20:37 , Jun 7, 2019 |  BC Extra  |  Company News

June 7 Company Quick Takes: Expanded label for PTC’s DMD drug; plus Achaogen, ICER on migraine and Nucala

PTC’s DMD drug approved in patients ages 2-5  FDA approved an sNDA for Emflaza deflazacort from PTC Therapeutics Inc. (NASDAQ:PTCT) to treat Duchenne muscular dystrophy in patients ages 2-5. The drug was first approved in...
22:52 , Jan 15, 2019 |  BC Week In Review  |  Company News

AZ's Bohen departing after cancer-focused tenure

AstraZeneca plc (LSE:AZN; NYSE:AZN) said Sean Bohen is leaving as CMO and EVP of global medicines development after a tenure marked by mixed results for the pharma's checkpoint inhibitor. Shortly after Bohen joined the pharma...
23:49 , Jan 14, 2019 |  BC Extra  |  Company News

AZ's Bohen departing after cancer-focused tenure

AstraZeneca plc (LSE:AZN; NYSE:AZN) said Sean Bohen is leaving as CMO and EVP of global medicines development after a tenure marked by mixed results for the pharma's checkpoint inhibitor. Shortly after Bohen joined the pharma...
20:49 , Dec 19, 2018 |  BC Innovations  |  Distillery Therapeutics

Inflammation; pulmonary

INDICATION: Asthma; pulmonary fibrosis Mouse studies suggest an inhaled prodrug of a PI3K inhibitor could help treat asthma and pulmonary fibrosis. In mouse models of acute allergic asthma and chronic asthma, inhalation of a methylbenzoate-based...
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...