Discgenics Inc., of Salt Lake City

IDCT

Allogeneic injectable disc cell therapy

Degenerative disc disease

Japan's PMDA approved a clinical trial notification application; 38-patient study expected to begin enrolling patients in Japan in first half of 2019

Diurnal Group plc, of Cardiff, U.K.

Chronocort

Modified-release hydrocortisone

Congenital adrenal hyperplasia

Submitted regulatory package requesting scientific advice to EMA; subject to favorable outcome, company anticipates submitting MAA in the fourth quarter of 2019

Intra-Cellular Therapies Inc., of New York

Lumateperone

Modulates serotonin, dopamine and glutamate

Schizophrenia

FDA accepted for review the NDA; PDUFA date is Sept. 27, 2019

Portola Pharmaceuticals Inc., of South San Francisco

Ondexxya (andexanet alfa)

Recombinant modified version of human activated factor X

Anticoagulant for factor Xa inhibitors apixaban and rivaroxaban

EMA's Committee for Medicinal Products for Human Use (CHMP) extended the review period for the MAA, with an opinion now expected by Feb. 28, 2019; CHMP canceled oral explanation scheduled for Dec. 12, 2018

Zambon SpA, of Bresso, Italy

Colistimethate sodium powder for nebulizer solution

Antibiotic

Non-cystic fibrosis bronchiectasis

FDA granted fast track and qualified infectious disease product designations

Notes

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