Results 91 to 100 of about 1,536,180 (350)

Imbalance in glycemic control between the treatment and placebo groups in cardiovascular outcome trials in type 2 diabetes

open access: yesJournal of Pharmaceutical Policy and Practice, 2019
Background Glycated hemoglobin (HbA1c) is accepted as the most reliable marker for assessing chronic glycemia. The present study aimed to investigate glycemic control in cardiovascular outcome trials (CVOTs) performed by pharmaceutical sponsors, at the ...
Rumiko Shimazawa, Masayuki Ikeda
doaj   +1 more source

Evaluation of KRAS and NRAS mutations in metastatic colorectal cancer: an 8‐year study of 10 754 patients in Turkey

open access: yesMolecular Oncology, EarlyView.
This nationwide study evaluated KRAS and NRAS mutations in 10 754 Turkish patients with metastatic colorectal cancer. The results revealed a mutation frequency of 51.1%, with 46.6% having KRAS mutations, 4.5% having NRAS mutations, and 48.5% being wild‐type for both.
Gozde Kavgaci   +6 more
wiley   +1 more source

Landscape of BRAF transcript variants in human cancer

open access: yesMolecular Oncology, EarlyView.
We investigate the annotation of BRAF variants, focusing on protein‐coding BRAF‐220 (formerly BRAF‐reference) and BRAF‐204 (BRAF‐X1). The IsoWorm pipeline allows us to quantify these variants in human cancer, starting from RNA‐sequencing data. BRAF‐204 is more abundant than BRAF‐220 and impacts patient survival.
Maurizio S. Podda   +5 more
wiley   +1 more source

Regulating Access to Developmental Drugs for Terminally Ill Patients: Abigail Alliance v FDA [PDF]

open access: yes
This amicus brief was filed in support of the Abigail Alliance for Better Access to Developmental Drugs in their lawsuit to force the Food and Drug Administration to provide patient access to drugs for cancer and other life-threatening illnesses after ...
Calfee, John E.   +4 more
core   +1 more source

An Analysis of New Drug Examination and Approval System of PRC [PDF]

open access: yes, 2012
This paper analyzes the new drug examination and approval systems before and after the Measures was amended in 2007 and evaluates the effectiveness of the 2007 Amendment.
Sun, Xiaopu
core  

TRPM8 levels determine tumor vulnerability to channel agonists

open access: yesMolecular Oncology, EarlyView.
TRPM8 is a Ca2+ permissive channel. Regardless of the amount of its transcript, high levels of TRPM8 protein mark different tumors, including prostate, breast, colorectal, and lung carcinomas. Targeting TRPM8 with channel agonists stimulates inward calcium currents followed by emptying of cytosolic Ca2+ stores in cancer cells.
Alessandro Alaimo   +18 more
wiley   +1 more source

Clinical Trial 2.0: Can Health 2.0 Transform the FDA Drug Approval Process? [PDF]

open access: yes, 2012
Historically, patient activism has played a great part in shaping the drug approval process. Today, aided by developing web technologies, patients are once again seeking increased involvement in their medical care.
Atanassova, Mira
core  

Evidence and Extrapolation: Mechanisms for Regulating Off-Label Uses of Drugs and Devices [PDF]

open access: yes, 2014
A recurring, foundational issue for evidence-based regulation is deciding whether to extend governmental approval from an existing use with sufficient current evidence of safety and efficacy to a novel use for which such evidence is currently lacking ...
Abbott, Ryan, Ayres, Ian
core   +3 more sources

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

open access: yesMolecular 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   +10 more
wiley   +1 more source

Assessing the Impacts of the Prescription Drug User Fee Acts (PDUFA) on the FDA Approval Process [PDF]

open access: yes
Congress enacted and renewed the Prescription Drug User Fee Acts (PDUFA) in 1992, and renewed it in 1997 and 2002, mandating FDA performance goals in reviewing and acting on drug applications within specified time periods.
Adrian H. B. Gottschalk   +3 more
core  

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