Search Results for “Novartis” – Page 14 – media

Amylyx Aims to Help Patients With a Novel GLP-1 Drug, But Not the Way You Think

Unlike GLP-1 agonist drugs marketed for weight loss, new Amylyx Pharmaceuticals drug avexitide blocks its target receptor. Amylyx plans to advance this GLP-1 antagonist into Phase 3 testing for post-bariatric hypoglycemia, a rare condition in which blood sugar levels drop precipitously. By Frank VinluanBefore GLP-1 drugs became a wildly popular pharmacologic way to treat obesity, bariatric surgery was a top option for those seeking a medical intervention for losing weight. While this procedure is effective for weight loss, it turns out that changing the structure of the gut can lead to a debilitating disorder in some patients. Amylyx Pharmaceuticals, months removed from a clinical trial failure that shattered its prospects in neurodegeneration, is now planting a flag in metabolic disease with the acquisition of a Phase 3-ready drug for this rare disorder with no FDA-approved therapies. The drug comes from Eiger BioPharmaceuticals, which last month sold off its assets in ...
- Source: drugdu
- 75
- July 12, 2024
Innovent sells its share in CAR T-cell therapy to IASO Bio for 18% equity

Chinese pharmaceutical manufacturer Innovent Biologics has transferred the licence for Fucaso (equecabtagene autoleucel), a chimeric antigen receptor (CAR) T-cell therapy, to its development and commercialisation partner IASO Biotechnology (IASO Bio). Although the companies did not disclose the sale price of the deal, Innovent stated that it would use the proceeds to acquire an 18% stake in IASO Bio. Following the agreement, IASO Bio holds global commercial rights to Fucaso. Fucaso is a B-cell maturation antigen (BCMA) targeting CAR T-cell therapy. It was approved by China’s National Medical Products Administration (NMPA) as a fourth-line therapy to treat relapsed and/or refractory multiple myeloma (r/r MM), last month. The companies have also received an investigational new drug (IND) application for Fucaso as a treatment for r/r MM patients who have undergone up to two lines of prior therapies and are refractory to Revlimid (lenalidomide). Fucaso has also received orphan drug, medicine advanced therapy ...
- Source: drugdu
- 87
- July 9, 2024
Tectonic bets on GPCR heart failure drug following reverse merger with Avrobio

Tectonic Therapeutic has completed a reverse merger with AVROBIO and will begin trading on the Nasdaq global market as Tectonic Therapeutic (ticker symbol ‘TECX’) on 21 June. Coinciding with the merger, the new company also completed a private placement of $130.7m with multiple US and European investors. Following the placement, Tectonic reported total cash reserves of $181m, before payment of final transaction-related expenses, which is expected to fund operations until mid-2027. As part of the merger, Avrobio enacted a 1-for-12 reverse stock split of its common shares, along with an issuance of a non-transferable contingent value right. Under that, shareholders will have the rights to cash payments received by Tectonic, if any, related to Avrobio’s pre-transaction legacy assets. Avrobio’s stockholders will own approximately 24.8% of the new company while old Tectonic shareholders, including the investors in the private placement, will hold 75.2% of the combined company’s outstanding common stock. The ...
- Source: drugdu
- 150
- June 25, 2024
Scemblix Shows Improved Major Molecular Response Treating Newly Diagnosed Philadelphia Chromosome-Positive Chronic Myeloid Leukemia

Don Tracy, Associate Editor Results of a Phase III trial indicated that Scemblix was more effective than standard-of-care tyrosine kinase inhibitors in treating newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase. Novartis announced promising results from the Phase III ASC4FIRST trial of Scemblix (asciminib), which showed superiority over standard-of-care tyrosine kinase inhibitors (TKIs) in treating newly diagnosed adults with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). “Patients living with CML need efficacious and well-tolerated treatment options that help them achieve meaningful outcomes as they manage their chronic condition,” said Shreeram Aradhye, MD, president, development, chief medical officer, Novartis, in a press release. “The compelling ASC4FIRST data highlight the potential of Scemblix to achieve better results than standard-of-care in newly diagnosed adults, while maintaining a favorable safety and tolerability profile. These results reinforce Scemblix as a proven treatment in Ph+CML-CP, as we continue to build on ...
- Source: drugdu
- 115
- June 4, 2024
Innovative Fundus Disease Drug Busilixumab Completes First Injections in Mainland Public Hospitals, Benefiting More Fundus Disease Patients

Recently, Guangdong Provincial People’s Hospital successfully completed the injection of the innovative drug Busiliximab, which is also the first batch of injection of this drug in public hospitals in mainland China. Relying on the “Hong Kong-Macau Pharmaceutical and Device Access” policy, Busiliximab has been approved for urgent clinical use in designated medical institutions in the Greater Bay Area. This new generation of anti-VEGF (vascular endothelial growth factor) drugs in public hospitals will enhance the accessibility of innovative therapies and benefit more patients with fundus diseases. China has more than 40 million patients with endophthalmic disease, and is in urgent need of new drugs to break through the treatment dilemma. The number of patients with fundus diseases in China is increasing, with the potential number of patients with fundus diseases reaching 40 million. The most common of them are diabetic retinopathy and age-related macular degeneration, in addition to many other types ...
- Source: drugdu
- 139
- May 25, 2024
Comprehensive cost and utilization of commercial CAR-T therapy in pediatric B-ALL patients

