Aesthetics

The EU is putting more flesh on the bones of the requirements for Annex XVI products as two guidances are issued in quick succession.

The EU’s Medical Device Regulation regulates a small group of products with a mainly aesthetic purpose for the first time. How much notified body capacity will these potentially risky products demand?

Austrian company Croma-Pharma is the trailblazer with its newly certified dermal filler.

Similar to its post-approval strategy in aesthetics less than a year ago, Revance will initially target a small number of doctors as it Daxxify to market in the US for cervical dystonia with a broader launch in 2024.

Lawyer applauds “courageous reaction” of manufacturers of devices without an intended medical purpose which fall under Annex XVI to the Medical Device Regulation and whose products are threatened by the delays in the publication of common specifications.

The European Medicines Agency has completed its investigation into the safety of nomegestrol and chlormadinone, and has started reviewing risks linked to the cough suppressant, pholcodine, and the epilepsy and migraine drug, topiramate.

The European Commission has launched an initiative to ensure products without a medical purpose that fall under the Medical Device Regulation are appropriately classified by risk, and subject to the same pre- and post-market requirements as comparable medical devices.

Emerging Company Profile: The US biotech is developing a series of recombinant fusion proteins to tackle alopecia and other diseases without supressing the immune system.    

The US agency is re-evaluating its criteria for certain human cells, tissues and cellular and tissue-based products (HCT/Ps) that are not ideally regulated as BLAs. A 2014 guidance on cord blood products could serve a template, industry suggests.

Viatris remains hopeful of obtaining FDA approval for its proposed biosimilar to Botox in partnership with Revance Therapeutics in 2026, after the latter’s manufacturing problems for another drug candidate stymied development of the rival to the world-renowned cosmetic brand.