BioCentury | Nov 11, 2019
Emerging Company Profile

Mycovia tackling chronic infections with antifungal pipeline

Mycovia plans to bring a new generation of antifungals against CYP51 to market for difficult-to-treat indications, starting with chronic vaginal and nail infections. The company's lead product VT-1161 otesaconazole is in Phase III testing for...
BC Extra | May 28, 2019
Company News

May 28 Company Quick Takes: Viela finds China partner for rare CNS disorder mAb; plus Santhera, Juvenescence’s Souvien and more

Viela partners with Hansoh on mAb for rare CNS disorder in China  Viela Bio Inc. (Gaithersburg, Md.) granted Hansoh Pharmaceutical Group Co. Ltd. (Lianyungang, China) rights to develop and commercialize Viela's humanized anti-CD19 mAb inebilizumab...
BC Week In Review | Aug 31, 2018
Clinical News

Allergan uterine fibroids therapy hits regulatory setback

Allergan plc (NYSE:AGN) said FDA issued a complete response letter for its NDA for ulipristal acetate to treat abnormal uterine bleeding in women with uterine fibroids. The company said FDA requested additional information and cited...
BC Extra | Aug 21, 2018
Company News

Allergan uterine fibroids therapy hits regulatory setback

Allergan plc (NYSE:AGN) said FDA issued a complete response letter for its NDA for ulipristal acetate to treat abnormal uterine bleeding in women with uterine fibroids. The company said FDA requested additional information and cited...
BioCentury | Jun 30, 2018
Finance

Eyes on launches

The annual summer slowdown isn’t restricted to just the stock market this year, as the clinical catalyst calendar also appears to be on holiday in 3Q18. Buysiders are therefore turning their attention to a spate...
BC Week In Review | Apr 6, 2018
Clinical News

Allergan's cariprazine meets again in Phase III for bipolar I depression

Allergan plc (NYSE:AGN) and Gedeon Richter plc (Budapest:RICHTER) said low-dose cariprazine met the primary endpoint in the Phase III RGH-MD-53 trial to treat bipolar I depression. Allergan reiterated its plan to submit an sNDA to...
BC Extra | Apr 3, 2018
Clinical News

Allergan's cariprazine meets again in Phase III for bipolar I depression

Allergan plc (NYSE:AGN) and Gedeon Richter plc (Budapest:RICHTER) said low-dose cariprazine met the primary endpoint in the Phase III RGH-MD-53 trial to treat bipolar I depression. Allergan reiterated its plan to submit an sNDA to...
BC Week In Review | Mar 9, 2018
Clinical News

FDA extends review for Allergan's ulipristal acetate

Allergan plc (NYSE:AGN) said FDA extended its review of an NDA for ulipristal acetate (Ella, ellaOne, PGL4001) to treat abnormal uterine bleeding in women with uterine fibroids. The company had previously expected a decision from...
BioCentury | Jan 6, 2018
Finance

Burgeoning bellwethers

  The miserable performance of large cap biotechs last quarter is likely to be a boon for small- and mid-cap players this year, in more ways than one. Buysiders spent most of 2017 focusing to...
BC Week In Review | Dec 22, 2017
Clinical News

Allergan planning sNDA for cariprazine in bipolar I depression after Phase III readout

Allergan plc (NYSE:AGN) and Gedeon Richter plc (Budapest:RICHTER) said cariprazine (MP-214, RGH-188) met the primary endpoint in the Phase III RGH-MD-54 trial to treat bipolar I depression. Allergan plans to submit an sNDA to FDA...
Items per page:
1 - 10 of 107
BioCentury | Nov 11, 2019
Emerging Company Profile

Mycovia tackling chronic infections with antifungal pipeline

Mycovia plans to bring a new generation of antifungals against CYP51 to market for difficult-to-treat indications, starting with chronic vaginal and nail infections. The company's lead product VT-1161 otesaconazole is in Phase III testing for...
BC Extra | May 28, 2019
Company News

May 28 Company Quick Takes: Viela finds China partner for rare CNS disorder mAb; plus Santhera, Juvenescence’s Souvien and more

Viela partners with Hansoh on mAb for rare CNS disorder in China  Viela Bio Inc. (Gaithersburg, Md.) granted Hansoh Pharmaceutical Group Co. Ltd. (Lianyungang, China) rights to develop and commercialize Viela's humanized anti-CD19 mAb inebilizumab...
BC Week In Review | Aug 31, 2018
Clinical News

Allergan uterine fibroids therapy hits regulatory setback

Allergan plc (NYSE:AGN) said FDA issued a complete response letter for its NDA for ulipristal acetate to treat abnormal uterine bleeding in women with uterine fibroids. The company said FDA requested additional information and cited...
BC Extra | Aug 21, 2018
Company News

Allergan uterine fibroids therapy hits regulatory setback

Allergan plc (NYSE:AGN) said FDA issued a complete response letter for its NDA for ulipristal acetate to treat abnormal uterine bleeding in women with uterine fibroids. The company said FDA requested additional information and cited...
BioCentury | Jun 30, 2018
Finance

Eyes on launches

The annual summer slowdown isn’t restricted to just the stock market this year, as the clinical catalyst calendar also appears to be on holiday in 3Q18. Buysiders are therefore turning their attention to a spate...
BC Week In Review | Apr 6, 2018
Clinical News

Allergan's cariprazine meets again in Phase III for bipolar I depression

Allergan plc (NYSE:AGN) and Gedeon Richter plc (Budapest:RICHTER) said low-dose cariprazine met the primary endpoint in the Phase III RGH-MD-53 trial to treat bipolar I depression. Allergan reiterated its plan to submit an sNDA to...
BC Extra | Apr 3, 2018
Clinical News

Allergan's cariprazine meets again in Phase III for bipolar I depression

Allergan plc (NYSE:AGN) and Gedeon Richter plc (Budapest:RICHTER) said low-dose cariprazine met the primary endpoint in the Phase III RGH-MD-53 trial to treat bipolar I depression. Allergan reiterated its plan to submit an sNDA to...
BC Week In Review | Mar 9, 2018
Clinical News

FDA extends review for Allergan's ulipristal acetate

Allergan plc (NYSE:AGN) said FDA extended its review of an NDA for ulipristal acetate (Ella, ellaOne, PGL4001) to treat abnormal uterine bleeding in women with uterine fibroids. The company had previously expected a decision from...
BioCentury | Jan 6, 2018
Finance

Burgeoning bellwethers

  The miserable performance of large cap biotechs last quarter is likely to be a boon for small- and mid-cap players this year, in more ways than one. Buysiders spent most of 2017 focusing to...
BC Week In Review | Dec 22, 2017
Clinical News

Allergan planning sNDA for cariprazine in bipolar I depression after Phase III readout

Allergan plc (NYSE:AGN) and Gedeon Richter plc (Budapest:RICHTER) said cariprazine (MP-214, RGH-188) met the primary endpoint in the Phase III RGH-MD-54 trial to treat bipolar I depression. Allergan plans to submit an sNDA to FDA...
Items per page:
1 - 10 of 107