Company Product Description Indication Status
Alnylam Pharmaceuticals Inc., of Cambridge, Mass. Lumasiran RNAi therapeutic Primary hyperoxaluria type 1 U.K.’s Medicines and Healthcare products Regulatory Agency granted a positive scientific opinion through EAMS (early access to medicines scheme), allowing eligible PH1 patients to gain access to drug prior to marketing authorization
Clinigen Group plc, of Burton Upon Kent, U.K. Aldesleukin Non-glycosylated interleukin-2 product Amyotrophic lateral sclerosis FDA granted orphan designation
Cytodyn Inc., of Vancouver, Washington Leronlimab CCR5 antagonist HIV Received a refuse to file letter from FDA regarding BLA seeking approval as combination therapy with HAART for highly treatment-experienced patients; company intends to request type A meeting with FDA to discuss request for additional information; FDA request does not require any additional clinical trials
Enzychem Lifesciences Inc., of Englewood, N.J. EC-18 CCL26 gene inhibitor; TLR modulator Acute respiratory distress syndrome due to COVID-19 pneumonia Filed IND with FDA for a phase II trial testing use as preventive therapeutic
Pfizer Inc., of New York, and Biontech SE, of Mainz, Germany BNT-162b1 and BNT-162b2 mRNA-based vaccines COVID-19 FDA granted fast track designation to both
Protokinetix Inc., of Marietta, Ohio PKX-001 AAGP molecule Type 1 diabetes Submitted amendments to Health Canada; upon approval, company will deliver 75 grams of drug to University of Alberta to accommodate ongoing trial; study will treat islet cells prior to transplantation in type 1 diabetes patients

Notes

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

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