Food and Drug Administration (FDA)
NEWS
One year after stepping down from her role as president and chief operating officer of Celgene, Jacqualyn (Jackie) Fouse has taken over the reins of Cambridge, Mass.-based Agios Pharmaceuticals.
As we move into the last quarter of 2018, plenty of companies are looking at potential catalysts. George Budwell, writing for The Motley Fool, takes a look at three potentially high-reward biotech companies, but along with their big catalysts comes high risk.
It hasn’t been a particularly good year for Celgene. But, are company shares about to bounce back? Some analysts think so.
EMD Serono is shaking up its leadership. The biopharmaceutical arm of Germany-based Merck KGaA named Rehan Verjee as the new president of EMD Serono and global head of innovative medicine franchises at the parent company.
Researchers at the University of Texas Southwestern Medical Center used CRISPR gene editing to treat Duchenne muscular dystrophy (DMD) in dogs. Their work was published in the journal Science.
The U.S. Food and Drug Administration has had a busy August. In addition to the number of draft guidance documents the agency issued during the month, the FDA has also been busy approving a number of new treatments for a variety of diseases.
Nearly two months ahead of the planned PDUFA date, the U.S. Food and Drug Administration approved two new HIV-1 treatments developed by Merck. The FDA gave the go ahead for Delstrigo, a once-per day triple combination treatment and Pifeltro, a new non-nucleoside reverse transcriptase inhibitor.
The U.S. FDA announced a new pilot program aimed at stimulating the use of complex innovative clinical trial designs for drugs and biologics. Announced on Wednesday, August 29, the pilot program will continue through September 30, 2022.
Maryland-based REGENXBIO is expanding its gene therapy pipeline to include a new treatment for late-infantile neuronal ceroid lipofuscinosis type 2 (CLN2) disease, one of the most common forms of Batten disease.
JOBS
IN THE PRESS