Accelerate Clinical Trial TimelinesThe total cost of a trial from Phase I to Phase III/Submission is estimated to be approximately $1 Billion with patient recruitment challenges being one of the largest cost drivers.
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Sitetrove(サイトトローブ)は、170か国・40万人以上の治験責任医師(PI: Principal Investigator)と235以上の疾患に対応する11万7千か所以上の治験施設に関する情報を収録するデータベースです。治験責任医師と治験施設に関して業界で最も正確で包括的な情報を提供することで、コスト増につながる治験の遅延を最小化し、お客様の臨床試験を成功に導くようサポートします。Sitetroveに登録される治験責任医師は、豊富な臨床経験や治験に関する十分な知識をもっていることをアナリストにより精査されています。
Key benefits:
Trialtrove(トライアルトローブ)は医療用医薬品の開発状況を常に把握できる医薬品業界随一の臨床試験情報データベースです。計画段階から完了まで、260疾患・29万件の臨床試験をトラッキングし、250以上の学会をカバーしています。4万以上の情報ソースから収録した臨床試験に関するデータを250名のアナリストが精査し、リアルタイムで更新しています。学会発表や企業発のニュースは即日収録されます。アラート機能や可視化ツールを活用することで、特定の臨床試験のモニタリングや資料作成も可能です。
Key benefits:
Pharmaprojects(ファーマプロジェクツ)は、医薬品業界で代表的な開発パイプライン(医療用医薬品候補化合物)のデータベースとして、医薬品企業をはじめとする多くのお客様にご利用いただいています。前臨床試験から上市済み医薬品まで、現在開発中の15,000の薬剤を含む68,000以上の開発パイプライン情報を収録しています。さらに、43,000以上の医薬品を網羅した35年間にわたる過去のデータベースにもアクセスできます。グローバル競争が激しくなる中、競合分析や研究開発戦略の策定に威力を発揮するデータベースです。
Key benefits:
Citeline’s Custom Analytics service provides expert analytical and project-orientated support for your strategic business questions.
Key benefits:
HBW Insight : コンシューマーヘルスケア産業のニュース
11 Dec 2019
Senate's Over-the-Counter Monograph Safety, Innovation, and Reform Act goes next for consideration by House, which has had a bill by the same title on its floor for a vote since it was passed by Energy and Commerce Committee in late June.
HBW Insight : コンシューマーヘルスケア産業のニュース
11 Dec 2019
Farah Ahmed, president and CEO of the Fragrance Creators Association, discusses the trade group’s expansion in recent years beyond immediate regulatory and legislative concerns to a platform for robust member collaboration in the name of positively impacting the world.
HBW Insight : コンシューマーヘルスケア産業のニュース
06 Dec 2019
Recent statement that FDA has not found evidence supporting CBD as GRAS for use in human or animal food potentially points to NDI notifications as the only option manufacturers, marketers and other businesses will have to convince agency about safety for CBD and other hemp-derived substances used in dietary supplements.
HBW Insight : コンシューマーヘルスケア産業のニュース
By Tom Gallen 06 Dec 2019
GSK has launched Flunase in Japan following the switch of fluticasone propionate. JSMI’s Toshi Tominaga gives his assessment of the product’s prospects as an OTC drug.
HBW Insight : コンシューマーヘルスケア産業のニュース
28 Nov 2019
Industry advocates working to support GRASE determinations for eight UV filters are faced with a dilemma. They would like to share nonpublic studies with the FDA on a confidential basis – at least to get initial temperature readings from the agency as to the studies’ usefulness in addressing data gaps – but under the current OTC monograph framework, no such pathway exists.
HBW Insight : コンシューマーヘルスケア産業のニュース
27 Nov 2019
Before Congress de-scheduled hemp at end of 2018 and forced agency's hand on considering lawful use of ingredients derived from the plant in supplements and food, the floodgate for sales of the products was opened in 2013 by a DoJ policy change to de-emphasize enforcement of most federal marijuana laws.
HBW Insight : コンシューマーヘルスケア産業のニュース
22 Nov 2019
Aspirational OTC products such as probiotics are outstripping demand for traditional symptom relievers, IQVIA's Andy Tisman told the recent Ceuta International Conference. Consumer health players must adapt their portfolios to cater for the more health conscious, informed, and digitally-connected consumer, Tisman advises
Topic business-strategies
HBW Insight : コンシューマーヘルスケア産業のニュース
13 Nov 2019
In latest study casting doubt on the nutrients' effect on chronic illness, researchers find vitamin D and fish oil ineffective in staving off type 2 diabetics' kidney failure. Editorial also published in JAMA says further research is needed to analyze the nutrients’ possible benefits to diabetics with chronic kidney disease.
Topic clinical-trials
HBW Insight : コンシューマーヘルスケア産業のニュース
13 Nov 2019
Following a landmark win against the German government for the Rx-to-OTC switch of desloratadine last month, Novartis has again secured a victory in the German Higher Court system, this time to continue marketing its Biosan probiotics range in the country.
HBW Insight : コンシューマーヘルスケア産業のニュース
08 Nov 2019
"This was an area that the agency thought was just going to disappear on its own," says Freddie Ann Hoffman, who chaired FDA homeopathic working group that helped develop CPG adopted in 1988 to allow sales of homeopathics to continue without pre-market approval.
Topic fda policy-and-regulation
HBW Insight : コンシューマーヘルスケア産業のニュース
By Tom Gallen 08 Nov 2019
Recalling Zantac in North America over contamination concerns and tightening regulatory requirements in Europe combined to impede growth at Sanofi Consumer Healthcare in Q3. New CEO Paul Hudson says he is still taking time to get to know the business before making any strategic moves.
Topic policy-and-regulation
HBW Insight : コンシューマーヘルスケア産業のニュース
01 Nov 2019
Revised draft guidance identifies types of homeopathics posing "higher risks to public health." FDA withdraws 1988 compliance policy guide that allows homeopathic to be available even though they are not subject to pre-market approval or other review process agency imposes on all other drugs.
Topic fda policy-and-regulation
HBW Insight : コンシューマーヘルスケア産業のニュース
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
HBW Insight : コンシューマーヘルスケア産業のニュース
29 Jul 2019
Research in JAMA Internal Medicine studied "longitudinal associations between [e-cigarette] use and tobacco smoking patterns in a large population-based cohort study" and found use was associated with reduction in smoking and an increased probability of smoking cessation. But the researchers saw that e-cigarette users who quit tobacco "tended to relapse to smoking more frequently than" former smokers who didn't use e-cigarettes.
Topic medtech
HBW Insight : コンシューマーヘルスケア産業のニュース
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.
Topic Drug review Drug approval
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