Sept 21 (Reuters) - U.S. Food and Drug Administration (FDA)::FDA warns about serious liver injury with Ocaliva for rare chronic liver disease.Says Ocaliva (Obeticholic Acid) medicine of Intercept Pharmaceuticals being incorrectly dosed in some patients.
Sept 21 (Reuters) - Biocryst Pharmaceuticals Inc :Biocryst’s Rapivab (peramivir injection) receives FDA approval for a pediatric indication.Biocryst Pharmaceuticals Inc - FDA has approved a supplemental new drug application for Rapivab.
Sept 21 (Reuters) - BIOORGANIC RESEARCH AND SERVICES SA ::SAYS GETS PATENT IN CHINA FOR ITS MOLECULE USEFUL IN IMMUNOTHERAPY FOR LEISHMANIASIS.
Sept 20 (Reuters) - PhaseRx Inc ::PhaseRx receives Orphan Drug Designation from FDA for PRX-ASL for the treatment of Argininosuccinate Lyase Deficiency.
Sept 20 (Reuters) - Jaguar Health Inc ::FDA indicates that jaguar’s Canalevia drug product candidate qualifies as “minor use” for Exercise-Induced Diarrhea (EID) in dogs, rendering Canalevia eligible for conditional approval for this indication.Jaguar Health Inc - expects to conduct commercial launch of Canalevia in first half of 2018 for EID and CID in dogs.
Sept 20 (Reuters) - KIADIS PHARMA NV ::KIADIS PHARMA RECEIVES FDA REGENERATIVE MEDICINE ADVANCED THERAPY (RMAT) DESIGNATION FOR ATIR101™.IN EUROPE ATIR101 WAS FILED FOR REGISTRATION IN APRIL 2017 AND WE CONTINUE TO PREPARE COMPANY FOR POTENTIAL EUROPEAN LAUNCH IN 2019 - CEO.
Sept 19 (Reuters) - ProQR Therapeutics NV :ProQR receives orphan drug designation from FDA for drug candidate QR-313 for dystrophic epidermolysis bullosa and will present data at two scientific conferences.ProQR Therapeutics NV - first-in-human clinical trial of QR-313 will be initiated in 2018.ProQR Therapeutics NV - clinical data from QR-313 program will also be available in 2018.
Sept 18 (Reuters) - Pluristem Therapeutics Inc :U.S. FDA grants fast track designation to Pluristem's PLX-PAD for the treatment of Critical Limb Ischemia (cli).Pluristem Therapeutics Inc - Pluristem's ongoing phase III cli trial has been selected for accelerated approval pathways in both U.S. and Europe.
Sept 18 (Reuters) - Biocon Ltd :Says Biocon's facility in Vishakhapatnam completes USFDA inspection with no observations.
Sept 18 (Reuters) - THROMBOGENICS NV ::THROMBOGENICS NV : THROMBOGENICS REGAINS GLOBAL RIGHTS TO JETREA (OCRIPLASMIN).ALCON AND NOVARTIS WILL WORK CLOSELY WITH THROMBOGENICS TO ENSURE CONTINUITY AND ACCESS TO JETREA FOR CUSTOMERS..UNDER THE TERMS OF THE AGREEMENT, THROMBOGENICS RECEIVES A CASH AMOUNT OF €53.7 MILLION AND A FORTHCOMING EQUITY INVESTMENT OF €10 MILLION IN THROMBOGENICS CAPITAL. .