-
1
-
-
70449686823
-
Balancing innovation, access, and profits - Market exclusivity for biologics
-
Engelberg, A.B. et al. Balancing innovation, access, and profits - Market exclusivity for biologics. New Engl J Med 2009,361(20): 1917-1919
-
(2009)
New Engl J Med
, vol.361
, Issue.20
, pp. 1917-1919
-
-
Engelberg, A.B.1
-
2
-
-
77950625009
-
-
Available at Accessed December 2, 2009
-
Generic Pharmaceutical Association annual report 2009. Available at http://www.gphaonline.org/sites/default/files/gpha-low-res.pdf. Accessed December 2, 2009.
-
(2009)
Generic Pharmaceutical Association Annual Report
-
-
-
4
-
-
77950619306
-
-
November 24. Available at Accessed November 30, 2009
-
Capell, K. How big pharma profits from swine flu. BusinessWeek 2009, November 24. Available at http://www.businessweek.com/globalbiz/content/nov2009/ gb20091124-846373.htm. Accessed November 30, 2009.
-
(2009)
How Big Pharma Profits from Swine Flu
-
-
Capell, K.1
-
5
-
-
67650381294
-
-
Pharmaceutical Research and Manufacturers of America. April Available at Accessed November 24, 2009
-
Pharmaceutical Research and Manufacturers of America. Pharmaceutical Industry Profile 2009 (PhRMA, April 2009). Available at http://www.phrma.org/ files/PhRMA%202009%20Profile%20FINAL.pdf. Accessed November 24, 2009.
-
(2009)
Pharmaceutical Industry Profile 2009
-
-
-
6
-
-
77950608055
-
-
Tufts Center for the Study of Drug Development press release, September 9, Available at Accessed November 26, 2009
-
Tufts Center for the Study of Drug Development. Marketing exclusivity for first-in-class drugs has shortened to 2.5 years. Tufts Center for the Study of Drug Development press release, September 9, 2009. Available at http://csdd.tufts.edu/NewsEvents/NewsArticle.asp?newsid=153. Accessed November 26, 2009.
-
(2009)
Marketing Exclusivity for First-in-class Drugs Has Shortened to 2.5 Years
-
-
-
7
-
-
47349126691
-
Biosimilars: Policy, clinical, and regulatory considerations
-
Gottlieb, S. Biosimilars: Policy, clinical, and regulatory considerations. Am J Health-Syst Pharm 2008, 65(Suppl. 6): S2-8.
-
(2008)
Am J Health-Syst Pharm
, vol.65
, Issue.SUPPL. 6
-
-
Gottlieb, S.1
-
8
-
-
69449095403
-
Biosimilar therapeutics -What do we need to consider?
-
Schellekens, H. Biosimilar therapeutics -What do we need to consider? NDT Plus 2009, 2(Suppl. 1): 127-136
-
(2009)
NDT Plus
, vol.2
, Issue.SUPPL. 1
, pp. 127-136
-
-
Schellekens, H.1
-
9
-
-
70449440279
-
WHO guidelines presage US biosimilars legislation?
-
Hodgson, J. WHO guidelines presage US biosimilars legislation? Nat Biotech 2009, 27(11): 963-965
-
(2009)
Nat Biotech
, vol.27
, Issue.11
, pp. 963-965
-
-
Hodgson, J.1
-
10
-
-
39549105384
-
Scientific and legal viability of follow-on protein drugs
-
Dudzinski, D.M., Kesselheim, A.S. Scientific and legal viability of follow-on protein drugs. New Engl J Med 2008, 358(8): 843-849
-
(2008)
New Engl J Med
, vol.358
, Issue.8
, pp. 843-849
-
-
Dudzinski, D.M.1
Kesselheim, A.S.2
-
11
-
-
77950617658
-
-
Pharmaceutical Research and Manufacturers Association. Pharma-ceutical Research and Manufacturers Association Press Release, October 19
-
Pharmaceutical Research and Manufacturers Association. PhRMA statement supporting fair Incentives for biologies innovation. Pharma-ceutical Research and Manufacturers Association Press Release, October 19, 2009.
