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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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With Germany moving to curb healthcare spending, Eli Lilly and Boehringer Ingelheim have rethought plans to invest in facilities, including a manufacturing plant for GLP-1 drugs.
In addition to a high rate of deaths, ADC Therapeutics’ Zynlonta plus rituximab showed no overall survival benefit in patients with diffuse large B cell lymphoma, casting doubt on its value as a second-line treatment in this indication.
All told, CytomX Therapeutics now stands to receive up to $4 billion over the course of its partnership with Regeneron, if all milestones are met.
Alnylam Pharmaceuticals will leverage Inceptive Nucleics’ generative machine learning models to accelerate the development of RNA interference therapies.
In this episode of Denatured, you’ll be hearing from Daniel Gil, CEO of Pelage Pharmaceuticals and Francisco Ramírez-Valle, senior vice president of immunology discovery at Eli Lilly. We dive into the long-overlooked hair loss space, exploring why true innovation has lagged, how a regenerative approach aims to reactivate dormant follicles and what early proof-of-concept means for patients.
It’s not unusual for it to take unemployed biopharma professionals awhile to land new jobs. Three experts discuss when employment gaps are an issue and how to explain them to prospective employers.
FDA inspectors found that Medline, which raised billions of dollars last year, failed to prevent repeat bacterial contamination of finished drug products.
Revolution Medicines stole the show at the 2026 American Society of Clinical Oncology meeting as full data from its pancreatic cancer drug lived up to expectations, while Summit and Akeso proved the PD-(L)1/VEGF mechanism and Eli Lilly showed that its in vivo CAR T bet is paying off.
NewLimit is pressing the gas, speeding into clinical trials much sooner than expected after lab research showed its epigenetic reprogramming asset reversed aging in human liver cells.
Celcuity’s gedatolisib doubled progression-free survival versus standard of care in certain patients with advanced breast cancer. Still, the biotech’s stock dropped more than 25% Tuesday.