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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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For the second quarter of 2024, there were 25% fewer jobs posted live on BioSpace compared to the same quarter of 2023. The year-over-year job response rate rose from 14.6% to 15.3%.
The FDA’s Complete Response Letter turned down Novo Nordisk’s Biologics License Application for its once-weekly basal insulin icodec injection for diabetes mellitus, with “requests” related to the manufacturing process and the type 1 diabetes indication.
Biotech venture capital firm Flagship Pioneering is looking to fund companies focused on artificial intelligence, human health and sustainability, bringing the total raised since 2021 to $6.4 billion.
Amgen has quietly discontinued the development of its Phase I bispecific T-cell engager AMG 794, which the company had been studying for several malignant solid tumors.
Eli Lilly becomes the latest to make a major investment in immunology and inflammation, while antibody-drug conjugate biopharma Myricx Bio nets a large Series A round and new research highlights the potential and possible risks of GLP-1s.
Artificial intelligence is making it faster to get drug candidates to the clinic, but to gain a competitive advantage, companies must have a strong foundation of data.
Interius BioTherapeutics has received approval from Australia’s Human Research Ethics Committee to begin the first-in-human trial of an investigational in vivo CAR-T therapy designed to treat B-cell malignancies.
The regulator Tuesday added atopic dermatitis to the label of Arcutis Biotherapeutics’ topical PDE4 inhibitor Zoryve for the treatment of patients six years of age and older.
Investment in the development of new antimicrobials is falling rapidly, even as the global public health threat of antimicrobial resistance is growing increasingly severe worldwide.
After pulling its ALS drug Relyvrio from the market, Amylyx Pharmaceuticals is looking to target the GLP-1 space with the purchase of Eiger BioPharmaceuticals’ avexitide, which has been studied for the treatment of hyperinsulinemic hypoglycemia.