-
(2009)
PhRMA Statement Supporting Fair Incentives for Biologies Innovation
-
-
-
12
-
-
78049362302
-
-
Available at Accessed December 3, 2009
-
WHO Expert Committee on Biological Standardization. Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs). Available at http://www.who.int/biologicals/publications/trs/areas/biological.therapeutics/ BS2110Dft-guidelines-Final-HK-IK-29July-09.pdf. Accessed December 3, 2009.
-
Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs)
-
-
-
13
-
-
40149095089
-
The challenge of biosimilars
-
Mellstedt, H., Niederwieser, D., Ludwig, H. The challenge of biosimilars. Ann Oncol 2008, 19(3): 411-419
-
(2008)
Ann Oncol
, vol.19
, Issue.3
, pp. 411-419
-
-
Mellstedt, H.1
Niederwieser, D.2
Ludwig, H.3
-
14
-
-
77950600802
-
-
Available at Accessed November 26,2009
-
Tufts Center for the Study of Drug Development. Outlook 2009. Available at http://csdd.tufts.edu/lnfoServices/OutlookPDFs/Outlook2009.pdf. Accessed November 26,2009.
-
(2009)
Outlook
-
-
-
15
-
-
77950612260
-
-
Tufts Center for the Study of Drug Development news release, July 22, Available at Accessed November 26, 2009
-
Tufts Center for the Study of Drug Development. Large pharmaceutical firms are getting more drugs into development while terminating unpromising candidates. Tufts Center for the Study of Drug Development news release, July 22, 2009. Available at http://csdd.tufts.edu/NewsEvents/NewsArticle.asp?newsid= 152. Accessed November 26, 2009.
-
(2009)
Large Pharmaceutical Firms Are Getting More Drugs into Development while Terminating Unpromising Candidates
-
-
-
17
-
-
67650021216
-
The 'big pharma' dilemma: Develop new drugs or promote existing ones?
-
Weiss, D., Naik, P., Weiss, R. The 'big pharma' dilemma: Develop new drugs or promote existing ones? Nat Rev Drug Discov 2009, 8(7): 533-534
-
(2009)
Nat Rev Drug Discov
, vol.8
, Issue.7
, pp. 533-534
-
-
Weiss, D.1
Naik, P.2
Weiss, R.3
-
18
-
-
56049120143
-
Are we approaching the post-blockbuster era? Pharmacodiagnostics and rational drug development
-
Jørgensen, J.T. Are we approaching the post-blockbuster era? Pharmacodiagnostics and rational drug development. Expert Rev Mol Diagn 2008, 8(6): 689-695
-
(2008)
Expert Rev Mol Diagn
, vol.8
, Issue.6
, pp. 689-695
-
-
Jørgensen, J.T.1
-
19
-
-
65749087825
-
Personalized medicine: Reality and reality checks
-
Leeder, J.S., Spielberg, S.P. Personalized medicine: Reality and reality checks. Ann Pharmacother 2009, 43(5): 963-966
-
(2009)
Ann Pharmacother
, vol.43
, Issue.5
, pp. 963-966
-
-
Leeder, J.S.1
Spielberg, S.P.2
-
20
-
-
70449513464
-
Back to the future: Why randomized controlled trials cannot be the answer to pharmacogenomics and personalized medicine
-
Frueh, F.W. Back to the future: Why randomized controlled trials cannot be the answer to pharmacogenomics and personalized medicine. Pharmacogenomics 2009, 10(7): 1077-1081
-
(2009)
Pharmacogenomics
, vol.10
, Issue.7
, pp. 1077-1081
-
-
Frueh, F.W.1
-
21
-
-
58449133694
-
