Relugolix

NCCN Announces Funding for Advanced Prostate Cancer Research Projects

Retrieved on: 
Martedì, Novembre 21, 2023
Relugolix, Research, Gonadotropin-releasing hormone, NCCN, ORP, National Comprehensive Cancer Network, Database, Patient, Knowledge, Collaboration, MD, Cancer, Roivant Sciences, ADT, Oncology, Registry, Medical imaging

PLYMOUTH MEETING, Pa., Nov. 21, 2023 /PRNewswire/ -- The National Comprehensive Cancer Network® (NCCN®) Oncology Research Program (ORP) today announced grants awarded for developing innovative investigator-initiated research involving the medication relugolix. Funding will be provided through support from Pfizer Global Medical Grants and Sumitomo Pharma America, Inc. (previously known as Myovant Sciences, Inc.).

Key Points: 
  • The National Comprehensive Cancer Network's Oncology Research Program selects projects to advance scientific knowledge of combination therapies that include relugolix in the treatment of patients with advanced prostate cancer.
  • PLYMOUTH MEETING, Pa., Nov. 21, 2023 /PRNewswire/ -- The National Comprehensive Cancer Network® ( NCCN ®) Oncology Research Program ( ORP ) today announced grants awarded for developing innovative investigator-initiated research involving the medication relugolix.
  • Their research will help us learn more about how to care for people with advanced prostate cancer."
  • The NCCN ORP fosters innovation and knowledge discovery that improve the lives of people with cancer and supports preclinical, translational, and clinical research and quality improvement projects in oncology at NCCN Member Institutions.

Clinigen initiates a Managed Access Program for relugolix in Europe for the treatment of advanced hormone-sensitive prostate cancer

Retrieved on: 
Martedì, Dicembre 20, 2022
Cancer, Clinical trial, Relugolix, Lung, European Medicines Agency, Authorization, Prostate cancer, Patient, Medicine, EMA, Pharmaceutical industry

Clinigen Limited (‘Clinigen’), the global pharmaceutical and services company, has entered into an agreement with Accord Healthcare (‘Accord’) to initiate a Managed Access Program in Europe for relugolix (ORGOVYX®).

Key Points: 
  • Clinigen Limited (‘Clinigen’), the global pharmaceutical and services company, has entered into an agreement with Accord Healthcare (‘Accord’) to initiate a Managed Access Program in Europe for relugolix (ORGOVYX®).
  • Relugolix was granted approval by the European Medicines Agency (EMA) in April 2022 for the treatment of adult patients with advanced hormone-sensitive prostate cancer.
  • The approval is applicable in specific European countries and is the first oral androgen deprivation treatment available.
  • Clinigen’s Unlicensed Medicines business will provide relugolix to patients in specific European countries until the medicine is available through normal commercial channels.

ORGOVYX® (relugolix) Now Available from Onco360 for the Treatment of Adult Patients with Advanced Prostate Cancer

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Lunedì, Giugno 6, 2022
Oncology, Health, General Health, Radiology, Pharmaceutical, Biotechnology, Gonadotropin-releasing hormone, Death, Adult, ORGOVYX, Roivant Sciences, Prostate cancer, Food, United, Relugolix, Disease, National Cancer Institute, FDA, Male, Patient, Program, Hospital, SEER, Oncology, Pfizer, Diagnosis, Journal of Oncology Pharmacy Practice, PharMerica, Specialty pharmacy, Regulation of tobacco by the U.S. Food and Drug Administration, Malignancy, Cancer, Pharmaceutical industry, Medical imaging, Epidemiology

Onco360 is honored to become a specialty pharmacy provider for ORGOVYX patients, said Benito Fernandez, Chief Commercial Officer, Onco360.

Key Points: 
  • Onco360 is honored to become a specialty pharmacy provider for ORGOVYX patients, said Benito Fernandez, Chief Commercial Officer, Onco360.
  • We are committed to supporting the highly specialized needs of patients battling advanced prostate cancer across the United States.
  • Prostate cancer is the most commonly diagnosed cancer in male patients.
  • Onco360 was founded in 2003 to bring together the stakeholders involved in the cancer treatment process and serve the specialized needs of oncologists, patients, hospitals, cancer centers of excellence, manufacturers, health plans, and payers.

