Moderna, Merck mRNA cancer vaccine cuts melanoma death or recurrence risk by 42% in Phase 3 trial
The personalized mRNA vaccine combined with Keytruda met key endpoints in the INTerpath001 melanoma study, a landmark result for mRNA cancer therapy that noneth
Biopharmadive · +14 outlets
Moderna shares plunge about 25%, shedding roughly $24 billion, after melanoma vaccine data leaked early
Cancer vaccine results appeared on social media ahead of the scheduled ESMO presentation, rattling investors even though the data themselves met expectations.
Bloomberg.com · +9 outlets
GSK, Ionis win FDA approval for Hibsago, a first-of-its-kind hepatitis B drug
Hibsago is viewed as a potential functional cure for chronic hepatitis B, though GSK simultaneously scrapped a trial of a next-generation hep B therapy.
Biopharmadive · +14 outlets
Gilead to pay $45 million to settle Texas Medicaid kickback charges
The Texas attorney general alleged the payments improperly influenced prescriptions covered by the state's Medicaid program.
STAT · +4 outlets
AstraZeneca wins FDA approval for drug treating rare kidney disease in adults
The clearance adds a rare disease medicine to AstraZeneca's portfolio amid a broad push into specialty care.
Reuters · +14 outlets
Treasury poised to propose rule restricting US investment in Chinese biotech sector
The rumored proposal would subject outbound licensing deals with Chinese biotech companies to additional scrutiny.
STAT · +13 outlets
Arbutus says FDA lifts clinical hold on AB-101 oral PD-L1 inhibitor
The removal of the hold lets Arbutus resume development of an oral checkpoint inhibitor candidate.
Mugglehead Investment Magazine · +7 outlets
Biohaven's previously rejected rare disease drug Vyglxia to get fresh FDA review
Regulators accepted a new submission for the medicine, offering a possible turnaround after a prior rejection under earlier FDA leadership.
Biopharmadive · +1 outlets
GLP-1 compounder issues recall for copycat Zepbound
The notice adds to safety concerns about knockoff weight loss drugs sold despite FDA warnings and legal pressure from Lilly and Novo.
Biopharmadive · +2 outlets
BioNTech opens mRNA manufacturing facility
The plant expands capacity for mRNA-based products as the company pushes beyond COVID vaccines into oncology.
Mirage News · +14 outlets
New bipartisan bill aims to speed clinical trials for rare disease treatments
Lawmakers introduced the measure to shorten development timelines for rare disease therapies.
CNBC · +1 outlets
Bharat Biotech's Nucelion and VeGen Bio target 2028 launch for India's first dual-target CAR-T therapy for myeloma
The partnership aims to bring an advanced CAR-T treatment for multiple myeloma to the Indian market.
ETV Bharat · +7 outlets
Arbor Biotechnologies nominates first CNS-targeted gene editors for clinical development
The nomination moves Arbor's gene editing pipeline toward human studies in central nervous system indications.
GenomeWeb · +3 outlets
Roche affirms sales outlook as Xolair misses expectations and generic competition looms
Lower-than-expected Xolair sales stood out as the Swiss drugmaker braces for generic pressure on top products.
Biopharmadive · +1 outlets
Calley Means resigns as White House MAHA adviser days ahead of midterms
The departure comes before an election that may serve as a referendum on the MAHA movement.
STAT · +13 outlets
Roivant claims another win as brepocitinib posts positive results in inflammatory eye condition
The results follow a recent clearance in dermatomyositis and suggest the drug may be best-in-disease for uveitis.
Biopharmadive · +2 outlets
AbbVie's lutikizumab succeeds in late-stage hidradenitis suppurativa trial but misses market expectations
The skin disorder drug hit its trial endpoint, but the results fell short of what investors had anticipated.
STAT
International study supports FDA approval of HIV drug for newborns
The research backed regulatory clearance of an HIV treatment for use in newborns.
UC San Diego Today