Results 51 to 60 of about 5,628,754 (380)

A Significant Anticancer Drug Approval Lag Between Japan and the United States Still Exists for Minor Cancers

Clinical pharmacology and therapy, 2018
Reports have indicated that approval lag for anticancer drugs between Japan and the United States has decreased. However, if this is also true for drugs used to treat minor cancers remains unknown.
Kenji Yamashita, M. Kaneko, M. Narukawa
semanticscholar   +1 more source

Communication and Freedom: An Althusserian Reading of Media-Government Relations [PDF]

, 2000
This essay draws on the work of French philosopher Louis Althusser, particularly his contributions to the development of ideology, in an assessment of the relationship between communication ana freedom.
Brennen, Bonnie
core   +2 more sources

Abiraterone acetate in metastatic castration-resistant prostate cancer after chemotherapy. A retrospective “Real Life” analysis of activity and safety [PDF]

, 2015
Abiraterone acetate (AA) is a potent, selective androge (CYP17) biosynthesis inhibitor, which showed to improve overall survival (HR = 0.646) in mCRPC patients progressing after docetaxel.
A., Giuli, A., Pellegrino, D., Santini, E. M., Ruggeri, E., Cortesi, F., Angelini, F., Longo, F., Primi, I., Sperduti, M. A., Fabbri, M. G., Chilelli, M. L., Mancini, Marchetti, Paolo, Milano, Annalisa, R., Ratta, S., Quadrini, T., Gamucci   +16 more
core   +1 more source

Clinical Trial Evidence Supporting US Food and Drug Administration Approval of Novel Cancer Therapies Between 2000 and 2016

JAMA Network Open, 2020
Key Points Question What are the available data on cancer treatment outcomes for new cancer therapies approved by the US Food and Drug Administration?
Aviv Ladanie, A. Schmitt, B. Speich, F. Naudet, A. Agarwal, Tiago V. Pereira, F. Sclafani, A. Herbrand, M. Briel, J. Martín-Liberal, Thomas Schmid, Hannah Ewald, J. Ioannidis, H. Bucher, B. Kasenda, L. Hemkens   +15 more
semanticscholar   +1 more source

Enteropathogenic E. coli shows delayed attachment and host response in human jejunum organoid‐derived monolayers compared to HeLa cells

FEBS Letters, EarlyView.
Enteropathogenic E. coli (EPEC) infects the human intestinal epithelium, resulting in severe illness and diarrhoea. In this study, we compared the infection of cancer‐derived cell lines with human organoid‐derived models of the small intestine. We observed a delayed in attachment, inflammation and cell death on primary cells, indicating that host ...
Mastura Neyazi, Pilar Samperio Ventayol, Natalie Burkard, Nicolas Schlegel, Carmen Aguilar, Sina Bartfeld   +5 more
wiley   +1 more source

Biovail v. Hoechst Aktiengesellschaf, Inc: An Analysis Under the Sherman Act and the Noerr-Pennington Doctrine [PDF]

, 2017
The Hatch-Waxman Act of 1984 regulates approval by the Food and Drug Administration (“FDA”) of generic counterparts to patented drugs. In a series of recent cases, large pharmaceutical companies have been accused of exploiting Hatch-Waxman in violation ...
Resek, John F., Ph.D.
core   +2 more sources

Ethical Issues in the Drug Approval Process [PDF]

, 2013
The Food and Drug Administration’s (FDA) drug approval process carries great significance for both pharmaceutical companies and for patients. In recent decades, there has been a shift towards expedited approval so that drugs, especially those for ...
McInnis, Meghan
core   +1 more source

Assessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017

JAMA Network Open, 2020
Key Points Question Have the number and characteristics of pivotal efficacy trials supporting US Food and Drug Administration approval of new drugs and biologics changed during the past 3 decades?
A. Zhang, Jeremy Puthumana, Nicholas Downing, N. Shah, H. Krumholz, J. Ross   +5 more
semanticscholar   +1 more source

Plasmodium falciparum gametogenesis essential protein 1 (GEP1) is a transmission‐blocking target

FEBS Letters, EarlyView.
This study shows Plasmodium falciparum GEP1 is vital for activating sexual stages of malarial parasites even independently of a mosquito factor. Knockout parasites completely fail gamete formation even when a phosphodiesterase inhibitor is added. Two single‐nucleotide polymorphisms (V241L and S263P) are found in 12%–20% of field samples.
Frederik Huppertz, Milagros Siebeck Caturelli, Lina S. Lehmann, Florian Kurth, Alexander G. Maier, Kai Matuschewski   +5 more
wiley   +1 more source

Impact of high-cost drugs for individual patient use [PDF]

, 2004
To document and describe the individual patient use (IPU) scheme at St Vincent's Hospital, Sydney in terms of submissions and approvals and assess the financial impact of the scheme on the hospital drug expenditure.
Brien, JE, Gallego, G, Melocco, T, Taylor, SJ   +3 more
core   +1 more source