Tag: Novartis

June 3, 2022 Off

Novartis’ Kisqali the only CDK4/6 inhibitor consistent significant overall survival across entire Phase III program

Novartis today announced new overall survival (OS) and quality of life (QoL) analyses which evaluated Kisqali® (ribociclib) plus endocrine therapy for patients with hormone receptor-positive/human epidermal growth factor receptor-negative (HR+/HER2-) advanced or metastatic breast cancer. These data will be presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, Novartis said.

April 28, 2022 Off

Novartis Announces Positive Phase III Results for its ESCC Drug

By Author

Novartis has announced positive topline results from an interim analysis of the Phase III RATIONALE 306 study, which showed anti-PD-1 immune checkpoint inhibitor tislelizumab plus chemotherapy significantly improved overall survival (OS) compared to chemotherapy in patients with previously untreated unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC), regardless of PD-L1 expression.

April 22, 2022 Off

Novartis Receives Positive CHMP Opinion for Tabrecta for Patients with METex14 Advanced NSCLC

By Author

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion and recommended granting marketing authorization of Novartis’s Tabrecta (capmatinib) as a monotherapy for the treatment of adults with advanced non-small cell lung cancer (NSCLC) harboring alterations leading to mesenchymal-epithelial-transition factor gene (MET) exon 14 (METex14) skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

April 6, 2022 Off

FDA Approves Novartis’s Vijoice as First and Only Treatment for Select Patients with PIK3CA-Related Overgrowth Spectrum (PROS)

By Author

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Novartis-s Vijoice (alpelisib) for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy.

April 5, 2022 Off

Novartis Presents New Four-Year Data on Efficacy and Safety of Kesimpta (ofatumumab) in People Living with Relapsing Multiple Sclerosis

By Author

Novartis has announced new long-term data from the Phase 3 ASCLEPIOS I/II trials and the ALITHIOS open-label extension that demonstrated long-term efficacy and safety of Kesimpta (ofatumumab), with continued reduced risk of disability worsening, for people living with relapsing multiple sclerosis following up to four years of treatment.

April 5, 2022 Off

Novartis Expands Zolgensma Manufacturing Capacity with Approval of Multi-Product North Carolina Facility

By Author

The U.S. Food and Drug Administration (FDA) has granted commercial licensure approval for Novartis’s Durham, N.C. site, a multi-product gene therapy manufacturing facility.

April 4, 2022 Off

Novartis Announces new Organizational Atructure to Accelerate Growth, Strengthen Pipeline and Increase Productivity

By Dino Mustafić

Novartis has announced the introduction of a new organizational structure and operating model designed to support the company’s innovation, growth, and productivity ambitions as a focused medicines company in the coming decade.

March 24, 2022 Off

FDA approves Novartis’s Pluvicto for Treatment of Advanced Prostate Cancer

By Dino Mustafić

The US Food and Drug Administration (FDA) has approved Novartis’s Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for the treatment of adult patients with a certain type of advanced cancer called prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer

March 14, 2022 Off

Novartis announces New Data on Zolgensma for Treating SMA

By Dino Mustafić

Novartis has announced new data that reinforce the transformational benefit of Zolgensma (onasemnogene abeparvovec), an essential one-time treatment for spinal muscular atrophy (SMA).

March 10, 2022 Off

Novartis Signs Initial Agreement with Carisma Therapeutics for the Manufacturing of HER 2 Targeted CAR-M Cell Therapy

By Dino Mustafić

Novartis has signed an initial agreement with Carisma Therapeutics, a biopharmaceutical pioneer in engineered macrophage-based therapeutics, to manufacture the HER 2 targeted CAR-M cell therapy, which is tested in initial trials for the treatment of solid tumors.