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In the SOUL trial, Rybelsus produced a 14% risk reduction of major adverse cardiovascular events in patients with type 2 diabetes and cardiovascular disease and/or chronic kidney disease.

The trial size adjustment, along with protocol modifications and the addition of higher-enrollment sites, is expected to facilitate completion of the NEPHRO CRRT study of Niyad in patients undergoing renal replacement therapy by the end of 2025.

LillyDirect will help provide services to millions of patients who have yet to be formally diagnosed with the disease.

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Qfitlia is the first FDA-approved antithrombin-lowering therapy indicated for routine prophylaxis to prevent or reduce bleeding episodes in patients over 12 years of age with hemophilia A or B.

Approval of Imfinzi marks the first and only perioperative immunotherapy indicated for muscle-invasive bladder cancer.

A monthly roundup of business and people news in the pharmaceutical industry.

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Results from the COCOON study showed that Rybrevant plus Lacluze reduced grade 2 or higher dermatologic events by 50% compared to standard care in patients with epidermal growth factor receptor-mutated non-small cell lung cancer.

Under terms of the deal, Novo Nordisk will obtain global rights to develop, manufacture, and commercialize LX9851 for obesity and metabolic disorders.

The high-stakes nature of cancer care, coupled with rapid scientific advancements and increasing payer and regulatory pressures, demands a specialized approach beyond traditional market access strategies.

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As part of the Fast Track designation, Sanofi is set to launch a Phase I/II trial to evaluate the immunogenicity and safety of its novel mRNA vaccine in preventing chlamydia.

Approval of Vykat XR marks the first treatment indicated for hyperphagia in patients with Prader-Willi syndrome.

The Healthwell Foundation published research that questioned over 1,500 Americans about their healthcare status.

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The new product will allow for improved mRNA production with reduced costs.

Results from multiple clinical trials showed that Tagrisso demonstrated survival benefits in EGFR-mutated non-small cell lung cancer, both as monotherapy and in combination therapies.

Blujepa marks the first new oral antibiotic to gain FDA approval for uncomplicated urinary tract infections in nearly 30 years.

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Under terms of the deal, Merck will gain global rights to develop, manufacture, and commercialize HRS-5346 for cardiovascular disease, excluding Greater China.

Under terms of the license agreement, Novo Nordisk will acquire the rights to develop and commercialize UBT251 outside of China for obesity and type 2 diabetes for an upfront payment of $200 million.

The potential vaccine is being developed in partnership with the Cleveland Clinic and the NCI.

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The facility, which is set to open amid Biogen’s 50th anniversary, will integrate research and development, technical operations, and commercial teams into one location.

Fanhalta marks the first and only treatment for C3 glomerulopathy to gain FDA approval.

The biotech won the award for its work in obesity and inflammation treatment.