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12:19 PM, Apr 13, 2018  |  BC Week In Review | Clinical News  |  Clinical Results

Virta reports data for continuous care intervention strategy for Type II diabetes

Data reported in Diabetes Therapy showed that the Virta Treatment intervention strategy from Virta Health Corp. (San Francisco, Calif.) safely reduced HbA1c, body weight and diabetes medication use in an open-label study in 349 Type...
12:06 PM, Apr 13, 2018  |  BC Week In Review | Clinical News  |  Regulatory

China advisory committee to review CASI's multiple myeloma therapy

CASI Pharmaceuticals Inc. (NASDAQ:CASI) said China's Expert Advisory Anti-Tumor (Oncology) Drugs Committee will meet to review an application for CASI's Evomela melphalan to treat multiple myeloma. China FDA's Center for Drug Evaluation told CASI the...
11:36 AM, Apr 13, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

Alphamab's HER2 bispecific antibody to enter clinic in China

Suzhou Alphamab Co. Ltd. (Suzhou, China) will begin in 3Q18 the dose-escalation portion of a Chinese Phase I trial evaluating KN026 to treat HER2-positive locally advanced and metastatic solid tumors in patients who failed previous...
11:18 AM, Apr 13, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

FDA lifts hold on trials of BPX-501

Bellicum Pharmaceuticals Inc. (NASDAQ:BLCM) said FDA lifted a clinical hold on U.S. trials of the company’s adjunct, safety switch-containing T cell therapy BPX-501. FDA placed the hold in January after the company reported three cases...
10:59 AM, Apr 13, 2018  |  BC Week In Review | Clinical News  |  Clinical Results

Ocugen reports Phase II data for dry eye disease candidate

Ocugen Inc. (Malvern, Pa.) reported data from a Phase II trial showing that dry eye disease candidate OCU310 met the primary endpoint of tolerability over a 12-week period. The company said the trial was not...
10:59 AM, Apr 13, 2018  |  BC Week In Review | Clinical News  |  Clinical Results

Valneva reports Phase I data for Lyme disease vaccine candidate

Valneva SE (Euronext Paris:VLA; VSE:VLA) reported interim data from a Phase I trial in 179 healthy volunteers ages 18-40 showing that Lyme disease candidate VLA15 (VLA15-101) met the primary endpoint by achieving a "favorable" safety...
10:59 AM, Apr 13, 2018  |  BC Week In Review | Clinical News  |  Clinical Results

Leap reports Phase I data from monotherapy arm of esophageal cancer trial

Leap Therapeutics Inc. (NASDAQ:LPTX) reported data from 16 patients with advanced esophagogastric cancer in the Phase I P102 trial showing that DKN-01 as monotherapy led to two partial responses, plus five cases of stable disease....
10:58 AM, Apr 13, 2018  |  BC Week In Review | Clinical News  |  Clinical Results

Wilson reports 72-week data Wilson’s disease candidate

Wilson Therapeutics AB (SSE:WTX) reported data from 20 evaluable patients with Wilson’s disease in the extension portion of the 24-week Phase II WTX101-201 trial showing that once-daily oral Decuprate bis-choline tetrathiomolybdate (WTX101) controlled mean nonceruloplasmin-bound...
10:55 AM, Apr 13, 2018  |  BC Week In Review | Clinical News  |  Regulatory

AbbVie's elagolix NDA PFUDA pushed to third quarter

AbbVie Inc. (NYSE:ABBV) said FDA extended by three months its review of an NDA for elagolix (ABT-620) to manage endometriosis with associated pain. The candidate's PDUFA date is now in 3Q18. The exact date is...
10:23 AM, Apr 13, 2018  |  BC Week In Review | Clinical News  |  Preclinical Results

ProMIS identifies new beta amyloid epitope to treat AD

Researchers at the University of British Columbia reported preclinical data showing that PMN300 decreased soluble beta amyloid aggregates and neurotoxicity in the brain in two mouse models of Alzheimer's disease. In a paper published in...

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