Company

Product

Description

Indication

Status

Actobio Therapeutics Inc., of Ghent, Belgium, wholly owned subsidiary of Intrexon Corp., of Germantown, Md.

AG-017

Oral Actobiotic consisting of genetically engineered Lactococcus lactis

Celiac disease

FDA approved IND application for phase Ib/IIa study in the U.S. and Europe, expected to begin enrollment this year

Clarus Therapeutics Inc., of Northbrook, Ill.

Jatenzo (testosterone undecanoate)

Androgen receptor agonist

Hypogonadism

FDA granted 3-year market exclusivity

Glenmark Pharmaceuticals Ltd., of Mumbai

Remo-M/Remozen-M (remogliflozin etabonate + metformin hydrochloride)

Sodium glucose co-transporter-2 + AMP activated protein kinase stimulator

Type 2 diabetes

Combination therapy approved in India to treat adults

Pharmamar SA, of Madrid, Spain

Lurbinectedin

RNA polymerase II inhibitor and TAT protein inhibitor

Small-cell lung cancer

Company plans to file NDA with FDA in fourth quarter, using accelerated approval pathway following discussion with agency, seeking approval for second-line treatment

Vanda Pharmaceuticals Inc., of Washington

Hetlioz (tasimelteon)

Dual melatonin MT1/MT2 receptor agonist

Jet lag disorder

Company said FDA issued complete response letter to sNDA, citing unclear clinical significance of findings that patients reported sleeping nearly 3 hours longer over 3 nights following transatlantic trip when treated than they did over 3 nights following untreated transatlantic trip


Notes

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

 

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