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


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


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


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


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


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