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The late-stage miss shakes analyst confidence in Regeneron’s clinical execution, according to BMO Capital Markets, also noting last year’s Phase 3 failure in chronic obstructive pulmonary disease.
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European pharma companies splashed billions of dollars into the U.S. biopharma sector in a matter of days, but there are differing views on whether the activity represents the rise of a new buyer class or a quirk of timing.
Three pharma CEOs joined the $30 million compensation club in 2025 but Eli Lilly’s David Ricks exceeded his nearest peer by more than $4 million.
After years of suffering from a bear market and more than 14 months of geopolitical turmoil shaking the macroenvironment, biotech appears to be moving on.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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XyloCor Therapeutics reported positive topline results Thursday from Phase II of the Phase I/II trial of its gene therapy for refractory angina.
The FDA approved Merck’s Keytruda for the treatment of stage IB, II or IIIA non-small cell lung cancer after resection or platinum-based chemotherapy.
Ocuphire Pharma’s oral diabetic retinopathy drug missed the primary endpoint of an improvement in patient scores on the diabetic retinopathy severity scale.
Phase I/II data showed AC Immune’s anti-amyloid-beta vaccine candidate could safely elicit an antibody response in patients with Alzheimer’s disease. Now, it will expand to Down Syndrome patients.
Following the death of a patient, Magenta Therapeutics placed a hold on Phase I/II dose-escalation trial of its acute myeloid leukemia therapy.
Small Pharma announced positive top-line results Wednesday from a Phase IIa study evaluating a short-duration psychedelic for major depressive disorder.
Three venture capitalists debuted Dimension I Wednesday, a new fund with $350 million to fuel modern biotech.
The FDA’s approval of Biogen and Eisai’s Leqembi and subsequent decision not to approve Eli Lilly’s donanemab have sparked debate anew about the anti-amyloid theory in Alzheimer’s.
Merck posted a rare defeat Wednesday for its blockbuster Keytruda (pembrolizumab) in prostate cancer while simultaneously announcing a victory in biliary tract cancer.
A group of 25 senators, led by Sen. Elizabeth Warren (D-MA), is requesting that HHS Sec. Xavier Becerra exercise march-in rights for Xtandi (enzalutamide), a prostate cancer therapeutic.