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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.
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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.
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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.
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Through its online pharmacy LillyDirect, Eli Lilly announced Tuesday it will allow patients to purchase single-dose vials of Zepbound—without the autoinjector—at a 50% discount or more versus other incretin obesity treatments.
The number of patients who will be eligible for Novo Nordisk’s blockbuster GLP-1 under new Medicare Part D plan guidelines will vary depending on how cardiovascular disease is defined, according to researchers.
Mirroring fellow pharmacy benefit manager CVS Caremark, Cigna’s Express Scripts is taking Humira off its major commercial formularies starting next year and focusing on more affordable biosimilar options.
With the FDA’s rejection of Ordspono in March, Monday’s green light from the European Commission marks the first approval worldwide and the first regulatory victory for Regeneron’s bispecific antibody platform.
Belgium-based biopharma UCB is selling its Chinese neurology and allergy business to Singapore asset management firm CBC Group and Abu Dhabi investment company Mubadala.
The Switzerland layoffs are the latest in Bayer’s 2024 workforce reductions, which already include 1,500 people and nearly half of the executive leadership team.
MBX Biosciences follows Bicara Therapeutics and Zenas Biopharma, which also announced last week their respective plans to go public in a potential boost to the recent slump in the IPO market.
Tome Biosciences, a gene editing startup that launched in late 2023 with $213 million in funding, will eliminate 131 positions in November, according to a Worker Adjustment and Retraining Act notice.
Johnson & Johnson’s proposed changes to the hospital drug discount program are inconsistent with the federal statute, according to the Health Resources and Services Administration.
In this deep dive BioSpace dissects the global obesity and diabetes markets along with the growing pipelines that aim to serve them.