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UniQure’s planned third-quarter submission for its Huntington’s disease gene therapy may be a harbinger of a more flexible FDA under acting commissioner Kyle Diamantas—but how long will it last? And how can companies be sure these positive decisions won’t just be reversed?
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While agents like AbbVie’s Humira have transformed the treatment landscape, not all patients benefit equally from the drug. Better biomarker analysis and more investment in mechanistic trials can inform the development of more effective therapies with broader clinical value.
Precision science is ruling the M&A scene as pharmas prepare for loss of exclusivity on key products, PwC says in a new report. Biotechs should be prepared with a dual-track process with the IPO window now open.
While biopharma’s overarching mission is to develop innovative medicines to improve patient outcomes, for these six people, the motivation came from much closer to home.
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FDA veteran Peter Marks will now shape the future of Eli Lilly’s vaccines work after the buys of Curevo, LimmaTech Biologics and Vaccine Company for up to $3.8 billion total.
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Eli Lilly sauntered into the American Diabetes Association meeting with a commanding lead in the metabolic space and put down more evidence for its pipeline, including new pill Foundayo and next-gen asset retatrutide, in new indications.
Analysts and investors were unimpressed by Phase 2 data posted in the spring showing that an amylin analog developed by Roche and partner Zealand Pharma elicited 9% weight loss, less than Eli Lilly’s rival candidate. Executives from both companies told BioSpace that premium weight loss is not the point of petrelintide.
The American Diabetes Association’s annual congress will feature a superstar lineup, including weight loss giants Eli Lilly and Novo Nordisk. But several scrappy biotechs will also present obesity candidates with the potential to match—if not outperform—their deep-pocketed competitors.
After discontinuing development of its lead asset, Fulcrum Therapeutics has provided more details on its restructure, with 48 of 57 employees headed out the door.
The FDA must provide consistent and predictable regulatory frameworks if the U.S. is to maintain its leadership in gene therapy, one of the most consequential therapeutic fields of our generation.
By inhibiting the APRIL cascade, Otsuka Pharmaceuticals’ Voyxact slowed kidney function decline in patients with IgAN, opening up a potential path for full approval while also reading through to Vertex and others with similar assets.
The FDA hasn’t been transparent and open enough with how it has implemented the Commissioner’s National Priority Voucher program, patient, industry and trade groups said Thursday.
Rather than getting hung up on what to call DEI in the workplace, leaders should take three specific actions to help their employees embrace and engage with it. Companies and the patients they serve will benefit.
Massachusetts’ life sciences jobs declined 1% in 2025, according to a new MassBioEd report. However, the report is projecting industry employment will increase 9.7% by 2030. It also noted reskilling needs for some roles, including scientists.
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.