Company

Product

Description

Indication

Status

Adial Pharmaceuticals Inc., of Charlottesville, Va.

AD-04

5-HT 3 receptor antagonist

Alcohol use disorder

CTA filed with Swedish Medical Products Agency for phase III trial in genetically targeted participants

Amryt Pharma plc, of London

AP-101 (Oleogel-S10)

Cyclooxygenase 2 stimulator

Epidermolysis bullosa

FDA granted fast track designation

Astrazeneca plc, of Cambridge, U.K.

PT-010 (budesonide/glycopyrronium/formoterol fumarate)

Fixed-dose combination of corticosteroid/long-acting muscarinic agonist/long-acting beta2-agonist

Chronic obstructive pulmonary disease

FDA issued complete response letter to NDA

Cabaletta Bio Inc., of Philadelphia

DSG3-CAART

Desmoglein-3 modulator

Mucosal pemphigus vulgaris

FDA cleared IND application to initiate first-in-human trial, expected to begin enrolling in 2020

Calliditas Therapeutics AB, of Stockholm

Nefecon

Modified-release oral formulation of corticosteroid budesonide

IgA nephropathy

EMA provided positive guidance on conditional marketing authorization of phase III asset

Evolus Inc., of Newport Beach, Calif.

Nuceiva (prabotulinumtoxinA)

900 kDa purified botulinum toxin type A formulation

Glabellar lines

European Commission approved for use to temporarily improve appearance of moderate to severe vertical lines between the eyebrows; decision applicable to all 28 EU member states plus Iceland, Norway and Liechtenstein

Geron Corp., of Menlo Park, Calif

Imetelstat

Telomerase inhibitor

Intermediate-2 or high-risk myelofibrosis

FDA granted fast track status for treatment of adults whose disease has relapsed after or is refractory to JAK inhibitor treatment, or relapsed/refractory MF; designation includes patients with primary MF and MF developed after essential thrombocythemia or polycythemia vera

Heron Therapeutics Inc., of San Diego

HTX-011

Dual-acting, fixed-dose combination of local anesthetic bupivacaine and low dose nonsteroidal anti-inflammatory drug meloxicam

Postoperative pain

Resubmitted NDA to FDA, based on outcome and final minutes of type A meeting to discuss April 2019 complete response letter; anticipates 6-month review

Lobsor Pharmaceuticals AB, of Uppsala, Sweden

Lecigon

Gel formulation of levodopa/carbidopa and entacapone in a 50-ml prefilled container for continuous infusion into small intestine

Parkinson's disease

Product approved, and Swedish Medical Products Agency confirmed end of procedure, according to European Mutual Recognition Procedure, including Denmark, Finland and Norway

Ziopharm Oncology Inc., of Boston

CD19-specific CAR T therapy

CAR T produced using rapid personalized manufacturing

Relapsed CD19-positive leukemias and lymphomas

FDA cleared an IND for a phase I study

Notes

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

 

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