19:59 , Feb 16, 2018 |  BC Week In Review  |  Clinical News

Sandoz gets CRL for generic Advair

The Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) said it is “highly unlikely” that it will be able to launch its version of Advair salmeterol/fluticasone from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) in the U.S. this year...
23:58 , Feb 8, 2018 |  BC Extra  |  Company News

GSK breathes easier after delay for Sandoz’s generic Advair

Sandoz said it is “highly unlikely” that it will be able to launch its version of Advair salmeterol/fluticasone from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) in the U.S. this year as planned after the Novartis AG (NYSE:NVS;...
20:27 , Feb 2, 2018 |  BC Week In Review  |  Clinical News

After Phase III results, AZ's COPD combo heading for submissions

AstraZeneca plc (LSE:AZN; NYSE:AZN) said triple combination therapy PT010 met six of seven primary endpoints evaluating lung function in the Phase III KRONOS trial to treat moderate to very severe chronic obstructive pulmonary disease (COPD)....
21:36 , Jan 26, 2018 |  BC Extra  |  Clinical News

After Phase III results, AZ's COPD combo heading for submissions

AstraZeneca plc (LSE:AZN; NYSE:AZN) said triple combination therapy PT010 met six of seven primary endpoints evaluating lung function in the Phase III KRONOS trial to treat moderate to very severe chronic obstructive pulmonary disease. The...
00:32 , Oct 20, 2017 |  BC Week In Review  |  Clinical News

FDA approves Symbicort to reduce COPD exacerbations

In September, FDA approved Symbicort budesonide/formoterol from AstraZeneca plc (LSE:AZN; NYSE:AZN) to reduce exacerbations of chronic obstructive pulmonary disorder (COPD). The combination of budesonide, an inhaled steroid, and formoterol, a long-acting adrenergic receptor beta 2...
22:25 , Mar 17, 2017 |  BC Extra  |  Company News

AZ, Circassia to share rights to two COPD therapies

AstraZeneca plc (LSE:AZN; NYSE:AZN) agreed to share rights to two chronic obstructive pulmonary disease therapies with Circassia Pharmaceuticals plc (LSE:CIR). Circassia is to lead promotion of AZ's Tudorza Pressair aclidinium bromide in the U.S., and...
21:45 , Feb 1, 2017 |  BC Week In Review  |  Clinical News

Symbicort regulatory update

FDA approved Symbicort budesonide/formoterol from AstraZeneca to treat asthma in children ages 6-11. The combination of budesonide, an inhaled steroid, and formoterol, a long-acting adrenergic receptor beta 2 (ADRB2) agonist (LABA), is approved to treat...
04:34 , Jan 27, 2017 |  BC Week In Review  |  Clinical News

Symbicort regulatory update

AstraZeneca said FDA granted 6 months of pediatric exclusivity to Symbicort budesonide/formoterol. The product is approved to treat asthma in patients ages ≥12 and as maintenance treatment of chronic obstructive pulmonary disorder (COPD) in adults....
21:24 , Nov 15, 2016 |  BC Week In Review  |  Clinical News

H.P. Acthar Gel: Ph IV started

Mallinckrodt began a U.S. Phase IV trial of H.P. Acthar Gel in about 230 patients. Patients will receive 1 mL H.P Acthar Gel twice weekly for 12 weeks in an open-label part, after which patients...
07:00 , Sep 5, 2016 |  BC Week In Review  |  Clinical News

Symbicort budesonide/formoterol: Phase III data

AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K.   Product: Symbicort budesonide/formoterol   Business: Inflammation   Molecular target: Corticoid receptors; Adrenergic receptor beta 2 ( ADRB2)   Description: Combination of budesonide, an inhaled steroid, and formoterol, a long-acting...