Regulatory

Blythedale Children’s Hospital and Burke Neurological Institute announce the appointment of Dianna E. Willis, Ph.D., as Director of Research for the Burke-Blythedale Pediatric Neuroscience Research Collaboration.
FDA
Attain Stability(TM) Quad MRI SureScan(TM) Lead Designed for Precise Placement and Stability
Pharma, biotech and life science companies from across the globe share data and progress on pipelines and other company events.
The Christiana Care Health System’s Gene Editing Institute, based in Wilmington, Del., is pulling together a preliminary investigational new drug application (IND) for the U.S. Food and Drug Administration (FDA).
The CRL called for additional CMC and non-clinical information for the post-operative pain treatment. It did not specify any safety or efficacy concerns.
The FDA gave the nod to AbbVie’s Mavyret for all six strains of hepatitis C in children ages 12 to 17 years. The drug was approved for adults 18 years or older in 2017.
Nabriva Therapeutics announced that the Food and Drug Administration (FDA) had issued a Complete Response Letter (CRL) for its New Drug Application (NDA) for Contepo (Fosfomycin) to treat complicated urinary tract infections (cUTI), including acute pyelonephritis.
Gene Editing Institute’s study will be a novel investigation of the use of CRISPR technology to treat K-ras-positive non-small cell lung cancer
Karolinska Development AB has published its Annual Report for 2018.
Following the capital increase and listing on Nasdaq, cash and cash equivalents totaled €314.1 million as of March 31, 2019
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