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Novartis AG (NVS), a global leader in pharmaceutical innovation, maintains this comprehensive news hub for stakeholders seeking authoritative updates on corporate developments and medical breakthroughs. Our curated collection provides timely access to official press releases, financial disclosures, and therapeutic advancement announcements.
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Novartis presented Phase III trial results for Fabhalta® (iptacopan), showing a 35.1% reduction in proteinuria in patients with C3 glomerulopathy (C3G) compared to placebo. Secondary endpoint data showed a numerical improvement in estimated glomerular filtration rate (eGFR) over 6 months. The drug exhibited a favorable safety profile with no new safety signals. C3G is an ultra-rare kidney disease with no approved treatments, leading to kidney failure in ~50% of patients within 10 years. Regulatory submissions are planned for the second half of 2024. An additional 6-month open-label period continues to evaluate Fabhalta's efficacy.
Novartis presented new data for Piqray (alpelisib) at the San Antonio Breast Cancer Symposium, demonstrating significant benefits in patients with HR+/HER2- metastatic breast cancer (mBC) and PIK3CA mutations. The BYLieve study showed a median overall survival of 26.4 months for patients treated with Piqray and fulvestrant after CDK4/6 inhibition. Approximately 48.7% of patients showed no disease progression at six months in the cohort treated after chemotherapy or endocrine therapy. No new safety signals were observed, confirming the drug's tolerability.
AavantiBio has appointed Dr. Jenny Marlowe as Chief Scientific Officer. She brings nearly 15 years of experience in the biopharmaceutical sector, previously serving at Bluebird Bio (NASDAQ: BLUE) as VP of Preclinical & Translational Development. Dr. Marlowe will lead scientific research and preclinical development at AavantiBio, which focuses on gene therapies for rare diseases. The company has secured over $107 million in Series A financing and is advancing its gene therapy pipeline, including partnerships with leading organizations such as the University of Florida.
On September 19, 2021, Novartis announced the final overall survival analysis of the Phase III MONALEESA-2 study for Kisqali (ribociclib) combined with letrozole in postmenopausal women with HR+/HER2- advanced breast cancer. The treatment showed a statistically significant median overall survival improvement (63.9 vs. 51.4 months) and a 12-month delay in chemotherapy initiation compared to letrozole alone. No new safety signals were reported. Novartis plans to submit these findings to health authorities for label updates, reinforcing Kisqali's position in advanced breast cancer treatment.
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