Company

Product

Description

Indication

Status

Allergan plc, of Dublin

Botox (onabotulinumtoxinA)

Acetylcholine receptor antagonist; p130Cas associated protein inhibitor

Pediatric upper and lower limb spasticity

FDA accepted sBLAs, designating priority review for upper limb spasticity indication with PDUFA date expected in second quarter, and standard review for lower limb spasticity with PDUFA date expected in fourth quarter

CASI Pharmaceuticals Inc., of Rockville, Md.

Marqibo (vincristine sulfate liposome injection)

Tubulin modulator

Philadelphia chromosome-negative acute lymphoblastic leukemia

China's NMPA approved clinical trial application for registration trial

Cytori Therapeutics Inc., of San Diego

Doxorubicin hydrochloride Cytori (previously ATI-0918)

Albumin-stabilized liposomal microtubule inhibitor

Breast and ovarian cancer, multiple myeloma, Kaposi's sarcoma

Filed NDA pre-submission request to EMA as precursor to filing marketing authorization application under centralized approval procedure

Foamix Pharmaceuticals Ltd., of Rehovot, Israel

FMX-101

Tetracycline antibiotic

Moderate to severe acne vulgaris

FDA accepted NDA for review, setting PDUFA date of Oct. 20, 2019

Genentech, unit of Roche Holding AG, of Basel, Switzerland, and Abbvie Inc., of North Chicago

Venclexta (venetoclax)

BCL-2 protein inhibitor

Chronic lymphocytic leukemia

Submitted an sNDA to the FDA for use, in combination with Gazyva (obinutuzumab, Roche), in those with previously untreated disease; agency granted breakthrough therapy designation in the indication and plans to review application under Real-Time Oncology Review pilot


Notes

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