17:23 , Mar 19, 2019 |  BC Extra  |  Clinical News

Urovant shares slide on vibegron overactive bladder data

Despite hitting the co-primary endpoints for an indication in need of treatment options, Urovant's overactive bladder therapy vibegron underwhelmed investors with its latest data on Tuesday by performing only marginally better than the generic comparator...
23:52 , Mar 14, 2019 |  BC Week In Review  |  Company News

Tonix's PTSD therapy loses breakthrough therapy designation

FDA rescinded breakthrough therapy designation for Tonix's Tonmya cyclobenzaprine (Sublingual TNX-102) to treat military-related posttraumatic stress disorder (PTSD), saying an interim analysis of the Phase III HONOR trial did not sufficiently support the designation. In...
19:48 , Feb 15, 2019 |  BC Week In Review  |  Company News

ZappRx, Teva partner to increase patient access to specialty respiratory drugs

The Teva Respiratory LLC unit of Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA) gained access to a digital platform from ZappRx Inc. (Boston, Mass.) to streamline prescription of Teva’s specialty respiratory medications. Financial terms were...
19:36 , Feb 1, 2019 |  BC Week In Review  |  Clinical News

Eyenovia planning NDA in 1Q20 for microdose ophthalmic solution to induce mydriasis

Eyenovia Inc. (NASDAQ:EYEN) plans to submit an NDA to FDA in 1Q20 for MicroStat to induce mydriasis (dilation of the pupil) after the product met the primary endpoint in the Phase III MIST-1 trial. MicroStat...
00:06 , Jan 23, 2019 |  BC Innovations  |  Distillery Techniques

Disease models

TECHNOLOGY: 3-D models A 3-D human tissue model that mimics beating adult myocardium could help assess the effects of heart disease therapies on myocardial contractility. Generation and use of the biomimetic model involves five steps:...
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...
22:18 , Dec 26, 2018 |  BC Extra  |  Company News

FDA accepts Acer, Kala NDAs before funding lapse

FDA accepted for review NDAs from Acer Therapeutics Inc. (NASDAQ:ACER) and Kala Pharmaceuticals Inc. (NASDAQ:KALA) before the partial government shutdown blocked the agency from taking on new user fee-based applications. The agency granted Priority Review...
19:26 , Dec 21, 2018 |  BC Week In Review  |  Clinical News

Medix planning Mexican NDA for obesity candidate

Saniona AB (SSE:SANION) said partner Medix Products S.A. de C.V. (Mexico City, Mexico) plans to submit an NDA next half in Mexico for obesity candidate tesofensine (NS2330) after two doses of the compound met the...
18:36 , Nov 9, 2018 |  BC Week In Review  |  Company News

AZ looks to new medicines to drive growth

AstraZeneca plc (LSE:AZN; NYSE:AZN) said Nov. 8 it will look to 10 new drugs to support a return to growth. The pharma reported 3Q18 product sales of $5.3 billion, up 9% at constant exchange rates...