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Fierce Pharma Asia—BioNTech's ADC clinical hold; Takeda's leukemia bet; China NMPA's meeting with FDA

2024-06-21

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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 HERBioNTechs been put on a partial clinical hold by theAscentageeda 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.

BioNTechalts MediLink BiHER3ch-MediLink ADC over 'significant risk of illness'FDA Novartis Scemblix FDA

TheFDAA 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.

2. TFDAda circles leukemia rival to Novartis' ScembliMediLink Therapeutics wBioNTechntageHER3-targeted BioNTech BioNTech

Takeda is paying $leukemiaion for anNovartistoScemblix a third-generation BCR-ABAscentagee kinase inhibitor from China’s Ascentage Pharma. The drug, called olverembatinib and already approved in China, is a competitor to Novartis’ Scemblix in chronic myeloid leukemia. Takeda is also making a $75 million investment in Ascentage, which is in line for up to about $1.2 billion in milestones if everything plays out positively.

Takedana’s NMPA visits US in first senior-level meeting at FDA HQ since 20BCR-ABL tyrosine kinase inhibitor BCR-ABL tyrosine kinase Ascentage Pharma olverembatinib Novartis Scemblix chronic myeloid leukemia Takeda Ascentage

Deputy Commissioner Zhao Junning of China’s National MedicaFDAroducts 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.

4. Day One inks $1.2B biobucks pact for MabCare’s solid tumor ADCFDA FDA FDA FDA

Day One Biopharmaceuticals paid $55 millMabCarefrosolid tumorts hands on ex-China rights to MabCare Therapeutics’ antibody-drug conjugate targeting PTK7, which is overexpressed in esophageal, ovarian, lung and endometrial cancers among adults, as well as in neuroblastoma, rhabdomyosarcoma and osteosarcoma in children. The Chinese biotech may get up to $1.15 billion in potential milestones.

Day One Biopharmaceuticalspilepsy tests but mulls path to market for Ovid-partnered prospectMabCare Therapeutics PTK7 neuroblastoma rhabdomyosarcoma osteosarcoma

Takeda’s soticlestat, forepilepsyt paid Ovid Therapeutics $196 millioOvid partner on, missed the primary endpoints in two phase 3 trials in two forms of epilepsy, refractory Lennox-Gastaut syndrome and Dravet syndrome, respectively. Still, arguing that the cholesterol 24 hydroxylase inhibitor showed some treatment effects, Takeda said it will discuss the totality of the data with the FDA.

6. India'soticlestatounces CEO pick for Ovid Therapeutics it moves into the CDMO arenaepilepsy refractory Lennox-Gastaut syndrome Dravet syndrome cholesterol 24 hydroxylase FDA

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.

Lupinergent, pivoting away from CDMO business, sells Baltimore Lupin Manufacturing Solutions $30MBayer Catalent Lonza Lupin FDA

EmeEmergentoSolutions has agreed to sell its fill-finish drug product facility in BaBoraore-Camden to Taiwanese CDMO Bora Pharmaceuticals for $30 million. Bora intends to keep about 350 Emergent employees currently stationed at the 87,000-square-foot facility. The deal follows Bora’s $210 million acquisition of Minnesota generic manufacturer Upsher-Smith Laboratories earlier this year.

Emergent BioSolutions Bora Pharmaceuticals Bora Emergent Bora Upsher-Smith Laboratories

8. Innovent braves bruising cytokine space, linking fusion protein to tumor responses in small study

9. InnoventBiologics upgrades another production pact, this time with tumorr for $223M

10.Samsung Biologicsdia unveils ad-free model for health podcasts, incBaxter Eisai-backed Alzheimer’s series

11. Biocon looks for partner to trial generic to Novo’s Wegovy, Ozempic in ChEisai