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8:13 PM, Aug 16, 2018  |  BC Week In Review | Clinical News  |  Clinical Results

Eisai's Belviq does not increase MACE in CVOT for weight management drug

Eisai Co. Ltd. (Tokyo:4523) said Belviq lorcaserin met the primary safety endpoint by not increasing the incidence of major adverse cardiovascular events (MACE), comprising CV death, non-fatal myocardial infarction (MI) and non-fatal stroke, in the...
8:13 PM, Aug 16, 2018  |  BC Week In Review | Clinical News  |  Clinical Results

Amgen's Repatha lowers LDL-C in Phase III for dyslipidemia in Type II diabetics

Amgen Inc. (NASDAQ:AMGN) reported in June that Repatha evolocumab met the co-primary endpoints in the Phase III BANTING trial to treat hypercholesterolemia or mixed dyslipidemia in Type II diabetics taking the maximum tolerated dose of...
8:12 PM, Aug 16, 2018  |  BC Week In Review | Clinical News  |  Clinical Results

Genentech reports Phase II data for sustained delivery eye implant of ranibizumab

The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) said the majority of patients who received Port Delivery System (PDS) administration of ranibizumab were able to go six months or longer between implantation and the first...
12:22 PM, Aug 10, 2018  |  BC Week In Review | Clinical News  |  Clinical Results

Spring Bank details peak HBV DNA and HBV RNA reductions for 100 mg dose of inarigivir

Spring Bank Pharmaceuticals Inc. (NASDAQ:SBPH) reported data from 20 patients in the third cohort of Part A of Phase II ACHIEVE trial to treat chronic HBV infection showing that 100 mg inarigivir soproxil led to...
11:53 AM, Aug 10, 2018  |  BC Week In Review | Clinical News  |  Clinical Results

Theravance's TD-9855 improves symptom severity in Phase II for hypotension

Theravance Biopharma Inc. (NASDAQ:TBPH) reported data from 16 patients with symptomatic neurogenic orthostatic hypotension in Part C of a Phase II trial showing that once-daily TD-9855 led to a mean symptom improvement of 2.4 points...
11:42 AM, Aug 10, 2018  |  BC Week In Review | Clinical News  |  Clinical Results

Phase III of Bellerophon's INOpulse for PAH stopped for futility

Bellerophon Therapeutics Inc. (NASDAQ:BLPH) said a DMC recommended stopping for futility the Phase III INOvation-1 trial of INOpulse to treat pulmonary arterial hypertension (PAH). A prespecified interim analysis of the first 75 patients who completed 16...
11:29 AM, Aug 10, 2018  |  BC Week In Review | Clinical News  |  Clinical Results

Strongbridge's Cushing syndrome candidate meets in Phase III

Strongbridge Biopharma plc (NASDAQ:SBBP) said Recorlev levoketoconazole met the primary and secondary endpoints in the Phase III SONICS trial to treat endogenous Cushing syndrome. On the 94-patient trial's primary endpoint, 30% of patients achieved normalization of...
11:26 AM, Aug 10, 2018  |  BC Week In Review | Clinical News  |  Clinical Results

Audentes reports Phase I/II muscle biopsy data for myopathy gene therapy

Audentes Therapeutics Inc. (NASDAQ:BOLD) reported data from its 24-week muscle biopsy analyses of the first dose cohort and said an IDMC recommended proceeding to the second dose cohort of the Phase I/II ASPIRO trial evaluating...
11:12 PM, Aug 09, 2018  |  BC Week In Review | Clinical News  |  Clinical Results

Spark reports new Factor VIII activity data for hemophilia A gene therapy

Spark Therapeutics Inc. (NASDAQ:ONCE) reported new Phase I/II data showing that the highest tested dose of hemophilia A gene therapy SPK-8011 led to lower than expected Factor VIII activity levels in two patients. Spark's open-label, international...
11:10 PM, Aug 09, 2018  |  BC Week In Review | Clinical News  |  Clinical Results

Bonti's EB-001A improves scar appearance following Mohs surgery in Phase IIa

Bonti Inc. (Newport Beach, Calif.) said EB-001A improved scar appearance by about 50% vs. placebo as measured by investigator-assessed visual analog scale (VAS) scores at day 30 in the Phase IIa SHINE-1 trial in 12...

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