00:24 , Jun 21, 2019 |  BC Extra  |  Company News

June 20 Company Quick Takes: Priority Review for Alexion, Melinta therapies; plus Alimera, Denovo and more

Priority Review for Alexion's Ultomiris sBLA  FDA accepted and granted Priority Review to an sBLA from Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) for Ultomiris ravulizumab-cwvz to block complement-mediated thrombotic microangiopathy in patients with atypical hemolytic uremic syndrome....
17:56 , May 28, 2019 |  BC Innovations  |  Distillery Therapeutics

Adrenergic receptor inhibitor combo to treat stroke

DISEASE CATEGORY: Neurology INDICATION: Stroke Mouse studies suggest inhibiting ADRA1, ADRA2 and ADRB could help treat acute ischemic stroke. In two mouse models of ischemic stroke, the combination of the ADRA1 antagonist prazosin, the ADRA2...
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FDA rescinded breakthrough therapy designation for Tonix's Tonmya cyclobenzaprine (Sublingual TNX-102) to treat military-related posttraumatic stress disorder (PTSD), saying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...
16:58 , Aug 3, 2018 |  BC Week In Review  |  Clinical News

Tonix stops Phase III of PTSD candidate on lack of separation from placebo

Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) said it will stop the Phase III HONOR trial of Tonmya (Sublingual TNX-102) to treat military-related post-traumatic stress disorder (PTSD) after the candidate showed "inadequate separation" from placebo at an...
02:31 , May 18, 2018 |  BC Week In Review  |  Clinical News

FDA approves US WorldMeds' Lucemyra for opioid withdrawal

FDA approved Lucemyra lofexidine from US WorldMeds LLC (Louisville, Ky.) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults. According to the agency, Lucemyra is the first non-opioid drug approved...
23:41 , May 16, 2018 |  BC Extra  |  Company News

FDA approves US WorldMeds' Lucemyra for opioid withdrawal

FDA approved Lucemyra lofexidine from US WorldMeds LLC (Louisville, Ky.) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults. According to the agency, Lucemyra is the first non-opioid drug approved...
17:59 , Apr 13, 2018 |  BC Week In Review  |  Clinical News

Ocugen reports Phase II data for dry eye disease candidate

Ocugen Inc. (Malvern, Pa.) reported data from a Phase II trial showing that dry eye disease candidate OCU310 met the primary endpoint of tolerability over a 12-week period. The company said the trial was not...
17:16 , Mar 30, 2018 |  BC Week In Review  |  Clinical News

FDA panel backs US WorldMeds' opioid withdrawal candidate

US WorldMeds LLC (Louisville, Ky.) said FDA's Psychopharmacologic Drugs Advisory Committee voted 11-1 to recommend approval of an NDA for lofexidine to reduce symptoms associated with opioid withdrawal and facilitation of completion of opioid discontinuation...
16:46 , Mar 16, 2018 |  BC Week In Review  |  Financial News

AI play BioXcel raises $60M IPO

Artificial intelligence company BioXcel Therapeutics Inc. (NASDAQ:BTAI) raised $60 million on March 8 through the sale of 5.5 million shares at $11 in an upsized IPO underwritten by Barclays, UBS, BMO and Canaccord Genuity. The...
18:37 , Mar 9, 2018 |  BC Week In Review  |  Clinical News

FDA panel to review US WorldMeds' opioid withdrawal candidate

FDA said its Psychopharmacologic Drugs Advisory Committee will meet on March 27 to discuss an NDA from US WorldMeds LLC (Lousiville, Ky.) for lofexidine to reduce symptoms associated with opioid withdrawal and facilitation of completion...