Company

Product

Description

Indication

Status

Astrazeneca plc, of Cambridge, U.K. and Fibrogen Medical Technology Development Co. Ltd., of Beijing

Roxadustat

Hypoxia-inducible factor prolyl hydroxylase inhibitor

Anemia

NMPA granted marketing authorization for roxadustat in China for the treatment of anemia caused by chronic kidney disease in non-dialysis-dependent patients

Beigene Ltd., of Beijing

Zanubrutinib

BTK inhibitor

Mantle cell lymphoma

FDA accepted NDA for zanubrutinib for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy; priority review; PDUFA date: Feb. 27, 2020

Chrysalis Biotherapeutics Inc., of Galveston, Texas

TP-508 (rusalatide acetate)

Regenerative peptide

Radiation sickness

FDA and EMA granted orphan status for the treatment of acute radiation syndrome

Clearside Biomedical Inc., of Alpharetta, Ga.

Xipere (triamcinolone acetonide)

Suprachoroidal suspension of corticosteroid

Macular edema

FDA requested stability data for company's manufacturing process; expecting CRL on or before Oct. 19 PDUFA date; plans to re-submit NDA in 2020 Q1 with requested stability data

Genmab A/S, of Copenhagen, Denmark

Darzalex (daratumumab)

CD38-targeting human IgG1k mAb

Multiple myeloma

Approved in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma ineligible for autologous stem cell transplant in Japan

Luye Pharma Group Ltd., of Tokyo

LY-03005 (ansofaxine hydrochloride)

Extended release formulation of serotonin-norepinephrine-dopamine triple reuptake inhibitor

Depression

CTA filed in Japan; phase III trials in China and U.S. pivotal study both underway

Mundipharma International Corp. Ltd.

Invokana (canagliflozin)

SGLT-2 inhibitor

Non-insulin dependent diabetes

EMA has accepted license extension submission to treat type 2 diabetes patients with chronic kidney disease

Mundipharma International Corp. Ltd.

Vokanamet (canagliflozin and metformin)

Fixed dose SGLT-2 inhibitor + insulin sensitizer

Non-insulin dependent diabetes

EMA has accepted license extension submission to treat type 2 diabetes patients with chronic kidney disease

Mustang Bio Inc., of New York and St. Jude Children's Research Hospital, of Memphis, Tenn.

MB-107

Lentiviral gene therapy

Severe combined immunodeficiency syndrome

Granted RMAT designation by the FDA

Rocket Pharmaceuticals Inc., of New York

RP-L102

FANCA gene stimulator

Fanconi anemia

Spanish Agency for Medicines and Health Products cleared it to start enrollment in FANCOLEN-II phase II registration-enabling study; primary endpoint is the emergence of mitomycin-C resistance in bone marrow colony forming cells

Seelos Therapeutics Inc., of New York

SLS-005 (trehalose)

Low molecular weight disaccharide

Sanfilippo syndrome

Received FDA clearance to start phase IIb/III study to assess safety, tolerability and efficacy of trehalose IV in Sanfilippo A and B

Shinkei Therapeutics LLC, of Princeton, N.J.

MR-201

NMDA-antagonist

Emotional lability

Filed IND to test novel formulation for treatment of pseudobulbar affect


Notes

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

 

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