18:56 , Nov 16, 2018 |  BC Week In Review  |  Company News

ICER: asthma mAbs should be 50% cheaper for cost effectiveness

The Institute for Clinical and Economic Review (ICER) said the costs of five asthma mAbs would need to decrease by at least 50% to be cost effective in a final evidence report . ICER said...
21:54 , Oct 31, 2018 |  BC Extra  |  Company News

GSK cuts some respiratory targets, keeps others in play

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) cut three respiratory programs against targets largely ignored by the rest of the industry after all three failed to meet efficacy targets in Phase II trials. The pharma disclosed the pruning...
17:57 , Sep 28, 2018 |  BC Week In Review  |  Company News

ICER finds asthma mAbs to be not cost-effective

In a draft evidence report , the Institute for Clinical and Economic Review (ICER) found that five biologics approved or in testing to treat asthma were not cost-effective compared with standard of care (SOC) therapies...
22:42 , Sep 13, 2018 |  BC Week In Review  |  Clinical News

FDA needs more data to support GSK's Nucala for COPD

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) received a complete response letter from FDA to an sBLA for Nucala mepolizumab to treat chronic obstructive pulmonary disease. According to the pharma, the agency said more clinical data are required...
22:17 , Sep 7, 2018 |  BC Extra  |  Company News

FDA needs more data to support Nucala for COPD

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) received a complete response letter from FDA to an sBLA for Nucala mepolizumab to treat chronic obstructive pulmonary disease. According to the pharma, the agency said more clinical data are required...
15:28 , Jul 27, 2018 |  BC Week In Review  |  Clinical News

Committee votes no on GSK's Nucala for COPD

FDA’s Pulmonary-Allergy Drugs Advisory Committee voted against approval of Nucala mepolizumab from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) to treat chronic obstructive pulmonary disease based on efficacy data and the drug's benefit-risk profile. The company is seeking...
22:43 , Jul 25, 2018 |  BC Extra  |  Company News

Committee votes no on GSK's Nucala for COPD

FDA’s Pulmonary-Allergy Drugs Advisory Committee voted against approval of Nucala mepolizumab from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) to treat chronic obstructive pulmonary disease based on efficacy data and the drug's benefit-risk profile. The company is seeking...
18:00 , Jun 1, 2018 |  BC Week In Review  |  Clinical News

AZ not planning regulatory submissions for Fasenra in COPD

AstraZeneca plc (LSE:AZN; NYSE:AZN) said it does not plan to submit regulatory applications for Fasenra benralizumab to treat chronic obstructive pulmonary disease (COPD) after the drug missed the primary endpoint of reducing exacerbations in a...
19:07 , May 30, 2018 |  BC Extra  |  Clinical News

AZ not planning regulatory submissions for Fasenra in COPD

AstraZeneca plc (LSE:AZN; NYSE:AZN) said it does not plan to submit regulatory applications for Fasenra benralizumab to treat chronic obstructive pulmonary disease after the drug missed the primary endpoint of reducing exacerbations in a second...
14:13 , May 18, 2018 |  BC Week In Review  |  Clinical News

AZ's Fasenra fails in Phase III COPD study

AstraZeneca plc (LSE:AZN; NYSE:AZN) said Fasenra benralizumab missed the primary endpoint of reducing exacerbations vs. placebo in the Phase III GALATHEA trial to treat chronic obstructive pulmonary disease. The company expects data this quarter from...