Apogee Therapeutics Inc.’s phase I home run put IL-13-targeting antibody APG-777 on an accelerated development path in atopic dermatitis, and the company touted its similarity to further-along IL-13 competitor lebrikizumab, from Eli Lilly and Co., as a likely indicator of further success.
The demand for semaglutide, a GLP-1 drug, and other popular prescription weight-loss drugs is adding to the U.S. FDA’s regulatory load as more and more companies are offering unapproved knockoffs of the products directly to consumers. The FDA posted two warning letters Feb. 13 – to Miami-based US Chem Labs and a New-York company, Synthetix Inc. doing business as Helix Chemical Supply – citing the companies for misbranding unapproved semaglutide and tirzepatide, also a GLP-1 drug, by marketing them on the Internet, along with claims about their therapeutic benefits.
Bioage Labs Inc.’s $170 million series D financing will pay for phase II trials with azelaprag, an apelin receptor agonist, to be tried in combination with Zepbound (tirzepatide), the glucose-dependent insulinotropic polypeptide receptor and glucagon-like peptide-1 (GLP-1) receptor agonist from Bioage partner Eli Lilly and Co.
Eli Lilly & Co. has selected FHD-909, a first-in-class oral BRM-selective inhibitor, for clinical development from its 2021 collaboration with Foghorn Therapeutics Inc. Lilly plans to file an IND for FHD-909 in the second quarter of this year. The primary target patient population is BRG1-mutated non-small-cell lung cancer.
Amgen Inc. reported its latest financial numbers but much of the conversation on the Feb. 6 conference call was about obesity. The same was true with Eli Lilly and Co. as weight loss drove the narrative.
The hearing has returned for the first person who has received gene therapy for treating genetic hearing loss in the U.S. Initial results from Akouos Inc.’s phase I/II study showed that within 30 days of receiving AK-OTOF-101, pharmacologic hearing was restored to an 11-year-old who had profound hearing loss from birth.
Analysts from the hosting firm talked up their takeaways on biopharma from the J.P. Morgan (JPM) Healthcare Conference and looked ahead to 2024, anticipating a generally better year than those in the recent past.
U.S. biopharma Sermonix Pharmaceuticals Inc. handed off China rights of lasofoxifene, an oral endocrine therapy in development for breast cancer, to Shanghai’s Henlius Biotech Inc., for an undisclosed up-front payment and up to $58 million in milestone fees.
U.S. biopharma Sermonix Pharmaceuticals Inc. handed off China rights of lasofoxifene, an oral endocrine therapy in development for breast cancer, to Shanghai’s Henlius Biotech Inc., for an undisclosed up-front payment and up to $58 million in milestone fees.
A company launched by Alphabet Inc.’s Deepmind in 2021, Isomorphic Labs Ltd., entered its first biopharmaceutical partnerships to discover small-molecule therapeutics with Eli Lilly and Co. and Novartis AG in deals worth $1.75 billion and $1.24 billion, respectively.
