Gonadotropin-releasing hormone

China Medical System （867.HK）2023 Annual Results: Despite of the Temporary Financial Performance Pressure Fresh Catalysts Emerged from Successive Innovation Breakthroughs

Retrieved on: 
Thursday, March 28, 2024
Sclerotherapy, RMB, Conditional sentence, NDA, IND, Creativity, Small RNA, Marketing, Gastroenterology, Central nervous system, FIC, City, BIC, CMS, NRDL, Injection, Dermatology, CDMO, Commercialization, Tablet, Pharmacy, Methotrexate, Hospital, Acquisition, Gonadotropin-releasing hormone, RCT, VBP, Rheumatoid arthritis, Growth, Varicose veins, Ecosystem, Blue, Government, Ophthalmology

SHENZHEN, CHINA, March 27, 2024 (GLOBE NEWSWIRE) -- On March 27, 2024, China Medical System (“CMS” or the “Company”) released its 2023 annual results.

Key Points: 
  • SHENZHEN, CHINA, March 27, 2024 (GLOBE NEWSWIRE) -- On March 27, 2024, China Medical System (“CMS” or the “Company”) released its 2023 annual results.
  • Based on above, CMS has successfully entered into its “New Period” of innovation and internationalization development.
  • 4 innovative drugs have started large-scale clinical application, unveiling CMS’s first year of commercialization era of innovative drugs.
  • Under its compliant and efficient commercialization system, the Company's innovative products and exclusive drugs will grow steadily.

XTANDI® (enzalutamide) Receives Health Canada Approval as the First and Only Treatment for High-Risk Patients with Non-Metastatic Castration-Sensitive Prostate Cancer (nmCSPC)

Retrieved on: 
Tuesday, January 30, 2024
Orbis, Patient, Prostate cancer, BCR, Therapy, Professor, MFS, Radiation, University, Cancer, Recurrence, Metastasis, Acquisition, Université de Montréal, ADT, New Drug Application, Gonadotropin-releasing hormone, Health Canada, Prostate, Diagnosis, Physician, Pharmaceutical industry

MARKHAM, ON, Jan. 30, 2024 /CNW/ - Today, Astellas Pharma Canada, Inc. announced that Health Canada has approved a supplemental New Drug Application for XTANDI® (enzalutamide) in a new prostate cancer treatment setting.

Key Points: 
  • MARKHAM, ON, Jan. 30, 2024 /CNW/ - Today, Astellas Pharma Canada, Inc. announced that Health Canada has approved a supplemental New Drug Application for XTANDI® (enzalutamide) in a new prostate cancer treatment setting.
  • "I welcome the approval of XTANDI as a promising earlier treatment option for eligible patients.
  • This marks a significant step forward in addressing unmet needs for prostate cancer treatment."
  • With our recent acquisition of Propella Therapeutics, Inc., we strive to achieve even more in the investigation of targeted prostate cancer treatments for patients of the future."

NCCN Announces Funding for Advanced Prostate Cancer Research Projects

Retrieved on: 
Tuesday, November 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.

Pfizer and Astellas' XTANDI® Approved by U.S. FDA in Earlier Prostate Cancer Treatment Setting

Retrieved on: 
Friday, November 17, 2023
Priority review, NYSE, Gonadotropin-releasing hormone, PFE, Food, Patient, Radiation, Astellas Pharma, FDA, Prostate cancer, TSE, New Drug Application, BCR, Pfizer, Recurrence, Fast Track, Metastasis, Pharmaceutical industry, Birth control

TOKYO and NEW YORK, Nov. 16, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Pfizer Inc. (NYSE: PFE) today announced that the companies received an approval by the U.S. Food and Drug Administration (FDA) of a supplemental New Drug Application for XTANDI® (enzalutamide), following FDA expedited development and review programs (Priority Review designation, Fast Track designation, Real-time Oncology Review), based on results from the Phase 3 EMBARK trial. With this approval, XTANDI becomes the first and only androgen receptor signaling inhibitor approved by the FDA for the treatment of patients with nonmetastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR). Patients with nmCSPC with high-risk BCR may be treated with XTANDI with or without a gonadotropin-releasing hormone (GnRH) analog therapy.

