BC Extra | Mar 28, 2019
Politics & Policy

China lists 30 more overseas drugs eligible for Priority Review

China’s Drug Evaluation Center posted a second batch of drugs already approved in the U.S., EU or Japan that could be eligible for Priority Review in China. Fourteen of the 30 drugs on the list...
BC Week In Review | Jul 28, 2017
Clinical News

CHMP recommends Santen's Verkazia for keratoconjunctivitis

EMA's CHMP recommended approval of Verkazia ciclosporin (Ikervis, Cyclokat) from Santen Pharmaceutical Co. Ltd. (Tokyo: 4536) to treat severe vernal keratoconjunctivitis, a rare eye allergy. The ophthalmic cationic emulsion form of the immunosuppressant cyclosporine A...
BC Extra | Jul 21, 2017
Company News

CHMP backs approval of basket of drugs

On Friday, EMA's CHMP recommended approval of a host of therapies, including Rydapt midostaurin to treat acute myelogenous leukemia (AML), and Verkazia ciclosporin to treat severe vernal keratoconjunctivitis, a rare eye allergy. CHMP backed approval...
BC Innovations | Dec 1, 2016
Product R&D

De-stressing about NASH

With a new use for an old compound, NeuroVive Pharmaceutical AB is positioning its cyclophilin inhibitor as a first-in-class treatment for NASH, adding the liver disease to the company’s repertoire of non-traditional mitochondrial disorders. The...
BC Week In Review | Jan 4, 2016
Company News

Santen sales and marketing update

The U.K.'s NICE issued final guidance recommending Ikervis ciclosporin from Santen to treat severe keratitis in adults with dry eye disease whose condition has not improved with artificial tears. Ikervis is an ophthalmic cationic emulsion...
BC Week In Review | Nov 9, 2015
Company News

Santen sales and marketing update

The U.K.’s NICE issued final draft guidance recommending Ikervis ciclosporin from Santen to treat severe keratitis in adults with dry eye disease that has not improved despite treatment with tear substitutes. In June, the agency...
BC Week In Review | Aug 10, 2015
Company News

Santen sales and marketing update

The U.K.’s NICE issued preliminary recommendations requesting more information from Santen for Ikervis ciclosporin to treat severe keratitis in adults with dry eye disease, which has not improved despite treatment with tear substitutes. The agency...
BC Week In Review | Jan 26, 2015
Clinical News

Ikervis ciclosporin regulatory update

EMA’s CHMP recommended approval of Ikervis ciclosporin eye drops from Santen to treat severe keratitis in patients with dry eye disease, which has not improved despite treatment with tear substitutes. Ikervis is cyclosporine A, an...
BioCentury | Jan 9, 2012
Finance

PDUFAs produce yawns

Stephen Hansen Senior Writer  There are more than twice as many PDUFA dates this year than last - at least 40 vs. 17 - but only a handful of potential approvals are drumming up interest among buysiders....
BC Week In Review | Oct 3, 2011
Company News

Novagali, Santen deal

Santen will acquire fellow ophthalmic company Novagali for €6.15 per share, or about €100 million ($134.2 million). The price is a 71% premium to Novagali's close of €3.59 on Sept. 27, before the deal was...
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