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世界の薬事規制動向&情報を配信

Pink Sheet – US Election and New Administration Coverage

Stay informed of the latest news from the recent US election and understand how the shift in power will affect pharma regulatory and policy issues both within the United States and abroad. Pink Sheet takes you behind the US election headlines for analysis on the real impact you can expect to see on your business.

Topic us-election-2020

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

With US Senate Wins In Georgia, Democrats Gain Path For Rx Price Reform, But It May Be Lower Priority

Warnock_Raphael_1200-USSenatorelect-5January2021

Razor-thin majorities in both chambers of Congress mean Democrats can’t enact a bold agenda, and the pandemic and attendant recession mean that the initial legislative focus won’t be on Rx issues.

Scrip: 世界の医療用医薬品&製薬産業に関するニュース

First In World COVID-19 Vaccine For Kids Below 12?

First In World COVID-19 Vaccine For Kids Below 12?

Could Serum Institute or Bharat Biotech be the first company to have a COVID-19 vaccine for children under 12 years of age? While Pfizer and Moderna have begun pediatric trials for children 12 years and above, Serum plans to begin testing its indigenous vaccine and Bharat Biotech its Covaxin in children under 12

Topic Coronavirus

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

UK Vaunts 'New Era' In Drug Approvals

PS2101_Pathway_To_Future_1494901280_1200

The UK regulator, the MHRA, has published guidance on its new integrated pathway for innovative drug approvals, which it says is intended to bring together partners including health technology assessment agencies, health care bodies and patient organizations to offer “sustained collaboration” with drug developers.

Scrip: 世界の医療用医薬品&製薬産業に関するニュース

How COVID-19 Defined 2020 For Biopharma

SP_Coronavirus_1643947495_1200

Development of vaccines usually takes years, but drug makers whittled the process down to a matter of months amid a concerted response to a global health threat.

Topic Coronavirus

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

US FDA's COVID Whirlwind: Pfizer Vaccine Adcom Set; Monoclonal EUAs Cleared; Trump Aggrieved

FDA Miss Deadline

Warp Speed’s Slaoui predicts vaccinations starting within days of the 10 December advisory committee for Pfizer’s coronavirus vaccine. Regeneron’s monoclonal cocktail follows Lilly’s antibody product with an EUA.

Topic Coronavirus FDA

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

covid19 vaccines distribution

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

Topic Vaccines Coronavirus Distribution

Generics Bulletin: ジェネリック&バイオシミラーニュース

EU Reforms Must Heed Pandemic Lessons

Covid19 Eu reforms

Reforms set out by the European Commission to better prepare the EU for future health crises must heed key lessons learned from experiences of the COVID-19 pandemic, such as the benefits of digitalization, Medicines for Europe has urged.

Topic Coronavirus EU Policy & Regulation

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

covid19 nasal spray R&D

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

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オンラインショップのレポートストアでは、医療用医薬品の市場調査・分析レポートを常時1000本以上販売しています。レポート1本単位で購入でき、オンラインでご提供いたします。

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