Company Product Description Indication Status
Amryt plc, of Dublin Myalept Metreleptin Partial lipodystrophy Received additional feedback via a type C written response on the proposed development plan and study design; FDA confirmed it is willing to consider an efficacy supplement based on 6-month efficacy and safety data from a randomized, placebo-controlled trial in PL patients; agreement was also received on Amryt’s responses addressing PL study design comments from previous FDA discussions, which have been incorporated into the study protocol for the phase III trial
Cansino Biologics Inc., of Tianjin, China Convidecia (Ad5-nCoV) Recombinant adenovirus-based vaccine COVID-19 prophylaxis Approved in Hungary
Incyte Corp., of Wilmington, Del. Pemazyre (pemigatinib) Selective fibroblast growth factor receptor inhibitor Biliary tract cancer Approved in Japan for treatment of patients with unresectable BTC with a fibroblast growth factor receptor 2 fusion gene1, worsening after cancer chemotherapy
Insmed Inc., of Bridgewater, N.J. Arikayce (amikacin) 30S ribosomal protein inhibitor Nontuberculous mycobacterial lung disease caused by Mycobacterium avium complex Approved in Japan for the treatment of patients who did not sufficiently respond to prior treatment with a multidrug regimen
JCR Pharmaceuticals Co. Ltd., of Ashiya, Japan Izcargo (pabinafusp alfa 10 mL, intravenous drip infusion; formerly JR-141) Iduronate 2-sulfatase stimulator Mucopolysaccharidosis II (Hunter syndrome) Approved in Japan
Merck & Co. Inc., of Kenilworth, N.J. Keytruda (pembrolizumab) Monoclonal antibody targeting PD-1 Locally advanced or metastatic esophageal or gastroesophageal junction carcinoma FDA approved it in combination with platinum- and fluoropyrimidine-based chemotherapy
Protagonist Therapeutics Inc., of Newark, Calif. Rusfertide (PTG-300) Injectable synthetic peptide mimetic of natural hormone hepcidin Polycythemia vera Based on feedback from FDA during an end-of-phase II meeting, it announced plans to initiate a global phase III study; the company also has received written comments from EMA supportive of the pivotal clinical development plan
Russian Direct Investment Fund, of Moscow Sputnik V Adenovirus-based vaccine COVID-19 prophylaxis Approved in Vietnam
Zealand Pharma A/S, of Copenhagen Zegalogue (dasiglucagon) injection Glucagon analogue Severe hypoglycemia in people with diabetes  FDA approved it

Notes

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