18:37 , Mar 16, 2018 |  BC Week In Review  |  Clinical News

Glenmark's Ryaltris meets in Phase III for seasonal allergic rhinitis

Glenmark Pharmaceuticals Ltd. (NSE:GLENMARK; BSE:532296) reported data from a Phase III trial in 1,180 patients with seasonal allergic rhinitis showing that twice-daily Ryaltris mometasone/olopatadine met the primary endpoint of improving average morning and evening patient-reported...
19:11 , Dec 22, 2017 |  BC Week In Review  |  Clinical News

Glenmark's Ryaltris meets in Phase III for perennial allergic rhinitis

Glenmark Pharmaceuticals Ltd. (NSE:GLENMARK; BSE:532296) reported top-line data showing that twice-daily Ryaltris mometasone/olopatadine (formerly GSP 301) met the primary safety endpoint and a secondary efficacy endpoint in a Phase III trial to treat perennial allergic...
22:03 , Dec 1, 2017 |  BC Week In Review  |  Clinical News

Auris misses in Phase III hearing loss trial

Auris Medical Holding AG (NASDAQ:EARS) stock fell 49% Nov. 28 after the company said brimapitide (AM-111) missed the primary endpoint in the Phase III HEALOS trial. Neither tested dose of intratympanic brimapitide gel significantly improved...
22:31 , Nov 28, 2017 |  BC Extra  |  Clinical News

Auris' lead candidate misses in Phase III hearing loss trial

Auris Medical Holding AG (NASDAQ:EARS) fell $0.40 (49%) to $0.42 Tuesday after it said brimapitide (AM-111) missed the primary endpoint in the Phase III HEALOS trial. Neither tested dose of intratympanic brimapitide gel significantly improved...
19:19 , Jun 2, 2017 |  BC Week In Review  |  Clinical News

FDA approves Nicox’s Zerviate for ocular itching

Nicox S.A. (Euronext:COX) said FDA approved an NDA for Zerviate cetirizine (AC-170) to treat ocular itching associated with allergic conjunctivitis. The approval is Nicox's first in the U.S. Last October, FDA issued a complete response...
23:05 , May 31, 2017 |  BC Extra  |  Company News

Nicox’s Zerviate wins FDA nod for ocular itching

Nicox S.A. (Euronext:COX) jumped €2.26 (21%) to €12.85 Wednesday after FDA approved an NDA for Zerviate cetirizine to treat ocular itching associated with allergic conjunctivitis. The approval is Nicox's first in the U.S. In October...
21:48 , Apr 20, 2017 |  BC Week In Review  |  Clinical News

TNX-102 SL: Ph III HONOR started

Tonix began the double-blind, placebo-controlled, U.S. Phase III HONOR trial to evaluate 5.6 mg sublingual TNX-102 daily at bedtime for 12 weeks in about 550 patients. An IDMC will perform an interim analysis when efficacy...
20:09 , Mar 10, 2017 |  BC Week In Review  |  Clinical News

Zerviate regulatory update

Nicox resubmitted an NDA to FDA for Zerviate cetirizine to treat ocular itching associated with allergic conjunctivitis. Last year, FDA issued a complete response letter to Nicox for the product due to concerns related to...
21:52 , Feb 9, 2017 |  BC Week In Review  |  Clinical News

Xyzal Allergy 24HR regulatory update

Sanofi said FDA approved Xyzal Allergy 24HR levocetirizine for OTC use to treat symptoms associated with seasonal and year-round allergies. Sanofi expects Xyzal Allergy 24HR will be available in spring. In 2006, Sanofi and UCB...
22:48 , Feb 8, 2017 |  BC Week In Review  |  Clinical News

CL-108 regulatory update

FDA issued a complete response letter for an NDA from Charleston and Daiichi for CL-108 to manage pain severe enough to require an opioid analgesic while preventing or reducing the associated opioid-induced nausea and vomiting...