20:44 , Jun 22, 2018 |  BC Week In Review  |  Clinical News

ObsEva's linzagolix meets in Phase IIb for endometriosis-associated pain

ObsEva S.A. (NASDAQ:OBSV) said three of four doses of linzagolix (OBE2109, KLH-2109) met the primary endpoint in the Phase IIb EDELWEISS trial to treat moderate to severe endometriosis-associated pain. The company plans to present additional...
19:58 , Mar 9, 2018 |  BC Week In Review  |  Clinical News

Gilead reports additional Phase III data from HIV switching trial of Biktarvy

Gilead Sciences Inc. (NASDAQ:GILD) reported additional data from the Phase III GS-US-380-1844 trial in 563 virologically suppressed adults with HIV-1 infection showing that switching from either Tivicay dolutegravir plus abacavir/lamivudine or Triumeq dolutegravir/abacavir/lamivudine to once-daily...
19:11 , Oct 13, 2017 |  BioCentury  |  Regulation

Seeking surrogates

Thanks to flaws in PTC Therapeutics Inc. ’s trials, the recent FDA advisory committee meeting to discuss Translarna ataluren did nothing to clarify what level of dystrophin expression would be necessary to support an accelerated...
17:17 , May 26, 2017 |  BC Week In Review  |  Clinical News

Amgen, UCB report CV safety signal in Phase III of osteoporosis candidate Evenity

Amgen Inc. (NASDAQ:AMGN) and UCB S.A. (Euronext:UCB) no longer expect FDA to approve Evenity romosozumab (AMG 785, CDP7851) this year after data from the Phase III ARCH trial in 4,093 postmenopausal women with osteoporosis at...
20:05 , May 12, 2017 |  BC Week In Review  |  Clinical News

Mereo starts Phase IIb for osteogenesis imperfecta

Mereo BioPharma Group plc (LSE:MPH) began the Phase IIb ASTEROID trial to evaluate BPS-804 to treat osteogenesis imperfecta. The double-blind, placebo-controlled, international trial will enroll up to 120 patients to receive 1 of 3 doses...
21:47 , Feb 10, 2017 |  BC Week In Review  |  Clinical News

Romosozumab: Additional Ph III BRIDGE data

Additional data from the double-blind, international Phase III BRIDGE trial in 245 men with osteoporosis showed that once-monthly 210 mg subcutaneous romosozumab significantly improved BMD at the lumbar spine from baseline to 12 months, the...
07:00 , Oct 17, 2016 |  BC Week In Review  |  Clinical News

KLH-2109: Phase IIb started

ObsEva began the double-blind, placebo-controlled, international Phase IIb EDELWEISS trial to evaluate 5 dose levels of oral OBE2109 once daily for 24 weeks in about 330 patients with pelvic pain associated with endometriosis. ObsEva has...
07:00 , Sep 12, 2016 |  BC Week In Review  |  Clinical News

Odanacatib: Development discontinued

Merck discontinued development of odanacatib after an independent adjudication and analysis of major adverse cardiovascular events confirmed an increased risk of stroke with the compound. Merck previously reported data from the double-blind, international Phase III...
07:00 , Sep 5, 2016 |  BC Week In Review  |  Clinical News

Prolia denosumab: Phase III data

Top-line data from the double-blind, double-dummy, international Phase III GIOP trial in 795 patients receiving glucocorticoid treatment showed that 60 mg subcutaneous Prolia every 6 months met the primary endpoint of non-inferiority to risedronate in...
07:00 , May 9, 2016 |  BC Week In Review  |  Clinical News

UX023: Interim Phase II data

Interim data from the open-label, U.S. Phase II UX023T-CL201 trial showed that 6 of 8 patients with TIO or epidermal nevus syndrome receiving subcutaneous KRN23 every 4 weeks for 48 weeks achieved serum phosphorus levels...