Company

Product

Description

Indication

Status

Allergan Inc., of Dublin

Juvéderm Voluma XC

Hyaluronic acid gel dermal filler

Age-related volume deficit in the mid-face

FDA approved use of the filler with a TSK Steriglide cannula

Calliditas Therapeutics AB, of Stockholm

Nefecon

2-step release of budesonide

IgA nephropathy

Received written feedback from the FDA allowing design change of part B of the NefIgard study; endpoint will now be a 2-year eGFR readout; study size is reduced from 450 to 360 patients for parts A and B combined; patients will be allowed to roll over into a repeat-dosing study prior to completing the 2-year study

Carsgen Therapeutics, of Shanghai

CT-053

CAR T targeting BCMA

Multiple myeloma

FDA granted orphan drug designation

Forty Seven Inc., of Menlo Park, Calif.

Magrolimab (5F9)

Monoclonal antibody against CD47

Myelodysplastic syndrome and acute myeloid leukemia

FDA granted fast track designation

Genetx Biotherapeutics LLC, of Sarasota, Fla., and Ultragenyx Pharmaceutical Inc., of Novato, Calif.

GTX-102

Antisense oligonucleotide inhibiting expression of UBE3A-AS

Angelman syndrome

FDA granted orphan designation and rare pediatric disease designation

Inotrem SA, of Paris

Nangibotide

TREM-1 inhibitor

Septic shock

FDA granted fast track designation

Janssen Pharmaceutical Cos., of Leiden, the Netherlands, a unit of Johnson & Johnson

Prophylactic RSV senior vaccine

Vaccine

Prevention of respiratory syncytial virus-mediated lower respiratory tract disease

FDA granted breakthrough therapy designation for use in adults, 60 and older

Kowa Co. Ltd., of Nagoya, Japan

K-321

Rho kinase inhibitor

Corneal endothelial diseases

Submitted IND to the FDA for a phase II study

Kuros Biosciences AG, of Zurich, Switzerland

Fibrin-PTH (KUR-113)

Natural fibrin-based healing matrix with truncated human PTH analogue

Degenerative disc disease

FDA approved IND for a phase IIa trial to test use in single-level transforaminal lumbar interbody fusion procedures, with autograft as comparator

OBI Pharma Inc., of Taipei, Taiwan

OBI-999

Antibody-drug conjugate targeting glycolipid antigen Globo H

Advanced solid tumors

FDA cleared the IND for a phase I/II study


Notes

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

 

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