OGN

Organon & Lilly Enter Commercialization Agreement in Europe for Two Migraine Medicines

Retrieved on: 
Monday, December 18, 2023
Health, Other Consumer, Consumer, Women, Other Health, Pharmaceutical, Biotechnology, Galcanezumab, Sale, Norton Lilly International, Vomiting, Woman, Migraine, NYSE, Headache, Disease, Patient, Light, OGN, Eli Lilly and Company, Nausea, Disability, Central nervous system, CGRP, Education, Pharmaceutical industry, Lilly, Organon

RAYVOW is a first-in-class serotonin 5-HT1F receptor agonist approved for the acute treatment of the headache phase of migraine attacks, with or without aura in adults.

Key Points: 
  • RAYVOW is a first-in-class serotonin 5-HT1F receptor agonist approved for the acute treatment of the headache phase of migraine attacks, with or without aura in adults.
  • “This commercialization agreement aligns seamlessly with Organon’s suite of central nervous system treatments in our Established Brands portfolio and, most importantly, it further bolsters our offerings to women, who are disproportionately impacted by migraine,” said Kevin Ali, Organon CEO.
  • “We are confident this collaboration with Organon will help even more people throughout Europe gain access to our innovative migraine treatments.”
    Under the terms of the agreement, Organon will become the sole distributor and promoter of Emgality and RAYVOW in Europe.
  • Total consideration to be paid to Lilly includes an upfront payment of $50 million and sales-based milestone payments.

Organon To Present at the Piper Sandler 35th Annual Healthcare Conference

Retrieved on: 
Tuesday, November 21, 2023
Health, Consumer, Women, General Health, Pharmaceutical, Biotechnology, EST, OGN, NYSE, Conference, Piper Sandler Companies, Pharmaceutical industry, Organon

Organon (NYSE: OGN), a global healthcare company with a focus on women’s health, announced today that Kevin Ali, Chief Executive Officer, and Matthew Walsh, Chief Financial Officer, are scheduled to participate in a fireside chat at the Piper Sandler 35th Annual Healthcare Conference on Wednesday, November 29, 2023 at 11:00 a.m. EST.

Key Points: 
  • Organon (NYSE: OGN), a global healthcare company with a focus on women’s health, announced today that Kevin Ali, Chief Executive Officer, and Matthew Walsh, Chief Financial Officer, are scheduled to participate in a fireside chat at the Piper Sandler 35th Annual Healthcare Conference on Wednesday, November 29, 2023 at 11:00 a.m. EST.

Samsung Bioepis & Organon Announce FDA Acceptance of Supplemental Biologics License Application (sBLA) for Interchangeability Designation for HADLIMA™ (adalimumab-bwwd), a Biosimilar to Humira®

Retrieved on: 
Tuesday, November 7, 2023
FDA, Psoriasis, NYSE, Food, Organon, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, OGN, Pharmacy, Head, Patient, Regulatory affairs, Pharmaceutical industry, Adalimumab

The sBLA was submitted to the FDA by Samsung Bioepis in August 2023.

Key Points: 
  • The sBLA was submitted to the FDA by Samsung Bioepis in August 2023.
  • We remain committed to helping more patients access biosimilar alternatives,” said Jon Martin, Head, US Biosimilars at Organon.
  • HADLIMA (adalimumab-bwwd) was first approved by the FDA in July 2019 as a low-concentration (40 mg/0.8 mL) formulation of prefilled syringe and prefilled autoinjector.
  • HADLIMA was introduced into the US commercial market on July 1, 2023 and is marketed by Organon.

Organon and Sempre Health Announce Collaboration on New Service to Help Eligible Patients Save Money and Stay on Their Medication as Prescribed

Retrieved on: 
Wednesday, November 1, 2023
Biotechnology, Women, Consumer, Health, Pharmaceutical, Mometasone, Sale, NYSE, Multimedia, OGN, Prescription, Partnership, Patient, Health insurance, Organon

Organon (NYSE:OGN) and Sempre Health today announced a strategic partnership designed to motivate eligible patients to refill their prescriptions on time and improve adherence through an innovative pricing program that offers personalized support.

Key Points: 
  • Organon (NYSE:OGN) and Sempre Health today announced a strategic partnership designed to motivate eligible patients to refill their prescriptions on time and improve adherence through an innovative pricing program that offers personalized support.
  • Eligible patients receive discounts at the point-of-sale, which increase as they remain on therapy and continue to fill on-time, helping them fill their medications and save money.
  • The program also includes natural language text message engagement, which leads to a personalized experience for those enrolled.
  • Now I’m able to better afford my medication as prescribed.”

