The response rate exceeded the prespecified efficacy threshold and suggests epcoritamab may hold its own against Roche’s rival CD3xCD20 bispecific Lunsumio, which won FDA approval in follicular lymphoma last year.
Featured Posts
The company halted studies of the treatment for a rare, advanced form of eye cancer after clinical results showed just one response in 47 patients.
An FDA advisory committee voted Wednesday that Ipsen’s fibrodysplasia ossificans progressive candidate palovarotene was effective and the benefits of the drug outweighed its risks.
The recommendation comes after the agency’s advisers backed the use of the shots last week in older adults, but stopped short of saying all of them should get the shots.
The two companies have been partners since 2018, when Lilly paid Sigilon $63 million for a licensing deal to develop cell therapies targeting type 1 diabetes and made an undisclosed equity investment.
The Phase III trial, which can potentially lead to a regulatory filing, will enroll about 600 patients, the companies said in a statement on Thursday.
The pharma industry is facing an opportunity to overcome rare and orphan disease patient resistance and build long-term relationships through support programs specifically designed to best serve these populations and improve patient outcomes.
The introduction of technology interoperability regulations and advancements in artificial intelligence, implementing technology tools can significantly reduce the burden at every level of organization operations. It can also improve the success rates of clinical trials and accelerate the development of new treatment options for the patients who need them.
Eli Lilly has agreed to pay $2.4 million to the U.S. Equal Employment Opportunity Commission to settle a lawsuit the agency filed, claiming that the pharma giant discriminated against older job candidates by changing its hiring preferences in 2017 to recruit more millennials.
Citing issues with a third-party contractor, the FDA rejected Regeneron’s regulatory application for a higher-dose regimen of Eylea, the company’s blockbuster eye injection treatment.