Results 131 to 140 of about 1,709,620 (289)

Manufacturing Barriers to Biologics Competition and Innovation [PDF]

, 2016
As finding breakthrough small-molecule drugs gets harder, drug companies are increasingly turning to “large molecule” biologics. Although biologics represent many of the most promising new therapies for previously intractable diseases, they are extremely
Price, W. Nicholson, II, Rai, Arti K.
core   +2 more sources

Is slower early growth beneficial for long-term cardiovascular health? [PDF]

, 2004
Background - Accelerated neonatal growth increases the later propensity to cardiovascular disease (CVD) in animals, whereas slower growth is thought to have a beneficial effect.
Cole, TJ, Deanfield, J, Fewtrell, M, Lucas, A, Singhal, A   +4 more
core   +1 more source

Pathogenic Neurofibromatosis type 1 gene variants in tumors of non‐NF1 patients and role of R1276

FEBS Open Bio, EarlyView.
Somatic variants of the neurofibromatosis type 1 (NF1) gene occur across neoplasms without clinical manifestation of the disease NF1. We identified emerging somatic pathogenic NF1 variants and hotspots, for example, at the arginine finger 1276. Those missense variants provide fundamental information about neurofibromin's role in cancer.
Mareike Selig, Swanhild Lohse, Sara Elahi, Nils Hartmann, Stefanie Deckert, Shutian Si, Alexander Desuki, Anja Harder   +7 more
wiley   +1 more source

Regulatory approval for autologous human cells and tissue products in the United States, the European Union, and Japan

Regenerative Therapy, 2015
Human cells and tissue products belong to a relatively new class of medical products. Therefore, limited information is available on the classification and premarket evaluation of human cells and tissue products in the United States (US), the European ...
Kazuo Yano, Natsumi Watanabe, Kenichiro Tsuyuki, Taisuke Ikawa, Hiroshi Kasanuki, Masayuki Yamato   +5 more
doaj   +1 more source

The Efficacy of Peripheral Opioid Antagonists in Opioid-Induced Constipation and Postoperative Ileus: A Systematic Review of the Literature. [PDF]

, 2017
Opioid-induced constipation has a negative impact on quality of life for patients with chronic pain and can affect more than a third of patients. A related but separate entity is postoperative ileus, which is an abnormal pattern of gastrointestinal ...
Baratta, Jaime L., Grant, Alexander E., McNulty, Stephen E., Schwenk, Eric S., Torjman, Marc C., Viscusi, Eugene R.   +5 more
core   +1 more source

Accelerated orphan drug approval: surrogate endpoints

, 2022
Candida Fratazzi, Jixiao Niu
openalex   +1 more source

TMC4 localizes to multiple taste cell types in the mouse taste papillae

FEBS Open Bio, EarlyView.
Transmembrane channel‐like 4 (TMC4), a voltage‐dependent chloride channel, plays a critical role in amiloride‐insensitive salty taste transduction. TMC4 is broadly expressed in all mature taste cell types, suggesting a possible involvement of multiple cell types in this pathway.
Momo Murata, Yoshikazu Saito, Yoichi Kasahara, Wataru Fujii, Takumi Misaka, Tomiko Asakura, Masataka Narukawa   +6 more
wiley   +1 more source

Strength of clinical evidence supporting the United States Food and Drug Administration Accelerated Approvals from 2015 to 2022

BMC Medicine
Background The Food and Drug Administration (FDA)’s Accelerated Approval (AA) pathway has increasingly used to authorize market approval of new drugs amid controversy.
Xiaofang Zhang, Carl C. Peck, Yaning Wang, Thomas D. Szucs, Wan Sun, Xue Bai, Siyu Chen, Fengzhi Wang, Yangfeng Wu   +8 more
doaj   +1 more source

SIRT4 positively regulates autophagy via ULK1, but independently of HDAC6 and OPA1

FEBS Open Bio, EarlyView.
Cells expressing SIRT4 (H161Y), a catalytically inactive mutant of the sirtuin SIRT4, fail to upregulate LC3B‐II and exhibit a reduced autophagic flux under stress conditions. Interestingly, SIRT4(H161Y) promotes phosphorylation of ULK1 at S638 and S758 that are associated with inhibition of autophagy initiation.
Isabell Lehmkuhl, Khawar Amin, Lydia Gabriel, Nils Hampel, Afshin Iram, Julia Hesse, Constanze Wiek, Jasmin Thuy Vy Nguyen, Helmut Hanenberg, Jürgen Scheller, M. Reza Ahmadian, Björn Stork, Doreen M. Floss, Roland P. Piekorz   +13 more
wiley   +1 more source

From bench to bedside, 2-in-1 design expedites phase 2/3 oncology drug development

Frontiers in Oncology, 2023
Cong Chen, Xuekui Zhang
doaj   +1 more source