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
21 Oct 2022
As biopharma continues to make progress developing novel and more targeted cancer therapies, regulators are responding with innovative and collaborative approaches to reviewing cancer products, aiming to resolve questions earlier and review products more quickly. Pink Sheet closely covers these programs, helping readers understand the expectations, challenges and opportunities, as well as lessons from companies putting policy into practice. This ebook takes some of our recent articles on special review mechanisms and regulators’ data expectations.
世界の薬事規制動向＆情報を配信
By Michael McCaughan 16 Jun 2022
The latest flurry of Executive Order activity on drug pricing reinforces the message that the President wants to own the headlines for being tough on the drug industry as Election Day looms. Looking for substance beyond that goal is a fool’s errand – but the headlines could still have significant consequences no matter who wins in November.
Topic US Election 2020
世界の薬事規制動向＆情報を配信
By Brian Yang 16 Jun 2022
Given the ongoing election challenges in the US, China has yet to officially congratulate Joe Biden as the next US president, although many world leaders are already hailing a reset in US foreign policy. Many are wondering if this and other moves indicate a quiet internal shift for China's high tech and life sciences sectors, just days after Beijing concluded a high-level plenary meeting outlining its priorities for the next five years.
Topic US Election 2020 China
世界の薬事規制動向＆情報を配信
By Bridget Silverman 19 Jan 2022
US FDA’s accelerated approvals hit a contemporary high in 2021, accounting for one-third of novel US approvals, but the big story was the agency’s crackdown on delinquent confirmatory trials for oncology AA indications.
世界の薬事規制動向＆情報を配信
By Vibha Sharma 18 Jan 2022
The EU will make it mandatory for clinical trial sponsors to prepare layperson summaries of their study results. Industry practices around content presentation, translation and dissemination of these documents will be keenly watched.
世界の薬事規制動向＆情報を配信
07 Dec 2021
Don’t miss updates on recent news in accelerated trials and its implications for drug development in the United States.
Topic Business Strategies
世界の薬事規制動向＆情報を配信
By Brenda Sandburg 01 Dec 2021
In 13-10 vote, panel finds reduction in COVID-19 hospitalizations and deaths outweighs risks. Four members say FDA should reconsider authorization if a more effective and safer therapy comes along. They concur molnupiravir should not be recommended for use in pregnancy but available to those who want it.
世界の薬事規制動向＆情報を配信
By Sue Sutter 03 Nov 2021
Whether a child receives the 10 mcg dose of COVID-19 vaccine authorized for 5-11 year-olds or the 30 mcg dose authorized for ≥12 year-olds should be based on age on day of vaccination, CDC says, but FDA is allowing some dosing flexibility for kids who celebrate their 12th birthday in the middle of the primary series.
世界の薬事規制動向＆情報を配信
By Sue Sutter 13 Oct 2021
Immune responses to a single booster dose of mRNA-1273 would be considered successfully bridged to the two-dose primary series if each of two immunobridging criteria were met, but the mRNA vaccine missed the prespecified success criteria for seroresponse rate, the FDA said.
世界の薬事規制動向＆情報を配信
By Francesca Bruce 12 Oct 2021
The company behind the CVnCOV COVID-19 vaccine candidate says the decision to withdraw from regulatory review is strategic. The EMA says outstanding issues affecting the benefit-risk balance remained to be answered at the time of withdrawal.
世界の薬事規制動向＆情報を配信
By Sue Sutter 16 Aug 2021
After repeatedly advising against tivozanib NDA submission on the basis of interim overall survival data that suggested a negative trend, agency ultimately concluded the final analysis did not suggest a detrimental effect in third-line renal cell carcinoma even though median overall survival was shorter than for the comparator agent, Bayer’s Nexavar.
世界の薬事規制動向＆情報を配信
By Leela Barham 03 Aug 2021
The Innovative Medicines Fund, due for launch in England later this year, may provide industry with an opportunity to hold key public bodies to account.
世界の薬事規制動向＆情報を配信
By Brenda Sandburg 03 Aug 2021
Ahead of CDC advisory committee this fall, Merck highlights additional bacteria serotypes its Vaxneuvance protects against while Pfizer touts Prevnar 13’s indication for pneumonia.
世界の薬事規制動向＆情報を配信
By Derrick Gingery 14 Jul 2021
US position remains that boosters are not needed yet, but CBER Director Peter Marks says regulators are discussing how to harmonize applications for booster shots.
世界の薬事規制動向＆情報を配信
By Francesca Bruce 30 Jun 2021
A delay to implementing drug pricing reforms is an opportunity for Canadian authorities to come up with better proposals, say industry representatives, while authorities remain adamant that action is necessary to lower prices.
世界の薬事規制動向＆情報を配信
03 Feb 2023
世界の薬事規制動向＆情報を配信
03 Feb 2023
世界の薬事規制動向＆情報を配信
03 Feb 2023
世界の薬事規制動向＆情報を配信
03 Feb 2023
世界の薬事規制動向＆情報を配信
03 Feb 2023
世界の薬事規制動向＆情報を配信
03 Feb 2023
世界の薬事規制動向＆情報を配信
03 Feb 2023
世界の薬事規制動向＆情報を配信
02 Feb 2023
世界の薬事規制動向＆情報を配信
02 Feb 2023
世界の薬事規制動向＆情報を配信
02 Feb 2023
世界の薬事規制動向＆情報を配信
02 Feb 2023
世界の薬事規制動向＆情報を配信
02 Feb 2023
世界の薬事規制動向＆情報を配信
01 Feb 2023
世界の薬事規制動向＆情報を配信
01 Feb 2023
世界の薬事規制動向＆情報を配信
01 Feb 2023
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