18:47 , Dec 15, 2017 |  BC Week In Review  |  Company News

Allergan to acquire Repros

Allergan plc (NYSE:AGN) is acquiring Repros Therapeutics Inc. (NASDAQ:RPRX) for $0.67 per share in cash. Repros said it expects the deal to close in 1Q18. An Allergan spokesperson told BioCentury the deal adds to its...
07:00 , Oct 10, 2016 |  BC Week In Review  |  Clinical News

Enclomiphene citrate regulatory update

EMA accepted for review an MAA from Repros for enclomiphene to treat secondary hypogonadism. Last year, FDA issued a complete response letter for the trans-isomer of clomiphene citrate to treat secondary hypogonadism in overweight men...
07:00 , Sep 19, 2016 |  BC Week In Review  |  Clinical News

Enclomiphene citrate regulatory update

Repros submitted an MAA to EMA for enclomiphene to treat secondary hypogonadism. Last year, FDA issued a complete response letter for the trans-isomer of clomiphene citrate to treat secondary hypogonadism in overweight men wishing to...
07:00 , Sep 5, 2016 |  BC Week In Review  |  Clinical News

Enclomiphene citrate: Interim Phase II data

Interim data from the double-blind, U.S. Phase II ZA-205 trial in about 50 obese male patients with hypogonadotropic hypogonadism and morning testosterone levels of <=300 ng/dL showed that enclomiphene significantly increased total testosterone and free...
08:00 , Feb 22, 2016 |  BC Week In Review  |  Clinical News

Enclomiphene citrate: Completed Phase II enrollment

Repros completed enrollment of >45 obese patients in the double-blind, placebo-controlled, U.S. Phase II ZA-205 trial evaluating 12.5 and 25 mg oral enclomiphene for 12 months in combination with diet and exercise. Last year, FDA...
08:00 , Dec 7, 2015 |  BC Week In Review  |  Clinical News

Enclomiphene citrate regulatory update

FDA issued a complete response letter to Repros for enclomiphene to treat secondary hypogonadism in overweight men wishing to restore normal testicular function. According to Repros, FDA stated that “based on recent scientific developments,” the...
08:00 , Nov 9, 2015 |  BC Week In Review  |  Clinical News

Enclomiphene citrate regulatory update

FDA cancelled the Nov. 3 meeting of its Bone, Reproductive and Urologic Products Advisory Committee to discuss an NDA from Repros for enclomiphene to treat secondary hypogonadism in overweight men. Repros said the cancellation is...
07:00 , Oct 22, 2015 |  BC Innovations  |  Distillery Therapeutics

Therapeutics: Undecaprenyl diphosphate synthase (uppS)

Infectious disease INDICATION: Staphylococcus In vitro studies suggest clomiphene could help treat Staphylococcus aureus infection. A screen of 1,600 FDA-approved drugs in S. aureus culture found that clomiphene inhibited bacterial growth with a minimum inhibitory...
07:00 , Oct 5, 2015 |  BioCentury  |  Finance

Event planner

For investors who are not inclined to sit it out until the volatility abates, the fourth quarter is bursting with late-stage catalysts. There are no fewer than 17 PDUFA dates on the calendar before year...
07:00 , Jul 30, 2015 |  BC Innovations  |  Distillery Therapeutics

Therapeutics: Calcium channel; serotonin (5-HT) transporter (SLC6A4; SERT); estrogen receptor; androgen receptor

Infectious disease INDICATION: Ebola In vitro and mouse studies identified a calcium channel blocker, a selective serotonin reuptake inhibitor (SSRI) and two hormone receptor modulators that could be repurposed to treat Ebola. In human and...