Astrazeneca plc, of Cambridge, U.K.

Farxiga (dapagliflozin)

SGLT2 inhibitor

Heart failure

FDA granted fast track designation

Bellerophon Therapeutics Inc., of Warren, N.J,

Nitric oxide

Gas delivered with the INOpulse system

Idiopathic pulmonary fibrosis

FDA granted orphan drug designation

CASI Pharmaceuticals Inc., of Rockville, Md.


CAR T targeting CD19

Relapsed B-cell acute lymphoblastic leukemia and B-cell non-Hodgkin lymphoma

Chinese National Medical Product Administration accepted the clinical trial application

Glenmark Pharmaceuticals Inc., of Mahwah, N.J.


Bispecific antibody targeting CD3 and CD38

Relapsed or refractory multiple myeloma

FDA granted orphan drug designation

Helsinn Healthcare SA, of Lugano, Switzerland, and Mundipharma China Pharmaceutical Co. Ltd., of Beijing

Akynzeo (netupitant/palonosetron)

Antagonist of substance P and NK1 receptors/binds 5-HT3 receptors

Chemotherapy-induced nausea and vomiting

Chinese National Medical Products Administration approved the oral formulation

Jaguar Health Inc., of San Francisco

Mytesi (crofelemer)

Inhibitor of cyclic adenosine monophosphate-stimulated cystic fibrosis transmembrane conductance regulator chloride ion (Cl¯) channel and calcium-activated Cl¯ channels

Noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy

Drug and Pharmacy Division of the Government of Puerto Rico Health Department approved registration of the drug

Janssen Pharmaceutical Co., a unit of New Brunswick, N.J.-based Johnson & Johnson

Tremfya (guselkumab)

Monoclonal antibody targeting the p19 subunit of interleukin-23

Active psoriatic arthritis

Submitted supplemental BLA to the FDA

Precision Biosciences Inc., of Durham, N.C.


Allogeneic anti-CD20 CAR T

Non-Hodgkin lymphoma

FDA accepted the IND; trial to start in the fourth quarter of 2019 with initial data expected in 2020

Seattle Genetics Inc., of Bothell, Wash., and Astellas Pharma Inc., of Tokyo

Enfortumab vedotin

Antibody-drug conjugate targeting nectin-4

Locally advanced or metastatic urothelial cancer after a PD-1/L1 inhibitor and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting

FDA accepted the BLA and granted a priority review; PDUFA action date of March 15, 2020

Tiziana Life Sciences plc, of London


Monoclonal antibody targeting CD3

Autoimmune and inflammatory diseases

FDA allowed start of a phase I study in healthy volunteers

Verrica Pharmaceuticals Inc., of West Chester, Pa.

VP-102 (cantharidin)

Activates the release of neutral serine proteases

Molluscum contagiosum

Submitted the 505(b)(1) NDA to the FDA

Wave Life Sciences Ltd., of Cambridge, Mass.


Oligonucleotide for exon 51 skipping

Duchenne muscular dystrophy

FDA granted fast track designation


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


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