Results 31 to 40 of about 914,390 (333)

Taking Biologics for Granted? Takings, Trade Secrets, and Off-Patent Biological Products [PDF]

, 2005
Biologics are complex medicines which are often genetically engineered, and which are sure to play an important role in curing some of humankind\u27s worst diseases. Not surprisingly, generic companies want a part of the biologic market. The FDA believes
Bergman, Karl-Olof, Milberg, Per, Wikstroem, Linnea   +2 more
core   +3 more sources

Analyzing FDA's approaches to using electronic health record and medical claims data to support regulatory decision making

Реальная клиническая практика: данные и доказательства, 2023
In 2021, the U.S. Food and Drug Administration (FDA) issued draft guidance on the use of electronic health records and medical claims data for regulatory decisions.
Ksenia S. Radaeva, M. V. Pchelintsev
doaj   +1 more source

The anticancer effect of the HDAC inhibitor belinostat is enhanced by inhibitors of Bcl‐xL or Mcl‐1 in ovarian cancer

Molecular Oncology, EarlyView.
The pan‐HDAC inhibitor belinostat increases the expression of the pro‐apoptotic proteins Bim, Puma, and Noxa and induces apoptosis in ovarian cancer cell lines and patient‐derived tumor organoids when used at high concentrations. Moreover, inhibiting the anti‐apoptotic proteins Bcl‐xL or Mcl‐1 sensitizes these preclinical models to the cytotoxic effect
Cécilia Thomine, Sterenn Guillemot, Louis‐Bastien Weiswald, Romane Florent, Edwige Abeilard, Florence Giffard, Emilie Brotin, Mélanie Briand, Enora Dolivet, Laurent Poulain, Marie Villedieu   +10 more
wiley   +1 more source

Sometimes the Silence Can Be like the Thunder: Access to Pharmaceutical Data at the FDA [PDF]

, 2006
Those committed to the free exchange of scientific information have long complained about various restrictions on access to the FDA\u27s pharmaceutical data and the resultant restrictions on open discourse.
Ankelhed, Daniel, Hansson, Anders, Helmersson, Anders   +2 more
core   +2 more sources

Sustained antigen delivery improves germinal center reaction and increases antibody responses in neonatal mice

npj Vaccines
Neonates and young infants are known to have limited responses to pediatric vaccines due to reduced germinal center formation. Extended vaccine antigen dosing was previously shown to expand germinal center formation and improve humoral responses in adult
Leda Lotspeich-Cole, Swetha Parvathaneni, Jiro Sakai, Lunhua Liu, Kazuyo Takeda, Robert C. Lee, Mustafa Akkoyunlu   +6 more
doaj   +1 more source

Orphanage at the FDA [PDF]

Journal of Cardiovascular Translational Research, 2010
In the late 1970s and early 1980s, social and political forces gave birth to a new movement to serve the needs of people with rare diseases, a movement that has only accelerated with the penetrance of internet connectivity. The FDA's Office of Orphan Products Development (OOPD) was established in 1982 to promote the development of products that ...
openaire   +3 more sources

Regulating Innovative Medicine: Fitting Square Pegs in Round Holes [PDF]

, 2005
Increasingly, innovative medical products are creating a quandary for the Food and Drug Administration ( FDA ) because they often transcend the FDA\u27s traditional categorical approach to regulating medical products. In a recent attempt to simplify this
Lavender, Mark
core   +1 more source

Circulating tumor DNA monitoring and blood tumor mutational burden in patients with metastatic solid tumors treated with atezolizumab

Molecular Oncology, EarlyView.
In patients treated with atezolizumab as a part of the MyPathway (NCT02091141) trial, pre‐treatment ctDNA tumor fraction at high levels was associated with poor outcomes (radiographic response, progression‐free survival, and overall survival) but better sensitivity for blood tumor mutational burden (bTMB).
Charles Swanton, Russell W. Madison, Candice Francheska B. Tambaoan, Funda Meric‐Bernstam, Christopher J. Sweeney, Razelle Kurzrock, Howard A. Burris III, David R. Spigel, Hanna Tukachinsky, Jason Hughes, Julia Malato, Bongin Yoo, Tania Szado, Cheryl Schwab, Lincoln W. Pasquina, Amaya Gasco, Katja Schulze, Claire F. Friedman   +17 more
wiley   +1 more source

Molecular imaging predicts trastuzumab‐deruxtecan (T‐DXd) response in head and neck cancer xenograft models

Molecular Oncology, EarlyView.
Trastuzumab‐deruxtecan, a HER2‐targeting antibody‐drug conjugate, shows promising antitumor activity in head and neck squamous cell carcinoma with low HER2 expression. In vitro and in vivo studies demonstrated dose‐dependent cell death and tumor growth reduction in low HER2‐expressing cell lines, which correlated with drug accumulation measured using a
Abdullah Bin Naveed, Lucas Mani, Muhammad Bilal Mirza, Ashtyn McAdoo, Takahito Kondo, Hidenori Tanaka, Nicole Meeks, Eben Rosenthal, Marisa Hom   +8 more
wiley   +1 more source

\u3ci\u3eUnited States v. Caronia\u3c/i\u3e: Off-Label Drug Promotion and First Amendment Balancing [PDF]

, 2018
Off-label drug promotion is commonplace in the United States, but it is not without its dangers. While the Food, Drug, and Cosmetic Act does not explicitly ban off-label promotion, the Food & Drug Administration (FDA)— in order to protect consumers from ...
Rabinowitz, Daniel P.
core   +1 more source