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BioWorld Science

Dec. 21, 2016

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ProMetic Life Sciences begins rolling submission of BLA for plasminogen

Phase I and phase II extension study results for fitusiran

Sage Therapeutics begins phase II program for SAGE-217 in mood disorders

Phase III study of closed triple combination therapy for asthma begins

Spring Bank and Arbutus to collaborate on preclinical studies of combination for HBV

FDA grants breakthrough therapy designation for TNX-102 SL

Circuit Therapeutics and Lundbeck enter research collaboration

Highly selective spleen tyrosine kinase inhibitor shows potential for autoimmune diseases

Topline results from an intranasal human abuse potential study of Egalet-002

FDA grants priority review to Tesaro's NDA for niraparib

Phase Ia/b data for chimeric fibril-reactive mAb 11-1F4 in patients with AL amyloidosis

Novel CD33-specific CAR T cells show promise in in vitro and in vivo models of AML

Novel forward-oriented therapeutic vector for hemoglobin disorders

JCAR-017 obtains FDA breakthrough therapy designation and EMA PRIME access

FDA grants fast track designation to ASP-0892

MediciNova's MN-166 granted orphan drug status in E.U. for ALS

GlaxoSmithKline patents KMO inhibitors

FDA accepts for review NDA for CCP-08

Sunshine Lake Pharma discloses 5-HT reuptake inhibitors and/or 5-HT1A receptor agonists

Rugen Holdings describes NR2B receptor antagonists

Teijin Pharma develops CDK4/cyclin D3 and CDK6/cyclin D3 inhibitors

Jiangsu Tasly Diyi Pharmaceutical presents antiviral agents

FDA extends PDUFA date for Genentech's ocrelizumab

Janssen applies for approval of daratumumab in Japan

Diurnal submits European pediatric use marketing authorization application for Infacort

Apellis Pharmaceuticals' APL-2 earns fast track designation from FDA

Akebia and Otsuka Pharmaceutical collaborate to develop and commercialize vadadustat in the U.S.

Allergan to acquire LifeCell

FDA gives fast track designation to KemPharm's KP201/IR

Circadian Therapeutics formed as a new Oxford spinout to study sleep and circadian rhythms

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