Regulatory
FDA grants elafibranor Breakthrough Therapy Designation, based on Phase 2 data, for treatment of PBC (Primary Biliary Cholangitis) in adults with inadequate response to UDCA
Director Peter Marks said FY18 was productive and exciting as the FDA department continued to support the advancement of 21st century medicine.
COPD is a progressive disease associated with tobacco smoking, air pollution or occupational exposure. It results in difficulties in breathing and increasing episodes of breathlessness.
As Ned Sharpless takes over as acting commissioner of the U.S. Food and Drug Administration, he is not planning any disruptions or course corrections to the federal regulatory agency.
Poietis, 4D Bioprinting company, announces the issuance by the European Patent Office of a third patent covering its bioprinting technology
Company on Track to Submit NDA to FDA in Mid-2019
Karolinska Development’s portfolio company Aprea Therapeutics has from FDA received an Orphan Drug Designation for APR-246 for the treatment of patients with Myelodysplastic Syndromes having a TP53 mutation.
MediciNova, Inc. announced that the U.S. Food and Drug Administration has completed its review of the protocol and determined that MediciNova may proceed with a Phase 2b/3 clinical trial of MN-166 in amyotrophic lateral sclerosis.
Novartis will use a priority review voucher to expedite review of the treatment that could hit blockbuster status within two years of launching.
The vast majority of immune cells are found in the gut but historically, the gut has been viewed as a liability to drug development. The question of whether or not greater understanding of harnessing the gut could drive more promising drug development has led to the formation of a new company, Kintai Therapeutics.
PRESS RELEASES