Janssen Pharmaceutical Cos., of Titusville, N.J., part of Johnson & Johnson

Esketamine nasal spray

Glutamate receptor modulator

Treatment-resistant depression

Submitted NDA to the FDA

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

Keytruda (pembrolizumab)

Anti-PD-1 antibody

Recurrent locally advanced or metastatic Merkel cell carcinoma

FDA accepted and granted priority review to supplemental BLA seeking accelerated use in adult and pediatric patients

Portola Pharmaceuticals Inc., of South San Francisco

Andexxa

Coagulation factor Xa (recombinant), inactivated

Anticoagulant reversal

Submitted a prior approval supplement to the FDA for large-scale generation 2 manufacturing process

Puma Biotechnology Inc., of Los Angeles

Nerlynx (neratinib)

Kinase inhibitor

Early stage, hormone receptor-positive HER2-overexpressed/amplified breast cancer

European Commission granted marketing authorization for use in patients who are less than 1 year from the completion of prior adjuvant trastuzumab-based therapy

Recro Pharma Inc., of Malvern, Pa.

I.V. meloxicam

Long-acting preferential COX-2 inhibitor

Management of moderate to severe pain

Based upon discussion at July type A meeting with FDA, the company anticipates resubmitting NDA by the end of September 2018

Sanofi SA, of Paris

Cablivi (caplacizumab)

Bivalent anti-vWF Nanobody

Acquired thrombotic thrombocytopenic purpura

Approved by European Commission for treating adults experiencing an episode of aTTP

Vertex Pharmaceuticals Inc., of Boston

Orkambi (lumacaftor/ivacaftor)

CFTR corrector/CFTR potentiator

Cystic fibrosis

Finalized agreement with Australian government allowing for reimbursement for patients, 6 and older, with CF who have 2 copies of the F508del mutation in the CFTR gene

Notes

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