| Today’s Big NewsMay 30, 2025 |
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| By Darren Incorvaia Less than a year after garnering the first anti-CLDN18.2 approval in the U.S., Astellas Pharma is not resting on its laurels. The Japanese pharma giant is doubling down on the star solid tumor target with a new licensing deal for a phase 2 antibody drug conjugate worth up to $1.34 billion. |
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By James Waldron Sanofi’s plans to submit itepekimab to regulators for approval this year have been thrown into doubt after the Regeneron-partnered drug failed one of a pair of phase 3 COPD trials. |
By Gabrielle Masson After communicating with the FDA about font sizes for potential packaging on its investigational injection, Stealth Biotherapeutics’ CEO thought approval for the ultrarare genetic disease treatment was imminent. |
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By Angus Liu In its first global phase 3 readout, Akeso and Summit Therapeutics’ closely watched PD-1xVEGF bispecific antibody ivonescimab significantly reduced the risk of progression or death by 48% in patients with previously treated EGFR-mutated nonsquamous non-small cell lung cancer. |
By Nick Paul Taylor Roche has shared long-term phase 2 data on its BTK inhibitor fenebrutinib in relapsing multiple sclerosis, providing evidence of durability over 96 weeks to build out its case ahead of the release of pivotal trial results. |
By Nick Paul Taylor Merck & Co. has posted phase 2 data on zilovertamab vedotin in lymphoma, providing more evidence of the narrow safety and efficacy window that is open to the ROR1-directed antibody-drug conjugate. |
By Darren Incorvaia,Zoey Becker In an effort to maximize the earnings potential of its plaque psoriasis cream, Danish dermatology biotech MC2 Therapeutics has hired a former GLP-1 leader to steer the ship. Trine Ahlgreen is the new CEO of MC2, replacing founding CEO Jesper Lange in a planned transition. |
By Ayla Ellison,Eric Sagonowsky,Kevin Dunleavy,Gabrielle Masson,Darren Incorvaia This week on "The Top Line," we break down first-quarter Big Pharma earnings, recap the latest gene therapy developments and preview what’s ahead at ASCO. |
By Zoey Becker Pfizer's Braftovi, combined with Eli Lilly's Erbitux and chemo, won an accelerated approval last year through the FDA's Project FrontRunner. Now, the company is working toward a potential full approval. |
By Heather Landi Healthcare C-suite leaders are trying to keep pace with rapid changes in U.S. economic and regulatory policies in the first four months of the second Trump administration. |
By Eric Sagonowsky China's anti-graft watchdog is investigating Bi Jingquan, the former head of the China Food and Drug Administration. Daiichi Sankyo, along with partner Merck & Co., pulled an FDA approval filing for an antibody-drug conjugate cancer prospect. Novartis expanded a commercial collaboration with Shanghai Pharma. Plus more. |
Fierce podcasts Don’t miss an episode |
| This week on "The Top Line," we break down first-quarter Big Pharma earnings, recap the latest gene therapy developments and preview what’s ahead at ASCO. |
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Thursday, June 5, 2025 | 11am ET / 8am PT Off-target binding can be a significant hurdle in the development of antibody-based therapies, with limitations of conventional screening methods being a key factor. Join our webinar to learn more about the latest approaches to specificity profiling. Register now. 
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