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Revolution Medicines stole the show at the 2026 American Society of Clinical Oncology meeting as full data from its pancreatic cancer drug lived up to expectations, while Summit and Akeso proved the PD-(L)1/VEGF mechanism and Eli Lilly showed that its in vivo CAR T bet is paying off.
From Chinese innovation to AI, biotech CEOs are being hit with challenges at a breakneck pace. Three leaders from BioSpace’s NextGen Class of 2026 told us about the issues keeping them up at night.
Deal dynamics between Chinese biotechs and global pharma companies are changing fast, with the biotechs seeking higher upfront payments and the Big Pharmas seeking more expansive platform deals.
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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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Albert Bourla confirmed that he called President Donald Trump after receiving a letter asking Pfizer and a clutch of other pharmaceutical companies to lower drug prices or face consequences.
BMN 390 fell short of an immunogenicity threshold that BioMarin was looking for to support its further development. Employees working on the program have been redeployed within the company.
The number of biopharma professionals let go has increased year over year for three straight months. In July, as many as 8,000 people lost or were projected to lose their jobs, due largely to news that Merck projects to cut roughly 6,000 employees as part of a multiyear process.
Vertex reported healthy revenue in its second quarter earnings report, though news of VX-993’s mid-stage trial results and lack of alignment with the FDA regarding an expanded label for Journavx tempered analyst reactions, sending the stock down 13%.
Praxis’ vormatrigine reduced seizures by 56.3%, an effect size that, according to analysts at Truist Securities, exceeds that of its closest competitors.
While the deaths occurred in patients who had been treated with Agios’ anemia treatment Pyrukynd, the biotech insisted in an SEC filing midday Monday that the drug’s risk-benefit profile remains unchanged.
In an open letter, 22 experts who designed and ran Replimune’s Phase III IGNYTE trial answered the FDA’s issues, as outlined in the complete response letter for the melanoma candidate RP1.
From innovation in manufacturing to more-flexible regulation and better communication with payers, much needs to happen to make CGTs commercially viable. But it is possible, experts agreed at a recent panel.
The primary focus in scaling up production should first be the adoption of lean manufacturing principles used in virtually every other industry.
According to reporting from multiple outlets, Richard Pazdur, head of the Oncology Center of Excellence at CDER, opposed the consensus opinion of CBER staff to approve the drug. Replimune’s stock has dropped precipitously since the rejection.