BioCentury | Oct 6, 2018
Finance

Large cap comeback

The biotech sector continued to be a stock pickers’ market through 3Q18 as there was a near even split between global biotech stocks that gained and lost value in the quarter. While 1H18 saw investors...
BC Week In Review | Aug 31, 2018
Clinical News

Allergan uterine fibroids therapy hits regulatory setback

Allergan plc (NYSE:AGN) said FDA issued a complete response letter for its NDA for ulipristal acetate to treat abnormal uterine bleeding in women with uterine fibroids. The company said FDA requested additional information and cited...
BC Extra | Aug 21, 2018
Company News

Allergan uterine fibroids therapy hits regulatory setback

Allergan plc (NYSE:AGN) said FDA issued a complete response letter for its NDA for ulipristal acetate to treat abnormal uterine bleeding in women with uterine fibroids. The company said FDA requested additional information and cited...
BC Week In Review | Mar 9, 2018
Clinical News

FDA extends review for Allergan's ulipristal acetate

Allergan plc (NYSE:AGN) said FDA extended its review of an NDA for ulipristal acetate (Ella, ellaOne, PGL4001) to treat abnormal uterine bleeding in women with uterine fibroids. The company had previously expected a decision from...
BC Week In Review | Dec 15, 2017
Company News

Allergan to acquire Repros

Allergan plc (NYSE:AGN) is acquiring Repros Therapeutics Inc. (NASDAQ:RPRX) for $0.67 per share in cash. Repros said it expects the deal to close in 1Q18. An Allergan spokesperson told BioCentury the deal adds to its...
BC Week In Review | Dec 1, 2017
Clinical News

FDA accepts NDA for ulipristal from Allergan for uterine bleeding

Allergan plc (NYSE:AGN) said FDA accepted for review an NDA for ulipristal acetate (Esmya - EU, Fibristal - Canada, Ella, ellaOne, PGL4001) to treat abnormal uterine bleeding in women with uterine fibroids. The company expects a 1H18...
BioCentury | Jul 8, 2017
Finance

A clinical quarter

Buysiders will find themselves digesting at least 23 Phase III data readouts in the next quarter, two of which could provide clarity on increasingly competitive markets in lung cancer and hemophilia. The third quarter is...
BC Week In Review | Jan 20, 2017
Clinical News

Ulipristal acetate: Ph III Venus II data

Top-line from the double-blind, U.S. Phase III Venus II trial in 432 premenopausal women ages 18-50 with abnormal bleeding due to uterine fibroids showed that 5 and 10 mg oral ulipristal acetate each met the...
BC Extra | Jan 18, 2017
Clinical News

Allergan/Gedeon uterine fibroids therapy headed for NDA

Allergan plc (NYSE:AGN) and Gedeon Richter Ltd. (Budapest:RICHTER) said ulipristal acetate ( PGL4001 ) met all co-primary and secondary endpoints in VENUS II, the second of two Phase III trials evaluating the compound to treat uterine fibroids....
BC Week In Review | May 16, 2016
Clinical News

Ulipristal acetate: Phase III data

Top-line data from the double-blind Phase III Venus I trial in 157 premenopausal women ages 18-50 with uterine fibroids showed that 5 and 10 mg ulipristal acetate for 12 weeks each met the co-primary endpoints...
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