Search Results for “Novartis” – media

16 billion yuan! Novartis “runs” to enter the market

Recently, the molecular glue star company Monte Rosa Therapeutics announced that it has reached a global exclusive development and commercialization license agreement with Novartis to advance the development of molecular glue protein degraders targeting VAV1, including the research therapy MRT-6160. Under the terms of the agreement, Novartis agreed to pay Monte Rosa an advance payment of US$150 million. In addition, Monte Rosa is eligible to receive up to US$2.1 billion in development, regulatory and sales milestone payments (US$2.25 billion is approximately RMB 16 billion). Monte Rosa Therapeutics is headquartered in Boston, USA. The company was founded in 2018 and is a biotechnology company focusing on the development of molecular glue drugs. Its core technology platform is the QuEEN platform, which is mainly dedicated to the discovery and development of molecular glue drugs. Under the terms of the agreement, Monte Rosa will continue to be responsible for completing the ongoing Phase ...
- Source: drugdu
- 43
- November 4, 2024
Baiyu Pharmaceutical announces exclusive licensing agreement with Novartis for a small molecule anti-tumor drug

On October 17th, Baiyu Pharmaceutical announced an exclusive licensing agreement with Novartis for a small molecule anti-tumor drug. According to the agreement, Baiyu will receive a down payment of 70 million US dollars (approximately 499 million yuan), as well as various milestone payments and corresponding royalties for development, registration, and commercialization up to 1.1 billion US dollars (approximately 7.8 billion yuan). Novartis will obtain exclusive global development and commercialization rights for this small molecule innovative drug. Founded in 2005, Baiyu Pharmaceutical is headquartered in Chengdu, Sichuan. It is a global pharmaceutical enterprise with innovative drugs as its core, integrating research and development, production, sales, and traditional Chinese medicine cultivation into a full industry chain group. 10 pipelines under research, 5 tumor pipelines According to the announcement, the asset of this transaction is a small molecule innovative drug for the treatment of malignant tumors invented and discovered by the Baiyu Innovative ...
- Source: drugdu
- 66
- October 25, 2024
Novartis plans to give priority review to two “nuclear medicine-related products”

Today (September 24), CDE plans to include Novartis’ Lutetium [177Lu] Texivirpitide Injection and Radioactive Drug Gallium [68Ga] Gozertide Injection Preparation Kit in the priority review. According to the CDE official website, both drugs are based on the “Opinions of the National Medical Products Administration on Reforming and Improving the Management System for the Review and Approval of Radioactive Drugs” (National Medical Products Administration Drug Note [2023] No. 20) and the “Medium- and Long-Term Development Plan for Medical Isotopes (2021-2035)”. After review, they comply with the “Drug Registration Management Measures” and the “Announcement of the National Medical Products Administration on the Release of the “Breakthrough Therapeutic Drug Review Work Procedures (Trial)” and other three documents (No. 82 of 2020). The requirements are agreed to be included in the priority review and approval procedure according to the priority review scope “(VI) Other circumstances prescribed by the National Medical Products Administration for priority ...
- Source: drugdu
- 65
- September 28, 2024
Siemens Healthineers plans to acquire Novartis’ diagnostic business for €200 million

Recently, according to the Financial Times, Siemens Healthineers plans to acquire the diagnostic business of Advanced Accelerator Applications (AAA), a subsidiary of Novartis, for 200 million euros (approximately 1.593 billion yuan). AAA specializes in producing radioactive nuclide drugs, also known as nuclear drugs, for molecular imaging equipment PET (positron emission tomography). The transaction is expected to be completed in the fourth quarter. Expand business territory AAA was spun off from the European Organization for Nuclear Research (CERN) in 2002 and is an innovative radiopharmaceutical company focused on targeted radioligand therapy, precise radioligand imaging, and molecular imaging product development. Its main focus is on the development, production, and commercial application of Molecular Nuclear Medicine (MNM) products. On October 30, 2017, Novartis acquired the company for $3.9 billion to strengthen its radiopharmaceutical business capabilities, making AAA a subsidiary of Novartis. After years of development, AAA has built a pipeline covering various diagnostic ...
- Source: drugdu
- 93
- August 30, 2024
US judge denies initial attempt by Novartis to block generic Entresto launch

Novartis’s bid to block the launch of a biosimilar for its best-selling drug Entresto (sacubitril/valsartan) got off to a faltering start, as the drugmaker failed to convince a US court that MSN Pharmaceuticals’ (MSNPI) copycat infringed on a patent. Richard Andrews, district judge for the District of Delaware, ruled the likelihood that Novartis would win the lawsuit was not high enough, meaning a preliminary injunction was not granted. While Andrews stated that stopping MSNPI’s generic launch was not justified, he did order a temporary 72-hour halt while Novartis goes to the US Court of Appeal to seek an injunction, as per a 12 August court document first released by Reuters. The hearing is part of a lawsuit initiated by Novartis to fend off MSNPI’s generic – which received US Food and Drug Administration (FDA) approval last month – to protect sales for its heart failure blockbuster. Novartis’s reference drug was ...
- Source: drugdu
- 67
- August 15, 2024
Novartis’ kidney disease drug Fabhalta receives US FDA approval

