Eli Lilly and Co., through its Loxo@Lilly oncology unit, secured its second accelerated approval for non-covalent Bruton’s tyrosine kinase (BTK) inhibitor Jaypirca (pirtobrutinib), this time to treat adults with chronic lymphocytic leukemia or small lymphocytic lymphoma. The U.S. FDA approval of 100-mg and 50-mg tablets is for patients who have received two prior lines of therapy, including another BTK inhibitor and a BCL-2 inhibitor. It is based on phase I/II data from a subset of 108 patients participating in the open-label, single-arm, multi-cohort Bruin trial.
Five months since Eli Lilly and Co.’s $2.4 billion buyout of Dice Therapeutics Inc. and its Delscape platform for oral small-molecule inhibitors of protein-protein interactions, Lilly rolled the dice again for novel PPI targets by partnering with Japanese biotech Prism Biolab Co. Ltd.
Eli Lilly and Co. shared insights into an inhibitor targeting ANGPTL3, named solbinsiran. Solbinsiran, a N-acetylgalactosamine (GalNAc) conjugated Dicer-substrate small interfering RNA (DsiRNA), is designed to target ANGPTL3 expression in the liver.
Astrazeneca plc will pay up to $2 billion for Eccogene Co. Ltd.’s oral weight loss candidate, ECC-5004, as big and small pharma players alike work to gain ground in the burgeoning obesity market where Eli Lilly and Co. scored the latest U.S. FDA approval of Zepbound (tirzepatide).
Astrazeneca plc will pay up to $2 billion for Eccogene Co. Ltd.’s oral weight loss candidate, ECC-5004, as big and small pharma players alike work to gain ground in the burgeoning obesity market where Eli Lilly and Co. scored the latest U.S. FDA approval of Zepbound (tirzepatide).
Orsobio Inc., already in the clinic with three candidates, has completed its $60 million series A financing. The company, CEO Mani Subramanian told BioWorld, has taken its time to find the right programs, put them together and only raised capital when it saw the programs had legs. Even the series A is a measured step, as Subramanian called the financing “modest.”
A year-and-a-half after Eli Lilly and Co.’s Mounjaro (tirzepatide) gained U.S. FDA approval for adults with type 2 diabetes, the GLP-1 and GIP dual agonist was cleared for chronic weight management in adults who are obese or overweight and who also have one related condition.
After a delay caused by the April complete response letter from the U.S. FDA for Eli Lilly and Co.’s Omvoh (mirikizumab-mrkz), regulators cleared the drug for moderately to severely active ulcerative colitis (UC) in adults. Given by infusion (300 mg/15 mL)/injection (100 mg/mL), Omvoh stands as the first and only interleukin (IL)-23p19 antagonist for the treatment of moderately to severely active UC in adults – as well as the pharma giant’s first drug approval in the space.
