BC Extra | Jul 23, 2019
Clinical News

July 23 Clinical Quick Takes: Achillion plans U.S. IND; plus Chiasma, Myovant, Marinus and Merck

Achillion plans U.S. IND after latest readout for ACH-5228  Achillion Pharmaceuticals Inc. (NASDAQ:ACHN) rose $1.19 (50%) to $3.57 since announcing early Monday that multiple ascending doses of its CFD inhibitor ACH-5228 led to 95% complement...
BC Extra | Oct 9, 2018
Politics & Policy

FDA pushes generic competition for transdermal complex drugs

FDA clarified how to develop generic versions of transdermal or topical complex drugs, releasing a series of guidances Tuesday as the agency continues its push for greater generics competition. Complex drugs, especially those with transdermal...
BC Week In Review | Mar 16, 2018
Clinical News

AbbVie's elagolix meets in second Phase III for uterine fibroids

AbbVie Inc. (NYSE:ABBV) said elagolix (ABT-620) met the primary and all ranked secondary endpoints in the Phase III ELARIS UF-II (M12-817) trial, the second of two replicate Phase III trials of the non-peptide small molecule...
BC Extra | Mar 13, 2018
Clinical News

AbbVie's elagolix meets in second Phase III for uterine fibroids

AbbVie Inc. (NYSE:ABBV) said elagolix (ABT-620) met the primary and all ranked secondary endpoints in the Phase III ELARIS UF-II (M12-817) trial, the second of two replicate Phase III trials of the candidate to treat...
BC Week In Review | Feb 23, 2018
Clinical News

AbbVie's elagolix meets in Phase III for uterine fibroids

AbbVie Inc. (NYSE:ABBV) said elagolix (ABT-620) met the primary and all ranked secondary endpoints in the Phase III ELARIS UF-I (M12-815) trial to treat uterine fibroids. The trial is the first of two replicate Phase...
BC Extra | Feb 21, 2018
Clinical News

AbbVie's elagolix meets in Phase III for uterine fibroids

AbbVie Inc. (NYSE:ABBV) said elagolix (ABT-620) met the primary and all ranked secondary endpoints in the Phase III ELARIS UF-I (M12-815) trial to treat uterine fibroids. The trial is the first of two replicate Phase...
BC Week In Review | Feb 15, 2016
Clinical News

Elagolix: Phase III started

AbbVie began double-blind, placebo-controlled, U.S. Phase III trial to evaluate oral elagolix with or without estradiol/norethindrone acetate in about 400 patients. The trial includes a 6-month extension study. Enrollment of the first patient triggered a...
BC Week In Review | Sep 21, 2015
Clinical News

Elagolix: Phase IIb data

The double-blind, international Phase IIb M12-813 trial in about 567 premenopausal women with heavy menstrual bleeding associated with uterine fibroids showed that twice-daily 300 mg and once-daily 600 mg oral elagolix for 24 weeks alone...
BC Week In Review | Mar 16, 2015
Clinical News

Secnidazole: Phase I data

An open-label Phase I trial in 54 healthy female volunteers showed that co-administration of a single dose of 2 g oral SYM-1219 a single dose of an ethinyl estradiol/norethindrone combination birth control pill on the...
BC Week In Review | Sep 8, 2014
Company News

Noven, Novartis deal

Hisamitsu Pharmaceutical Co. Inc. (Tokyo:4530, Tosu, Japan)and Novartis dissolved Vivelle Ventures LLC, a JV formed in 1998 between Novartis and Hisamitsu's Noven Pharmaceuticals Inc. subsidiary. Novartis said the partners mutually decided to dissolve the JV,...
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