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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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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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The company’s resubmission succeeded in getting the greenlight for tenapanor, now to be marketed as Xphozah, to lower serum phosphorus levels in chronic kidney disease patients.
After the FDA released draft guidance on increasing diversity in clinical trials, companies have been left to figure out the details. Here’s what experts say is working.
The Pharma Proteomics Project isn’t the first precompetitive collaboration between pharma companies, but it’s one of the largest. Members recently published associations they’ve uncovered in UK Biobank data.
In its first financial report since the Kenvue consumer health spinoff, Johnson & Johnson beat analyst expectations fueled by strong pharmaceutical sales including Darzalex, Erleada and Stelara.
Life sciences talent acquisition teams are examining internal processes and thinking critically about their employer value proposition as they prepare for innovation and market swings.
Months after a denial of its rare eye cancer injection, Aldeyra Therapeutics is bracing for another potential rejection by the regulator, this time for its investigational dry eye disease treatment.
In a follow-up readout, data from the head-to-head SEQUENCE study showed that AbbVie’s Skyrizi induced better rates of steroid-free remission in Crohn’s disease than Johnson & Johnson’s Stelara.
The blockbuster PD-1 inhibitor’s label expanded further on Monday when the FDA greenlit Keytruda as a perioperative treatment for certain patients with earlier stages of non-small cell lung cancer.
The biopharma discontinued its late-stage study after an interim review found that its investigational treatment for immunoglobin A nephropathy did not achieve statistically significant improvement over placebo.
The company’s experimental lgG4 antibody met the primary endpoint in a late-stage study of the rare skin disease. AnaptysBio will submit an application to the FDA by the third quarter of 2024.