PharmaFocus Today – Page 351 – media

FDA Approves Novartis’ Lutathera for Pediatric Patients with Gastroenteropancreatic Neuroendocrine Tumors

Davy James Lutathera is the first FDA-approved treatment for younger patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors. The FDA has approved Novartis’ Lutathera (lutetium Lu 177 dotatate) to treat patients aged 12 years and older with somatostatin receptor (SSTR)–positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut NETs. The regulatory action makes Lutathera the first therapy specifically approved to treat GEP-NETs in a pediatric patient population.1 “Lutathera is now the very first therapy approved specifically for children with GEP-NETs, offering new hope to young patients living with this rare cancer,” Tina Deignan, Novartis therapeutic area head, Oncology US, said in a press release. “Radioligand therapies (RLTs) have extraordinary potential to shape the future of cancer care. With this approval, we have taken another vital step toward fulfilling that vision, strengthening our commitment to researching and developing the RLT platform across multiple cancer types and treatment settings.” NETs, which are ...
- Source: drugdu
- 711
- April 25, 2024
Positive Results from Phase 3 SELECT-GCA Study of Upadacitinib (RINVOQ®) in Patients with Giant Cell Arteritis

On April 18, AbbVie announced positive results from SELECT-GCA. Based on the results of this Phase 3, multicenter, randomized, double-blind, placebo-controlled study, upadacitinib (RINVOQ®; 15 mg once daily) in combination with a 26-week hormone tapering regimen met the primary endpoint of sustained remissiona in adult patients with giant cell arteritis (GCA) from Week 12 to Week 52. In this study, 46% of patients treated with Rinvoq in combination with the 26-week hormone tapering regimen achieved sustained remission, compared to 29% of patients treated with placebo in combination with the 52-week hormone tapering regimen (p=0.0019). Dr. Kori Wallace, Vice President, Global Head of Clinical Development, Immunology at AbbVie, said, “Many patients with GCA continue to suffer from the potentially debilitating symptoms of the disease, and their treatment options are limited. These results demonstrate that there remains a significant medical need for this type of disease, and we are relentlessly committed to ...
- Source: drugdu
- 537
- April 25, 2024
First Subject Dosed for Phase 1 Clinical Trial of Henlius’ Novel Anti-GARP/TGF-β1 mAb HLX6018

Shanghai, China, April 23, 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) announced the first subject was dosed for a phase 1 clinical trial of HLX6018 (NCT06310746), a novel anti-GARP/TGF-β1 monoclonal antibody (mAb) independently developed by the company. HLX6018 is the first innovative product of Henlius in the treatment field of chronic inflammatory diseases, and it was recently approved by the National Medical Products Administration (NMPA) for the treatment of idiopathic pulmonary fibrosis (IPF). Currently, no product targeting GARP/TGF-β1 has been approved for marketing globally. Fibrosis is a pathological process characterised by persistent tissue scars which attributed to excessive deposition of extracellular matrix (ECM). This condition can be induced by a variety of stimuli such as infections, autoimmune reactions, radiation, and tissue injury. Common fibrosis-related diseases include IPF, non-alcoholic steatohepatitis (NASH)/metabolic dysfunction-associated steatohepatitis (MASH), cirrhosis, chronic kidney disease (CKD), myocardial infarction (MI), etc. Among them, IPF is a chronic, progressive interstitial ...
- Source: drugdu
- 404
- April 25, 2024
Boehringer Ingelheim and Ochre Bio partner on liver disease in deal worth over $1bn

Chronic liver disease and associated cirrhosis account for one million deaths every year Boehringer Ingelheim and Ochre Bio have partnered to discover and develop novel, first-in-class regenerative treatments for chronic liver disease (CLD), including late-stage metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis. The partnership aligns with Boehringer’s drive to improve outcomes for patients living with interconnected cardiovascular, renal and metabolic diseases. Accounting for approximately one million deaths per year, CLD and associated cirrhosis cause significant morbidity, loss of health-related quality of life and economic burden. As CLD progresses, the liver’s natural ability to regenerate and repair diminishes, resulting in serious complications such as liver failure or liver cancer. Under the terms of the agreement, Ochre will receive up to $35m in upfront and near-term research-based milestone payments, as well as possible milestones for clinical, regulatory and commercial success plus tiered royalties, with an overall deal value with the potential to exceed $1bn. ...
- Source: drugdu
- 653
- April 25, 2024
Trial reveals mechanisms that contribute to impact of malnutrition and HIV infection

