Drug Development
After years of quiet maturation, new approach methodologies and emerging clinical success for cell therapies are fueling parallel momentum for induced pluripotent stem cells.
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BioSpace is launching an IPO dashboard to help the industry keep tabs on U.S. biotechs that have taken the public plunge in 2026.
The first-time CEO says her own sponsors took chances on her—and that industry leaders need to do the same to rebuild momentum for gender equity.
After Abogen Biosciences’ COVID shot missed the commercial window, the big question was whether its mRNA technology could create value beyond vaccines. Novartis’ $575 million upfront commitment is the clearest external validation yet of that broader therapeutic potential.
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The candidate is an oral version of ecnoglutide, a subcutaneous formulation of which is approved in China for type 2 diabetes and weight management. Pfizer owns commercialization rights for ecnoglutide in the Asian country.
Johnson & Johnson beat analyst expectations in the third quarter but left Wall Street wanting more; BMS dominated the news cycle on Monday with a Phase 3 win validating its $4.1 billion RayzeBio buy and mixed data in a late-stage pulmonary fibrosis trial; Revolution Medicines’ newly approved pancreatic cancer drug works better for patients with certain mutations; and Caribou Biosciences may be on its way out.
While BNT113 failed to improve progression-free survival in patients with a type of head and neck cancer during a Phase 3 trial, BioNTech is holding out hope for an overall survival win—but analysts say that outcome is now “less likely.”
Syndax Pharmaceuticals will no longer test Niktimvo for idiopathic pulmonary fibrosis, but the company’s work to expand the drug’s label in chronic graft-versus-host disease, for which it was approved in 2024, will continue.
A low-dose win could derisk a regulatory pathway for BMS’ LPA1 antagonist in idiopathic pulmonary fibrosis after a recently reported patient death, but a miss at the higher dose leaves analysts awaiting full data.
Data released by the FDA show that Revolution Medicine’s newly approved pancreatic cancer drug underperformed in a large subgroup of patients, but analysts say the biotech still has a clear winner.
The centerpiece of Bristol Myers Squibb’s 2024 RayzeBio buy has read out, hitting the primary endpoint in a late-stage tumor trial.
CDMO-sponsor relationships have shifted from transactional outsourcing to strategic collaboration built on shared risk, regulatory fluency and technical insight. As rising compliance pressure and geopolitical volatility reshape manufacturing, partners like Rose BioSolutions argue that true value now comes from challenging assumptions, anticipating hurdles and protecting programs before problems surface.
TRexBio and Retension Pharmaceuticals are set to debut Friday, bringing this year’s biotech IPO count to 29 as the sector’s rebound continues. City Therapeutics and Iambic Therapeutics hope to push that number even higher.
Leveraging recently proposed regulatory flexibilities, the gene-editing sector is working to cut R&D costs and unlock indications that were previously economically unviable, according to a new playbook published by the Alliance for Regenerative Medicine.