Vaccine
09/28, Sanofi, COVID-19
Sanofi to focus its COVID-19 development efforts on the recombinant vaccine candidate
Pfizer and BioNTech Submit Initial Data to U.S. FDA From Pivotal Trial of COVID-19 Vaccine in Children 5 to <12 Years of Age
Pfizer and BioNTech Receive First U.S. FDA Emergency Use Authorization of a COVID-19 Vaccine Booster
Johnson & Johnson Announces Real-World Evidence and Phase 3 Data Confirming Strong and Long-Lasting Protection of Single-Shot COVID-19 Vaccine in the U.S.
Antibody
09/30, Roche, COVID-19
Phase II/III trial shows Ronapreve™ (casirivimab and imdevimab) significantly reduces viral load within seven days of treatment in patients hospitalised with COVID-19
Sanofi to focus its COVID-19 development efforts on the recombinant vaccine candidate
- サノフィはCOVID-19関連の開発努力を遺伝子組み換えワクチン候補に集中する（mRNAワクチンの開発中止を決定した）。
Pfizer and BioNTech Submit Initial Data to U.S. FDA From Pivotal Trial of COVID-19 Vaccine in Children 5 to <12 Years of Age
- ファイザーとビオンテックは5歳から12歳の小児におけるCOVID-19ワクチンの申請用臨床試験の初期データをFDAに提出した。
Pfizer and BioNTech Receive First U.S. FDA Emergency Use Authorization of a COVID-19 Vaccine Booster
- ファイザーとビオンテックはCOVID-19ワクチンのブースター接種に関するFDAの緊急使用許可を取得した。
Johnson & Johnson Announces Real-World Evidence and Phase 3 Data Confirming Strong and Long-Lasting Protection of Single-Shot COVID-19 Vaccine in the U.S.
- ジョンソンエンドジョンソンは米国においてCOVID-19ワクチン単回接種による強く持続的な免疫を確認したリアルワールドのフェーズ３試験データを発表した。
Antibody
09/30, Roche, COVID-19
Phase II/III trial shows Ronapreve™ (casirivimab and imdevimab) significantly reduces viral load within seven days of treatment in patients hospitalised with COVID-19
- COVID-19による入院患者を対象としたロナプリーブ（カシリビマブ・イムデビマブ）のフェーズ2/３試験において、治療開始後７日以内にウイルス量が有意に減少した。
09/16, LLY, COVID-19
Emergency Use Authorization for Lilly's bamlanivimab and etesevimab administered together expanded to include post-exposure prophylaxis for COVID-19
Antivirals
09/27, PFE, COVID-19
Pfizer Starts Global Phase 2/3 EPIC-PEP Study of Novel COVID-19 Oral Antiviral Candidate for Post-Exposure Prophylaxis in Adults
Veklury® (Remdesivir) Significantly Reduced Risk of Hospitalization in High-Risk Patients with COVID-19
Merck and Ridgeback Biotherapeutics Announce Initiation of Pivotal Phase 3 MOVe-AHEAD Study Evaluating Molnupiravir for Post-Exposure Prophylaxis of COVID-19 Infection
Emergency Use Authorization for Lilly's bamlanivimab and etesevimab administered together expanded to include post-exposure prophylaxis for COVID-19
- リリーのバムラニビマブとエテセビマブ併用に対する緊急使用許可にCOVID-19接触後の感染予防が追加された。
Antivirals
09/27, PFE, COVID-19
Pfizer Starts Global Phase 2/3 EPIC-PEP Study of Novel COVID-19 Oral Antiviral Candidate for Post-Exposure Prophylaxis in Adults
- ファイザーは成人のCOVID-19接触後の感染予防薬とする新規経口抗ウイルス薬候補のグローバル第2/3相臨床試験EPIC-PEPを開始する。
Veklury® (Remdesivir) Significantly Reduced Risk of Hospitalization in High-Risk Patients with COVID-19
- ベクラリー（レムデシビル）はCOVID-19の高リスク患者の入院リスクを有意に減少した。
Merck and Ridgeback Biotherapeutics Announce Initiation of Pivotal Phase 3 MOVe-AHEAD Study Evaluating Molnupiravir for Post-Exposure Prophylaxis of COVID-19 Infection
- メルクとリッジバック・バイオセラピューティッスはモルヌピラビルに関してCOVID-19接触後の感染予防を評価する申請用臨床試験ムーブアヘッドを開始する。
