Pearls of Wisdom
Novartis wins race to market, earns FDA approval for first CAR-T therapy
The U.S. Food and Drug Administration granted regular approval to the first chimeric antigen receptor T-cell (CAR-T) immunotherapy in the United States. Dubbed a “historic action” by the agency, FDA approved tisagenlecleucel (KYMRIAH®, Novartis...
VisionTech Partners, Pearl Pathways form alliance to fuel growth in Indiana’s Life Sciences startups
Pearl Pathways announces a partnership with VisionTech Partners, the parent of Indiana’s most active angel investing group, to fuel Indiana's life science startup community. The Pearl Pathways-VisionTech Partners alliance will focus on three essential...
FDA, EMA agreement furthers mutual recognition of drug manufacturing facility inspections
The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have signed a new confidentiality commitment. The commitment to share confidential info marks a milestone in the process to implement mutual recognition of drug...
Experienced biopharma leader joins Pearl Pathways
Pearl Pathways announces the hiring of Mark Slisz as a Senior Advisor serving biopharmaceutical, medical device, and diagnostic life science companies. Slisz brings over 35 years of experience in the pharmaceutical industry to Pearl Pathways. His...
Trial designs for drugs & devices entering market through FDA accelerated approval pathway under fire
The U.S. Food and Drug Administration (FDA) provides various ways to speed new drugs and medical devices to market. Even though some contest that FDA is too slow when it comes to product approvals, data suggests otherwise. However, in spite of quicker...