BioCentury | Nov 15, 2019
Product Development

Minerva on the verge in neuropsychiatry with two compounds close to verdict

Minerva Neurosciences is on the precipice of two clinical readouts that could determine whether its founding bet on a pair of neuropsychiatry compounds from Mitsubishi Tanabe has panned out. Neither molecule represents a shift from...
BioCentury | Jun 21, 2019
Company News

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

...commercial rights to DB105 (formerly ORM-12741) from Orion Corp. (HSE:ORNAV; HSE:ORNBV), and will develop the ADRA2C...
...detection or clinical trial recruitment, which could lead to the formation of new companies. Targets: ADRA2C...
...Sciences Inc. Denovo Biopharma LLC Janssen Johnson & Johnson Melinta Therapeutics Inc. Orion Corp. University of California Berkeley University of California San Francisco Adrenergic receptor alpha 2c (ADRA2C) Complement...
BioCentury | May 28, 2019
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...
BioCentury | Apr 11, 2019
Company News

Ocugen to go public via Histogenics reverse merger

Ocugen will reverse merge with Histogenics to form a public company focused on discovering, developing and commercializing therapies for rare eye diseases. Ocugen Inc. (Malvern, Pa.) stockholders will own about 90% of the resulting company,...
BioCentury | Mar 14, 2019
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FDA rescinded breakthrough therapy designation for Tonix's Tonmya cyclobenzaprine (Sublingual TNX-102) to treat military-related posttraumatic stress disorder (PTSD), saying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...
BioCentury | Feb 1, 2019
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...
BioCentury | Aug 3, 2018
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...
BioCentury | May 18, 2018
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...
BioCentury | May 16, 2018
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...
BioCentury | Apr 13, 2018
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...
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