05:26 , Dec 22, 2018 |  BC Extra  |  Politics & Policy

Partial shutdown sees 41% of FDA staff furloughed

FDA has furloughed almost half its staff after the U.S. government partially shut down early Dec. 22, potentially slowing approvals and stalling advisory committee meetings. Commissioner Scott Gottlieb confirmed in a tweet Friday that FDA...
00:58 , Dec 22, 2018 |  BC Extra  |  Politics & Policy

FDA could furlough 40% of employees, slow drug reviews under partial shutdown

A lapse of federal funding would mean a partial shutdown at FDA with the potential to slow approvals and advisory committee meetings stretching beyond the length of the impasse. While negotiations in Washington continue, the...
07:00 , May 30, 2016 |  BC Week In Review  |  Clinical News

Feburic febuxostat regulatory update

Teijin said Japan approved an expanded label for Feburic febuxostat to include treatment of hyperuricemia caused by chemotherapy. The non-purine selective inhibitor of xanthine oxidase is approved in Japan for hyperuricemia with or without gout....
08:00 , Jan 11, 2016 |  BC Week In Review  |  Clinical News

AC-201 CR: Interim Phase IIa data

Interim data from 36 gout patients in the first cohort of the double-blind, Taiwanese Phase IIa AC-201-GOU-002 trial showed that twice-daily oral AC-201 CR met the criteria of >=2 more responders, defined as achieving a...
08:00 , Nov 16, 2015 |  BC Week In Review  |  Clinical News

Zurampic lesinurad: Additional Phase III data

AstraZeneca reported additional data from the double-blind, placebo-controlled, international Phase III CRYSTAL trial of lesinurad in 324 gout patients with tophi (visible nodules of uric acid crystals that are deposited in joints and skin). In...
07:00 , Jul 13, 2015 |  BC Week In Review  |  Clinical News

Febuxostat regulatory update

The European Commission approved an expanded label for Adenuric febuxostat from Menarini to include the prevention and treatment of hyperuricemia in adults undergoing chemotherapy for hematologic malignancies at intermediate- to high-risk of tumor lysis syndrome....
07:00 , Jun 22, 2015 |  BC Week In Review  |  Clinical News

Lesinurad: Additional Phase III data

Additional data from the double-blind, placebo-controlled, international Phase III CRYSTAL trial in 324 gout patients with tophi (visible nodules of uric acid crystals that are deposited in joints and skin) showed that 76.1% of patients...
07:00 , Mar 9, 2015 |  BC Week In Review  |  Clinical News

Adenuric febuxostat regulatory update

EMA’s CHMP recommended approval of an expanded label for Adenuric febuxostat from Menarini to include prevention and treatment of hyperuricemia in adults undergoing chemotherapy for hematologic malignancies at intermediate to high risk of tumor lysis...
03:03 , Feb 25, 2015 |  BC Extra  |  Clinical News

CymaBay falls on Phase IIb gout data

CymaBay Therapeutics Inc. (NASDAQ:CBAY) fell $2.27 (19%) to $9.98 on Tuesday after reporting interim data from its Phase IIb trial of arhalofenate ( MBX-102 ) to treat gout. While the trial met its primary endpoint...
08:00 , Feb 2, 2015 |  BC Week In Review  |  Clinical News

Arhalofenate: Preliminary Phase II data

Preliminary data from an open-label, U.S. Phase II trial in 32 patients with gout showed that 7%, 43% (p<0.05) and 79% of patients receiving once-daily 600 mg oral arhalofenate plus 40 mg febuxostat and 20%,...