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The Denton site is part of a network of manufacturing plants Novartis is building across the U.S. to make cancer drugs that must be shipped to patients quickly.
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IPO
LB Pharma needed $350 million to advance a promising schizophrenia candidate at a time when the biotech markets were locked up tight. Fortunately, it wasn’t CEO Heather Turner’s first rodeo.
Rare disease drug developers struggle to survive in a biopharma investment market that prioritizes large patient populations. Initiatives like the Orphan Therapeutics Accelerator are attempting to solve what CEO Craig Martin says is not a science problem, but a math problem.
Eli Lilly’s win in a head-to-head trial drove Novo Nordisk’s market cap to pre-Wegovy levels not long after the victor became the first pharma company to top a $1 trillion valuation. It seems one company can do no right, while the other can do no wrong.
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Read our takes on the biggest stories happening in the industry.
FDA
Following the FDA’s refusal to review Moderna’s investigational mRNA flu vaccine last week, Commissioner Marty Makary faced questions from the U.S. president about the agency’s handling of vaccines. It’s a clear signal that the tension long brewing at the drug regulator has now gone all the way to the top.
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BMO Capital Markets analyst Evan Seigerman said luvadaxistat’s inconsistencies between mid-stage trials raise questions about Neurocrine Biosciences’ developmental efforts moving forward.
Armed with readouts from the PURPOSE 1 and 2 trials, Gilead Sciences is now gearing up for global regulatory submissions for lenacapavir as a pre-exposure prophylactic option for human immunodeficiency virus.
FDA
One patient developed elevated liver blood tests after receiving Astellas Pharma’s non-hormonal small molecule blocker, leading the regulator to add a warning to the drug’s label.
Tremfya’s ulcerative colitis approval on Wednesday comes as Johnson & Johnson’s blockbuster immunotherapy Stelara continues to face growing competition from biosimilars.
As it nears a crucial FDA action date for its transthyretin amyloid cardiomyopathy candidate, BridgeBio focuses on its late-stage pipeline.
Sanofi will join Big Pharma peers Novartis, BMS and Eli Lilly in radioligands, striking a $110 million licensing deal with RadioMedix and Orano Med to develop AlphaMedix for neuroendocrine tumors.
With a Friday advisory committee meeting looming, the sole indication for Intercept Pharmaceuticals’ Ocaliva appears to be at risk as the regulator flags issues regarding its post-marketing results.
In an effort to build its commercial capacity, Moderna on Thursday announced it is lowering research and development spending, while pushing back its target for breaking even by two years to 2028.
When doses were increased rapidly in a Phase I study, patients on Roche’s investigational oral GLP-1 receptor agonist experienced nausea, vomiting, constipation, diarrhea, as well as abdominal distension.
In this episode, Lori and guests discuss practical approaches regarding artificial intelligence and investor and industry confidence in its current state.