Medicine. Racing forward: The genomics and personalized medicine act
-
Lee, S.S., Mudaliar, A. Medicine. Racing forward: The genomics and personalized medicine act. Science 2009, 323(5912): 342-344
-
(2009)
Science
, vol.323
, Issue.5912
, pp. 342-344
-
-
Lee, S.S.1
Mudaliar, A.2
-
25
-
-
60849106348
-
Ethical and scientific implications of the globalization of clinical research
-
Glickman, S.W., McHutchison, J.G., Peterson, E.D., Cairns, C.B., Harrington, R.A., Califf, R.M., Schulman, K.A. Ethical and scientific implications of the globalization of clinical research. New Engl J Med 2009, 360(8): 816-823
-
(2009)
New Engl J Med
, vol.360
, Issue.8
, pp. 816-823
-
-
Glickman, S.W.1
McHutchison, J.G.2
Peterson, E.D.3
Cairns, C.B.4
Harrington, R.A.5
Califf, R.M.6
Schulman, K.A.7
-
26
-
-
57349103095
-
Clinical trials registry -India: Redefining the conduct of clinical trials
-
Pandey, A., Aggarwal, A., Seth, S., Maulik, M., Bano, R., Juneja, A. Clinical trials registry -India: Redefining the conduct of clinical trials. lnd J Cancer 2008, 45(3): 79-82.
-
(2008)
Lnd J Cancer
, vol.45
, Issue.3
, pp. 79-82
-
-
Pandey, A.1
Aggarwal, A.2
Seth, S.3
Maulik, M.4
Bano, R.5
Juneja, A.6
-
27
-
-
48749112420
-
Clinical trials in India: Ethical concerns
-
Chatterjee, P. Clinical trials in India: Ethical concerns. Bull WHO 2008, 86(8): 581-582
-
(2008)
Bull WHO
, vol.86
, Issue.8
, pp. 581-582
-
-
Chatterjee, P.1
-
29
-
-
33748324666
-
Can open-source R&D reinvigorate drug research?
-
Munos, B. Can open-source R&D reinvigorate drug research? Nat Rev Drug Discov 2006, 5(9): 723-729
-
(2006)
Nat Rev Drug Discov
, vol.5
, Issue.9
, pp. 723-729
-
-
Munos, B.1
-
30
-
-
77950611238
-
-
Bloomberg News Release, October 19, Available at Accessed December 4, 2009
-
Bloomberg. Pfizer may cut $3 billion in research deal with Wyeth (update 3). Bloomberg News Release, October 19, 2009. Available at http://www.bloomberg.com/apps/news?pid=20601103&sid=a8U9oCkKn5dU. Accessed December 4, 2009.
-
(2009)
Pfizer May Cut $3 Billion in Research Deal with Wyeth (Update 3)
-
-
-
31
-
-
85057999032
-
-
March 9, Available at Accessed December 4, 2009
-
Singer, N. Merck to buy Schering-Plough for $41.1 billion. New York Times, March 9, 2009. Available at http://www.nytimes.com/2009/03/10/ business/10drug.html. Accessed December 4, 2009.
-
(2009)
Merck to Buy Schering-Plough for $41.1 Billion
-
-
Singer, N.1
-
32
-
-
78651272674
-
-
March 12, Available at Accessed December 4, 2009
-
Pollack, A. Roche agrees to buy Genentech for $46.8 billion. New York Times, March 12, 2009. Available at http://www.nytimes.com/2009/03/13/ business/worldbusiness/13drugs.html. Accessed December 4, 2009.
-
(2009)
Roche Agrees to Buy Genentech for $46.8 Billion
-
-
Pollack, A.1
-
33
-
-
73449101512
-
Lessons from 60 years of pharmaceutical innovation
-
Munos, B. Lessons from 60 years of pharmaceutical innovation. Nat rev Drug Discov 2009, 8(12): 959-968
-
(2009)
Nat Rev Drug Discov
, vol.8
, Issue.12
, pp. 959-968
-
-
Munos, B.1
|