Novartis announced that the US FDA has granted accelerated approval for Fabhalta (iptacopan), a first-in-class complement inhibitor for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. This is generally defined as a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g (1). Fabhalta specifically targets the alternative complement pathway of the immune system. When overly activated in the kidneys, the complement system is thought to contribute to the pathogenesis of IgAN (1-4). This indication is granted under accelerated approval based on the pre-specified interim analysis of the Phase III APPLAUSE-IgAN study measuring reduction in proteinuria at 9 months compared to placebo. It has not been established whether Fabhalta slows kidney function decline in patients with IgAN. The continued approval of Fabhalta may be contingent upon verification and description of clinical benefit from the ongoing Phase III APPLAUSE-IgAN study, evaluating whether Fabhalta slows disease ...
- Source: drugdu
- 102
- August 10, 2024
FDA Grants Priority Review to Novartis’ Scemblix for Newly Diagnosed Patients with Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Chronic Phase

By Don Tracy, Associate Editor Results from the ASC4FIRST study lead to FDA priority review designation of Scemblix in newly diagnosed patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase. Blood cell red 3d background vein flow platelet wave cancer medicine artery abstract. Red cell hemoglobin blood donate anemia isolated plasma leukemia donor vascular system anatomy hemophilia vessels. Image Credit: Adobe Stock Images/Five Million StocksThe FDA has granted priority to review to Novartis’ Scemblix (asciminib) for newly diagnosed adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (CML) in chronic phase (Ph+ CML-CP). According to the company, the designation was based on promising results from the Phase III ASC4FIRST trial, in which Scemblix showed superior major molecular response (MMR) rates compared to current standard-of-care (SoC) tyrosine kinase inhibitors (TKIs), such as imatinib, nilotinib, dasatinib, and bosutinib.1 “We welcome the FDA’s decision to grant Priority Review and Breakthrough Therapy designations to ...
- Source: drugdu
- 69
- August 2, 2024
Novartis reports 43% increase in net income in Q2 2024

Novartis has reported a significant 43% increase in net income from continuing operations, reaching $3.24bn in the second quarter (Q2) of 2024, up from $2.27bn in the same period of 2023. This notable growth in net income was attributed primarily to an increase in core operating income. Operating income for Q2 2024 soared to $4.01bn – a substantial year-on-year increase from $2.80bn. The rise in operating income has been chiefly attributed to higher net sales and reduced impairments, although this was partly offset by a rise in research and development investments. Net sales from continuing operations for the company stood at a robust $12.51bn in Q2 2024, an increase on the $11.43bn recorded in Q2 2023. Alongside the growth in net sales, Novartis also experienced a 40% rise in free cash flow from continuing operations, which amounted to $4.61bn compared to $3.29bn in the corresponding period of 2023. For the ...
- Source: drugdu
- 93
- July 20, 2024
Novartis China President and Managing Director Leo Lee Joins PhRMA China Executive Liaison Group

The Pharmaceutical Research and Manufacturers of America (PhRMA) China Office announced that Mr. Leo Lee, President and Managing Director of Novartis China, has joined the PhRMA China Executive Liaison Group. Mr. Lee, a long-time veteran of the biopharmaceutical industry who has held senior management positions in a number of multinational corporations and has extensive experience in strategy development and implementation, business development and operational management, joins PhRMA’s China Executive Liaison Group and expresses its confidence that Mr. Lee will bring invaluable experience to the group, as well as its appreciation to the member companies for their continued support of PhRMA. Novartis is a member of the Pharmaceutical Research and Manufacturers of America (PhRMA). About the PhRMA China Executive Liaison Group The China Executive Liaison Group (CELG) consists of the China General Managers of PhRMA member companies. As an important bridge between PhRMA China Office and member companies in China, the ...
- Source: drugdu
- 87
- July 2, 2024
Novartis Pivotal Phase III ASC4FIRST Study Provides Efficacy and Safety Data for Scemblix in Newly Diagnosed CML Patients

Novartis recently presented positive results from the pivotal Phase III ASC4FIRST study at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting: the treatment of patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP) with Scemblix® at Week 48 demonstrated greater efficacy and safety than the investigator’s choice of tyrosine kinase inhibitors (TKIs) (imatibe Scemblix demonstrated a superior major molecular response (MMR) rate at week 48 than both investigator-selected tyrosine kinase inhibitors (TKIs) (imatinib, nilotinib, dasatinib, and bosutinib) and imatinib alone.Scemblix demonstrated a higher MMR rate at week 48 than the second-generation TKIs (nilotinib, dasatinib, and bosutinib) with higher rate values.The MMR rate was higher than that of the second-generation TKIs. In addition, Scemblix demonstrated a favorable safety and tolerability profile, with fewer adverse events (AEs) and treatment interruptions relative to imatinib and second-generation TKIs. Tim Hughes, M.D., professor at the South Australian ...
- Source: drugdu
- 96
- June 5, 2024

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