Regulatory Landscape Newsletter – August 2019

We saw regulatory hiring slow down slightly in July, which is fairly normal for the summer. There is still a high demand for Regulatory CMC, Regulatory Strategy, and Regulatory Advertising & Promotions professionals at all levels across the country. Hiring remains strong in the SF Bay Area and the Boston/Cambridge market. In July Dennis Partners[…]

Top Regulatory News Stories – Week Ending August 2, 2019

Celgene received FDA approval for Otezla to treat oral ulcers associated with Behçet’s Disease. https://www.pharmaceutical-business-review.com/news/celgene-otezla-behcets-disease/ Apic Bio, Inc. announced that the FDA has granted orphan drug designation to APB-102, a gene therapy soon to be in clinical development for the treatment of genetic SOD1 amyotrophic lateral sclerosis (ALS).  http://www.firstwordpharma.com/node/1654288#axzz5uQCOiPcE Biohaven Pharmaceuticals reported that the FDA[…]