With the biggest biosimilar launch in the U.S. just days away, Humira’s (adalimumab) record-breaking ride is quickly slowing down, but the Abbvie Inc. mega-blockbuster immunology drug is nowhere near the end of its road. Meanwhile, the U.S. journey is just beginning for the eight adalimumab biosimilars that could come to market as early as July 1 through licensing agreements with Abbvie. Besides revving their engines against Humira, the new launches will be looking to overtake Amgen Inc.’s biosimilar, Amjevita, which got a five-month headstart in the U.S., thanks to the first-mover status Amgen earned for being the first to sign a licensing agreement with Abbvie. Read More
Opko Health Inc. stands to receive a $90 million milestone payment from partner Pfizer Inc. on the U.S. FDA approval of once-weekly human growth hormone analogue Ngenla (somatrogon) for pediatric patients with growth hormone deficiency. Pfizer expects to make the drug available to patients starting in August 2023. Read More
With the latest data from the phase II Sequel study, Cognition Therapeutics Inc. added new physiological evidence for the neuroprotective effect of CT-1812 in mild to moderate Alzheimer’s disease (AD) bolstering earlier results related to target engagement and the compound’s impact on cognitive changes. But the results failed to hit statistical significance, and shares of New York-based Cognition (NASDAQ:CGTX) closed June 28 at $2.18, down 32 cents, almost 13%. Read More
South Korea’s JW Pharmaceutical Corp. announced a redo of its IND application to the Taiwan FDA on June 27 for its phase III trial on gout treatment URC-102 (epaminurad). The second filing comes in response to a regulatory rejection in March citing a problem with the proposed reference drug. Read More
The development of an embryo in its early stages involves a series of processes in which cells interact and organize to form tissues. In humans, these stages are studied with animal models, stem cells and cell aggregates that mimic natural development phases, or with human embryos, depending on their availability and a strict protocol. Now, in back-to-back papers published online in Nature, scientists from Yale University and the University of Cambridge have two new embryonic models formed from human stem cells to study development after embryo implantation in the uterus. Read More
Despite imperfect data and the use of post hoc analyses to overcome a failed endpoint, the U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 10-4 June 28 that Ipsen SA’s ultra-rare bone disease drug, palovarotene, demonstrated efficacy in treating patients with fibrodysplasia ossificans progressiva (FOP). Read More
Biopharmas raising money in public or private financings, including: Ambrx, Axsome, Evommune, Hemostemix, Immutep, Longeveron, Minerva, Moonlake, Sonnet. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adicet, Aldeyra, Aveo, Bavarian Nordic, Biorestorative, Bioxytran, Black Diamond, Cassava, Edgewise, Eli Lilly, Freya, Harpoon, Idorsia, Inozyme, Lobe, Meiragtx, Minervax, Nkarta, Regulus, Sanofi. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Exevir, Huadong Medicine, Sanyou, Trethera. Read More
