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Findings from the Phase III VESALIUS-CV study reinforce the cholesterol-lowering benefit of Repatha in high-risk patients without prior cardiovascular disease, for which the drug was approved in August 2024.
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With results from highly anticipated trials of Eli Lilly’s orforglipron and Viking Therapeutics’ VK2735 “underwhelming” investors, William Blair’s Andy Hsieh predicts weight loss pills will play a bigger role in low- and middle-income countries than in the U.S.
Regulations aiming to lower the cost of vital medicines will instead end up restricting access and disincentivizing R&D.
Capricor Therapeutics met with the FDA last week for a type A meeting, during which CEO Linda Marbán aimed to explain to the regulator that it got it wrong. Capricor plans to resubmit the application based on deramiocel’s existing dataset.
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The SURVEYOR Study met its primary endpoint demonstrating a statistically significant difference as measured by the HD-Cognitive Assessment Battery ( HD-CAB) composite score at baseline between healthy participants and participants with Huntington’s Disease (HD) prior to any treatment with dalzanemdor (SAGE-718) or placebo; further underscoring the cognitive impact of HD For participants with HD that received dalzanemdor or placebo, dalzanemdor was generally well-tolerated with no new
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Novo Nordisk, under new CEO Maziar Mike Doustdar, has a new attitude. It’s making Pfizer livid.
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The White House is clamping down on pharma’s ability to buy new molecules from Chinese biotechs; Sanofi, Merck and others abandon the U.K. after the introduction of a sizeable levy; Novo CEO Maziar Mike Doustdar lays off 9,000 while the company presents new data at EASD; Capsida loses a patient in a gene therapy trial; and CDER Director George Tidmarsh walks back comments on FDA adcomms.
This manufacturing site in Richmond, Virginia, is the first of four projects that Eli Lilly plans to reveal this year as part of a $27 billion U.S. investment announced earlier this year.
The over-representation of males and Hispanic patients in Eli Lilly’s Phase III ATTAIN-1 study could explain why orforglipron “underperformed” expectations in a previous readout, according to analysts at BMO Capital Markets.
OLN324 targets both VEGF and Ang2, the same mechanism of action as Roche’s Vabysmo, the Swiss giant’s multi-blockbuster treatment for wet macular degeneration and diabetic macular edema.
Transparency doesn’t drive people away. It attracts the right ones and keeps them committed. Leadership coach Angela Justice discusses the problem with leaders only selling the upside and the value of setting accurate expectations from the start.
The world of healthcare is evolving to more predictive care and patients are taking greater control—a trend already emerging around GLP-1 weight loss treatments. As PwC warns, pharma will need to be ready.
From a small team of researchers and skipped salaries, CEO Michelle Xia has steered Akeso to become one of the most exciting companies in the industry today.
While the FDA is trumpeting this new initiative as “sweeping reforms” to the way drug companies can advertise, experts say the regulator is going after a problem that doesn’t exist.
The FDA has vowed to fix a pharma ad loophole—but they’re targeting the wrong one.
A new analyst survey suggests that doctors are still prescribing Sarepta’s Elevidys, even after a series of deaths in certain populations marred the gene therapy’s record.