A new editorial paper was published in Oncoscience (Volume 11) on April 25, 2024, entitled, “The price of hope: CAR-T therapy in pediatric leukemia.” We stand at the crossroads of medical innovation, where cutting-edge scientific discoveries intersect with the resilience of the human body, providing hope to families grappling with a diagnosis of pediatric leukemia. In this new editorial, researcher Alex Hoover from the University of Minnesota Medical School’s Division of Pediatric Blood and Marrow Transplantation discusses the chimeric antigen receptor T-cell (CAR-T) therapy tisagenlecleucel (tisa-cel) -; a groundbreaking development in the treatment of B-cell lineage acute lymphoblastic leukemia (B-ALL) (the most common childhood cancer). Following the pivotal ELIANA trial, tisa-cel was approved in the United States for the treatment of refractory or second or greater relapse of B-ALL in patients under age 25. This innovative therapy involves genetically modifying a patient’s native T-cells – immune cells with the ability ...
- Source: drugdu
- 93
- May 21, 2024
BIOSECURE bill targets more Chinese companies as biotechs and their customers adapt to defunding

On Wednesday, 3 April, 2024, a letter from the House’s Select Committee on the Chinese Communist Party recommended more companies to add to the Pentagon’s list of firms that are allegedly working with the Chinese military. The letter identifies several companies, including two headquartered in California—Innomics (Sunnyvale, CA, US) and Axbio (Santa Clara, CA, US)—as potentially Chinese military-backed companies, and implied the companies may have tried to hide their affiliation with Chinese-headquartered BGI Genomics (Shenzhen, China), which has been on the security risk list since 2022. Other Chinese companies recommended for the list are Origincell (Shanghai, China), Vazyme Biotech (Nanjing, China), and STOmics (Shenzhen, China). The letter states that Innomics recently registered to conduct business operations in Kentucky under BGI. Innomics provides sequencing services to institutional and corporate clients for research purposes and STOmics sells lab kits and reagents. BGI asserts that both Innomics and STOmics belong to BGI but ...
- Source: drugdu
- 112
- May 2, 2024
FDA Drug Approval Marks a New Day for Treating Pediatric Brain Cancer

Day One Biopharmaceuticals drug Ojemda is now FDA-approved for advanced pediatric low-grade glioma, the most common type of brain cancer in children. The regulatory decision for Ojemda covers a broader swath of patients than a drug combination from Novartis approved for treating this childhood cancer. By Frank Vinluan on April 24, 2024 One quirk of the most common type of pediatric brain cancer is that as a child gets older, the tumors eventually stop growing. The reasons for this tumor senescence aren’t fully understood, but pediatric low grade glioma, or pLGG, still wreaks plenty of havoc until then, says Sam Blackman, a pediatric oncologist and the co-founder and head of R&D for Day One Biopharmaceuticals. “Whether it’s the tumor pressing on an optic nerve creating blindness, damage to the hypothalamus or pituitary gland causing profound endocrine disorders, or pressure on motor structures in the brain causing hemiparesis or loss of ...
- Source: drugdu
- 81
- April 26, 2024
UK charities condemn continued drug shortages

Ahandful of UK charities and community pharmacists urged the UK government to find a fix for the ongoing drug shortage issue to prevent further patient suffering. The UK Epilepsy Society, SUDEP Action, Epilepsy Action and Parkinson’s UK, joined forces to call for a meeting with the Health Secretary, Victoria Atkins. The Association of Independent Multiple Pharmacies (AIMp) found that community pharmacists are spending an average of two hours every day to find patients’ medications due to the disruptions. In a 11 April press release, Dr. Leyla Hannbeck, AIMp’s CEO, said, “The system is overly complex and shrouded in secrecy – what we need is openness and transparency. Pharmacists are in the same position as patients – we are at the end of the supply chain but are the last people to find out about medication shortages. Consequently, we are unable to plan in advance and support the people who rely ...
- Source: drugdu
- 163
- April 16, 2024
Merck Drug for Heart and Lung Disorder Wins a First-in-Class FDA Approval

Merck drug Winrevair is the first in a new class of pulmonary arterial hypertension therapies that address a key signaling pathway behind the disease. The drug comes from Merck’s $11.5 billion acquisition of Acceleron Pharma. By FRANK VINLUANPulmonary arterial hypertension, a disease that leads to worsening lung and heart problems that eventually become life-threatening, is treated with drugs that alleviate symptoms. FDA approval of a new Merck drug marks the first for a therapy addressing an underlying cause of the disease. The Tuesday approval of the Merck drug covers the treatment of adults whose pulmonary arterial hypertension (PAH) is at intermediate or high risk of progression. The drug, known in development as sotatercept, will be marketed under the brand name Winrevair. Hypertension—high blood pressure—is common. PAH is a rare form of hypertension that specifically affects the arteries carrying blood from the right side of the heart and into the lungs. ...
- Source: drugdu
- 93
- March 28, 2024

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