A patient’s death has caused the FDA to place a partial clinical hold on Alpine Immune Sciences Inc.’s phase I study NEON-2 in adults with advanced malignancies.
To counter the worldwide growth of antimicrobial resistance, a subject of worldwide concern but little actual progress, Arrepath Inc. has raised a $20 million seed financing to advance its machine learning-based platform for discovering new classes of anti-infectives.
After two years of developing its platform, Vesalius Therapeutics Inc. now has $75 million in its pocket from Flagship Pioneering to understand and treat the diseases that account for 90% of the world’s illnesses. To resolve this massive amount of biological and industry complexity, Doug Cole, Vesalius’ chairman and co-founder and Flagship’s managing partner, noted the distinction between illness and disease. “Illness is what bothers you, it’s the experience of being sick and what the doctor might find when you’re examined,” Cole told BioWorld. “Disease is the mechanistic problem with the biology underlying the illness.”
Despite Reata Pharmaceuticals Inc.’s complete response letter (CRL) for bardoxolone in treating kidney function loss in those with Alport syndrome, the street treated the company well on Feb. 28.
After years of turbulent development that included a clinical hold, a COVID-19 stumble, a withdrawn approval application and an extended PDUFA date, the FDA has approved CTI Biopharma Corp.’s Vonjo (pacritinib) for treating the bone marrow cancer myelofibrosis.
Despite Reata Pharmaceuticals Inc.’s complete response letter (CRL) for bardoxolone in treating kidney function loss in those with Alport syndrome, the street treated the company well on Feb. 28. The stock (NASDAQ:RETA) rose 25.3% as the company decides how it wants to handle the CRL.
Following an FDA advisory committee’s guidance in December that unanimously concluded the benefits of Reata Pharmaceuticals Inc.’s bardoxolone methyl do not outweigh the risks in treating a rare kidney disease, the FDA issued the company a complete response letter (CRL).
Three companies from the pharmaceutical and med-tech sectors are among this year’s most influential innovators, according to the newest edition of Clarivate plc’s Top 100 Global Innovators 2022. The pharmaceutical companies that were found to be the most innovative in the top 100 list are Johnson & Johnson, of New Brunswick, N.J., and Roche AG, of Basel, Switzerland. Royal Philips NV, of Amsterdam, was found to be the most innovative med-tech company in the top 100.
In the quest for regulatory approval for their COVID-19 vaccine, Sanofi SA and Glaxosmithkline plc (GSK) said they plan to submit their phase III and booster efficacy study data showing it induced a significant increase in neutralizing antibodies after a primary series of mRNA or adenovirus vaccines.
The FDA’s approval of Agios Therapeutics Inc.’s Pyrukynd (mitapivat) for treating hemolytic anemia marks a turnaround from nearly a year ago. That’s when Agios sold its commercial, clinical and research-stage oncology portfolio to privately held Servier Pharmaceuticals LLC to concentrate on rare diseases.
