Alaric DeArment
Reporter
Latest From Alaric DeArment
BioMarin Rolls Up Sleeves To Prepare For Roctavian’s EU Debut
The company plans to start in Germany with an outcomes-based payment model. But while a US FDA nod seems likely, analysts have been more cautious about calling US approval a done deal.
Novartis Scores Its First Tumor-Agnostic Label For Two Nearly Decade-Old Cancer Drugs
The FDA approved Tafinlar/Mekinist for BRAF V600E-mutated solid tumors, based in part on a Phase II basket trial studying more than two dozen drugs across dozens of cancers based on genetic testing.
Galderma Hopes To Break Into Prurigo Nodularis Market, But May Face Rivals
The dermatology specialist announced positive results from the OLYMPIA 2 trial of nemolizumab, but Sanofi and Regeneron are already pursuing a similar indication for Dupixent.
AstraZeneca/Merck Reinforce Lynparza’s Prostate Cancer Position With First-Line Data
The companies published data showing the drug was effective in patients with both homologous recombinant repair mutated and non-mutated disease.
Rhythm Leans On Imcivree Rare Disease Commercialization For New Indication
The company got FDA approval for the drug in Bardet-Biedl syndrome, on top of the existing approval from November 2020 in obesity due to POMC, PCSK1 and LEPR deficiency.
Adaptimmune Starts Planning TCR Commercialization For An Ultra Rare Patient Population
CEO Adrian Rawcliffe talked with Scrip about filing and early commercial plans for afami-cel in synovial carcinoma if it is approved by the FDA.