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New data on Hengrui Pharma and Kailera Therapeutics’ investigational oral GLP-1 have validated the late-stage weight loss asset and paved the road for a regulatory submission in China, but analysts pointed to high rates of nausea and vomiting that could challenge the ongoing U.S. study.
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Molecular glue degraders are gaining traction in the clinic as well as funding from Big Pharma, with their potential to treat previously “undruggable” cancers and immunological diseases. Here are five clinical programs worth keeping an eye on.
Last month, the FDA launched TrialBlazer, intended to streamline the IND path and bring early clinical trials and medical innovation home to the U.S. It’s a start, but new agency leadership must see it through.
Significant leadership instability at the FDA—compounded by continued workforce attrition—led to a slight slowdown in overall regulatory productivity in the first half of this year, but the agency has been catching up of late.
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Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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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.
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.
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.