Organon Canada Announces Availability of a High-Concentration, Citrate-Free Formulation of HADLIMA®, a Biosimilar to HUMIRA*

Retrieved on: 
Thursday, October 26, 2023
Inflammatory Bowel Diseases, Psoriasis, Adolescence, NYSE, Health, Physician, Health Canada, McGill University Health Centre, Rheumatoid arthritis, RA, Ulcerative colitis, McGill University, Crohn's disease, Adalimumab, OGN, Hidradenitis suppurativa, MUHC, Ankylosing spondylitis, Patient, Psoriatic arthritis, Pharmaceutical industry, Organon, Medicine, QC

The availability of both low and high concentration citrate-free options will help enhance patient care for Canadians through more treatment options, while reinforcing Organon's commitment towards biosimilars

Key Points: 
  • The availability of both low and high concentration citrate-free options will help enhance patient care for Canadians through more treatment options, while reinforcing Organon's commitment towards biosimilars
    KIRKLAND, QC, Oct. 26, 2023 /CNW/ - Organon Canada, a subsidiary of Organon (NYSE: OGN), a global healthcare company with a focus on women's health, today announced the availability of HADLIMA® (adalimumab), a biosimilar for Humira* (adalimumab), in a high-concentration, citrate free (40 mg/0.4 mL) version.
  • With this launch, the company reinforces its commitment of offering patients more treatment options and reducing healthcare costs by increasing access to biosimilars.
  • HADLIMA® was previously approved by Health Canada as a low-concentration formulation (40 mg/0.8 mL) in May 2018 and subsequently in a high-concentration (40 mg/0.4 mL) in December 2022.2
    "The launch of citrate-free high concentration HADLIMA® is important for biosimilars in Canada and for Canadians gaining expanded access to treatment options," said Michael Casia, President and Managing Director, Organon Canada.
  • "Organon Canada is committed to the continued expansion of its biosimilar portfolio, helping to strengthen our healthcare system and support patients in need."

Organon To Report Third Quarter Results and Host Conference Call on November 2, 2023

Retrieved on: 
Thursday, October 19, 2023
Health, Consumer, Women, Managed Care, General Health, Pharmaceutical, Biotechnology, EST, Interest, OGN, ID, NYSE, Webcast, Security (finance), Organon

Organon (NYSE: OGN), a global healthcare company with a focus on women’s health, will release its third quarter 2023 financial results on November 2, 2023, prior to the company’s webcast and conference call scheduled for 8:30 a.m. EST.

Key Points: 
  • Organon (NYSE: OGN), a global healthcare company with a focus on women’s health, will release its third quarter 2023 financial results on November 2, 2023, prior to the company’s webcast and conference call scheduled for 8:30 a.m. EST.
  • Interested parties may access the live call via webcast on the Organon website at https://www.organon.com/investor-relations/events-and-presentations/ .
  • A replay of the webcast will be available approximately two hours after the conclusion of the live event on the company’s website.
  • Institutional investors and analysts interested in participating in the call must register in advance by clicking on this link: https://conferencingportals.com/event/VfCOQYEG .

Lululemon Athletica & Hubbell Set to Join S&P 500; Others to Join S&P MidCap 400 and S&P SmallCap 600

Retrieved on: 
Friday, October 13, 2023
Organon & Co., NYSE, Microsoft, OGN, Hubbell, LULU, S&P, Hubbell Incorporated, S&P 400, Activision Blizzard, Organon, NASD, MSFT, ATVI, HUBB, Onto Innovation, Bookkeeping

NEW YORK, Oct. 13, 2023 /PRNewswire/ -- S&P Dow Jones Indices will make the following changes to the S&P 500, S&P MidCap 400, and S&P SmallCap 600 indices effective prior to the opening of trading on Wednesday, October 18:

Key Points: 
  • NEW YORK, Oct. 13, 2023 /PRNewswire/ -- S&P Dow Jones Indices will make the following changes to the S&P 500, S&P MidCap 400, and S&P SmallCap 600 indices effective prior to the opening of trading on Wednesday, October 18:
    Lululemon Athletica Inc. (NASD:LULU) will replace Activision Blizzard Inc. (NASD:ATVI) in the S&P 500.
  • S&P 500 and S&P 100 constituent Microsoft Corp. (NASD: MSFT) acquired Activision Blizzard in a transaction completed today, October 13.
  • S&P MidCap 400 constituent Hubbell Inc. (NYSE:HUBB) will replace Organon & Co. (NYSE:OGN) in the S&P 500, S&P SmallCap 600 constituent Onto Innovation Inc. (NYSE:ONTO) will replace Hubbell in the S&P MidCap 400, and Organon & Co will replace Onto Innovation in the S&P SmallCap 600.
  • Hubbell is more representative of the large-cap market space, Onto Innovation is more representative of the mid-cap market space, and Organon & Co is more representative of the small-cap market space.

