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City Therapeutics, one of BioSpace’s NextGen companies for 2026, was started by RNA royalty John Maraganore, former CEO of Alnylam.
FEATURED STORIES
After a $625 million IPO, the biggest ever in biotech, obesity-focused Kailera Therapeutics is readying a commercial strategy that puts patients at the center.
The FDA has expanded the regulatory toolkit during President Donald Trump’s second term, adding new mechanisms for rare diseases while putting the Biden-era platform technology designation into action.
As the FDA tries to clarify its intent for former FDA Commissioner Marty Makary’s plausible mechanism framework for bespoke therapies, experts emphasize the importance of expanding its scope to encompass rare diseases that affect more than just one or a few individuals.
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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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The Phase III, open-label extension study suggests EPX-100 has a “positive” risk/benefit profile for the treatment of Dravet syndrome, analysts at H.C. Wainwright & Co. said Tuesday.
For certain monospecific antibodies, three-month toxicology studies plus other supportive evidence will suffice, eliminating the need for six-month testing.
Experts unpack the implications of CBER Director Vinay Prasad’s claim that COVID vaccines have caused 10+ child deaths; the 2025 Clinical Trials on Alzheimer’s Disease conference continues following two disappointing readouts; and Novo Nordisk’s amycretin yields promising weight loss results.
With new UK clinical trial rules landing in 2026, the EU Biotech Act on the horizon and China and Australia gaining ground, CROs are zeroing in on study timelines, AI/ML and data privacy as the industry’s next pressure points.
Early decisions about manufacturing and supply chains could prove costly as a company reaches the commercial stage.
Venture capital flow to women-founded companies has stabilized in the post-pandemic environment. BioSpace looks back at five companies that have nabbed the most over the past two decades.
While the TrumpRx deals only cover Lilly and Novo for now, the agreements are good for any cardiometabolic biotechs waiting in the wings, according to a new 2026 preview report from PitchBook.
Newly appointed Center for Drug Evaluation and Research director Richard Pazdur has filed retirement papers with the agency—three weeks after accepting the role—amid clashes with Commissioner Marty Makary over certain FDA programs.
With no evidence to support the claim that 10 children died due to COVID-19 vaccines, experts unpack the impact of CBER chief Vinay Prasad’s leaked vaccine memo.
While Imvax’s autologous immunotherapy IGV-001 missed the primary endpoint of progression-free survival in a Phase IIb trial, the company will request a meeting with the FDA to discuss next steps for “synergistic” treatment.