News
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 role of a clinical research nurse can be rewarding, but it’s not without challenges. Find out more about the role of a clinical research nurse and what it takes to become one in our guide.
Shares of Horizon Therapeutics are soaring in premarket trading Wednesday after the rare disease company confirmed it is being courted for a potential acquisition by three pharma giants.
Nimbus reported positive Phase IIb results for NDI-034858 in moderate-to-severe plaque psoriasis, which researchers hope will have the efficacy of JAK inhibitors without the safety issues.
Nectin Therapeutics announced dosing of the first solid tumor patient in a Phase I clinical trial while additional investors jumped in to expand the company’s Series A to just over $25 million.
Full data from the Phase III Clarity AD trial show Eisai and Biogen’s lecanemab has a favorable safety profile in patients with Alzheimer’s disease.
BigHat Biosciences will team up with Merck to design candidates for three drug discovery programs backed by the company’s proprietary AI technology platform.
BMS is terminating a seven-year-old gene therapy collaboration to develop potential treatments for congestive heart failure with uniQure N.V. valued at $1 billion.
With $96 million in Series A financing, Cajal Neuroscience launched Tuesday to develop drug candidates to target neurodegeneration in Alzheimer’s and Parkinson’s diseases.
As the FDA cracks down on accelerated approvals, Genentech, a Roche company, voluntarily withdrew its monoclonal antibody, Tecentriq, for metastatic bladder cancer.
AstraZeneca and Neogene have entered into a definitive acquisition agreement in which AstraZeneca will buy all outstanding equity in the smaller company.