Company Product Description Indication Status
3DBio Therapeutics Inc., of New York Aurinovo 3D-bioprinted tissue seeded with patient's own auricular cartilage cells Reconstruction of outer ear in microtia FDA granted rare pediatric disease designation for drug-device combination product
Amgen Inc., of Thousand Oaks, Calif. Avsola (infliximab-axxq) Biosimilar to Remicade (infliximab) Rheumatoid arthritis and other autoimmune disorders Approved by FDA
Aptevo Therapeutics Inc., of Seattle APVO-436 Bispecific antibody Acute myelogenous leukemia FDA granted orphan designation
Bristol-Myers Squibb Co., of Princeton, N.J. Reblozyl (luspatercept-aamt) Erythroid maturation agent Anemia in adults with very low- to intermediate-risk myelodysplastic syndromes Notified by FDA that supplemental BLA will not be reviewed by Oncology Drugs Advisory Committee set for Dec. 18, 2019; sBLA seeking approval for use in patients who have ring sideroblasts and require red blood cell transfusions
Intellipharmaceutics International Inc., of Toronto Aximris XR Abuse-deterrent oxycodone hydrochloride extended-release tablets Pain management Joint meeting of FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee will discuss NDA during Jan. 15, 2019, meeting
Ipsen SA, of  Paris Palovarotene Small-molecule retinoic acid receptor gamma agonist Fibrodysplasia ossificans progressiva and multiple osteochondromas FDA placed partial clinical hold for pediatric population under age 14 for studies conducted under IND120181 and IND135403; hold follows safety reports of early growth plate closure in pediatric patients with FOP treated with palovarotene; studies are allowed to continue in patients 14 and older
Y-mabs Therapeutics Inc., of New York Omburtamab Targets tumors expressing B7-H3 CNS/leptomeningeal metastases from neuroblastoma EMA agreed to company’s proposed pediatric investigation plan

Notes

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

No Comments