Clinical research
In this episode of Denatured, presented by Cytiva, Jennifer Smith-Parker speaks to Nicolas Pivet, VP & GM, Manufacturing & Digital Solutions at Cytiva. In this episode, we explore how biopharma’s real bottleneck isn’t too little data—it’s too little confidence in the decisions that drive development, manufacturing and commercialization.
Revolution Medicines’ recently approved drug showed a 24% overall response rate and a high rate of side effects in patients whose cancer has a G12D mutation, reinforcing Mizuho’s view that a more specific agent such as Verastem Oncology’s VS-7375 “should come first for G12D patients.”
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.
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.
Argenx shares have fallen more than 13% after the surprise futility finding, which overshadowed a mid-stage celiac disease win for a separate asset acquired in the company’s $2.2 billion Forte Biosciences buy.
After one patient death prompted an FDA hold this spring, Newron Pharmaceuticals has now shared that a total of four fatalities have been recorded among participants receiving its schizophrenia candidate. A fifth death was recorded among those taking the placebo.
For the second time in a week, Zealand Pharma’s weight loss pipeline has delivered mixed results, this time in a Phase 2 trial for the Roche-partnered asset petrelintide.
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