薬事規制と承認審査の動向＆データベース
インフォーマ・ファーマインテリジェンスは新薬候補および承認済み医薬品に加えて、診断／医療機器の薬事規制と承認審査に関するニュース＆データベースを提供。商業的成功まで最短ルートをとることが可能です。
インフォーマ・ファーマインテリジェンスは新薬候補および承認済み医薬品に加えて、診断／医療機器の薬事規制と承認審査に関するニュース＆データベースを提供。商業的成功まで最短ルートをとることが可能です。
承認を指示する根本的な臨床エビデンスを探すことは、ときに時間がかかり非常に困難です。また、開発プログラムに要した時間および規制当局による承認時期を知ることも非常に重要です。
承認済み医薬品および開発段階中後期の医薬品開発パイプラインを基本的な臨床試験情報とシームレスに結びつけ、最良の臨床試験デザインおよび標的の市場で成功している対照群に焦点を合わせる必要があります。
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The single most comprehensive consumer healthcare information source covering regulatory, legislative, legal and commercial news across the over the counter medicines, vitamins and dietary supplements, and cosmetics industries.
Key benefits:
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.
Key benefits:
Scrip: 世界の医療用医薬品＆製薬産業に関するニュース
15 Aug 2019
The US FDA informed the company it will convene an advisory committee meeting to review the REDUCE-IT sNDA for the proprietary fish oil pill, delaying the approval by at least three months and surprising investors.
Topic fda drug-approval
Scrip: 世界の医療用医薬品＆製薬産業に関するニュース
By Jessica Merrill 15 Aug 2019
Lilly's IL-17A inhibitor ixekizumab outperformed J&J's IL-23 inhibitor guselkumab on achieving complete skin clearance in moderate-to-severe psoriasis patients at 12 weeks in a head-to-head trial.
Topic Clinical trials
Scrip: 世界の医療用医薬品＆製薬産業に関するニュース
14 Aug 2019
Drugs like Ibrance and Lynparza show that in the cancer market, it can be hard for new entrants to catch early standouts.
Scrip: 世界の医療用医薬品＆製薬産業に関するニュース
12 Aug 2019
With the continuation of the US-China trade standoff, the rapid increase in R&D costs and a gruelling centralized bidding process, foreign pharma firms have a lot on their plates in China. Gain insight on these key challenges through this Scrip article pack
Topic business-strategies
HBW Insight
07 Aug 2019
Japan's new Rx-to-OTC switch procedure has exacerbated a "switch lag" compared with developed countries, says Japan Self-Medication Industry senior adviser Toshi Tominaga in an exclusive interview with HBW Insight. Tominaga proposes improvements such as self-care education for consumers and drug usage advice included by firms in switch applications to help balance the risk-benefit decisions of expert judges.
Topic policy-and-regulation
Scrip: 世界の医療用医薬品＆製薬産業に関するニュース
By Brian Yang 05 Aug 2019
Opened with a big splash just two months ago in a brand new headquarters in Shanghai, Pfizer's Upjohn established products subsidiary is now merging with Mylan to create the world's largest generics group, stirring up local concerns that the focus could shift from China back to the US.
Scrip: 世界の医療用医薬品＆製薬産業に関するニュース
By Jessica Merrill 05 Aug 2019
Pfizer's ambitious plans to spin out its Upjohn branded and generics business will result in a smaller, innovation-focused pharma. The decision comes after nine years of back-and-forth about whether the move would unlock value.
Scrip: 世界の医療用医薬品＆製薬産業に関するニュース
30 Jul 2019
The launch of Mvasi will be the first biosimilar version of Avastin in the US, a huge blockbuster for Roche approved for multiple cancer indications. Scrip looks at the development and commercial history of Avastin since its FDA approval in 2004.
Scrip: 世界の医療用医薬品＆製薬産業に関するニュース
30 Jul 2019
Amgen and Allergan launched the first US biosimilar for Roche's Herceptin – and the Swiss pharma's Avastin – at a 15% discount to the brand-name products' list prices. Scrip's infographic reviews Herceptin's past and its future competitors.
Topic biosimilars
Scrip: 世界の医療用医薬品＆製薬産業に関するニュース, In Vivo: 医療用医薬品・医療機器産業の経営層向けニ...
25 Jul 2019
AstraZeneca’s pact with the UK-based artificial intelligence leader BenevolentAI, in April 2019, is one component in a string of recent deals that have highlighted big pharma’s desire to embed AI and machine learning within the R&D process. In total, 13 such collaborations have been tracked in the past 24 months, according to the Strategic Transactions database.
Topic digital-health strategy medtech
Scrip: 世界の医療用医薬品＆製薬産業に関するニュース
22 Jul 2019
Biopharma companies are reluctant to rely on real-world evidence trials, but while uncertainty remains about how these novel studies will be accepted, US and other regulators are encouraging drug developers to take a chance – and some have taken on the challenge.
Topic policy-and-regulation
Scrip: 世界の医療用医薬品＆製薬産業に関するニュース
By Brian Yang 22 Jul 2019
Chinese venture funding to the US biotech sector has fallen by nearly 60% in the latest sign of cooling in the previously booming bilateral life sciences investment sector.
Topic business-strategies
Scrip: 世界の医療用医薬品＆製薬産業に関するニュース
By Ian Schofield 12 Jul 2019
The pharmaceutical industry has come under attack by a UK parliament committee for failing to make medicinal cannabis products available for clinical trials, saying that a "robust research base" is needed on which to base future treatment decisions.
Topic clinical-trials drug-approval
10 Jul 2019
Cannabidiol (CBD) is being looked at more and more by health beauty and wellness companies for new OTC drugs, cosmetics and supplements. It is highly controversial because while CBD has many natural benefits for treating a variety of symptoms and conditions, it is the active ingredient in cannabis which comes from the hemp plant.
05 Jul 2019
The UK's cannabidiol market, which according to the Cannabis Trades Association is the largest in Europe, awaits clarification on the legal status of CBD-containing food supplements. Meanwhile, major retailers like Walgreen Boots Alliance are stepping into the space with branded products.
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