Swiss biotech ObsEva has announced a corporate restructuring and layoffs following a notice from the FDA that the company’s new drug application (NDA) for its lead candidate linzagolix for uterine fibroids has deficiencies that are keeping the agency from advancing its review.
The FDA informed ObsEva that its application for oral GnRH antagonist linzagolix in uterine fibroids has important deficiencies that prevents the agency from moving the review further. Although the Swiss biotech said it has a plan to address the problems with additional data, it doesn’t believe it can deliver a fix by the original FDA target decision date of Sept. 13.
 -Yselty® (linzagolix) is the first and only approved GnRH antagonist to provide flexible dosing options with and without hormonal add-back therapy- -Theramex to commercialize Yselty®; ObsEva to...
LONDON--(BUSINESS WIRE)--The European Commission (EC) has granted Marketing Authorization for Yselty® (linzagolix), an oral GnRH antagonist, indicated for the treatment of moderate to severe symptoms of Uterine Fibroids (UF) in adult women (over 18 years of age) of reproductive age. This announcement is in partnership with ObsEva SA (Nasdaq: OBSV), a biopharmaceutical company developing and commercializing novel therapies for women’s health
-Data featured in two oral presentations at the 8th Society of Endometriosis and Uterine Disorders Congress and a poster presentation at the International Society of Gynecological Endocrinology 20th...
GENEVA, Switzerland – April 25, 2022 – ObsEva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies for women’s health, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has confirmed its previously adopted positive opinion, recommending approval of linzagolix for the treatment of uterine fibroids (UF).
GENEVA, Switzerland – April 25, 2022 – ObsEva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies for women’s health, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has confirmed its previously adopted positive opinion, recommending approval of linzagolix for the treatment of uterine fibroids (UF).
-Reductions in dysmenorrhea (DYS) and non-menstrual pelvic pain (NMPP), the co-primary efficacy endpoints, compared to placebo were observed for both doses after 1 and 2 months of treatment,...
LONDON--(BUSINESS WIRE)--Theramex, a leading global pharmaceutical company specialising in women’s health, has entered into a licensing agreement with ObsEva SA, a biopharmaceutical company developing and commercializing novel therapies for women’s health, to commercialise and launch Linzagolix, an oral GnRH antagonist. The launch will be for global markets outside of the U.S., Canada, and Asia.
GENEVA, Switzerland – February 4, 2022 – ObsEva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies for women’s health, today announced that based on ongoing communications with the European Medicines Agency (EMA), further questions on the marketing authorisation application for linzagolix may be forthcoming, thereby extending the application timeline. ObsEva is in dialogue with the EMA to understand areas that may require further clarification and is committed to promptly addressing any questions that could arise.