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FDA warns about serious liver injury with Ocaliva for rare chronic liver disease

12:20pm EDT

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.

Biocryst’s Rapivab receives FDA approval for a pediatric indication

6:00am EDT

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​.

Bionaturis gets patent for BNT005 in China

4:37am EDT

Sept 21 (Reuters) - BIOORGANIC RESEARCH AND SERVICES SA ::SAYS GETS PATENT IN CHINA FOR ITS MOLECULE USEFUL IN IMMUNOTHERAPY FOR LEISHMANIASIS.

PhaseRx receives Orphan Drug Designation from FDA for PRX-ASL

Wednesday, 20 Sep 2017 02:08pm EDT

Sept 20 (Reuters) - PhaseRx Inc ::PhaseRx receives Orphan Drug Designation from FDA for PRX-ASL for the treatment of Argininosuccinate Lyase Deficiency.

Jaguar Health says FDA indicates co's Canalevia drug qualifies as “minor use” for exercise-induced diarrhea in dogs

Wednesday, 20 Sep 2017 09:00am EDT

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.

Kiadis Pharma receives FDA regenerative medicine advanced therapy (RMAT) designation for ATIR101

Wednesday, 20 Sep 2017 01:00am EDT

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​.

ProQR gets orphan drug designation from FDA for drug candidate QR-313

Tuesday, 19 Sep 2017 07:00am EDT

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.

U.S. FDA grants fast track designation to Pluristem's PLX-PAD for treating Critical Limb Ischemia

Monday, 18 Sep 2017 07:00am EDT

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.

Biocon says US FDA completes inspection with no observations for Vishakhapatnam facility

Monday, 18 Sep 2017 06:15am EDT

Sept 18 (Reuters) - Biocon Ltd :Says Biocon's facility in Vishakhapatnam completes USFDA inspection with no observations.

Thrombogenics regains global rights to Jetrea

Monday, 18 Sep 2017 01:30am EDT

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. ​.

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