Company

Product

Description

Indication

Status

Diamedica Therapeutics Inc., of Minneapolis

DM-199

Recombinant human serine protease kallikrein

Chronic kidney disease

FDA accepted the clinical trial protocol for the phase II study; company plans to start enrollment in the next few weeks

Eli Lilly and Co., of Indianapolis

Reyvow (lasmiditan)

Serotonin (5-HT)1F receptor agonist

Migraine

FDA approved the drug

Flexion Therapeutics Inc., of Burlington, Mass.

Zilretta (triamcinolone acetonide)

Extended-release glucocorticoid

Osteoarthritis knee pain

FDA needs additional time to review the supplemental NDA requesting revision of the label to include data from a phase IIIb study testing repeat administration of the drug; agency indicated that the review would be complete in the coming weeks and hasn't requested any additional clinical data; PDUFA action date was Oct. 14, 2019

I-Mab Biopharma Co. Ltd., of Shanghai and Morphosys AG, of Martinsried, Germany

TJ-202/MOR-202

Monoclonal antibody targeting CD38

Multiple myeloma

National Medical Products Administration of China cleared the IND for phase II and phase III studies

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

Xarleto (rivaroxaban)

Factor Xa inhibitor

Prevention of venous thromboembolism in hospitalized acutely ill medical patients at risk for thromboembolic complications who are not at high risk of bleeding

FDA approved the expanded label

Pfenex Inc., of San Diego

PF-708

Portion of human parathyroid hormone

Osteoporosis

Company submitted data from a human factors study to the FDA to seek designation of PF-708 as a therapeutically equivalent "A" rated drug to Forteo

Ultragenyx Pharmaceutical Inc., of Novato, Calif.

UX-007 (triheptanoin)

Medium-chain triglyceride

Long-chain fatty acid oxidation disorders

FDA accepted the NDA and assigned a PDUFA action date of July 31, 2020

Xenikos BV, of Nijmegen, the Netherlands

T-Guard

Toxin-conjugated monoclonal antibodies that target CD3 and CD7 on T cells and NK cells

Steroid-refractory acute graft-vs.-host disease following allogeneic stem cell transplantation

FDA granted fast track designation

Notes

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

 

No Comments