Pink Sheet: 世界の薬事規制と承認審査に関するニュース

Vaccine Distribution Priorities To Rely On Governors, Not ACIP, HHS Secretary Azar Says

Azar says ACIP’s prioritization recommendations should carry weight, but states will be final arbiter of who is vaccinated

Topic Vaccines Coronavirus Distribution

HBW Insight : コンシューマーヘルスケア産業のニュース

UK Researchers Seek Commercial Partner For Nasal Spray Shown To 'Prevent' COVID-19

A nasal spray formulated using compounds already approved by regulatory bodies in Europe and the US can “prevent and slow” transmission of COVID-19, according to UK researchers who are now seeking a partner to commercialize the product.

Topic Coronavirus Research & Development Vaccines OTC Drugs

Scrip: 世界の医療用医薬品＆製薬産業に関するニュース

Quick Listen: Scrip's Five Must-Know Things

Join us for a brief audio tour around the past week's key developments in the global biopharma industry, in this podcast version of Scrip's Five Must-Know Things

Topic Coronavirus research vaccines

Scrip: 世界の医療用医薬品＆製薬産業に関するニュース

Russia Prepares $10 COVID-19 Vaccine For International Launch

Russia is promising the best of both worlds – a low price with a near-perfect efficacy. While the basic science is plausible, its best-in-class claims are bound to generate skepticism

Topic Coronavirus vaccines

Scrip: 世界の医療用医薬品＆製薬産業に関するニュース

Oxford/AZ's COVID-19 Vaccine Cuts Virus Spread By 60%

Oxford University/AstraZeneca’s COVID-19 vaccine cuts the spread of the virus by 60%, apart from having 70% efficacy in reducing infections in vaccinated individuals. While that is good news for their Indian partner, Serum Institute, the 90% efficacy shown in a subset due to a dosing error causes a dilemma.

Topic Coronavirus Vaccines

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

In Vivo: 医療用医薬品・医療機器産業の経営層向けニュース

COVID-19 Vaccine Expectations Are Ambitious Not Impossible

Johan Van Hoof, global head of vaccines at Janssen, talks to In Vivo about the company’s platform, how it is approaching COVID-19 research and the impact of today’s global pandemic on the future of vaccine R&D.

Topic Coronavirus vaccines

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

COVID-19 Vaccine Advisory Committee May Help Determine US FDA Approach To Licensure

The October panel will not review a specific application, but is expected to offer FDA advice on whether emergency use authorization is an appropriate pathway for COVID vaccines, and what data would be needed for full licensure. Sponsors may present data on their candidate vaccines.

Topic Coronavirus vaccines

Scrip: 世界の医療用医薬品＆製薬産業に関するニュース

Coronavirus Update: Moderna In Advanced Talks With Europe On Vaccine Supplies

The deal would include an option for expansion to 160 million doses of the mRNA-based vaccine.

Topic Coronavirus clinical-trials vaccines