Sumitomo Pharma America
55 Cambridge Parkway Suite 102W
Cambridge, MA 02142
About Sumitomo Pharma America
We tackle unmet patient needs in the crucial fields of psychiatry and neurology, oncology, urology, women's health, rare diseases, and cell and gene therapies.
We unlock innovative science and solutions through cutting-edge technology. Advanced in-house technology platforms and data analytics capabilities de-risk and optimize clinical and commercial programs to accelerate insights in science, research, and discovery.
Advocating for Patients
We reimagine what’s possible We see people as more than the conditions they are managing. We are unwavering in our promise to advocate for patients and their families on the things that matter most to them. This promise is central to everything we do as we pursue unprecedented medical innovation.
We are building on a legacy With Sumitomo Pharma's 125-year legacy as our foundation, Sumitomo Pharma America was formed through the consolidation of Sumitomo Pharma’s US affiliates. Our parent company, the Sumitomo Group, is over 400 years old, with an extensive history of supporting health and wellbeing.
166 articles about Sumitomo Pharma America
Myovant Sciences Announces Corporate Updates and Financial Results for First Quarter Fiscal Year 2020
New Drug Application (NDA) for relugolix monotherapy tablet in advanced prostate cancer accepted for Priority Review by the FDA with target action date of December 20, 2020 NDA for relugolix combination tablet in uterine fibroids submitted in May 2020 Additional USD 200 million low-interest, five-year term loan commitment from Sumitomo Dainippon Pharma and commercial collaboration agreement with Sunovion Pharmaceuticals increases financial flexibility and provides access to well-establis
Myovant Sciences Announces Further Financing Support from Sumitomo Dainippon Pharma and Commercial Collaboration with Sunovion Pharmaceuticals
USD 200 million low-interest, five-year term loan commitment from Sumitomo Dainippon Pharma to further support planned commercialization of relugolix across multiple indications Agreement with Sunovion Pharmaceuticals provides access to well-established commercial infrastructure currently utilized across multiple successful products BASEL, Switzerland, Aug. 05, 2020 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men,
Myovant Sciences Presents Additional Data on Relugolix Combination Therapy from Phase 3 LIBERTY Studies in Women with Uterine Fibroids and from Ovulation Inhibition Study
Data from Phase 3 LIBERTY program show improvement in patient-reported outcomes in addition to improvement in hemoglobin levels in anemic women Detailed data from ovulation inhibition study demonstrate 100% ovulation inhibition and 100% return of ovulation upon treatment discontinuation Findings presented during European Society of Human Reproduction and Embryology (ESHRE) virtual 36th Annual Meeting taking place July 5-8, 2020
6/29/2020It was a busy week for clinical trial updates. Here’s a look.
Myovant Sciences Announces Positive Results from Second Phase 3 Study Evaluating Once-Daily Relugolix Combination Therapy in Women with Endometriosis
Co-primary endpoints met with response rates of 74.5% for dysmenorrhea (menstrual pain) and 58.5% for non-menstrual pelvic pain (p-values < 0.0001) Women receiving relugolix combination therapy, on average, had a 73.3% reduction on the Numerical Rating Scale for dysmenorrhea from 7.3 (severe pain) to 1.8 (mild pain) Achieved all seven key secondary endpoints, including dyspareunia (painful intercourse) and a greater proportion of women not using opioids, with a generally well-tolerat
6/23/2020Relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist.
Myovant Sciences Announces Priority Review and FDA Acceptance of New Drug Application for Once-Daily, Oral Relugolix for Advanced Prostate Cancer
Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, today announced that its New Drug Application (NDA) for once-daily, oral relugolix (120 mg) for the treatment of men with advanced prostate cancer has been accepted for Priority Review by the U.S. Food and Drug Administration (FDA).
The company presented the data at the American Society of Clinical Oncology Virtual Scientific Program and also published data simultaneously in the New England Journal of Medicine.
