Novo Nordisk’s leadership gets another shake-up as President Trump promises to significantly slash prices for its GLP-1 drugs; Summit/Akeso, Exelixis and more present new data at ESMO 2025; Replimune pops as FDA accepts resubmitted BLA; FDA names first winners of Commissioner’s National Priority Voucher program; and more.
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Novo Nordisk dominated the news cycle this week, with more leadership changes as the Novo Foundation replaced the company’s board, which will now be headed by former CEO Lars Rebien Sørensen. Meanwhile, President Donald Trump promised last week that Novo’s Ozempic will cost about $150 when he and Centers for Medicare & Medicaid Services Administrator Mehmet Oz are done negotiating, though Oz clarified that said negotiations have not yet begun.
Over in Berlin, the 2025 European Society for Medical Oncology featured presentations from Akeso and Summit Therapeutics on PD-1/VEGF inhibitor ivonescimab in first line non-small cell lung cancer (NSCLC) and Exelixis’ oral kinase inhibitor zanzalintini in colorectal cancer. In addition to reporting that ivonescimab “significantly improved” progression-free survival in first-line NSCLC, Summit said on a Q3 call Monday that it would submit a regulatory application with the FDA for the drug in second-line EGFR-mutated NSCLC. In other cancer news, shares of Replimune soared after the FDA accepted its resubmitted biologics license application for RP1 in advanced melanoma, nearly three months after its July rejection.
Also on the regulatory front, the FDA named the first nine recipients of its Commissioner’s National Priority Voucher program. Winners of the expedited review vouchers include Regeneron, Disc Medicine and Sanofi. The FDA agency also awarded its second-ever platform designation to Krystal Biotech—after granting the first such designation to Sarepta Therapeutics earlier this year for its AAV vector and then rescinding it after the platform was linked to multiple deaths. Finally, Sandra Retzky, formerly director of the FDA’s Office of Orphan Products Development, joins the lengthy leadership exodus at the agency this year.
In BioPharm Executive, BioSpace look at how Johnson & Johnson weathered the erosion of its cornerstone drug Stelara. And is hair loss the new weight loss? Two biopharma companies—Veradermics and Pelage Pharmaceuticals—reeled in large financing rounds for their respective hair loss/regrowth programs. They’re part of an uptick in mega rounds of late, but experts say it’s not a full biotech comeback just yet.