Myovant Sciences Announces Preliminary Financial Results for Third Quarter of Fiscal Year 2021

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Lunedì, Gennaio 10, 2022
Infertility, Pain, Man, LinkedIn, Gonadotropin-releasing hormone, FDA, Health care, Webcast, Roivant Sciences, Total, New Drug Application, European Commission, Female, Pregnancy, Union, Private Securities Litigation Reform Act, Medication, Woman, Norethisterone, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Adoption, SEC, Gedeon Richter, Endometriosis, Patient, Uterine fibroid, Food, Therapy, NYSE, Risk, Twitter, GLOBE, Royal commission, ORGOVYX, Sumitomo Dainippon Pharma, Growth, Testosterone, Marketing, Conference, Adult, Relugolix, Review, Prostate cancer, U.S. Securities and Exchange Commission, Fossil fuel, Pharmaceutical industry, Fine chemical, Audit, Pfizer

Furthermore, this press release includes information regarding Myovant Sciences preliminary financial results for the third fiscal quarter ended December 31, 2021.

Key Points: 
  • Furthermore, this press release includes information regarding Myovant Sciences preliminary financial results for the third fiscal quarter ended December 31, 2021.
  • Myovant Sciences is currently in the process of finalizing its financial results for the third fiscal quarter ended December 31, 2021, and the preliminary financial results presented in this press release are based only on preliminary information available to Myovant Sciences as of January 10, 2022.
  • These preliminary financial results should not be viewed as a substitute for audited consolidated financial statements prepared in accordance with U.S. GAAP, and undue reliance should not be placed on Myovant Sciences preliminary financial results.
  • Myovant Sciences independent registered public accounting firm has not audited or reviewed the preliminary financial results included in this press release or expressed any opinion or other form of assurance on such preliminary financial results.

DGAP-News: BB Biotech: Gains realized following COVID-19 vaccine booster update enable increases in oncology and CNS

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Venerdì, Ottobre 22, 2021
NBI, MSCI, CNS, Incyte, Health care, Alzheimer's disease, Prescription, Center for Biologics Evaluation and Research, Atopic dermatitis, Clinical trial, COVID-19, Therapy, BB Biotech, Neurocrine, Relugolix, Democratic Party, RNA transfection, CMS, EUA, Insurance, ETF, Centers for Medicare & Medicaid Services, Alnylam Pharmaceuticals, Robert Califf, Solution, Prostate cancer, Physician, Industry, Political lists, Net asset value, National coverage determination, NAV, Severe acute respiratory syndrome coronavirus 2, Center, Uterine fibroid, CHF, Medicare, Esperies, Conditional sentence, Senate, Commissioner of Food and Drugs, Radius, Biogen, IPO, NCD, S&P, Patient, FDA, Tafasitamab, Injection, Valbenazine, Pharmaceutical industry, Fine chemical, Vaccine

BB Biotech shares showed a return of -3.3% in CHF and -2.0% in EUR for the third quarter of 2021.

Key Points: 
  • BB Biotech shares showed a return of -3.3% in CHF and -2.0% in EUR for the third quarter of 2021.
  • The Investment Team did close its position in Halozyme after 11 years and realized a total profit of USD 235 mn on this investment.
  • The FDA VRBPAC panel voted unanimously to support Moderna COVID-19 vaccine booster dose in certain at risk populations.
  • The quarterly report of BB Biotech AG as at September 30, 2021 can be downloaded at report.bbbiotech.ch/Q321 or www.bbbiotech.com

Myovant Sciences to Host Second Fiscal Quarter 2021 Earnings Conference Call at 8:30 a.m. Eastern Time on October 26, 2021

Retrieved on: 
Martedì, Ottobre 12, 2021
Twitter, Uterine fibroid, Man, Pain, Endometriosis, Adult, Norethisterone, Pregnancy, Shanda, Food, Gonadotropin-releasing hormone, GLOBE, LinkedIn, Female, Webcast, Relugolix, FDA, Sumitomo Dainippon Pharma, Review, Infertility, Woman, New Drug Application, NYSE, Patient, Pharmaceutical industry

The webcast and conference call will be held at8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time onOctober 26, 2021.

Key Points: 
  • The webcast and conference call will be held at8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time onOctober 26, 2021.
  • Investors and the general public may access a live webcast of the call by visiting the investor relations page of Myovants website at investors.myovant.com .
  • Institutional investors and analysts may also participate in the conference call by dialing 1-800-532-3746 in theU.S.or+1-470-495-9166 from outside theU.S.
  • A replay of the webcast, along with the earnings press release and presentation materials, will be archived on Myovants investor relations website.

Myovant Sciences to Participate in the 2021 Baird Global Healthcare Conference

Retrieved on: 
Mercoledì, Settembre 1, 2021
Royal commission, Norethisterone, Gonadotropin-releasing hormone, Twitter, GLOBE, Female, Food, Man, Pregnancy, NYSE, Investor, Relugolix, Adult, Patient, European Commission, Sumitomo Dainippon Pharma, LinkedIn, Conference, Uterine fibroid, FDA, Endometriosis, Woman, Infertility, Pharmaceutical industry

BASEL, Switzerland, Sept. 01, 2021 (GLOBE NEWSWIRE) -- Myovant Sciences(NYSE: MYOV), a healthcare company focused on redefining care for women and for men, will participate in the 2021 Baird Global Healthcare Conference on September 15, 2021.