Myovant Sciences Submits New Drug Application (NDA) to the FDA for Once-Daily Relugolix Combination Tablet for the Treatment of Women with Uterine Fibroids
NDA is supported by positive data from two Phase 3 studies and a long-term extension study, demonstrating sustained reduction in heavy menstrual bleeding while maintaining bone health through one year If approved, relugolix combination tablet would be the first once-daily, oral treatment for women with heavy menstrual bleeding associated with uterine fibroids in the U.S. BASEL, Switzerland, June 01, 2020 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV), a healthcare company focused on
Myovant Sciences Announces Additional Positive Efficacy and Cardiovascular Safety Data from Phase 3 HERO Study of Once-Daily, Oral Relugolix in Advanced Prostate Cancer and Publication in the New England Journal of Medicine
Phase 3 data presented in oral presentation during the ASCO20 Virtual Scientific Program , with simultaneous publication in the New England Journal of Medicine Presentation expands on previous results demonstrating superiority of relugolix to leuprolide acetate, with additional data on testosterone suppression and recovery, prostate-specific antigen (PSA) response, and cardiovascular safety Relugolix treatment showed a 54% lower risk of major adverse cardiovascular events compared
Myovant Sciences to Present New Data on Relugolix in Prostate Cancer at American Society of Clinical Oncology (ASCO) 2020 Annual Meeting
Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, today announced that it will present new efficacy and cardiovascular safety data from the Phase 3 HERO study of once-daily, oral relugolix (120 mg) in men with advanced prostate cancer at the American Society of Clinical Oncology (ASCO)’s upcoming ASCO20 Virtual Scientific Program , to be held May 29-31, 2020. The new data will be pre
Myovant Sciences Announces Publication of Abstracts Detailing Additional Efficacy and Safety Findings from Phase 3 LIBERTY Studies in Uterine Fibroids in Obstetrics & Gynecology
Abstracts accepted for presentation in oral and poster sessions at the 2020 American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting Treatment with relugolix combination therapy resulted in significant improvements in pain and quality of life in women with heavy menstrual bleeding associated with uterine fibroids Relugolix combination therapy preserved bone mineral density over 24 weeks compared with relugolix monotherapy BASEL, Switzerland, Ap
4/27/2020Despite the domination of the news cycle by the COVID-19 pandemic, quite a number of biopharma companies reported on non-COVID-19 clinical trials last week, although there remains plenty of ongoing trial news related to the pandemic. Here’s a look.
- Myovant Sciences submits New Drug Application (NDA) to the FDA for once-daily, oral relugolix (120 mg) for the treatment of men with advanced prostate cancer. - Myovant announces positive results from Phase 3 SPIRIT 2 study evaluating once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with endometriosis and from a separate ovulation inhibition study. - Myovant expects to submit an NDA for once-daily rel
This morning, the Switzerland-based company said its SPIRIT-2 study met its co-primary efficacy endpoints and six key secondary endpoints for endometriosis treatment.
Myovant Sciences Announces Positive Results from Phase 3 SPIRIT 2 Study Evaluating Once-Daily Relugolix Combination Therapy in Women with Endometriosis and from Ovulation Inhibition Study
Co-primary endpoints met with 75.2% response rate for dysmenorrhea (menstrual pain) (p < 0.0001) and 66.0% response rate for non-menstrual pelvic pain (p < 0.0001) Women receiving relugolix combination therapy, on average, had a 75.1% reduction on the Numerical Rating Scale for dysmenorrhea from 7.2 (severe pain) to 1.7 (mild pain) Achieved six key secondary endpoints, including improvement in impact of pain on daily activities and a greater proportion of women not using opioids
Myovant Sciences and HealthyWomen Launch Storytelling Initiative to Elevate Conversations About Menstrual Health
Initiative to spotlight diverse, personal stories about menstruation in partnership with storytelling nonprofit The Moth HealthyWomen joins Female Forward Together, a cross-sector coalition committed to advancing women’s health Information on how to participate available on FemaleForwardTogether.com BASEL, Switzerland and RED BANK, N.J., April 14, 2020 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV), a healthcare company focused on developing innovative treatments for women's
Myovant Sciences and Gedeon Richter Enter into Exclusive License Agreement to Commercialize Relugolix Combination Tablet for Uterine Fibroids and Endometriosis in Certain Territories Outside the U.S.
Gedeon Richter to commercialize relugolix combination tablet for uterine fibroids and endometriosis in Europe, Russia - CIS, Latin America, Australia, and New Zealand
Myovant Sciences Announces Cancellation of Presentation and Webcast at the Barclays Global Healthcare Conference 2020
Myovant Sciences (NYSE: MYOV), a healthcare company focused on developing innovative treatments for women's health and prostate cancer, today announced the cancellation of its presentation and webcast at the Barclays Global Healthcare Conference, previously scheduled to take place on Wednesday, March 11 at 10:15 a.m. Eastern time. This follows the announcement by the organizer to cancel the in-person aspects of the conference due to circum
2/17/2020It was a very busy week for clinical trial news. Here’s a look.