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Added: Cherese Skelton - Date: 19.09.2021 09:35 - Views: 12946 - Clicks: 7770

At the Interim Analysis, 7. Through Day 29, no deaths were reported in patients who received molnupiravir, as compared to 8 deaths in patients who received placebo.

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At the recommendation of an independent Data Monitoring Committee and in consultation with the U. Food and Drug Administration FDArecruitment into the study is being stopped early due to these positive. FDA as soon as possible based on these findings and plans to submit marketing applications to other regulatory bodies worldwide.

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This press release features multimedia. Davis, chief executive officer and president, Merck. Our partnership with Merck is critical to ensuring rapid global access if this medicine is approved, and we appreciate the collaborative effort to reach this important stage of development. Eligibility criteria required that all patients had laboratory-confirmed mild-to-moderate COVID, with symptom onset within 5 days of study randomization.

All patients were required to have at least one risk factor associated with poor disease outcome at study entry. Fewer subjects discontinued study therapy due to an adverse event in the molnupiravir group 1. Merck expects to produce 10 million courses of treatment by the end ofwith more doses expected to be produced in Earlier this year, Merck entered into a procurement agreement with the U.

Government under which Merck will supply approximately 1. Additionally, Merck has entered into supply and purchase agreements for molnupiravir with other governments worldwide, pending regulatory authorization, and is currently in discussions with other governments. As part of its commitment to widespread global access, Merck ly announced that the company has entered into non-exclusive voluntary licensing agreements for molnupiravir with established generic manufacturers to accelerate availability of molnupiravir in more than low- and middle-income countries LMICs following approvals or emergency authorization by local regulatory agencies.

The MOVe-OUT trial MK NCT was a global Phase 3, randomized, placebo-controlled, double-blind, multi-site study of non-hospitalized adult patients with laboratory-confirmed mild to moderate COVID, at least one risk factor associated with poor disease outcomes, and symptom onset within five days prior to randomization.

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Molnupiravir has been shown to be active in several preclinical models of SARS-CoV-2, including for prophylaxis, treatment, and prevention of transmission. Additionally, pre-clinical and clinical data have shown molnupiravir to be active against the most common SARS-CoV-2 variants. Ridgeback received an upfront payment from Merck and also is eligible to receive contingent payments dependent upon the achievement of certain developmental and regulatory approval milestones. Any profits from the collaboration will be split between the partners equally.

Since d by Ridgeback, all funds used for the development of molnupiravir have been provided by Merck and by Wayne and Wendy Holman of Ridgeback. Molnupiravir is also being evaluated for post-exposure prophylaxis in MOVe-AHEAD, a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study, which is evaluating the efficacy and safety of molnupiravir in preventing the spread of COVID within households.

Headquartered in Miami, Florida, Ridgeback Biotherapeutics LP is a biotechnology company focused on emerging infectious diseases. All equity capital in Ridgeback Biotherapeutics, LP originated from Wayne and Wendy Holman, who are committed to investing in and supporting medical technologies that will save lives.

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The team at Ridgeback is dedicated to working toward finding life-saving and life-changing solutions for patients and diseases that need champions. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals — including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases — as we aspire to be the premier research-intensive biopharmaceutical company in the world.

For more information, visit www. Private Securities Litigation Reform Act of There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual may differ materially from those set forth in the forward-looking statements. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

View source version on businesswire. Chrissy Carvalho Chrissy goldin. Ridgeback Bio Logo 60 KB. Unsubscribe from alerts. We are committed to providing leading innovations for today and the future that save and improve lives around the world. No Duty to Update The information contained in this website was current as of the date presented.

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