Company

Product

Description

Indication

Status

La Jolla Pharmaceutical Co., of San Diego

Giapreza (angiotensin II)

Vasoconstrictor

Refractory hypotension

EC approved the drug

Roche Holding AG, of Basel, Switzerland

Tecentriq (atezolizumab)

Monoclonal antibody targeting PD-L1

Unresectable locally advanced or metastatic triple-negative breast cancer

EC approved the drug in combination with Abraxane (nab-paclitaxel, Celgene Corp.)

Springworks Therapeutics Inc., of Stamford, Conn.

Nirogacestat

Gamma-secretase inhibitor

Progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis

FDA granted breakthrough designation

Trevena Inc., of Chesterbrook, Pa.

Oliceridine

Opioid

Moderate to severe acute pain

Company completed nonclinical work to characterize the 9662 inactive metabolite and finished the drug product validation reports that are required for an NDA resubmission, which is scheduled for the first quarter of 2020

Zensun USA Inc., of San Diego

Neucardin

Recombinant human neuregulin-1 fragment

Chronic heart failure

FDA granted fast tract designation; National Medical Products Administration in China granted a priority review for the conditional approval application


Notes

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

 

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