Key Points: 
  • TOKYO and NEW YORK, Nov. 16, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Pfizer Inc. (NYSE: PFE) today announced that the companies received an approval by the U.S. Food and Drug Administration (FDA) of a supplemental New Drug Application for XTANDI® (enzalutamide), following FDA expedited development and review programs (Priority Review designation, Fast Track designation, Real-time Oncology Review), based on results from the Phase 3 EMBARK trial.
  • With this approval, XTANDI becomes the first and only androgen receptor signaling inhibitor approved by the FDA for the treatment of patients with nonmetastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR).
  • Patients with nmCSPC with high-risk BCR may be treated with XTANDI with or without a gonadotropin-releasing hormone (GnRH) analog therapy.
  • Of men who have undergone definitive prostate cancer treatment, including radical prostatectomy, radiotherapy, or both, an estimated 20-40% will experience biochemical recurrence (BCR) within 10 years.1

AKEEGA™ (niraparib and abiraterone acetate) Now Available from Onco360

Retrieved on: 
Tuesday, October 3, 2023
General Health, Health, Pharmaceutical, Clinical Trials, Oncology, Janssen Pharmaceuticals, Disease, Journal of Oncology Pharmacy Practice, PharMerica, HRR, ADP, Abiraterone acetate, CI, National Cancer Institute, Janssen, ADT, Toxicity, Pharmacy, Prednisone, Death, BRCA2, Hospital, Specialty pharmacy, HIV disease progression rates, Patient, Risk, Testosterone, SEER, Johnson & Johnson, Gonadotropin-releasing hormone, BRCA, FDA, PARP, Orchiectomy, Phase, CYP17, Prostate cancer, Pharmaceutical industry, Epidemiology

Onco360®, the nation’s leading independent Specialty Pharmacy, has been selected as a pharmacy partner by The Janssen Pharmaceutical Companies of Johnson & Johnson for AKEEGA™ (niraparib and abiraterone acetate).

Key Points: 
  • Onco360®, the nation’s leading independent Specialty Pharmacy, has been selected as a pharmacy partner by The Janssen Pharmaceutical Companies of Johnson & Johnson for AKEEGA™ (niraparib and abiraterone acetate).
  • Patients should be selected for therapy based on an FDA-approved test for AKEEGA.
  • Patients taking AKEEGA should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had a bilateral orchiectomy.
  • “Onco360 is thankful for the opportunity to partner with the team at Janssen and become a specialty pharmacy provider for AKEEGA,” said Benito Fernandez, Chief Commercial Officer.

Expanding Access to Women’s Health Fresenius Kabi Launches Generic Fertility Treatment

Retrieved on: 
Monday, July 10, 2023
Health, Consumer, Women, Research, Science, Pharmaceutical, Biotechnology, Hypersensitivity, Vaginal bleeding, News, Gonadotropin, Ganirelix, Pregnancy, Anaphylaxis, Society, Ovarian hyperstimulation syndrome, Fresenius (company), American Society for Reproductive Medicine, Parent, Ovulation, LH, Woman, ART, Infertility, Multimedia, USP, Fertilisation, Luteinizing hormone, Abdominal pain, ML, Injection site reaction, Assisted reproductive technology, LaTeX, Patient, Physician, Risk, Injection, Fertility, HCG, SART, Nausea, Gonadotropin-releasing hormone, Reproductive medicine, FDA, Headache, Syringe, Pharmaceutical industry, Birth control, Organon

Fresenius Kabi announced today it has launched Ganirelix Acetate Injection, a generic fertility drug, as part of the company’s expansion in women’s health.

Key Points: 
  • Fresenius Kabi announced today it has launched Ganirelix Acetate Injection, a generic fertility drug, as part of the company’s expansion in women’s health.
  • Ganirelix Acetate Injection is available immediately from Fresenius Kabi in 250 mcg/0.5 mL prefilled syringes.
  • View the full release here: https://www.businesswire.com/news/home/20230710582430/en/
    Now available: Fresenius Kabi Ganirelix Acetate Injection.
  • Ganirelix Acetate Injection is the third product offering in Fresenius Kabi’s Women’s Health portfolio, which includes Chorionic Gonadotropin for Injection, USP (hCG) and Progesterone Injection, USP.

Antev Receives US FDA Guidance on Teverelix® Phase 3 Trial Design for Treating Advanced Prostate Cancer Patients with Increased Cardiovascular Risk

Retrieved on: 
Wednesday, March 8, 2023
History, Mortality, Phase 3, Circulatory system, CMO, Follicle-stimulating hormone, Prostate cancer, Cardiovascular disease, Death, Standard of care, Cancer, ADT, CVD, FDA, Principal Scientific Adviser to the Government of India, Hormone, Breast, Bray, Pituitary gland, Patient, Disease, GenesisCare, Follicle, Prostate, Treatment, MACE, Personalized medicine, American Heart Association, Testosterone, Incidence, Prevalence, Androgen deprivation therapy, Luteinizing hormone, Gonadotropin-releasing hormone, US Foods, Risk, Pharmaceutical industry, Medical imaging, Birth control, Ernst Antevs

Up to 30% of advanced prostate cancer patients on Androgen Deprivation Therapy have pre-existing Cardiovascular Disease.

Key Points: 
  • Up to 30% of advanced prostate cancer patients on Androgen Deprivation Therapy have pre-existing Cardiovascular Disease.
  • This would be the first Phase 3 trial for a specific label to treat prostate cancer in patients with increased cardiovascular risk, addressing a significant need for prostate cancer drugs with a better cardiac toxicity profile.
  • Teverelix, a decapeptide, has the potential to be the first hormone therapy specifically approved to treat advanced prostate cancer patients with a history of cardiovascular disease.
  • “We are delighted to reach this critical milestone in Antev’s journey to secure regulatory guidance to develop Teverelix in advanced prostate cancer patients with increased cardiovascular risk,” commented Amit Kohli, Chief Executive Officer of Antev.

