Scrip: 世界の医療用医薬品＆製薬産業に関するニュース

Dr Reddy's To Steer Russian COVID-19 Vaccine Plans In India

Dr Reddy’s combines forces with the Russian Direct Investment Fund for clinical trials and supply of Sputnik V in India, amid what it views as “very important” data points in early studies of the COVID-19 vaccine.

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

Quick Listen: Scrip's Five Must-Know Things

Join us for a quick audio roundup of major events in the global biopharma industry over the past week, as reported by Scrip.

Topic Coronavirus Clinical Trials Vaccines

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

US FDA Expects COVID-19 Vaccines To Meet 'EUA Plus' Standards, Marks Says

CBER director said that all the manufacturing data may not be available, but the safety and efficacy data needed for a BLA are expected before an emergency use authorization is granted.

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

Plasma Authorization Raises Fears Of Politically-Influenced COVID-19 Vaccine Decisions, Compromised FDA

US FDA Commissioner Hahn’s credibility is in question following an emergency use authorization for convalescent plasma, leading some former officials to push for new agency leadership. Hahn’s actions, combined with President Trump’s attack on FDA staff as being ‘deep state’ actors, may compromise the public trust in the agency’s work during COVID-19 and beyond, former FDA officials say

Topic us-election-2020 vaccines Coronavirus

Scrip: 世界の医療用医薬品＆製薬産業に関するニュース

AstraZeneca's COVID Vaccine On Hold: A Reminder Drug Development Is Never Straightforward

The company – one of the frontrunners in the race to develop a COVID-19 vaccine – has voluntarily put a hold on the Phase III trial due to an adverse event.

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

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 Could Have Advantage Over Pfizer's Cold Chain

Cold chain distribution requirements are a major downside for mRNA-based vaccines, but Moderna may have the edge over Pfizer/BioNTech's candidate.

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

Pfizer Lays Out Multi-Phase COVID-19 Vaccine Commercial Strategy

The pandemic phase will last through late 2021/early 2022, becoming a more seasonal opportunity for several years after, Pfizer management predicted during the company's second quarter call.

Topic Coronavirus vaccines Sales Earnings