Company

Product

Description

Indication

Status

Almirall LLC, of Exton, Pa., a unit of Almirall SA

Aczone (7.5% gel)

Dapsone

Acne

FDA expanded approval to include patients, ages 9-11, in treating inflammatory and non-inflammatory acne

Bioxcel Therapeutics Inc., of New Haven, Conn.

BXCL-701

Inhibits dipeptidyl peptidase 8/9 and blocks immune evasion by targeting fibroblast activation protein

Acute myeloid leukemia

FDA granted orphan drug designation

Merck KGaA, of Darmstadt, Germany

Tepotinib

MET inhibitor

Metastatic non-small-cell lung cancer

FDA granted breakthrough designation for use in patients whose disease harbors MET exon 14 skipping alterations and who progressed following platinum-based cancer therapy

Omeros Corp., of Seattle

Narsoplimab

Monoclonal antibody targeting mannan-binding lectin-associated serine protease-2

Hematopoietic stem cell transplant-associated thrombotic microangiopathy

FDA agreed with the company's proposed schedule for the rolling submission of the BLA

Prevail Therapeutics Inc., of New York

PR-009

Gene therapy

Neuronopathic Gaucher disease

Following discussions with FDA after submitting IND, company is modifying design of phase I/II trial to start at a higher dose than originally proposed; IND for pediatric nGD placed on clinical hold, pending FDA review of amendment detailing that trial modification; trial start now expected in first half of 2020

Puma Technology Inc., of Los Angeles

Nerlynx (neratinib)

Inhibitor of HER2 and EGFR

HER2-positive metastatic breast cancer

FDA accepted the supplemental NDA seeking use in patients who have failed 2 or more prior lines of HER2-directed therapy; PDUFA action date in late April 2020

Teva Pharmaceutical Industries Ltd., of Jerusalem

Herzuma (trastuzumab)

Biosimilar of HER2-targeting antibody Herceptin

Breast and gastric cancers

Canadian subsidiary received Health Canada notice of compliance for Herzuma to treat adults with early breast cancer, metastatic breast cancer and metastatic gastric cancer

United Therapeutics Corp., of Silver Spring, Md.

Trevyent (treprostinil)

Patchpump delivering the vasodilator

Pulmonary arterial hypertension

FDA accepted the NDA; PDUFA action date of April 27, 2020


Notes

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

 

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