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Eli Lilly and Boehringer Ingelheim received a complete response letter from the FDA for their supplemental NDA for Jardiance (empagliflozin) 2.5mg as an adjunct to insulin for adults with type 1 diabetes. Read More
State pharmacy boards in Idaho, Ohio, Nevada and Texas are restricting prescriptions of certain drugs that may hold potential in treating the coronavirus, including chloroquine and hydroxychloroquine, following a spike in demand. Read More
Dozens of clinical trials are being put on hold as the clinical trial industry grapples with the fallout from COVID-19. The outbreak has put the brakes on virtually all new trials being planned, except those focused on COVID-19 vaccines and treatments. Read More
Windlas Healthcare drew a warning letter from the FDA after agency investigators found serious data integrity violations at its API manufacturing facility in Uttarakhand, northern India. Read More
Biogen has filed suit against New York-based Creative Biolabs, claiming that the company has been copying its patented Alzheimer’s drug candidate aducanumab and selling imitation products to researchers online. Read More
Sponsors in the EU should conduct risk assessments of all trial procedures in the face of the COVID-19 outbreak, according to a guidance issued by the European Medicines Agency (EMA) on Friday that also suggests they should hold off on initiating trials or adding participants to current trials. Read More
Several drugmakers have committed to donating antimalaria treatments chloroquine and hydroxychloroquine after the Trump Administration showed interest in the drugs as potential COVID-19 treatments. Read More
The pace of research is ramping up as drugmakers and organizations accelerate efforts on COVID-19 treatment and vaccine candidates, with a number of accomplishments recently, especially for vaccines: Read More