Pharma Intelligenceはインフォーマ株式会社が運営するビジネスインテリジェンス事業部の医薬品部門です。
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
11 Apr 2019
Reform "is going to happen,” promised Energy & Commerce Oversight Subcommittee Chair Diana DeGette, suggesting the panel’s next hearing on insulin price reform may be held in July.
Topic Diabetes
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
10 Apr 2019
As a CRO professional, you need to stay abreast of the issues and news that can have a profound effect on your clients’ clinical trials. For essential insights into these types of R&D and regulatory matters, turn to the accurate and comprehensive information and analysis from Pink Sheet.
Topic Clinical trials Research
Pink Sheet: 世界の薬事規制と承認審査に関するニュース, Scrip: 世界の医療用医薬品＆製薬産業に関するニ...
09 Apr 2019
Together, Scrip and Pink Sheet are your winning strategic advantage amidst today’s uncertain global political climate and shifting policy focus. By subscribing to Scrip in concert with Pink Sheet, you gain a a clear line of site between regulation and policy changes and their impact on business strategies, technology investments, clinical trial developments, industry partnerships and much more.
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...
By Mary Jo Laffler 01 Apr 2019
2019年2月14日(木)に行われました無料オンラインセミナー『リアルワールドエビデンス～How Real World Evidence Is Playing Out In The Real World』の動画です。
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
22 Mar 2019
Of the 14 applications for entry onto the European Medicines Agency’s priority medicines scheme during the first two months of 2019, only two – from AstraZeneca and Freeline – made the grade.
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
22 Feb 2019
By partnering with the Pink Sheet. Pink Sheet is the world’s premier provider of compliance, legislation, policy regulation and industry developments for biopharma decision makers, arming subscribers with the critical information they rely on daily to implement their strategies.
Topic biopharmaceutical
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
By Francesca Bruce 22 Feb 2019
Regulatory harmonization is gathering pace in Latin America, which is good news for pharmaceutical companies.
Topic Policy and regulation
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 14 Feb 2019
Here is what to expect from – and some free advice for – seven industry executives as they prepare for a hearing on drug pricing in the Senate Finance Committee.
Topic drug-approval
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
By Brenda Sandburg 07 Feb 2019
'Number of different initiatives' coming in next several months to make drugs more affordable, including for PrEP prophylaxis, HHS Assistant Secretary for Health Giroir says. Multi-agency approach is key strategy.
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
By Brenda Sandburg 01 Feb 2019
Fallout from Supreme Court's Escobar decision and Department of Justice memos could impact types of healthcare fraud complaints in which the government intervenes.
Topic Drug approval Strategy
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
01 Feb 2019
Proposed US rule would establish two new safe harbors against anti-kickback enforcement, one covering price reductions at the point of sale and the other protecting flat service fees paid by manufacturers to pharmacy benefit managers. But rebates to "PBMs to buy formulary position" in Medicare/Medicaid would lose protection.
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
28 Jan 2019
FDA cosmetics operations likely shuttered with shutdown; Stomp leads Kemin's global marketing; Unilever delivers on fragrance transparency pledge; Lentein protein to Canada through CK Ingredients; and Deciem founder Truaxe dead at 40.
Topic US Shutdown FDA
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
By Sue Sutter 28 Jan 2019
Exhaustion of US FDA's PDUFA funds before partial federal government shutdown ends could lead sponsors or agency to assert that reviews for certain types of drugs should continue under an exception to the Anti-Deficiency Act, former FDA officials say.
Topic US Shutdown fda
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
By Derrick Gingery 28 Jan 2019
Compounding carryover money runs out, crippling some activities although inspections will continue; countdown to the end of PDUFA fee balance continues.
Topic US Shutdown fda
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
28 Jan 2019
More than 300 generic drug applications might be officially filed when the shutdown ends, substantially increasing stress on assessors and other Office of Generic Drugs staff.
Topic US Shutdown fda
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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。
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.
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.
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