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The FDA’s real-time clinical trial mechanism allows drug sponsors to transmit data immediately to the regulator through the cloud—a system that could “compress drug development timelines,” Jefferies analysts said.
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Cancer cocktails pairing Moderna’s mRNA-4359 with Merck’s Keytruda and Marengo’s invikafusp alfa with Gilead Sciences’ Trodelvy showed promising results, while a complex combination by Agenus and MiNK Therapeutics failed to elicit an overall response.
The new CEO has at least five years and a large M&A war chest to position Sanofi for life after the loss of exclusivity on its cornerstone immunology product.
As cell and gene therapy leaders gathered in Maryland to discuss accelerating clinical trials in children, one “cutting edge” session focused on the need to expedite more bespoke gene editing treatments like the one that saved young KJ Muldoon.
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In 2025, landmark obesity drug deals, China’s biotech surge, and AI’s deeper integration into pharma operations drove a year of transformation and renewed momentum for life sciences.
The strategic initiative will extend Metagenomi’s cash runway into the fourth quarter of 2027. That same year, the company expects to generate initial Phase I data for its lead asset MGX-001 in hemophilia A.
Altimmune’s pemvidutide showed “class-leading signals” in non-invasive assessments and has “potentially best-in-class tolerability,” according to analysts at H.C. Wainwright.
Aside from offering to acquire all remaining shares of Neuphoria, existing investor Lynx1 Master Fund also announced its plan to nominate directors in the biotech’s upcoming board elections.
With immunology and inflammation blockbusters like AbbVie’s Skyrizi and Rinvoq reeling in nearly $7 billion combined in the third quarter, the pipeline-in-a-product strategy has never been more attractive.
Pfizer seals the deal with Metsera for $10 billion after Novo Nordisk bowed out; President Donald Trump welcomes executives from Novo and Eli Lilly to the White House to announce that the companies’ GLP-1 medicines would be sold at a reduced cost; and the FDA grants the second round of priority review vouchers—primarily to already marketed drugs.
With pricing pressures climbing, Pfizer, Eli Lilly and other major drugmakers are looking to sell their products directly to patients. Analysts are skeptical that these efforts, including those announced to much fanfare from the White House, will result in meaningful reductions in drug spending.
The appointment of Richard Pazdur, currently director of the FDA’s Oncology Center of Excellence, comes less than a week after he reportedly declined the post, and just nine days after his predecessor’s controversial exit.
Data presented at this year’s American Heart Association Scientific Sessions in New Orleans underline rapid advancements in the cardiovascular field.
The mid-stage failure was unexpected to analysts at BMO Capital Markets, who viewed ‘770 as mostly derisked given its similar mechanism of action to Johnson & Johnson’s Spravato.