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13 April 2015 | By Victoria White
The FDA has modified the partial clinical hold on the IND for TKM-Ebola to permit repeat dosing of healthy volunteers at a dose of 0.24 mg/kg/day...
13 April 2015 | By Victoria White
ReNeuron has announced that it has filed an Investigational New Drug (IND) application with the United States Food and Drug Administration (FDA) to commence a Phase I/II clinical trial with its human Retinal Progenitor Cell (hRPC) therapy candidate for retinitis pigmentosa (RP).
13 April 2015 | By Victoria White
ABIVAX, a biotechnology company developing first-in-class anti-viral drugs and vaccines, has announced publication of the mechanism of action of ABX464...
13 April 2015 | By Victoria White
Novo Nordisk has opened a manufacturing facility in the Kaluga region of Russia for formulation and filling of modern insulin for the treatment of diabetes...
13 April 2015 | By Victoria White
Shire has announced that the FDA has accepted for filing the New Drug Application (NDA) for Lifitegrast and granted a Priority Review designation...
13 April 2015 | By Victoria White
DBV Technologies has announced that the FDA has granted Breakthrough Therapy Designation to Viaskin Peanut for children with peanut allergies...
10 April 2015 | By Yusen Logistics
Yusen Logistics was initially appointed by this leading global pharmaceutical manufacturer to implement lean principles in 2007, which involved re-engineering its European flows as part of its international requirement to deliver over 1 billion packs to patients...
Yusen Logistics’ European Pharmaceutical Superhighway is contracted to carry over 1.25 million pallets this year, providing both shared and single use solutions to highly complex supply chain requirements for customers ranging from global manufacturers to small biotech companies.
9 April 2015 | By Victoria White
MedImmune has announced that it has received fast track designation from the U.S. Food and Drug Administration (FDA) for the development of MEDI8897...
9 April 2015 | By Victoria White
INO-3112 DNA immunotherapy has generated strong T cell responses in patients with head and neck cancer associated with human papillomavirus (HPV)...
9 April 2015 | By Victoria White
Exelixis has announced that the FDA has granted Fast Track designation to cabozantinib for treatment of patients with advanced renal cell carcinoma...
9 April 2015 | By Victoria White
Santhera has announced that the FDA has granted Fast Track designation for Santhera's Raxone/Catena for the treatment of Duchenne Muscular Dystrophy...
9 April 2015 | By Victoria White
Shire has announced that the Phase 2 IMAGO trial of its investigational compound SHP625 did not meet the primary or secondary endpoints...
9 April 2015 | By Victoria White
Merck has announced that grazoprevir/elbasvir has received two new Breakthrough Therapy designations from the U.S. Food and Drug Administration (FDA)...
9 April 2015 | By Victoria White
Genetic screening could improve doctors’ ability to work out which women are at increased risk of developing breast cancer, a major study has shown...
