Citing insufficient safety evidence for one of the drug’s main ingredients, the regulator in a Complete Response Letter rejected the company’s application for Parkinson’s disease candidate IPX203.
China’s Commerce Minister told foreign pharmaceuticals firms they can expect “more development opportunities” during a roundtable on Wednesday, his ministry said, as drugmakers bemoan government procurement policies pricing them out of the market.
The vaccine maker said today it had signed a memorandum of understanding and a land collaboration agreement to work towards opportunities for it to research, develop and manufacture mRNA medicines in China.
21GRAMS is helping Moons, a company that sells period products, in its goal to make menstruation a more positive experience for menstruators by giving them a role in stem cell research.
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.
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 company said the trial site’s principal investigator, who enrolled 40% of the study participants at that site, was found to have fabricated email correspondence related to timing of the filing of a serious side-effect with the company’s vendor responsible for monitoring safety of the drug.
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.
