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...
07:00 , Mar 18, 2013 |  BioCentury  |  Strategy

Japan's biggest biotech

Japanese pharmaceutical companies have historically been thought of as stodgy, insular and opaque, but that is changing fast. One year into the job, Kyowa Hakko Kirin Co. Ltd.'s CEO is building his company along lines...
07:00 , Aug 3, 2009 |  BC Week In Review  |  Clinical News

Patanase olopatadine hydrochloride regulatory update

Alcon disclosed that last quarter it submitted an sNDA to FDA for Patanase olopatadine hydrochloride nasal spray to treat seasonal allergic rhinitis in pediatric patients ages 6 months to 12 years. The histamine H1...
07:00 , May 11, 2009 |  BioCentury  |  Product Development

Conjoined against Conjunctivitis

By Mike Ward Senior Editor Although treatment of allergic conjunctivitis is dominated by prescription antihistamines, generic steroids and over-the-counter products, Fovea Pharmaceuticals S.A. thinks its Prednisporin prednisolone/cyclosporine A combination will deliver enough improvement in symptom control...
07:00 , May 11, 2009 |  BC Week In Review  |  Clinical News

Prednisporin: Phase II data

Data from a double-blind, U.S. Phase II trial in 150 patients showed that Prednisporin (0.1% prednisolone/0.01% cyclosporine A) met the primary endpoint of non-inferiority to Pred Forte 1% prednisolone in reducing ocular itching and redness...
08:00 , Jan 12, 2009 |  BioCentury  |  Finance

New products to watch

New products to watch Selected drugs that received regulatory approval in 2008. Company Product Indication 2008 approval Abbott (NYSE:ABT) Simcor extended-release niacin / immediate-release simvastatin Manage cholesterol in patients with...
08:00 , Nov 10, 2008 |  BC Week In Review  |  Clinical News

Allelock olopatadine hydrochloride regulatory update

Kyowa said that in July it submitted a Chinese marketing application for Allelock to treat allergies. The company co-markets an eye drop formulation of the histamine H1 receptor antagonist with Alcon Laboratories Inc. (NYSE:ACL,...
07:00 , Jul 7, 2008 |  BioCentury  |  Finance

2Q approvals

2Q approvals Selected second quarter product approvals. The list does not include an FDA approvable letter for Zentase pancrealipase capsules to treat exocrine pancreatic insufficiency from Eurand (NASDAQ:EURX). While not a full approval, the...
07:00 , Apr 21, 2008 |  BC Week In Review  |  Clinical News

Patanase olopatadine hydrochloride regulatory update

FDA approved an NDA from Alcon for Patanase olopatadine nasal spray to treat seasonal allergic rhinitis in patients 12 years and older. The company plans to launch the twice-daily intranasal formulation of the selective ...