BioCentury | Aug 31, 2018
Clinical News

Allergan uterine fibroids therapy hits regulatory setback

...The company has European rights to ulipristal acetate to treat gynecological indications, excluding contraception, from HRA Pharma S.A....
...Allergan’s Ulipristal Acetate" ). Allergan plc (NYSE:AGN), Dublin, Ireland Gedeon Richter plc (Budapest:RICHTER), Budapest, Hungary HRA Pharma S.A....
...Fibristal - Canada) Business: Genitourinary Paul Bonanos EllaOne, Esmya, Fibristal, Ulipristal, ulipristal acetate (PGL4001, cdb-2914, ella) Gedeon Richter plc HRA Pharma S.A. Allergan...
BioCentury | Mar 9, 2018
Clinical News

FDA extends review for Allergan's ulipristal acetate

...The company has European rights to ulipristal acetate to treat gynecological indications, excluding contraception, from HRA Pharma S.A....
...in Canada as Fibristal. Allergan plc (NYSE:AGN), Dublin, Ireland Gedeon Richter plc (Budapest:RICHTER), Budapest, Hungary HRA Pharma S.A....
...PGL4001) (formerly CDB-2914) Business: Genitourinary Alicia Parker EllaOne, Esmya, Fibristal, Ulipristal, ulipristal acetate (PGL4001, cdb-2914, ella) Gedeon Richter plc HRA Pharma S.A. Allergan...
BioCentury | Dec 1, 2017
Clinical News

FDA accepts NDA for ulipristal from Allergan for uterine bleeding

...The company has European rights to ulipristal acetate to treat gynecological indications, excluding contraception, from HRA Pharma S.A....
...in Canada as Fibristal. Allergan plc (NYSE:AGN), Dublin, Ireland Gedeon Richter plc (Budapest:RICHTER), Budapest, Hungary HRA Pharma S.A....
...EU, Fibristal - Canada, Ella, ellaOne, PGL4001) (formerly CDB-2914) Business: Genitourinary Jaime De Leon Ella ellaOne Esmya Fibristal PGL4001 Ulipristal acetate Gedeon Richter plc HRA Pharma S.A. Allergan...
BioCentury | Jan 20, 2017
Clinical News

Ulipristal acetate: Ph III Venus II data

...The company has European rights to ulipristal acetate to treat gynecological indications, excluding contraception, from HRA Pharma...
...in Canada as Fibristal. Allergan plc (NYSE:AGN), Dublin, Ireland Gedeon Richter plc (Budapest:RICHTER), Budapest, Hungary HRA Pharma S.A....
...Activities subscale score and safety Status: Phase III data Milestone: Submit NDA (2H17) Jaime De Leon Esmya Fibristal Ulipristal acetate HRA Pharma S.A. Allergan...
BioCentury | Jan 18, 2017
Clinical News

Allergan/Gedeon uterine fibroids therapy headed for NDA

...III study (see BioCentury Extra, May 9, 2016) . Gedeon has rights to ulipristal from HRA Pharma S.A....
BioCentury | May 16, 2016
Clinical News

Ulipristal acetate: Phase III data

...The company has European rights to ulipristal acetate to treat gynecological indications, excluding contraception, from HRA Pharma...
...in Canada as Fibristal. Allergan plc (NYSE:AGN), Dublin, Ireland Gedeon Richter Ltd. (Budapest:RICHTER), Budapest, Hungary HRA Pharma S.A....
BioCentury | May 10, 2016
Clinical News

Ulipristal meets Phase III uterine fibroid endpoints

...no treatment-related adverse events in the 157-patient study. Gedeon Richter has rights to ulipristal from HRA Pharma S.A....
BioCentury | Oct 26, 2015
Clinical News

Ulipristal acetate: Phase III data

...Gedeon Richter has European rights to ulipristal acetate to treat gynecological indications, excluding contraception, from HRA Pharma...
...American rights to the compound for benign gynecological disorders. Gedeon Richter Ltd. (Budapest:RICHTER), Budapest, Hungary HRA Pharma S.A....
BioCentury | Apr 13, 2015
Financial News

Embera completes venture financing

...Shreveport, La. Business: Neurology Date completed: 2015-04-10 Type: Venture financing Raised: $2 million Investors: HRA Pharma...
BioCentury | Oct 13, 2014
Clinical News

Ketoconazole HRA regulatory update

...approval of oral ketoconazole HRA to treat endogenous Cushing's syndrome in patients ages >12 years. HRA Pharma...
...the indication in October 2013 for risks associated with hepatotoxicity, adrenal insufficiency and drug interactions. HRA Pharma S.A....
Items per page:
1 - 10 of 63
BioCentury | Aug 31, 2018
Clinical News

