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Merck & Co., Inc. reports news across a global pharmaceutical business known as MSD outside the United States and Canada. Company updates center on human health products for areas such as oncology, cardiometabolic disease and infections; vaccines including Gardasil; and Merck Animal Health medicines, devices and customer-support systems.
Recurring developments include FDA approvals, clinical and regulatory disclosures, research publications, pipeline additions, business development transactions, material agreements, capital-structure updates, governance matters, and operating and financial results. Recent themes include the approved HIV-1 regimen IDVYNSO, investigational programs such as enlicitide decanoate and TERN-701, technology partnerships for research, manufacturing and commercial functions, and animal health digital engagement initiatives.
Merck (NYSE: MRK) and Ridgeback Biotherapeutics have announced that the FDA granted Emergency Use Authorization (EUA) for molnupiravir, an investigational oral antiviral for treating mild to moderate COVID-19 in high-risk adults. This milestone marks a significant step in the fight against COVID-19. Molnupiravir must be administered within five days of symptom onset. The companies plan to produce and distribute millions of courses globally, with commitments to equitable access. Concerns exist regarding the drug's use in pregnant individuals due to potential risks.
Merck (NYSE: MRK) and Ridgeback Biotherapeutics have announced a new deal with the U.K. Government to purchase an additional 1.75 million courses of molnupiravir (MK-4482), boosting total courses to 2.23 million. Molnupiravir, marketed in the U.K. as LAGEVRIO, has received conditional marketing authorization for treating mild to moderate COVID-19. Merck has secured supply agreements for molnupiravir with over 30 countries globally, with plans to produce 10 million courses by the end of 2021 and at least 20 million in 2022.
Organon (NYSE: OGN) announced that CEO Kevin Ali and CFO Matthew Walsh will engage in a fireside chat at the 40th Annual J.P. Morgan Healthcare Virtual Conference on January 10, 2022, at 2:15 p.m. ET. The event will be accessible via a live audio webcast for investors, analysts, media, and the public. As a global healthcare company focusing on women's health, Organon offers over 60 products and aims to expand its biosimilars business while collaborating with biopharmaceutical innovators. For more details, visit here.
Merck (NYSE: MRK) received a positive opinion from the European Medicines Agency's CHMP for KEYTRUDA, recommending its approval as an adjuvant treatment for adults with renal cell carcinoma (RCC) at risk of recurrence post-nephrectomy. This decision is based on the Phase 3 KEYNOTE-564 trial, which showed a 32% improvement in disease-free survival compared to placebo. The final decision by the European Commission is expected in Q1 2022. This advancement in treatment options aims to address a significant gap for RCC patients following nephrectomy.
Merck (NYSE: MRK) and Ridgeback Biotherapeutics announced that the MOVe-OUT trial results for molnupiravir, an oral antiviral for COVID-19, were published in the New England Journal of Medicine. The Phase 3 trial showed a 50% reduction in hospitalization or death for high-risk, unvaccinated adults. The drug has gained authorization in the UK and is under review by the FDA and EMA. The study involved a diverse population across 20 countries and indicated molnupiravir's effectiveness against COVID-19 variants, including Omicron.
Merck (NYSE: MRK) has received approval from the European Commission for VAXNEUVANCE™, a Pneumococcal 15-valent Conjugate Vaccine, which will be marketed in all 27 EU Member States, as well as Iceland, Norway, and Lichtenstein. This vaccine targets invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 and older. The approval is based on positive results from seven clinical studies involving 7,438 participants, showing that VAXNEUVANCE achieved immune responses superior to the previously available 13-valent vaccine.
Merck has received approval from the European Commission for its pneumococcal vaccine, VAXNEUVANCE, aimed at preventing invasive disease and pneumonia caused by Streptococcus pneumoniae in adults 18 and older. This approval follows a positive opinion from the European Medicines Agency based on data from clinical studies involving 7,438 participants. VAXNEUVANCE is now authorized for marketing in all 27 EU member states, as well as in Iceland, Norway, and Lichtenstein, offering a new immunization option for patients in these regions.
Merck (NYSE: MRK) announced that the FDA has placed clinical holds on several investigational new drug applications for islatravir (MK-8591) due to decreases in lymphocyte and CD4+ T-cell counts observed during clinical studies. The holds affect oral and injectable formulations for HIV-1 treatment and prevention, halting further dosing and enrollment in several trials. Affected studies include Phase 3 trials for oral islatravir as pre-exposure prophylaxis (PrEP) in high-risk populations. Merck remains committed to addressing unmet needs in HIV care.
Organon (NYSE: OGN) has completed its acquisition of Forendo Pharma, enhancing its women's health pipeline with novel treatments for endometriosis and polycystic ovarian syndrome (PCOS). The transaction includes a $75 million upfront payment and potential total consideration of up to $954 million based on development and commercial milestones. Forendo's lead candidate, FOR-6219, is entering Phase 2 clinical trials and aims to offer a long-term treatment option for endometriosis, addressing significant unmet needs in women's health.
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