Obesity
The filing comes as Novo fights tooth-and-nail with rival Lilly to regain its footing at the top of the weight loss market.
Participants in a Phase III trial who switched to Eli Lilly’s orforglipron after 72 weeks of treatment with Wegovy or Zepbound largely maintained their weight loss for up to a year.
Eli Lilly’s retatrutide exceeds expectations in Phase III, capping off a sparkling 2025 for the obesity titan; an internal FDA safety review finds no confirmed pediatric deaths caused by COVID-19 vaccines, and Commissioner Marty Makary says no black box warning will be attached to the shots; and BioSpace looks at six biotechs that could be pharma’s next buy.
These deals radically reshaped the biopharma world, either by one vaccine rival absorbing another, a Big Pharma doubling down after another failed acquisition or, in the case of Pfizer and Novo, two heavyweights duking it out over a hot obesity biotech.
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.
Coming up in the back half of December, the FDA will issue a verdict on Vanda Pharmaceuticals’ gastroparesis drug tradipitant, which it rejected last September, triggering a very public dispute with the company.
Analysts were hoping for a safety profile similar to what was achieved in Phase II but an abnormal sense of touch, called dysesthesia, has emerged in the late-stage TRIUMPH-4 trial.
Also on Thursday, Zealand held its Capital Markets Day in London, outlining the strategy for its weight management franchise in the near-term, including launching five products by 2030.
Pfizer deals again in obesity space as Wave and Structure drop splashy weight loss results; what CDER Director Richard Pazdur’s sudden retirement means for biopharma; neuro diseases take center stage at CTAD; and more.
Pfizer apparently had more in the tank after the high-profile battle to acquire Metsera earlier this fall. The company has licensed a new GLP-1 from YaoPharma.
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