Pink Sheet: 世界の薬事規制と承認審査に関するニュース

Coronavirus Efforts Could Benefit From Little-Used Medical Countermeasures Incentives

US FDA’s Medical Countermeasures Initiative authorities like emergency use authorization have not yet had much of an impact on drugs and biologics, but agency is committed to supporting a swift response to the new strain of coronavirus.

Topic Infectious Diseases Vaccines Coronavirus

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

For Coronavirus US FDA Is At The Podium But Not On The Task Force

The FDA is curiously not one of the HHS entities coordinating the US response to the outbreak, but must monitor for manufacturing disruptions and shortages, as well as approve new treatments and diagnostics.

Topic fda vaccines infectious-diseases Coronavirus

Scrip: 世界の医療用医薬品＆製薬産業に関するニュース

Atriva Fast Tracks Antiviral Candidate As Coronavirus Arrives In Germany

The antiviral specialist says MEK inhibitor could work against 2019-nCoV, but tests will take time.

Topic Coronovirus vaccines

Scrip: 世界の医療用医薬品＆製薬産業に関するニュース

Coronavirus: Can Companies Achieve Vaccine Ambition?

As the death toll rises in China and new cases emerge in other countries, researchers are aiming to slash development times to generate a vaccine against the 2019-nCoV coronavirus.

Topic Coronovirus research vaccines

Scrip: 世界の医療用医薬品＆製薬産業に関するニュース

Moderna Inovio Coronavirus Vaccine Candidates Fast-Tracked By International Coalition

The Coalition for Epidemic Preparedness Innovations adds new deal with mRNA specialist Moderna for rapid development of coronavirus vaccine.

Topic Company Analysis Coronovirus Infectious Diseases Vaccines

Scrip: 世界の医療用医薬品＆製薬産業に関するニュース

Real-World Evidence Sought In Sanofi Pasteur Observational Flu Vaccine Trial

Vaccine maker Sanofi Pasteur and managed care group Kaiser Permanente have joined forces in an observational trial using electronic medical records from 1.6 million people to highlight the benefits of integrated big data.

Topic clinical-trials influenza-virus vaccines