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The Japan-based pharma is acquiring Orchard Therapeutics for approximately $477.6 million, if all conditions are met. Orchard’s pediatric gene therapy has a PDUFA date set for March 2024.
Following a fatality due to the rare blood disease hemophagocytic lymphohistiocytosis, the regulator slapped a partial clinical hold on two studies of Innate Pharma’s investigational therapy lacutamab.
Despite the lack of a randomized controlled trial for US WorldMeds’ investigational drug, an FDA advisory committee found that the company provided adequate data to support its benefit in high-risk neuroblastoma.
Patients with treatment-resistant depression treated with Johnson & Johnson’s Spravato were significantly more likely to reach remission and stay relapse-free for up to 32 weeks.
Data from the Mayo Clinic shows limited eligibility for the anti-amyloid treatment. However, Michael Irizarry, Eisai’s deputy chief clinical officer, says some patients could still be eligible.
AbbVie, Amgen, Gilead, Merck and Novartis are among the 31 members that have formed the Partnership for the U.S. Life Science Ecosystem to push back against federal antitrust reforms.
The pharmaceutical giant aims to hire another 50 people by the end of this year to work on a new platform dedicated to harnessing data and AI insights in drug discovery.
The French pharma paid $500 million upfront, with up to $1 billion in future milestone payments, to co-develop and co-commercialize Teva’s Phase II anti-TL1A antibody for inflammatory bowel disease.
Its reversible nature offers the potential for RNA editing to go beyond rare diseases, eliciting excitement and buy-in from large pharmas like GSK and Eli Lilly.
In its briefing document for Thursday’s FDA advisory committee meeting, the regulator contends that the company’s confirmatory CodeBreaK 200 trial for Lumakras is not an “adequate and well-controlled” study.
The companies are expanding their long-standing CRISPR/Cas9 gene editing collaboration for the second time, now seeking to target neurological and muscular conditions.
New Phase I/II trial results show that one more type 1 diabetes patient achieved insulin independence after treatment with Vertex Pharmaceuticals’ investigational stem cell therapy VX-880.