Drug Development

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In the midst of regulatory and political upheaval, biopharma’s R&D engine kept running, churning out highs and lows in equal parts. Here are some of this year’s most glorious clinical trial victories.
Every year in biopharma brings its share of grueling defeats, and 2025 was no different, especially for companies targeting neurological diseases. Some failures split up partners, and one particularly egregious case even led to the demise of an entire company.
The R&D pipeline for depression therapies faced a demoralizing 2025 as five high-profile candidates, including KOR antagonists by Johnson & Johnson and Neumora Therapeutics, flunked late-stage clinical trials, underscoring the persistent challenges of CNS drug development.
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Armed with readouts from the PURPOSE 1 and 2 trials, Gilead Sciences is now gearing up for global regulatory submissions for lenacapavir as a pre-exposure prophylactic option for human immunodeficiency virus.
As it nears a crucial FDA action date for its transthyretin amyloid cardiomyopathy candidate, BridgeBio focuses on its late-stage pipeline.
Sanofi will join Big Pharma peers Novartis, BMS and Eli Lilly in radioligands, striking a $110 million licensing deal with RadioMedix and Orano Med to develop AlphaMedix for neuroendocrine tumors.
When doses were increased rapidly in a Phase I study, patients on Roche’s investigational oral GLP-1 receptor agonist experienced nausea, vomiting, constipation, diarrhea, as well as abdominal distension.
In this episode, Lori and guests discuss practical approaches regarding artificial intelligence and investor and industry confidence in its current state.
On the heels of Terns’ positive Phase I results that analysts compared with Lilly’s and Pfizer’s weight loss pills in development, Novo Nordisk showcased more details about its own oral candidate.
No patients have received Casgevy, CRISPR Therapeutics and Vertex Pharmeceuticals’ recently approved sickle cell gene therapy. Experts weigh in on the path to profit for the treatment and the therapeutic class in general.
Without revealing specific details, GSK announced that it is terminating the development of its investigational herpes simplex virus vaccine after failing to meet the study’s primary efficacy objective.
A study published Tuesday in The New England Journal of Medicine showed that children between the ages of six and 12 who took liraglutide for just over a year experienced a significant reduction in body mass index compared to placebo.
The late-stage clinical trial results showed that Eli Lilly’s once-weekly insulin efsitora matched daily injections for patients with type 1 and 2 diabetes, respectively.