BioCentury | May 4, 2020
Deals

Stemline takeout gives Menarini U.S. oncology beachhead

Although Menarini will gain a modest-selling drug by acquiring Stemline for up to $677 million, the Italian biopharma will also establish a U.S. oncology presence as its cancer pipeline matures. The deal gives Menarini Group...
BC Week In Review | Jan 25, 2019
Clinical News

FDA panel backs Takeda's gout drug Uloric for some patient populations

A joint FDA advisory panel voted 19-2, with one abstention, that gout drug Uloric febuxostat has a favorable benefit-risk profile for some patient populations. The U.S. business unit of Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) markets...
BC Extra | Dec 22, 2018
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...
BC Extra | Dec 22, 2018
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...
BC Week In Review | May 30, 2016
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....
BC Week In Review | Jan 11, 2016
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...
BC Week In Review | Nov 16, 2015
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...
BC Week In Review | Jul 13, 2015
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....
BC Week In Review | Jun 22, 2015
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...
BC Week In Review | Mar 9, 2015
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...
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