China’s NMPA has given 10 of Sihuan Pharmaceutical Holdings Group Ltd.’s skin repair products medical device registration certificates. The products are developed by its medical aesthetics platform, Beijing Meiyan Kongjian Biology Medicine Co. Ltd.

Privately held Leo Pharma Inc. has worked its way through a complete response letter issued in April to see the FDA approve Adbry (tralokinumab-ldrm) for treating moderate to severe atopic dermatitis in adults. The CRL noted FDA requests for additional data related to the device component, a prefilled syringe of tralokinumab, but it did not request new efficacy or safety data related to the drug product formulation. In April and on Dec. 28, the company did not provide details on the device-related data that were requested.

Prospects for Zerigo Health Inc. brightened with a series B fundraising round that brought in $43 million to support expansion of the company’s at-home ultraviolet B phototherapy system for chronic skin conditions. The connected system enables a physician to ensure the prescribed dose is delivered while freeing patients from the thrice-weekly office visits often required for treatment of psoriasis, vitiligo and eczema.

Castle Biosciences Inc. is acquiring gastrointestinal (GI) diagnostics company Cernostics Inc. in a transaction valued up to $80 million. The deal marks a move from Castle’s focus on dermatology diagnostics to include GI disorders and could expand its estimated U.S. total addressable market by approximately $1 billion, the company said. Shares of Castle Biosciences (NASDAQ:CSTL) jumped 7.8% to close at $67.58 on Tuesday Oct. 19.

Polarityte Inc.’s Skinte product met primary and secondary endpoints in a randomized clinical trial evaluating healing of diabetic foot ulcers. Skinte is a human cellular and tissue-based product made from a patient’s own skin. Results from the trial and data from the product’s use from 2017 to 2021 during a period of enforcement discretion by the FDA were used by the company in its filing earlier this week of an investigational new drug application for Skinte.

A not-unexpected complete response letter (CRL) for Nexobrid, being developed by Mediwound Ltd., delayed the therapy’s approval and knocked the company’s share values backward. Nexobrid, proteolytic enzymes enriched in bromelain for treating for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns, had a June 29 PDUFA date.

More than four months after its original PDUFA date of Feb. 2, 2021, Mallinckrodt plc’s Stratagraft gained FDA approval for use in deep partial-thickness thermal burns.

PARIS – Urgo Group SAS has just been awarded $27.7 million in financial support from the French government, to help develop artificial skin for treating deep skin wounds and massive burns.

Debx Medical BV has advanced to the pre-launch phase for its new topical desiccant gel for the treatment of chronic infected and necrotic wounds. Two months after obtaining CE mark approval for Debrichem, the Rotterdam, Netherlands-based company is starting distribution of its class IIb medical device in Europe – in the Netherlands, Italy and Spain – as well as in Hong Kong, South Africa, New Zealand and Australia.

The Human Skin Cell Atlas, comprising transcriptomes of 528,253 single cells, shows that cellular processes involved in skin development in embryos are reactivated in inflammatory skin diseases. In addition to suggesting potential new drug targets for atopic dermatitis and psoriasis, the transcriptomes provide a new route to understanding other inflammatory diseases, and provide a template for culturing skin for wound repair, according to the authors of a paper published in the Jan. 22, 2021, issue of Science.