shares sharply higher, reframing the company's outlook.
BioPharm International · +12 outlets
FDA accepts uniQure's Huntington's gene therapy BLA for priority review
A priority review shortens the agency's action timeline for what the company calls a defining milestone in Huntington's disease.
Fierce Biotech · +12 outlets
FDA places partial clinical hold on Bright Minds' BMB-101 seizure program over mouse toxicity
The hold covers the BMB-101 Phase 2 epilepsy study and a new pediatric IND, clouding the biotech's near-term timeline.
TipRanks · +10 outlets
Hanmi launches Korea's first homegrown obesity drug EPPE, undercutting Wegovy and Mounjaro on price
A domestically developed GLP-1 entering at a 26-44% discount pressures the imported obesity drug franchise in Korea.
Koreabizwire · +8 outlets
Keytruda biosimilars approach but face an uphill commercial battle
Merck's dominant immunotherapy is set to lose exclusivity, and the biosimilar wave will test pricing and formulary dynamics.
BioPharma Dive · +3 outlets
Drugmakers rush to partner with Summit's ivonescimab ahead of key data verdict
Partnering interest in the PD-1/VEGF bispecific signals how much rides on its upcoming trial readout.
BioSpace
China holds 21 of Asia-Pacific's 30 obesity drug candidates, South Korea six, report finds
The pipeline tally underscores China's lead in the region's next wave of obesity therapies beyond semaglutide.
아시아경제 · +3 outlets
Weight-loss drug demand pushes Eli Lilly shares toward record highs
Investor enthusiasm for incretin therapies keeps lifting the sector's largest player.
TheStreet · +14 outlets
Sun Pharma wins India approval for oral semaglutide pill
The clearance brings an oral GLP-1 option into India's diabetes market, a large and price-sensitive population.
شبكة تواصل الإخبارية · +14 outlets
BridgeBio prepares rare muscular dystrophy launch as FDA approval nears
The company is building commercial infrastructure ahead of a decision in a rare LGMD subtype.
BioSpace · +2 outlets
AbbVie Q3 call highlights raised outlook and pipeline progress
The company lifted guidance while pointing to pipeline advances beyond its immunology base.
TradingView · +5 outlets
FDA delays PDUFA action on Agios' mitapivat sNDA for sickle cell disease
The extension pushes back a potential label expansion for the company's pyruvate kinase activator.
Genetic Engineering and Biotechnology Ne · +5 outlets
Moderna shares fall on $2B convertible notes offering
The financing comes as investors weigh the company's pipeline beyond its COVID vaccine franchise.
TradingKey · +7 outlets
Edwards reports PROGRESS trial results for its valve procedure
The trial found the valve procedure cut heart failure hospitalizations by more than half versus monitoring.
TipRanks · +14 outlets
Ascletis' oral GLP-1 posts strong Phase II diabetes data with solid safety profile
A pill-form GLP-1 could broaden access beyond injectable incretins if later trials confirm the results.
TipRanks · +2 outlets
Merck completes adult enrollment in two trials of monthly HIV prevention pill
A once-monthly oral PrEP option could simplify adherence versus daily regimens if the trials succeed.
Stock Titan · +6 outlets
In a Phase 3 trial, Cerus' treated red blood cells matched conventional cells on hemoglobin gains
The readout supports the pathogen-reduced blood product approach in transfusion medicine.
Stock Titan · +2 outlets
Cancer medicine prices set to fall in India from Nov 9, with MRP cuts
The reduction is projected to save patients roughly Rs 2,500-3,500 crore a year.
Livemint