Organon Recognized on Fortune’s 2023 Change the World List for Leadership in Expanding Access to Contraceptive Choice

Retrieved on: 
Wednesday, September 27, 2023
Other Health, Media, Professional Services, Pharmaceutical, Consumer, Medical Devices, Publishing, Biotechnology, Women, Communications, Medical Supplies, Health, Environmental, Social and Governance (ESG), UNFPA, Education, Public, United Nations Population Fund, Birth, Woman, OGN, Organization, Dominican Republic, Investment, Nature, Child, ESG, Family, NYSE, Pharmaceutical industry, Birth control, Organon

Organon has a portfolio of programs , collaborations, and investments designed to lift women for generations to come through family planning education and contraceptive access.

Key Points: 
  • Organon has a portfolio of programs , collaborations, and investments designed to lift women for generations to come through family planning education and contraceptive access.
  • Fortune’s annual list recognizes companies that have had a positive social impact through activities that are part of their core business strategy.
  • Part of that responsibility is to address contraception education and access barriers globally,” said Kevin Ali, CEO of Organon.
  • Fortune's Change the World list is selected and ranked by the editors of Fortune based on the magazine's own reporting and analysis.

On World Contraception Day, Organon Canada Declares Support for Universal Access to Contraception in Canada

Retrieved on: 
Tuesday, September 26, 2023
Employment, Family planning, Education, Public affairs (military), Birth, Woman, Human, OGN, Movement, Policy, Health, Birth control, Action Canada, NYSE, Organon, QC

In recognition of World Contraception Day on September 26, the company is joining a growing number of local organizations advocating for improved and equitable contraceptive access, education, and support for women in Canada and around the world.

Key Points: 
  • In recognition of World Contraception Day on September 26, the company is joining a growing number of local organizations advocating for improved and equitable contraceptive access, education, and support for women in Canada and around the world.
  • "When implemented correctly, universal contraception coverage represents an important step on this journey, and Organon Canada is proud to be adding its voice to the growing movement advocating for universal contraception in Canada."
  • Findings from a recent global report show that access to modern, effective and affordable contraception differs from province to province in Canada.
  • In addition to universal access to contraception, Organon Canada is a firm believer that education, awareness, and resources are key pillars to help reduce unintended pregnancies.

First Real-World Observational Study of the JADA® System, a Medical Device to Control Postpartum Hemorrhage (PPH), Published in ACOG’s Obstetrics & Gynecology

Retrieved on: 
Thursday, September 14, 2023
Women, Biotechnology, Pharmaceutical, General Health, Health, Medical Devices, Consumer, Clinical Trials, Columbia University, Columbia University Irving Medical Center, Internal bleeding, JADA, RBC, Society, ACOG, Obstetrics, PPH, Trial of the century, Obstetrics and gynaecology, Record, Woman, Multimedia, OGN, Hospital, Bleeding, Patient, Hysterectomy, Department of Obstetrics and Gynecology (Massachusetts General Hospital), ICU, American College, SMM, NYSE, Birth control, Gynaecology, Organon

Organon (NYSE: OGN), a global healthcare company focused on improving women’s health, today announced that Obstetrics & Gynecology (“The Green Journal”), the peer-reviewed journal of the American College of Obstetrics and Gynecology (ACOG), published the results of the RUBY study ( NCT04995887 ) which reached its primary effectiveness outcome of successfully treating abnormal postpartum uterine bleeding and postpartum hemorrhage (PPH) with the JADA® System.1 JADA is an intrauterine vacuum-induced hemorrhage control device intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted.1

Key Points: 
  • Organon (NYSE: OGN), a global healthcare company focused on improving women’s health, today announced that Obstetrics & Gynecology (“The Green Journal”), the peer-reviewed journal of the American College of Obstetrics and Gynecology (ACOG), published the results of the RUBY study ( NCT04995887 ) which reached its primary effectiveness outcome of successfully treating abnormal postpartum uterine bleeding and postpartum hemorrhage (PPH) with the JADA® System.1 JADA is an intrauterine vacuum-induced hemorrhage control device intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted.1
    This press release features multimedia.
  • View the full release here: https://www.businesswire.com/news/home/20230913796173/en/
    “PPH is a potentially life-threatening obstetric emergency that can occur after childbirth and requires timely medical intervention.1,6 Appropriate management of abnormal postpartum uterine bleeding is critical to minimize the potential clinical consequences of PPH7 and its associated severe maternal morbidities, such as the need for blood transfusions, ICU admission or hysterectomy,”1,8,9 said lead author Dena Goffman, M.D., a maternal-fetal medicine subspecialist, and professor and vice chair for quality and patient safety in the Department of Obstetrics and Gynecology at Columbia University Irving Medical Center in New York.
  • “The new study, which included a larger population than the pivotal trial, showed how the device is being used outside of a controlled clinical trial environment.
  • Secondary outcome measures, including time to bleeding control, in-dwelling time, total blood loss and red blood cell transfusions, were also presented.