Company

Product

Description

Indication

Status

Eisai Co. Ltd., of Tokyo

Lenvima (lenvatinib)

Multiple kinase inhibitor

Endometrial carcinoma

Granted accelerated approval by FDA, as part of Project Orbis, in conjunction with decisions by Australia's TGA and Health Canada; cleared for use in combination with Keytruda (pembrolizumab, Merck & Co. Inc.) in patients with advanced disease that is not microsatellite instability-high or mismatch repair deficient and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation

Merck & Co. Inc., of Kenilworth, N.J.

V-920

Ebola vaccine

Ebola Zaire virus infection prophylaxis

FDA accepted the BLA and granted a priority review; PDUFA action date is March 14, 2020

Transgene SA, of Strasbourg, France

TG-4050

Myvac individualized immunotherapeutic candidate

Solid tumors

Received approval from France's National Agency for the Safety of Medicines and Health Products to proceed with 2 phase I trials, 1 in newly diagnosed, locoregionally advanced human papillomavirus-negative squamous cell carcinoma of the head and neck and 1 in ovarian cancer

Vertical Pharmaceuticals LLC, of Bridgewater, N.J., a unit of Osmotica Pharmaceuticals plc

RVL-1201 (oxymetazoline)

Alpha-adrenergic receptor agonist

Acquired blepharoptosis

NDA submitted to the FDA

Notes

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

 

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