Takeda’s TAK-721 is back, ARS Pharma will be back soon to appeal neffy complete response letter, US FDA’s Project Renewal brings Temodar labeling in current day, and more highlights from the Pink Sheet’s US FDA Performance Tracker.

The once-daily oral somatostatin receptor type 2 (SST2) agonist outshined placebo in patients switching from standard of care, offering an attractive alternative to once-monthly injectables.

Chiesi-owned Amryt and Krystal Biotech have approved treatments for epidermolysis bullosa but they only treat one subtype - dystrophic - and a single wound. Paradigm CEO Robert Ryan tells Scrip that SD-101, a topical cream he helped develop over 20 years ago, has the potential to be offer a far more extensive and efficacious solution for many more sufferers.   

Amryt/Chiesi’s birch bark extract gel, Filsuvez, is the first ever treatment for epidermolysis bullosa, a group of rare skin disorders, to be recommended by NICE for English reimbursement.