Alteogen Inc. signed its first billion-dollar partnership this year for ALT-B4 technology through two separate contracts with Astrazeneca plc’s U.K.- and U.S.-based Medimmune subsidiaries worth up to $1.35 billion combined.
Becoming the second drug approved by the U.S. FDA for tenosynovial giant cell tumors, Deciphera Pharmaceuticals Inc.’s oral CSF1R inhibitor vimseltinib, newly branded Romvimza, could take significant market share from a competitor in the same class. A phase III trial showed a higher objective response rate with Romvimza than a separate phase III trial showed with Daiichi Sankyo Co. Ltd.’s Turalio (pexidartinib), and the latter’s label contains a boxed warning on rare but serious and sometimes life-threatening liver side effects.
EMA approval of the Alzheimer’s disease therapy Leqembi (lecanemab) has stalled once again, after the European Commission did not as usual nod through the agency’s recommendation, but told it to examine safety data that have recently become available.
Marking the second global approval after Japan, the U.S. FDA has approved Datroway (datopotamab deruxtecan), a trophoblast cell surface antigen 2-directed antibody-drug conjugate (ADC) from Daiichi Sankyo Co. Ltd. and Astrazeneca plc, for treating adults with hormone receptor-positive, HER2-negative unresectable or recurrent breast cancer after prior chemotherapy.
Daiichi Sankyo Co. Ltd.’s trophoblast cell surface antigen 2 (Trop2)-directed antibody-drug conjugate (ADC), datopotamab deruxtecan (dato-dxd), has been approved in Japan for treating adults with hormone receptor (HR)-positive, HER2-negative unresectable or recurrent breast cancer after prior chemotherapy.
Daiichi Sankyo Co. Ltd. and Astrazeneca plc have submitted a new BLA to the U.S. FDA for accelerated approval for datopotamab deruxtecan for treating locally advanced or metastatic epidermal growth factor receptor-mutated non-small-cell lung cancer patients who have received prior systemic therapies.
Daiichi Sankyo Co. Ltd. and Astrazeneca plc have submitted a new BLA to the U.S. FDA for accelerated approval for datopotamab deruxtecan for treating locally advanced or metastatic epidermal growth factor receptor-mutated non-small-cell lung cancer patients who have received prior systemic therapies.
Alteogen Inc. scored another deal for its human recombinant enzyme, ALT-B4, on Nov. 8, reeling in Daiichi Sankyo Co. Ltd. in a potential $300 million deal including $20 million up front and up to $280 million in milestone payments, along with royalties based on net sales.
Alteogen Inc. scored another deal for its human recombinant enzyme, ALT-B4, on Nov. 8, reeling in Daiichi Sankyo Co. Ltd. in a potential $300 million deal including $20 million up front and up to $280 million in milestone payments, along with royalties based on net sales.
Virus is associated with sickness, but oncolytic virus therapies, which harness viruses to attack and kill cancer cells, may soon change the standard of treatment for cancer, including those long deemed uncurable like malignant glioma.
