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.
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.
As Novo Nordisk A/S has struggled with supply of its GLP-1 drug Wegovy (semaglutide), its controlling shareholder, Novo Holdings A/S, has agreed to acquire global contract development and manufacturing organization Catalent Inc. and its more than 50 global sites for $63.50 per share in cash, about $16.5 billion.
The U.S. FDA cleared an IND for Neurobo Pharmaceuticals Inc.’s weight loss drug, prompting the company to say a phase I study in obesity will begin sometime during the first half of this year. The stock catapulted upward on the news.
Sciwind Biosciences Co. Ltd.’s oral ecnoglutide (XW-004) produced strong weight loss results after short-term treatments, up to a 6.8% body weight decrease in obese and overweight participants after once-daily dosing for six weeks, according to data from the first four cohorts of the phase I trial.
A U.K. national health service (NHS) hospital has begun offering Allurion Technologies Inc.’s swallowable gastric balloon to patients struggling to lose weight for surgery. The move is a boon for the company amid rising competition in the weight loss market from GLP-1 agonists.
Sciwind Biosciences Co. Ltd.’s oral ecnoglutide (XW-004) produced strong weight loss results after short-term treatments, up to a 6.8% body weight decrease in obese and overweight participants after once-daily dosing for six weeks, according to data from the first four cohorts of the phase I trial.
Innovent Biologics Inc. said its glucagon-like peptide-1 receptor and glucagon receptor dual agonist, mazdutide, met the primary endpoints and all key secondary endpoints in its first phase III trial in Chinese adults who were overweight or obese. The company plans to submit the first mazdutide NDA for weight management to China's NMPA shortly.
Rhythm Pharmaceuticals Inc. is picking up LG Chem Ltd.’s oral small-molecule drug, LB-54640, for potentially $305 million, effectively growing its MC4R pipeline that houses U.S. FDA-approved Imcivree (setmelanotide) for genetic obesity disorders.
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