CASI Pharmaceuticals and Juventas Cell Therapy recently received approval from China's National Medical Products Administration (NMPA) for Yuanruida, a domestic CD19-targeting CAR-T therapy for relapsed/refractory B-Cell Acute Lymphocytic Leukemia.
Novartis announced today (Monday August 28) that new long-term data from its open-label trial extension demonstrated twice-yearly dosing inclisiran with statin therapy provides consistent low-density lipoprotein cholesterol (LDL-C) reduction beyond six...
Bristol Myers Squibb will boost its cell therapy manufacturing network with in-house viral vector production thanks to the acquisition of Novartis’ Libertyville, Illinois facility.
The European Medicines Agency (EMA) is planning to alert healthcare professions about liver failure cases linked to Zolgensma, a gene therapy against spinal muscular atrophy (SMA), which is developed by Novartis.
Novartis has set out how it expects biosimilars to affect its business in the coming years, identifying sales of $80bn that are open to its off-patent business and expressing confidence in the ability of some of its own products to weather the arrival...
Sandoz said the US Food and Drug Administration (FDA) has accepted its biologics license application (BLA) for a natalizumab biosimilar, developed by Polpharma Biologics.
The pharmaceutical company is expanding its alliance with historically Black medical schools to bolster the battle against systemic health disparities.
The US Food and Drug Administration (FDA) has granted commercial licensure approval for Novartis’ Durham, N.C. site, a multi-product gene therapy manufacturing facility, which will start producing Zolgensma immediately.
Janssen’s Carvykti, a therapy for multiple myeloma, has been approved for conditional marketing authorization (CMA) by the European Medicines Agency (EMA).
Novartis continues down the third-party manufacturing route, as it secures an agreement with Carisma Therapeutics, a firm developing a cell therapy platform focused on engineered macrophage-based therapeutics.
Novartis has introduced its T-Charge platform at ASH 2021, which it says will serve as the foundation for various new investigational CAR-T cell therapies in its pipeline.
Oxford Biomedica plc has announced an extended commercial supply agreement with Novartis for the manufacture of lentiviral vectors for several Novartis CAR-T products.
Novartis has signed a new initial agreement with BioNTech for COVID-19 vaccine manufacturing: with its sterile manufacturing facilities in Ljubljana, Slovenia, to fill at least 24 million doses in 2022.
Novartis’s Kymriah CAR-T therapy did not meet its primary endpoint of event-free survival in a phase 3 study in patients with aggressive B-cell non-Hodgkin lymphoma (NHL) after relapse or lack of response to first-line treatment.
The World Health Organization’s Solidarity PLUS trial will kick off in 52 countries, trialing three drugs to treat patients hospitalized with COVID-19.
The pharma firm is working with five US colleges and universities onto create programming designed to boost recruitment of Black talent in the industry
The EMPHATHY clinical trial will enroll patients with COVID-19 to test the drug’s effectiveness in preventing worsening of symptoms and hospitalization.
Novartis reported today that a clinical trial of the drug, known as canakinumab, when combined with chemotherapy agent, docetaxel, failed to extend the lives of patients with advanced or metastatic non-small cell lung cancer compared to just chemotherapy...
Novartis has acquired Vedere Bio, giving the company a new platform for AAV-based delivery of gene therapies and an optogenetics program for the treatment and prevention of vision loss and blindness.
BioNTech will acquire Novartis’ GMP certified manufacturing facility in Marburg, Germany: with the site set to become one of the largest mRNA manufacturing plants in Europe.
Zolgensma has received a recommendation for approval despite running into problems recently, including manufacturing questions and data integrity issues.
Vineti’s latest financing round sees Novartis and Gilead join forces to invest in technology platform that enables scale-up of CAR Ts and allogeneic cell therapies.
US FDA places a hold on a clinical study testing Novartis’ Zolgensma in patients with SMA Type 2, after information provided to the authorities by AveXis.
Novartis announces its third quarter results that show Zolgensma is outperforming sales expectations, but company notes approval in EU and Japan pushed back over manufacturing queries.
