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 FDA has rejected Soligenix’s NDA for HyBryte (synthetic hypericin), a therapeutic developed to treat early-stage cutaneous T-cell lymphoma.
The Pregnant Workers Fairness Act (PWFA) has been praised by many in the life sciences who see it as a step forward in protecting the rights of pregnant employees.
Fresh off of his Sanofi exit, John Reed is joining Johnson & Johnson, where he will serve as executive vice president, pharmaceuticals, R&D.
Vivek Ramaswamy, the founder of Roivant Sciences, is officially running for president, the GOP hopeful announced Tuesday.
Clene, Inc. posted new data from a Phase II trial of CNM-AU8 in multiple sclerosis featuring MRI results it claims reinforce neurological improvements reported in November 2022.
Bristol Myers Squibb and 2seventy bio published positive results Friday from a pivotal Phase III trial of Abecma in multiple myeloma patients who had received two to four prior lines of therapy.
Sanofi’s global head of R&D, John Reed, is leaving his position to pursue another opportunity outside the company, the French multinational announced Monday.
Due to safety concerns, Aristea Therapeutics announced Friday that it was discontinuing the development of its Phase II lead program. As a result, the San Diego-based biotech is also dissolving its business.
Feb. 11 is the International Day of Women and Girls in Science. BioSpace spoke with influential women in biotech and biopharma who are working to make a difference in the lives of other women.
Eliem Therapeutics is dropping a depression drug candidate and laying off 55% of staff in an attempt to stretch its cash runway to 2027.