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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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Therapeutic Solutions International is targeting long COVID with a new stem cell therapy, as Tonix and Pfizer explore their own treatment options.
What sets Verseon apart is its use of molecular physics modeling to enable the atomic-level engineering of new molecules. The company has 14 small molecule drugs in development.
The FDA placed a clinical hold on the program due to a determination that there is insufficient information to support dose escalation with the product.
Orphalan announced the FDA has granted full approval to Cuvrior (trientine tetrahydrochloride) for the treatment of Wilson’s Disease, a rare genetic disorder.
Hutchmed failed to secure FDA approval for its proposed drug for pancreatic cancer. The company will have to go through another trial if they want U.S. approval.
Arguments regarding the Purdue Pharma opioid settlement continue to be heard in court, Natera battles a class-action lawsuit, Walgreens is involved in a public nuisance suit and more.
Emergent BioSolutions Founder and former chief executive officer Fuad El-Hibri has died, the company reported.
Enavate Sciences launched with an initial capital investment of $300 million from health care investment firm Patient Square Capital. Enavate is a new biotech investment firm.
Gilead and Dragonfly announced their collaboration today, with an end goal of bringing the DF7001 NK engager program designed for patients with cancer or inflammatory diseases.
Tarsus announced positive topline data from its Phase III clinical trial of TP-03 Demodex blepharitis, along with the commencement of an underwritten public offering of $50 million of shares of its common stock.