Company Product Description Indication Status
Bayer AG, of Basel, Switzerland Lampit Nifurtimox Chagas disease FDA approved it for the treatment of children 
Biogen Inc., of Cambridge, Mass., and Eisai Co. Ltd., of Tokyo Aducanumab Beta-amyloid antagonist Alzheimer's disease FDA accepted the BLA and the application was granted priority review, with a PDUFA date of March 7, 2021; the FDA has stated that, if possible, it plans to act early on this application under an expedited review
Canbridge Pharmaceuticals Inc., of Beijing Nerlynx (neratinib) EGFR antagonist; Erbb2/Erbb4 tyrosine kinase receptor inhibitor Early stage HER2-positive breast cancer  Received marketing approval from the Taiwan Food and Drug Administration for the extended adjuvant treatment of adult patients following adjuvant trastuzumab-based therapy
Cytodyn Inc., of Vancouver, Wash. Leronlimab (PRO-140) CCR5 antagonist HIV and COVID-19 Announced it will submit requests for pre-submission meetings in the U.K. for leronlimab as an HIV treatment in combination with HAART for highly treatment-experienced HIV patients, as well as for emergency approval for COVID-19 patients with mild to moderate symptoms 
Intellia Therapeutics Inc., of Cambridge, Mass. NTLA-2001 Systemically delivered CRISPR/Cas9 therapy Transthyretin amyloidosis Submitted a CTA to the U.K.’s MHRA to initiate a phase I trial
Kazia Therapeutics Ltd., of Sydney Paxalisib PI3K pathway inhibitor Diffuse intrinsic pontine glioma FDA granted rare pediatric disease designation 
PTC Therapeutics Inc., of South Plainfield, N.J., and Roche Holding AG, of Basel, Switzerland Evrysdi (risdiplam) Small-molecule SMN2-directed RNA splicing modifier Spinal muscular atrophy Approved by FDA under priority review; application granted a rare pediatric disease voucher
Viiv Healthcare Ltd., of London Dovato (dolutegravir/lamivudine) Once-daily, single pill combining integrase strand transferase inhibitor and nucleoside analogue reverse transcriptase inhibitor HIV-1 infection FDA approved an expanded indication, as a complete regimen for the treatment of HIV-1 infection to replace the current antiretroviral regimen in adults who are virologically suppressed on a stable ARV regimen with no history of treatment failure and no known resistance to the individual components of Dovato

Notes

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

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