Archives

Use the basic search or click on advanced for more search options.

Advanced Search Basic Search Advanced Search

Publications

Section

Select publication to see the relevant sections.

Publication Date

    E.g., 2018-08-19
    E.g., 2018-08-19

Archive Search

Pages

45 results
1:02 PM, Mar 02, 2018  |  BC Week In Review | Clinical News  |  Regulatory

Priority review for Shire's HAE prophylactic

a portfolio of HAE drugs that meet different patient needs. Among them is prophylactic treatment Cinryze
four days. Lanadelumab, which is dosed every two weeks, could provide a dosing benefit over Cinryze
12:16 PM, Sep 15, 2017  |  BC Week In Review | Clinical News  |  Clinical Results

Shire's subcutaneous HAE candidate meets in Phase III

SHP616 consecutively for 28 weeks. SHP616 is a lower-dose volume, subcutaneous liquid formulation of IV Cinryze
an IV therapy, or who have had complications of indwelling central catheters. Shire markets IV Cinryze
4:50 PM, Dec 19, 2016  |  BC Week In Review | Clinical News  |  Regulatory

Cinryze regulatory update

EMA’s CHMP recommended expanding the label of Cinryze from Shire for treatment and pre-procedure prevention of …
for routine prevention of attacks to include children ages 6-11 with severe and recurrent HAE. Cinryze
angioedema attacks in adults and adolescents with HAE. Shire plc (LSE:SHP; NASDAQ:SHPG), Dublin, Ireland  Product: Cinryze
12:00 AM, Oct 26, 2015  |  BC Week In Review | Clinical News  |  Regulatory

Cinryze regulatory update

FDA granted Fast Track designation to Cinryze from Shire to treat antibody-mediated rejection in patients who …
of the month, the company will start a double-blind, placebo-controlled, international Phase III trial of Cinryze
attacks in patients with hereditary angioedema (HAE). Shire plc (LSE:SHP; NASDAQ:SHPG), Dublin, Ireland   Product: Cinryze
12:00 AM, Aug 05, 2013  |  BC Week In Review | Clinical News  |  Clinical Status

Subcutaneous Cinryze: Phase IIb discontinued

ViroPharma discontinued a double-blind, crossover, international Phase IIb trial evaluating subcutaneous Cinryze in combination with Halozyme's …
trial, which completed enrollment of 41 adolescent and adult patients, was evaluating 1,000 units subcutaneous Cinryze
plus 24,000 units rHuPH20 twice weekly and 2,000 units Cinryze plus 48,000 units rHuPH20 twice weekly …
12:00 AM, Apr 01, 2013  |  BC Week In Review | Clinical News  |  Regulatory

Cinryze regulatory update

The All Wales Medicines Strategy Group (AWMSG) recommended the use of Cinryze from ViroPharma on the …
and pre-procedural prevention of angioedema attacks in adults and adolescents with hereditary angioedema (HAE). Specifically, Cinryze
for routine prophylaxis of acute attacks of HAE. ViroPharma Inc. (NASDAQ:VPHM), Exton, Pa.   Product: Cinryze
12:00 AM, Dec 24, 2012  |  BC Week In Review | Clinical News  |  Clinical Status

Subcutaneous Cinryze: Phase IIb started

ViroPharm began a double-blind, crossover, international Phase IIb trial to evaluate subcutaneous Cinryze in combination with …
8 weeks in about 40 adolescent and adult patients. Patients will receive 1,000 units subcutaneous Cinryze
plus 24,000 units rHuPH20 twice weekly and 2,000 units Cinryze plus 48,000 units rHuPH20 twice weekly …
12:00 AM, Oct 29, 2012  |  BC Week In Review | Clinical News  |  Regulatory

Cinryze regulatory update

Health Canada approved an NDS from ViroPharma for Cinryze for routine prevention of angioedema attacks in …
IV complement 1 (C1) esterase inhibitor in Canada as early as 2Q13. ViroPharma already markets Cinryze
for routine prophylaxis of acute attacks of HAE. ViroPharma Inc. (NASDAQ:VPHM), Exton, Pa.   Product: Cinryze
12:00 AM, Sep 24, 2012  |  BC Week In Review | Clinical News  |  Clinical Status

Subcutaneous Cinryze: Phase II resumed

partner ViroPharma said FDA lifted a clinical hold on a Phase II trial of subcutaneous Cinryze
said it believes the concerns about the antibodies are limited to subcutaneous HyQ. ViroPharma markets Cinryze
6 years, and in the U.S. for routine prophylaxis of acute attacks of HAE. Cinryze
12:00 AM, Aug 13, 2012  |  BC Week In Review | Clinical News  |  Regulatory

Cinryze regulatory update

approved an sBLA from ViroPharma for industrial scale manufacturing changes for hereditary angioedema (HAE) drug Cinryze
for routine prophylaxis of acute attacks of HAE. ViroPharma Inc. (NASDAQ:VPHM), Exton, Pa.   Product: Cinryze

Pages