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.

Pfizer, Opko win FDA nod for once-weekly growth hormone drug Ngenla

Pfizer Inc.’s once-weekly human growth hormone analogue, Ngenla (somatrogon), is expected to be available to U.S. patients in August, following FDA approval for use in pediatric patients, ages 3 and older, who have growth failure due to inadequate secretion of endogenous growth hormone. Ngenla, already approved in more than 40 markets, including Canada, Japan and the EU member states, had met with delay in the U.S., where it received a complete response letter in early 2022. The approval is expected to trigger a milestone payment to partner Opko Health Inc., which licensed rights to Ngenla in 2014.

Phase II data from Cognition in Alzheimer’s sink shares

Cognition Therapeutics Inc. disclosed top-line results from its phase II double-blind, single-crossover Sequel study of lead candidate CT-1812 in 16 adults with mild to moderate Alzheimer’s disease (AD). The experiment conducted in the Netherlands met its primary endpoints for safety and tolerability and showed positive effects for CT-1812-treated participants as measured via quantitative electroencephalogram. Measuring brain wave changes in AD over four weeks of treatment, Sequel showed that participants treated with the drug experienced a numerical reduction in relative theta power compared to the period on placebo, though the data fell short of statistical significance. CT-1812 is an orally delivered small molecule designed to penetrate the blood-brain barrier and bind selectively to the sigma-2 receptor complex. Shares of New York-based Cognition (NASDAQ:CGTX) were trading midday at $1.91, down 59 cents, or 23%.

JW Pharma refiles Taiwan IND for URC-102 phase III in heated search for novel gout drug in Asia

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. “The TFDA determined the reference drug in the [original] clinical design did not comply with its standard, leading to the [first IND] rejection,” the disclosure on the Korea Exchange read. “We reapplied after updating the reference drug accordingly.” To BioWorld, a company official said that the issue with the control drug was not related to either the ingredient or trial design – and JW Pharma resubmitted the application after updating the original domestic febuxostat product to an unnamed febuxostat brand recognized by the Taiwanese regulator.

New human embryonic models bring hope for insights, but also lots of brouhaha

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.

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