世界の薬事規制動向＆情報を配信
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有料購読｜薬事ニュース「Pink Sheet」
米国食品医薬品局、欧州医薬品庁他、各国規制当局の最新動向が分かるデジタルニュース
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世界の薬事規制動向＆情報を配信
CDER Director Cavazzoni also wants to loosen conflict of interest rules and improve technology for remote meetings. Given FDA’s approval of Aduhelm, her comments, made in a prerecorded interview for the BIO Digital annual meeting, may raise some eyebrows. Industry is also working on recommendations for the agency on the topic.
世界の薬事規制動向＆情報を配信
Biogen/Eisai Alzheimer’s drug wins agency nod on basis of amyloid plaque reduction, a surprising use of the accelerated approval pathway that was not considered by an FDA advisory committee; approval raises feasibility questions about confirmatory trial and daunting prospect of market withdrawal if studies fail to verify clinical benefit.
世界の薬事規制動向＆情報を配信, Scrip: 世界の医療用医薬品＆製薬産業に関するニュース
Tap into expert coverage of the complex world of drug pricing with insights from analysts at Scrip and Pink Sheet. This eBook includes vital information about issues affecting drug pricing for the US, EU, and other global markets, including patient access, regulatory issues, commercial challenges, value-based pricing, and more.
Topic drug-pricing
In Vivo: 医療用医薬品・医療機器産業の経営層向けニュース, 世界の薬事規制動向＆情報を配信
The COVID-19 pandemic has brought about significant manufacturing and distribution challenges and opportunities for Pharma. Seize new opportunities and avoid risk with the strategic commercial and regulatory intelligence you need to stay competitive by subscribing to Pink Sheet and In Vivo.
Topic strategy
世界の薬事規制動向＆情報を配信
Drug manufacturers still have a variety of ways to limit the impact of the Biden administration’s historic decision. Whether the huge political loss for industry translates into more than just headline-risk or faster global COVID vaccination remains to be seen. It's also not clear whether it’s an ominous sign for other industry battles in the US, including the drug pricing debate.
世界の薬事規制動向＆情報を配信
A simplified process for registering and evaluating clinical trials promised by the EU Clinical Trial Regulation is finally set to become a reality.
世界の薬事規制動向＆情報を配信
The team behind Sputnik V has attacked what it calls “fake news and provocations” in the EU as political arguments over the vaccine claim another ministerial scalp.
世界の薬事規制動向＆情報を配信
Peter Marks says agency is getting first RWE readouts of vaccine safety; AstraZeneca’s vaccine has no expiration date, so stockpile is not currently at risk of being thrown out, the CBER director tells a House hearing.
ターゲット市場の実像をつかむ, 世界の薬事規制動向＆情報を配信, Scrip: 世界の医療用医薬品＆製薬産業に関するニュ...
Listen to the Pharma Intelligence podcasts on Spotify, Apple Podcasts, Soundcloud and Alexa
Topic Coronavirus Manufacturing Market Intelligence clinical-trials-blog clinical-trials drug-pricing
世界の薬事規制動向＆情報を配信
Companies seeking marketing authorizations in the UK or Great Britain will be able to make use of two new “reliance” procedures offering regulatory assessment times of 67 days or less if their products have already gone through the EU centralized or decentralized approval systems.
Topic brexit Pharma-Brexit
世界の薬事規制動向＆情報を配信
There may not be a great deal in the new UK-EU trade and cooperation deal for the life sciences industry but a new working group could act as the forum for constructive discussions on regulatory cooperation.
Topic Regulation Brexit Pharma-Brexit
世界の薬事規制動向＆情報を配信
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
世界の薬事規制動向＆情報を配信
Tactic aims to allow incoming Administration to scrutinize so-called ‘midnight rules’ issued in the final days of the Trump Administration before they take effect. Regulators may also solicit stakeholder comments on delayed rules.
世界の薬事規制動向＆情報を配信
The number of new drugs containing new active substances approved in the EU rose significantly in 2020, underpinned by a strong showing for orphan-designated products and a string of novel medicines for cancer and infectious diseases. Notable among the new clutch of approvals was the first ever COVID-19 vaccine, Pfizer/BioNTech's Comirnaty.
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
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.
世界の薬事規制動向＆情報を配信
21 Jun 2021
世界の薬事規制動向＆情報を配信
21 Jun 2021
世界の薬事規制動向＆情報を配信
21 Jun 2021
世界の薬事規制動向＆情報を配信
21 Jun 2021
世界の薬事規制動向＆情報を配信
21 Jun 2021
世界の薬事規制動向＆情報を配信
21 Jun 2021
世界の薬事規制動向＆情報を配信
21 Jun 2021
世界の薬事規制動向＆情報を配信
18 Jun 2021
世界の薬事規制動向＆情報を配信
18 Jun 2021
世界の薬事規制動向＆情報を配信
18 Jun 2021
世界の薬事規制動向＆情報を配信
17 Jun 2021
世界の薬事規制動向＆情報を配信
17 Jun 2021
世界の薬事規制動向＆情報を配信
17 Jun 2021
世界の薬事規制動向＆情報を配信
17 Jun 2021
世界の薬事規制動向＆情報を配信
17 Jun 2021
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