BioCentury | Dec 28, 2020

Myovant’s deal with Pfizer for $650M up front is the latest sign women’s health is back

...tablet includes 40 mg relugolix, 1.0 mg estradiol...
BioCentury | Aug 18, 2020
Product Development

Gilead, Tango expand cancer partnership; plus Roche approval, Novavax COVID-19 efficacy study and G1, Myovant and PTC applications under review

...heavy menstrual bleeding associated with uterine fibroids. The PDUFA date for the combination of the GNRHR antagonist plus estradiol...
BioCentury | Jun 24, 2020

Myovant eyes third NDA for relugolix after endometriosis readout

...III trial for the disease. In the SPIRIT 1 study, a combination of relugolix plus estradiol...
BioCentury | Jun 2, 2020

June 1 Quick Takes: CHMP recommendations, plus FDA action on AbbVie-Neurocrine, Shionogi, AZ, Lilly, Genentech

...menstruation therapy AbbVie Inc. (NYSE:ABBV) and Neurocrine Biosciences Inc. (NASDAQ:NBIX) said FDA approved Oriahnn elagolix, estradiol...
BioCentury | Apr 23, 2020
Product Development

April 22 Quick Takes: Accelerated approval for Immunomedics’ Trodelvy; plus BioNTech-Pfizer, AskBio, Astellas, Merck KGaA, oNKo-Gilead, Myovant, Afyx and Sangam

...therapy programs. Myovant planning relugolix NDA for endometriosis Myovant Sciences Ltd. (NYSE:MYOV) said relugolix plus estradiol...
BioCentury | Jul 23, 2019
Clinical News

July 23 Clinical Quick Takes: Achillion plans U.S. IND; plus Chiasma, Myovant, Marinus and Merck

...Phase III for uterine fibroids Myovant Sciences Ltd. (NYSE:MYOV) said relugolix (TAK-385) in combination with estradiol/norethindrone...
BioCentury | Jun 26, 2019
Company News

June 25 Company Quick Takes: Conatus restructuring; plus Almirall-Dermira, Acer, Glenmark and more

...lambrolizumab) lebrikizumab (MILR1444A, RG3637, tnx-650, anti-IL13) Ryaltris, mometasone/olopatadine (gsp 301) Seven-day contraceptive patch, Twirla (AG200-15, ag-200-15, Agile Patch, estradiol/levonorgestrel) Agile...
BioCentury | Jan 5, 2019

Ready to launch

The proposed $74 billion takeout of Celgene Corp. by Bristol-Myers Squibb Co. will not shift buysider attention away from upcoming and maturing drug launches heading into 2019, with plenty to track following a record year...
BioCentury | Oct 9, 2018
Politics & Policy

FDA pushes generic competition for transdermal complex drugs

...irritation and sensitization potential; and 25 product-specific guidances, including two new guidances for capsaicin and estradiol/norethindrone...
BioCentury | Oct 6, 2018

Seeking validation

...NASDAQ:SBPH) Inarigivir soproxil Chronic HBV Additional Ph II ACHIEVE data November TherapeuticsMD Inc. (NASDAQ:TXMD) TX-001HR estradiol/progesterone...
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