政策研ニュースNo27

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ただきよひろもり
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2 Points of View IMS World Review IMS Health Pfizer Johnson & Johnson Merck & Co Abbott Eli Lilly Amgen Wyeth Bristol Myers Squibb Schering Plough ForestBaxterMylanGlaxoSmithKline Novartis Sanofi Aventis Aventis Sanofi Synthelabo Astrazeneca Roche GenentechBayer Schering AG Boehringer Ingelheim Novo Nordisk Merck KGaA Akzo Nobel Servier No

3 ATC No

4 Pfizer Johnson & Johnson Merck & Co Abbott Eli Lilly Amgen Wyeth Bristol Myers Squibb Schering Plough MylanGlaxoSmithKline Novartis Sanofi Aventis Astrazeneca Roche GenentechBayer Boehringer Ingelheim Novo Nordisk Merck KGaA Sevier No

5 ATC AAA No

6 No

7 Points of View GE GE GE GE G CSF Sandoz Hexal Hospira Teva GE GE Merck AstraZeneca Eli Lilly Omnitrope Sandoz Valtropin Biopartners Binocrit Sandoz Epoetin alfa Hexal Hexal Abseamed Medice Arzneimittel Retacrit Hospira Silapo Stada Arzneimittel Ratiograstim Ratiopharm Biograstim CT Arzneimittel Tevagrastim Teva Generics Filgrastim ratiopharm Ratiopharm Zarzio Sandoz Filgrastim Hexal Hexal EMEA European Generic medicines Association GE Sandoz Hexal Novartis GE Hospira Abbott GE AstraZeneca Eli Lilly No

8 GE vs GE GE MCB WCB ICH GE GE PK PD GE GE MCB WCB MCB WCB No

GE Product IMS LifeCycle IMS Health Follow on biologics GE GE GE Budget of the United States Government Fiscal YearDepartment of Health and Human

9 GE Product IMS LifeCycle IMS Health Follow on biologics GE GE GE Budget of the United States Government Fiscal YearDepartment of Health and Human Services generic biologics FDA Henry Waxman Promoting Innovation and Access to Life Saving Medicine Act Anna Eshoo Pathway for Biosimilars Act No

10 Points of View IMS World Review IMS Health IMS LifeCycle IMS Health Pharmaprojects No

Baxter ForestGlaxoSmithKline Novartis Sanofi Aventis

11 VS BV Non BV Pharmaprojects Pfizer Johnson & Johnson Merck Abbott Lilly Wyeth Bristol Myers Squibb Schering Plough Baxter ForestGlaxoSmithKline Novartis Sanofi Aventis AstraZeneca Roche Bayer Boehringer Ingelheim Novo Nordisk Merck KGaA Servier No

12 EUBV USBV JNBV Pharmaprojects No

13 No

14 Points of View No No No

15 NME NME NME NME NME NME NME No No

16 Pharmaprojects ATC Pharmaprojects IMS World Review IMS Health ATC ATC ijlkt βjt βjt β lt β jl βikt εijlkt ij l k tε Henderson RCockburn IScale scope and spillovers The determinants of research productivity in drug discovery Rand Journal of Economics No

17 Pharmaprojects IMS World Review IMS Health ATC β Henderson and Cockburn No

18 No

19 No

20 Points of View No

21 DII Derwent Innovation Index Thomson Reuters Prognosis Prognostic Surrogate Diagnostic Disease DII Derwent Innovation Index Thomson Reuters IPC AK No

22 No

23 No

24 A B C D E F G H I J K L No

25 No No

26 Points of View PMDA HIV HIV No No

27 SD PMDA PMDA PMDA n SD n SD n SD HIV HIV PMDA No

28 PMDA PMDA PMDA No

29 PMDA PMDA No

30 Points of View ATC NME NME NME NME NME No

31 NME ATC NME NME ATC a b b a IMS World Review IMS Health Web NME IMS World ReviewIMS Health TopWeb NME NME Web No

32 NME NME ATC NME NME NME NME IMS World Review IMS Health Web NME NME NME NME n n n NME IMS World Review IMS Health Web No

33 NME NME NME NME NME No No

34 Points of View No

35 ICD No

36 Market Exclusivity PREA Assessments EU Paediatric Regulation PIP Paediatric Investigation Plan BPCA Best Pharmaceuticals for Children Act PREA Pediatric Research Equity Act BPCA THE PEDIATRIC ASSESSMENT Pediatric Research Equity Act ofpublic Law No PhRMA Medicines in Development for Children SPC Supplementary Protection Certificate EU MAA EU SPC REGULATION EC No REGULATION EC No No

37 FDA Food and Drug Administration EMEA European Medicines Agency Public Private Partnership EMEA EUDRACT EMEA s public database of clinical trials FDA Principles of Interactions Between EMEA and FDA Pediatric Therapeutics June No

38 GVP GPSP PMDA No

39 ICD HIV HIV No

40 No

41 Pharma Dr Steve Arlington Pricewaterhouse Coopers Global Pharmaceuticals and Life Sciences Advisory Services Leader No No Drug Pipelines and Pharmaceutical Licensing AEA Applied Econometrics Association Conference No NPO PPH NPO Malaysian Biotechnology Corporation Parameswaran N Elina Jani No

42 No No No No

43 OPIR Office of Pharmaceutical Industry Research TEL FAX http www jpma or jp opir

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23 3 23 3 15 3.7 21 44,612 22 46,28 3.4 21 1,185 22 1,53 9,283 2 4,435 6 8.1 21 35,956 22 38,864 67.1 21 379 22 633 12,745 2.6 1.1 No.84 15 6 24 1 11 1 21 22 3.2 1.4 2291 22 4 2 5 15 1 6 5 1998 1999 11