A partial clinical hold on BioNTech's ADC candidate, Takeda's option deal with Ascentage, and a senior leadership meeting between Chinese and U.S. drug regulators made our news this week. BioNTech and MediLink's HER3 ADC has been put on a partial clinical hold by the FDA. Takeda has identified a potential challenger to Novartis' Scemblix. Senior officials from China and U.S. drug authorities met at the FDA's headquarters for the first time since 2017. And more. 1. FDA halts trial of BioNTech-MediLink ADC over 'significant risk of illness' The FDA has put a partial hold on a phase 1 trial of MediLink Therapeutics’ BioNTech-partnered HER3-targeted antibody-drug conjugate. A BioNTech presentation recently showed that as of Feb. 4, two patients from the fifth dose cohort and one in the seventh dose group had died in the study. In the slides, BioNTech said it will focus further clinical development on lower dose levels. 3. China’s NMPA visits US in first senior-level meeting at FDA HQ since 2017 (tweets) Deputy Commissioner Zhao Junning of China’s National Medical Products Administration met with FDA Deputy Commissioner Kim Trzeciak Tuesday in the first senior-level meeting between the two agencies at FDA’s headquarters since 2017. The two agencies discussed the 2007 FDA-SFDA China Agreement on the Safety of Drugs and Medical Devices, including their 2024 work plan, according to the FDA. 5. Takeda flunks pivotal epilepsy tests but mulls path to market for Ovid-partnered prospect 6. India's Lupin announces CEO pick for new subsidiary as it moves into the CDMO arena
Lupin is venturing into the CDMO space with its new subsidiary Lupin Manufacturing Solutions, which will work on the development, production and sale of active pharmaceutical ingredients. The unit will be led by Abdelaziz Toumi, who previously worked at Bayer, Catalent, Lonza and other companies. Lupin has in the past dealt with drug recalls and FDA citations. 7. Emergent, pivoting away from CDMO business, sells Baltimore plant to acquisitive Bora for $30M 8. Innovent braves bruising cytokine space, linking fusion protein to tumor responses in small study 10. Mission Based Media unveils ad-free model for health podcasts, including Eisai-backed Alzheimer’s series