Veru Reports Fiscal 2023 First Quarter Financial Results

Retrieved on: 
Thursday, February 9, 2023
Treatment, Telephone, Breast, Food and Drug Administration, Patient, Enobosarm, High Risk, COVID-19, EU, BPH, Medicines and Healthcare products Regulatory Agency, Pregnancy, Article 18 of the European Convention on Human Rights, Eli Lilly and Company, CDK, Prostate cancer, Tadalafil, Capsule, MFDS, Ministry of Education (Malaysia), Combination, Prostate, FDA, Health care, Death, Finasteride, TGA, WHO, EMA, Mortality, Gonadotropin-releasing hormone, MHRA, Pharmaceutical industry, Birth control, Medical imaging, Food

MIAMI, FL, Feb. 09, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral ARDS-related diseases and for oncology, today announced financial results for its fiscal 2023 first quarter and provided a business update.

Key Points: 
  • ET
    MIAMI, FL, Feb. 09, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral ARDS-related diseases and for oncology, today announced financial results for its fiscal 2023 first quarter and provided a business update.
  • We are actively enrolling subjects in our advanced breast and prostate cancer Phase 3 clinical studies.
  • To join the conference call via telephone, please dial 1-800-341-1602 (domestic) or 1-412-902-6706 (international) and ask to join the Veru Inc. call.
  • A telephonic replay will be available on February 9, 2023 at approximately 12:00 p.m.

Myovant Sciences Announces Corporate Updates and Financial Results for Third Fiscal Quarter 2022

Retrieved on: 
Thursday, January 26, 2023
Research, Prostate cancer, Food, Gonadotropin-releasing hormone, USPI, Scott Richter, Endometriosis, Hart–Scott–Rodino Antitrust Improvements Act, History, Sale, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, FDA, SG, Roivant Sciences, SPIRIT, ORGOVYX, New Drug Application, EMA, Woman, RWS, Shanda, United Kingdom, Type 2, TRX, Richter, Pain, Safety, PDUFA, R, NYSE, Type, Risk, European Medicines Agency, Calendar, Patient, Growth, Uterine fibroid, German–Soviet Commercial Agreement (1940), Leuprorelin, Video game, Fine chemical, Credit, Security (finance), Pharmaceutical industry, Health insurance, Medical imaging, Airline, Takeda, Accord, Pfizer

Third fiscal quarter 2022 net product revenues for ORGOVYX in the U.S. were $48.7 million, reflecting 12% sequential growth compared to the second fiscal quarter 2022.

Key Points: 
  • Third fiscal quarter 2022 net product revenues for ORGOVYX in the U.S. were $48.7 million, reflecting 12% sequential growth compared to the second fiscal quarter 2022.
  • Approximately 4,000 new patients started treatment with ORGOVYX in the third fiscal quarter of 2022, reaching approximately 26,000 cumulative patients since launch.
  • In December 2022, Myovant completed a New Drug Submission to Health Canada seeking marketing approval for ORGOVYX for advanced prostate cancer.
  • Third fiscal quarter 2022 net product revenues for MYFEMBREE in the U.S. were $10.5 million, reflecting 64% sequential growth compared to second fiscal quarter 2022.

New Data Presented at SABCS 2022 Reveal Expanded Predictive Value of the Breast Cancer Index™ Test for Ovarian Function Suppression in Premenopausal Women with HR+ Breast Cancer

Retrieved on: 
Tuesday, December 6, 2022
Biotechnology, Health, Women, Pharmaceutical, Oncology, Medical Devices, Research, Genetics, Consumer, Science, Clinical Trials, Recurrence, Tamoxifen, OFS, Full, Biomarker, Patient, University, HOLX, Hologic, Gonadotropin-releasing hormone, HR, Breast cancer, Chandos Chair of Medicine and Anatomy, Woman, CST, Risk, Medical imaging, Birth control

The Breast Cancer Index test is the first biomarker to be evaluated in a cohort from the landmark Suppression of Ovarian Function Trial (SOFT).

Key Points: 
  • The Breast Cancer Index test is the first biomarker to be evaluated in a cohort from the landmark Suppression of Ovarian Function Trial (SOFT).
  • The landmark SOFT trial was an international, three-arm, non-blinded, randomized clinical trial of 3,066 premenopausal women with HR+ breast cancer.
  • The study also confirmed the prognostic value of the Breast Cancer Index test, as women with higher Breast Cancer Index test risk scores were more likely to experience disease recurrence.
  • These new data further establish the Breast Cancer Index test as a significant endocrine response biomarker and reveal additional predictive capabilities of the test.