Company

Product

Description

Indication

Status

Date


Argenx SE, of Breda, the Netherlands

Efgartigimod (ARGX-113)

Fc-portion of an antibody with increased affinity for FcRn

Generalized myasthenia gravis

Received feedback from the Pharmaceuticals and Medical Devices Agency in Japan for a 150-patient, placebo-controlled study that the company plans to start before the end of 2018

8/29/18

Beigene Ltd., of Beijing

Tislelizumab

Anti-PD-1 antibody

Hodgkin's disease

CNDA accepted NDA for drug in relapsed/refractory classical Hodgkin's lymphoma

8/31/18

Reflection Biotechnologies Ltd., of Hong Kong

RBIO-101

Gene therapy

Bietti's Crystalline Dystrophy

FDA granted orphan drug designation

8/28/18

Sirona Biochem Corp., of Vancouver, British Columbia

TFC-039

SGLT-2 inhibitor

Non-insulin dependent diabetes

Received $500,000 milestone payment from partner Wanbang Biopharmaceuticals Co. Ltd. for approval by the CNDA of phase I trial

8/28/18


Notes

The date indicated refers to the BioWorld Regulatory actions table in which the news item can be found.

For more information about individual companies and/or products, see Cortellis.

No Comments