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An inspection of a facility making Elevar’s rivoceranib uncovered deficiencies, leading the FDA to reject a combination therapy that includes the drug. The rebuff is the third strike for the partners after the agency issued manufacturing-related denials for the other drug in the combo.
FEATURED STORIES
As antibody-drug conjugates advance and move into earlier lines of treatment, drug developers have to build gentler therapies that don’t just extend survival but improve it.
FDA’s rare disease decisions are strongest when the patient community has a voice in advisory committee decisions.
The lineup at the Alzheimer’s Association International Conference will provide critical insight into where the industry is headed with regard to targets being explored to vanquish the elusive neurodegenerative disease.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
THE LATEST
Eli Lilly and obesity rival Novo Nordisk stole the show at the American Diabetes Association conference, though plenty of other companies also had data to show for their own weight loss assets; GSK strikes the biggest traditional pharma buyout of 2026; and FDA initiatives still lack clarity.
As the industry faces policy changes and significant cuts to federal funding, local ecosystems can bolster companies through innovative resources to sustain growth and keep the U.S. at the center of biomedical innovation.
Over the past decade, Eli Lilly has bought out more biotechs than any of the other top 12 pharmas by revenue—with 10 of those acquisitions arriving just this year.
Members of the American Biotech Innovation Alliance (ABIA) want to build a national biotech strategy—just like China did years ago.
The money will enable the addition of aseptic filling and oral solid dose capabilities to support Hikma’s products and contract manufacturing clients.
The public biotech universe has shrunk by more than 20% since 2021, yet financial stress remains entrenched across the sector, according to a report from EY Tuesday.
While Merck and Gilead Sciences reported back-to-back late-stage victories for their weekly HIV pill, the partners also discontinued a Phase 3 program for their cancer combo after disappointing lung cancer survival data.
AstraZeneca is pushing its small molecule GLP-1 drug to Phase 3 development for weight control, diabetes and other cardiometabolic conditions despite the asset failing to best one from Structure Therapeutics.
Nuvalent Bio is GSK’s third big-ticket purchase this year, after the pharma dropped $2.2 billion in January for RAPT Therapeutics and $950 million in February for 35Pharma.
Newly approved weight loss pill Foundayo reduced blood sugar more than Novo Nordisk’s semaglutide and other comparators in multiple Phase 3 type 2 diabetes trials. Eli Lilly will seek approval in this indication.