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Pink Sheet: 世界の薬事規制と承認審査に関するニュース
05 Dec 2018
A UK report on patient access to cancer drugs suggests that the European Medicines Agency could learn from the US Food and Drug Administration and best practice elsewhere in the world when it comes to taking a faster, more flexible approach to assessing evidence.
Topic cancer
Scrip: 世界の医療用医薬品＆製薬産業に関するニュース, Pink Sheet: 世界の薬事規制と承認審査に関するニ...
09 Nov 2018
Pharma Intelligence offers a wealth of pharmaceutical industry news and strategic insight into the healthcare & biotechnology markets from around the world. Working in an interconnected global network, our 65 journalists and over 300 in-house analysts supply comprehensive analysis and reports.
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
31 Oct 2018
If approved, ALKS 5461 would be first opioid-containing product to carry indication for depression; Alkermes CEO Pops tells Pink Sheet that agency's safety and efficacy concerns are surmountable because "all depression drugs have mixed results."
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
26 Oct 2018
President Trump touts CMS proposal that would peg Part B prices to an international index in the hopes of lowering US costs; industry calls it foreign price controls and warns it will hinder access.
Pink Sheet：世界の薬事規制と承認審査に関するニュース
By Michael McCaughan 18 Oct 2018
Treating mandatory wholesale acquisition cost disclosure in TV ads as a major drug pricing reform is close to ludicrous. But the broad approval of the action is an important sign of the continued public image cost of the ads to the drug companies.
Topic drug-approval drug-review
Pink Sheet：世界の薬事規制と承認審査に関するニュース
By Ian Schofield 18 Oct 2018
Companies wanting to compete in the newly off-patent adalimumab market in England have until Oct. 22 to submit their bids. They will need to offer “competitive prices” if they are to secure the highest share of sales to the national health service. At the same time, NHS trusts and clinical commissioning groups have been warned not to accept discounted interim offers from suppliers keen to get a foot in the door.
Pink Sheet：世界の薬事規制と承認審査に関するニュース
26 Sep 2018
Approach has been endorsed by Express Scripts as more workable solution than trying to cut list prices for drugs already on the market.
Pink Sheet：世界の薬事規制と承認審査に関するニュース
By Cathy Kelly 21 Sep 2018
Even though measure was blocked in Congress, it may still advance through regulation.
Pink Sheet：世界の薬事規制と承認審査に関するニュース
12 Sep 2018
Clusters of excellence, competition as well as co-operation, Brexit, and aiming high. Danish Medicines Agency head Thomas Senderovitz talks national agencies and engagement in an interview with the Pink Sheet.
Pink Sheet：世界の薬事規制と承認審査に関するニュース
12 Sep 2018
Thomas Senderovitz will chair the management group of the EU Heads of Medicines Agencies for at least the next two years. The Danish regulator tells the Pink Sheet of his big plans for the network.
Pink Sheet：世界の薬事規制と承認審査に関するニュース
12 Sep 2018
The European Medicines Agency and drug regulators throughout the EU are having to invest huge amounts of time and effort in dealing with the fall-out from Brexit - and it hasn't even happened yet. Plans for working together on bigger issues agreed on a few years ago will likely have to change, senior regulator Thomas Senderovitz tells the Pink Sheet.
Topic Brexit Business strategies
Pink Sheet：世界の薬事規制と承認審査に関するニュース
12 Sep 2018
Changing mindsets, technologies outpacing regulatory frameworks, intense international collaboration, and the future of the randomized controlled clinical trial. Big data is forcing us to think big, senior European regulator Thomas Senderovitz tells the Pink Sheet.
Topic brexit business-strategies
Pink Sheet：世界の薬事規制と承認審査に関するニュース
By Neena Brizmohun 06 Sep 2018
A new deal between Novartis and England’s National Health Service is one of the fastest funding approvals in the 70-year history of the NHS.
Topic cancer
Pink Sheet：世界の薬事規制と承認審査に関するニュース
By nielsen-hobbs 30 Aug 2018
"At least four" guidances will replace it, Commissioner Gottlieb notes in frank update which states "I don’t want to look back ten years from now and wish there were more policies we had pursued, or more steps we had taken, to stop the advance of this crisis."
Topic fda
Pink Sheet：世界の薬事規制と承認審査に関するニュース
By Michael McCaughan 23 Aug 2018
HHS’ “First 100 Days” take on the drug pricing “Blueprint” is a novel use of a tried-and-true milestone for presidential action. But it is probably more enlightening to look at what has happened in the 1,000 days since drug pricing became the overwhelming focus of political attention.
Topic us-election
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06 Dec 2018
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Biomedtracker(バイオメドトラッカー)は開発中の医療用医薬品の承認に影響を与えるイベントをリアルタイムで追跡し、アメリカ食品医薬品局(FDA)の承認確率(LOA: Likelihood of Approval)で示すデータベースです。臨床試験の結果や学会発表、ライセンス活動や規制当局の動きなど、開発中医薬品の商業的可能性に影響を与える過去と未来のイベントを包括的に分析し、承認確率として算出するデータベースサービスです。
A well-respected and trusted industry source for the last 15 years, Generics Bulletin from Informa Pharma Intelligence provides in-depth news and analysis on issues that matter most to businesses across the generics, biosimilars and value-added medicines industries.
HBW Insight is a single source of regulatory, legislative, legal and commercial news and insight connecting the dots across 3 sectors, including over the counter medicines, vitamins and dietary supplements, and cosmetics, which have increasing points of intersection, helping you to anticipate global challenges, risks, and opportunities.
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