Company

Product

Description

Indication

Status

Cstone Pharmaceuticals Co. Ltd., of Suzhou, China

CS-3002

Inhibits cyclin-dependent kinases 4 and 6

Advanced solid tumors

Study received ethics approval from the Human Research Ethics Committee in Australia and Australia's Therapeutic Goods Administration has acknowledged the electronic Clinical Trial Notification; plans to initiate the dose-escalation and dose-expansion study shortly

Glenmark Pharmaceuticals Ltd., of Mumbai

Fulvestrant

Generic of the estrogen receptor antagonist Faslodex (Astrazeneca plc)

Breast cancer

FDA granted final approval to the ANDA

Oxthera AB, of Stockholm

Oxabact 

Oxalobacter formigenes oxalate-degrading bacterium

Primary hyperoxaluria

EMA approved the pediatric investigational plan

Stalicla SA, of Geneva

STP1

2 undisclosed repurposed drugs

Autism spectrum disorder

Completed pre-IND meeting with the FDA; plans to start a phase Ib study in early 2020


Notes

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

 

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