Regulatory
Santhera Pharmaceuticals announces that the UK’s Medicines and Healthcare Products Regulatory Agency has informed ReveraGen BioPharma about having designated vamorolone as Promising Innovative Medicine for the treatment of Duchenne muscular dystrophy
Minoryx Therapeutics announces that its lead drug candidate, leriglitazone (MIN-102), has been granted Orphan Drug Designation in Friedreich’s Ataxia by the US Food and Drug Administration (FDA).
Potential approval would validate the use of Algenex’ CrisBio® technology for the manufacture of recombinant subunit vaccines
Biocair, a global leader in specialist logistics, announced that its Frankfurt office has joined the company’s network of ISO 9001:2015 certified operations.
The Dutch company Xenikos B.V. announced that the U.S. Food and Drug Administration has granted Fast Track designation to T-Guard, Xenikos’ flagship product designed to treat steroid-refractory acute graft-versus-host disease in patients following allogeneic stem cell transplantation.
Motif Bio plc announced that the Company has received the official minutes of the Type B meeting with the U.S. Food & Drug Administration which took place on September 19, 2019..
New DAS organization within cluster reflects changes in health ecosystem and integrates techno-therapies
Heidelberg Pharma AG reported on the first nine months of fiscal year 2019 and the Group’s financial figures.
In September, House Speaker Nancy Pelosi unveiled a plan to lower prescription drug prices covered by government-funded plans that include tying those medications to an International Pricing Index – a move the pharmaceutical industry opposes wholeheartedly.
BioCardia announced renewal of the CE Mark for the Helix™ Biotherapeutic Delivery Catheter and Morph® Universal Deflectable Guide Catheter, both used in the delivery of biotherapeutics to the heart.
PRESS RELEASES