Allergan uterine fibroids therapy hits regulatory setback

...The company has European rights to ulipristal acetate to treat gynecological indications, excluding contraception, from HRA Pharma S.A....
...Allergan’s Ulipristal Acetate" ). Allergan plc (NYSE:AGN), Dublin, Ireland Gedeon Richter plc (Budapest:RICHTER), Budapest, Hungary HRA Pharma S.A....
...Fibristal - Canada) Business: Genitourinary Paul Bonanos EllaOne, Esmya, Fibristal, Ulipristal, ulipristal acetate (PGL4001, cdb-2914, ella) Gedeon Richter plc HRA Pharma S.A. Allergan...
BioCentury | Mar 9, 2018
Clinical News

FDA extends review for Allergan's ulipristal acetate

...The company has European rights to ulipristal acetate to treat gynecological indications, excluding contraception, from HRA Pharma S.A....
...in Canada as Fibristal. Allergan plc (NYSE:AGN), Dublin, Ireland Gedeon Richter plc (Budapest:RICHTER), Budapest, Hungary HRA Pharma S.A....
...PGL4001) (formerly CDB-2914) Business: Genitourinary Alicia Parker EllaOne, Esmya, Fibristal, Ulipristal, ulipristal acetate (PGL4001, cdb-2914, ella) Gedeon Richter plc HRA Pharma S.A. Allergan...
BioCentury | Dec 1, 2017
Clinical News

FDA accepts NDA for ulipristal from Allergan for uterine bleeding

...The company has European rights to ulipristal acetate to treat gynecological indications, excluding contraception, from HRA Pharma S.A....
...in Canada as Fibristal. Allergan plc (NYSE:AGN), Dublin, Ireland Gedeon Richter plc (Budapest:RICHTER), Budapest, Hungary HRA Pharma S.A....
...EU, Fibristal - Canada, Ella, ellaOne, PGL4001) (formerly CDB-2914) Business: Genitourinary Jaime De Leon Ella ellaOne Esmya Fibristal PGL4001 Ulipristal acetate Gedeon Richter plc HRA Pharma S.A. Allergan...
BioCentury | Jan 20, 2017
Clinical News

Ulipristal acetate: Ph III Venus II data

...The company has European rights to ulipristal acetate to treat gynecological indications, excluding contraception, from HRA Pharma...
...in Canada as Fibristal. Allergan plc (NYSE:AGN), Dublin, Ireland Gedeon Richter plc (Budapest:RICHTER), Budapest, Hungary HRA Pharma S.A....
...Activities subscale score and safety Status: Phase III data Milestone: Submit NDA (2H17) Jaime De Leon Esmya Fibristal Ulipristal acetate HRA Pharma S.A. Allergan...
BioCentury | Jan 18, 2017
Clinical News

Allergan/Gedeon uterine fibroids therapy headed for NDA

...III study (see BioCentury Extra, May 9, 2016) . Gedeon has rights to ulipristal from HRA Pharma S.A....
BioCentury | May 16, 2016
Clinical News

Ulipristal acetate: Phase III data

...The company has European rights to ulipristal acetate to treat gynecological indications, excluding contraception, from HRA Pharma...
...in Canada as Fibristal. Allergan plc (NYSE:AGN), Dublin, Ireland Gedeon Richter Ltd. (Budapest:RICHTER), Budapest, Hungary HRA Pharma S.A....
BioCentury | May 10, 2016
Clinical News

Ulipristal meets Phase III uterine fibroid endpoints

...no treatment-related adverse events in the 157-patient study. Gedeon Richter has rights to ulipristal from HRA Pharma S.A....
BioCentury | Oct 26, 2015
Clinical News

Ulipristal acetate: Phase III data

...Gedeon Richter has European rights to ulipristal acetate to treat gynecological indications, excluding contraception, from HRA Pharma...
...American rights to the compound for benign gynecological disorders. Gedeon Richter Ltd. (Budapest:RICHTER), Budapest, Hungary HRA Pharma S.A....
BioCentury | Apr 13, 2015
Financial News

Embera completes venture financing

...Shreveport, La. Business: Neurology Date completed: 2015-04-10 Type: Venture financing Raised: $2 million Investors: HRA Pharma...
BioCentury | Oct 13, 2014
Clinical News

Ketoconazole HRA regulatory update

...approval of oral ketoconazole HRA to treat endogenous Cushing's syndrome in patients ages >12 years. HRA Pharma...
...the indication in October 2013 for risks associated with hepatotoxicity, adrenal insufficiency and drug interactions. HRA Pharma S.A....
Items per page:
1 - 10 of 63