Weekly drug pipeline calendar (July25 - July29)

BioPharm Insight US wrote a column · Jul 22, 2022 17:19

- $Arcutis Biotherapeutics (ARQT.US)$ announced that Health Canada has accepted for review the New Drug Submission (NDS) for roflumilast cream 0.3% for the treatment of plaque psoriasis in adults and adolescents.

Roflumilast cream (ARQ-151) is a once-daily topical formulation of roflumilast, a highly potent and selective inhibitor of phosphodiesterase type 4 (PDE4), an enzyme that drives overactive immune responses. A new drug application (NDA) for roflumilast cream for the treatment of plaque psoriasis in adolescents and adults is also under review by the U.S. Food & Drug Administration (FDA). The FDA has set a target action date of July 29, 2022.

Weekly drug pipeline calendar (July25 - July29)

* PDUFA: The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authorizes FDA to collect fees from companies that produce certain human drug and biological products. Since the passage of PDUFA, user fees have played an important role in expediting the drug approval process.

* NDA Filing means a New Drug Application filed as a result of activities under this Agreement with the FDA, or the equivalent application to the equivalent agency in any other country of the Territory, the filing of which is necessary to market and sell a Product.

* A BLA is submitted by any legal person or entity who is engaged in manufacture or an applicant for a license who takes responsibility for compliance with product and establishment standards.

Travere Therapeutics Reports First Quarter 2022 Financial Results.

Aldeyra Therapeutics Announces that Post-Hoc Analysis Using Computer Automated Grading of Phase 3 TRANQUILITY Trial Digital Photography Demonstrated Statistical Significance in Favor of Reproxalap Over Vehicle for Primary Endpoint of Ocular Redness.

Rhythm Pharmaceuticals Reports First Quarter 2022 Financial Results and Business Update.

Seres Therapeutics Announces Confirmatory Results from Investigational Microbiome Therapeutic SER-109 ECOSPOR IV Open-Label Study in Recurrent C. Difficile Infection.

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