Key Points: 
  • BASEL, Switzerland, Sept. 01, 2021 (GLOBE NEWSWIRE) -- Myovant Sciences(NYSE: MYOV), a healthcare company focused on redefining care for women and for men, will participate in the 2021 Baird Global Healthcare Conference on September 15, 2021.
  • Company management will participate in a fireside chat at 2:35 p.m. Eastern Time in addition to participating in small group investor meetings.
  • Investors and the general public are invited to listen to the Baird fireside chat, which will be accessible on the Events page under the Investors & Media section of theMyovantwebsite at www.myovant.com .
  • Myovant Sciencesaspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy.Founded in 2016, we have two FDA-approved products.

Myovant Sciences Appoints Uneek Mehra as Chief Financial and Business Officer

Retrieved on: 
Giovedì, Agosto 12, 2021
International, Engineering, Gonadotropin-releasing hormone, Sumitomo Dainippon Pharma, Norethisterone, Uterine fibroid, Man, Birla Institute of Technology and Science, Pilani – Dubai Campus, Adult, Treasury, Infertility, NYSE, Management development, Birla Institute of Technology, Mesra, Food, LinkedIn, International Institute for Nanotechnology, University, Relugolix, Human resources, Technology, Twitter, PACT, GLOBE, Roivant Sciences, Leadership, Novartis, Risk, Association of Corporate Treasurers, Endometriosis, FDA, Patient, Growth, Pregnancy, IBM, IPO, Health, Business, Woman, Female, Citibank, Business administration, Management, Pharmaceutical industry

Were delighted to welcome Uneek to Myovant, said Dave Marek, Myovants Chief Executive Officer.

Key Points: 
  • Were delighted to welcome Uneek to Myovant, said Dave Marek, Myovants Chief Executive Officer.
  • Mr. Mehra joins Myovant from PACT pharma, a personalized cell therapy company targeting solid cancers, where, as Chief Financial Officer and Corporate Treasurer, he successfully built partnerships, and raised capital to scale the emerging company.
  • Prior to joining PACT, Uneek was Chief Financial Officer at Proteus Digital Health, a digital medicines company, with responsibility for Finance, Tax, Treasury, IT, Facilities, and Human Resources.
  • As Chief Financial Officer of the US Integrated Care and Critical Care Business Units, Mr. Mehra supported commercial excellence across multiple products; notably, driving the launch and execution of Cosentyx and Entresto.

Myovant Sciences Announces Financial Results for First Quarter of Fiscal Year 2021 and Corporate Updates

Retrieved on: 
Mercoledì, Luglio 28, 2021
Chemical compounds, Organic compounds, Chemistry, Pfizer, Relugolix/estradiol/norethisterone acetate, Relugolix

First fiscal quarter 2021 net product revenues for ORGOVYX in the U.S. were $10.5 million, driven by increased prescriber demand.

Key Points: 
  • First fiscal quarter 2021 net product revenues for ORGOVYX in the U.S. were $10.5 million, driven by increased prescriber demand.
  • The FDA approval of MYFEMBREE triggered a $100.0 million regulatory milestone payment from Pfizer, which Myovant received in July 2021 (Myovants second fiscal quarter 2021).
  • As previously announced, Myovant will hold a webcast and conference call at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) today, July28, 2021, to discuss financial results for its first fiscal quarter ended June 30, 2021 and corporate updates.
  • Sumitovant is the majority shareholder of Myovant, and wholly owns Urovant Sciences, Enzyvant Therapeutics, Spirovant Sciences, and Altavant Sciences.

Myovant Sciences Announces European Commission Approval for RYEQO® for the Treatment of Women With Uterine Fibroids

Retrieved on: 
Martedì, Luglio 20, 2021
Drugs, Chemical compounds, Chemistry, Combination drugs, Estrogens, Estranes, Prolactin releasers, GnRH antagonists, Relugolix/estradiol/norethisterone acetate, Uterine fibroid, Relugolix, Estradiol

With this approval, women and doctors finally have a long-term treatment option, which is important for the management of this condition.

Key Points: 
  • With this approval, women and doctors finally have a long-term treatment option, which is important for the management of this condition.
  • Todays approval of RYEQO, the first and only once-daily long-term treatment for women with uterine fibroids in Europe, marks a major milestone in expanding non-invasive treatment options for this common and potentially debilitating disease, said David Marek, Chief Executive Officer of Myovant Sciences, Inc.
  • Through our partnership with Gedeon Richter, we look forward to supporting even more women suffering from uterine fibroids.
  • RYEQO (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) is approved for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.