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Alternatives to opioids are desperately needed to better treat moderate to severe acute pain, but to date, we’ve seen few novel analgesics hit the market.
FEATURED STORIES
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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FROM OUR EDITORS
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.
THE LATEST
While sensitive and specific biomarkers for Alzheimer’s disease have recently taken a leap forward, the Parkinson’s space has lagged behind. Neurofilament Light Chain could change that.
The new Rice Biotech Launch Pad aims to harness local resources to grease the skids of innovation, from the lab to the clinic.
My colleagues and I have often been asked, “When is it time to start looking for another role?” This three-level rubric can help.
After failing its primary endpoint of progression-free survival, new data shows UV1 plus Bristol Myers Squibb’s Opdivo and Yervoy reduces risk of death by 27% over the checkpoint inhibitors alone.
AI and machine learning could transform drug discovery, but first, practitioners must overcome ethical challenges en route to medicines for all.
The abstracts, made available Tuesday ahead of the European Society for Medical Oncology Congress 2023, show strong efficacy data from some promising non-small cell lung cancer treatments.
FDA
The complement inhibitor won the FDA’s approval for the treatment of generalized myasthenia gravis, a rare autoimmune disease. The therapy will be sold under the brand name Zilbrysq.
FDA
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.