Company

Product

Description

Indication

Status

Cormedix Inc., of Berkeley Heights, N.J.

Neutrolin

Catheter lock solution

Prevention of catheter-related bloodstream infection in hemodialysis patients

Received FDA feedback regarding statistical analyses requested for primary and secondary endpoints for Lock-It-100 study; based on feedback, company believes it has completed phase III development and does not need to conduct another trial at this time

Helix Biopharma Corp., of Richmond Hill, Ontario

L-DOS47

Targets tumor microenvironment

Metastatic pancreatic cancer

Submitted IND to FDA for a phase I/II trial in combination with doxorubicin

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

Keytruda (pembrolizumab)

Anti-PD-1 antibody

Multiple cancer indications

FDA accepted for review 6 supplemental BLAs to update dosing frequency to include an every-6-weeks schedule option for use in melanoma, classical non-Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, gastric cancer, hepatocellular carcinoma and Merkel cell carcinoma; PDUFA date is Feb. 18, 2020


Notes

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