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Home » Authors » Lee Landenberger

Articles by Lee Landenberger

Woman scratching hives on shoulder

Dupixent bounces back in treating hives with FDA approval

April 21, 2025
By Lee Landenberger
The U.S. FDA issued a complete response letter in October 2023 for Dupixent (dupilumab) in treating chronic hives but has now approved the monoclonal antibody for the indication. The approval makes Dupixent the first targeted biologic the agency has approved in the past 11 years for chronic spontaneous urticaria.
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Earendil charts a course with a $1.8B bispecific deal with Sanofi

April 17, 2025
By Lee Landenberger
Earendil Labs will collaborate with Sanofi SA in a $1.8 billion license deal. Earendil, which specializes in artificial intelligence-based R&D for biologics, is getting $125 million up front and $50 million as a near-term payment. In return, Sanofi gets the exclusive global rights to the bispecific antibodies HXN-1002 and HXN-1003.
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Gloved hand holding petri dish containing world map
Immune

WHO member states outline pandemic plan

April 17, 2025
By Lee Landenberger
After more than three years of discussion, the World Health Organization’s Intergovernmental Negotiating Body (INB) has agreed on a proposal to prevent, prepare and respond to a pandemic. The plan is born, the INB proposal said, out of inequities around the world that slowed timely and equitable access to health products to respond to the COVID-19 pandemic.
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WHO member states outline pandemic plan

April 16, 2025
By Lee Landenberger
After more than three years of discussion, the World Health Organization’s Intergovernmental Negotiating Body (INB) has agreed on a proposal to prevent, prepare and respond to a pandemic. The plan is born, the INB proposal said, out of inequities around the world that slowed timely and equitable access to health products to respond to the COVID-19 pandemic.
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Sanofi advances asthma drug despite phase II miss

April 15, 2025
By Lee Landenberger
Despite missing a phase II study’s primary endpoint in moderate to severe asthma, Sanofi SA sees a way forward to a phase III program in the crowded disease space. Preliminary results showed the annualized exacerbation rate endpoint wasn’t met at the highest dosage of amlitelimab. Those numbers, at week 48, showed nominal significance at the medium dose.
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Illustration of human heart with DNA structure background

Early stage cardio data from Verve bump the stock

April 14, 2025
By Lee Landenberger
Positive early stage data for Verve Therapeutics Inc.’s base editing therapy points to a range of development options, including bringing partner Eli Lilly and Co. in a little closer. The new data helped ease the company’s pain from the April 2 enrollment pause of a similarly designed therapy from Verve. Verve’s Heart-2 phase Ib of VERVE-102 in treating 14 patients with heterozygous familial hypercholesterolemia and/or premature coronary artery disease showed one infusion led to dose-dependent decreases in blood PCSK9 protein levels and low density lipoprotein cholesterol.
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Lab mouse
Drug design, drug delivery & technologies

FDA wants a shift away from animal testing

April 14, 2025
By Lee Landenberger
In a roadmap to change animal testing requirements for INDs, the U.S. FDA said its new approach will improve drug safety, hasten the evaluation process, and lower costs for companies and patients. It’s another step in a process of changing rules put in place decades ago.
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Lab mouse

FDA wants a shift away from animal testing

April 11, 2025
By Lee Landenberger
In a roadmap to change animal testing requirements for INDs, the U.S. FDA said its new approach will improve drug safety, hasten the evaluation process, and lower costs for companies and patients. It’s another step in a process of changing rules put in place decades ago.
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Elderly woman and jigsaw puzzle

Alzheon’s lead candidate misses a phase III in early Alzheimer’s

April 10, 2025
By Lee Landenberger
Alzheon Inc.’s oral treatment for people in the early stages of Alzheimer’s disease missed its phase III primary endpoint, adding yet another therapy to a long list by many developers that can’t beat dementia. The study also received grant money, which is in increasingly short supply.
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More Lexeo data in Friedreich ataxia sees stock slump

April 7, 2025
By Lee Landenberger
Lexeo Therapeutics Inc. produced more positive interim data from early stage studies of its gene therapy to treat Friedreich’s ataxia cardiomyopathy. The results have prompted the company to continue their ongoing dialogue with U.S. FDA regulators to finalize a registrational study protocol and launch that study by early 2026 with data the following year.
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