Severe acute malnutrition is responsible for nearly half of all child deaths globally and affects 17 million children annually A trial led by researchers at Queen Mary University London, in partnership with two research institutes in Zambia and Zimbabwe, has identified the mechanisms that contribute to the long-term impacts of severe acute malnutrition (SAM) and HIV infection in children. Funded through the Medical Research Council’s (MRC) Global Challenges Research Fund, the study published in Nature Communications aims to identify a treatment to promote the healing of intestinal damage caused by SAM. Affecting around 17 million children every year, predominantly in Africa, SAM and malnutrition are responsible for almost half of all child deaths globally and cause damage to the enteropathy, the small intestine, by reducing its ability to absorb nutrients. The new phase 2 trial, involving 125 children who had been hospitalised due to complications from arising SAM, evaluated four ...
- Source: drugdu
- 799
- April 25, 2024
Bristol Myers Squibb, Cellares Ink $380M Deal to Manufacture CAR T-Cell Therapies

Don Tracy, Associate Editor Per the agreement, Cellares will integrate and automate some of Bristol Myers Squibb’s CAR T-cell therapies into its Cell Shuttle program. Bristol Myers Squibb (BMS) and Cellares announced that they have agreed to terms on a $380 million deal to enhance the manufacturing capabilities for chimeric antigen receptor (CAR) T-cell therapies. According to the companies, the deal will see Cellares incorporate a number of BMS’ therapies into its Cell Shuttle platform, which includes fully automated systems. With the deal aiming to improve access to CAR T-cell therapies to patients at a faster rate, BMS will be given exclusive use of Cellares’ smart factories across the United States, Europe, and Japan. “The agreement with Cellares is our latest step forward in support of our comprehensive strategy to unlock the full potential of CAR T therapy to deliver transformative treatments to as many patients as possible, as quickly ...
- Source: drugdu
- 410
- April 24, 2024
Boehringer Ingelheim Strikes Regenerative Med R&D Deal Spanning MASH & More Liver Diseases

The first FDA-approved MASH drug doesn’t treat patients with liver cirrhosis. A new Boehringer Ingelheim/Ochre Bio collaboration is researching regenerative medicines that could treat patients in this most advanced stage of the fatty liver disease. By Frank VinluanThe liver is the only organ in the human body capable of regenerating itself. Boehringer Ingelheim has begun a research alliance with a startup to see if its technology can produce new therapies that tap into the liver’s capacity for regeneration and repair. Boehringer is committing to pay Ochre Bio to up to $35 million to begin the partnership, which is focused on identifying, characterizing, and validating multiple novel regenerative targets for chronic liver diseases. Specific targets were not disclosed, but Monday’s announcement describes the deal as a multi-target, multi-year collaboration. Ochre develops RNA medicines for chronic liver diseases. The Oxford, U.K.-based startup hasn’t disclosed details about its internal pipeline, but the company ...
- Source: drugdu
- 400
- April 24, 2024
GenFleet Therapeutics Announces FDA’s Clinical Trial Approval for GFH925 (KRAS G12C Inhibitor) Monotherapy in Phase III Registrational Study Treating Metastatic Colorectal Cancer

SHANGHAI, April 19, 2024 /PRNewswire/ — GenFleet Therapeutics, a clinical-stage biotechnology company focusing on cutting-edge therapies in oncology and immunology, announced US Food and Drug Administration (FDA) has granted the clinical trial approval for GFH925 (KRAS G12C inhibitor) in a multi-center, open-label, randomized and controlled phase III study treating refractory metastatic colorectal cancer (CRC) patients. It is the first phase III trial of KRAS G12C inhibitor monotherapy targeting CRC patients worldwide, with GFH925 being the first G12C inhibitor that received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) for previously treated advanced CRC. GFH925 was also granted BTD and New Drug Application acceptance with Priority Review Designation by NMPA for previously treated advanced non-small cell lung cancer（NSCLC）patients with G12C mutation. The trial (GFH925X0301) will enroll refractory metastatic CRC patients harboring KRAS G12C mutation who have progressed or experienced disease recurrence on or after at least two prior ...
- Source: drugdu
- 481
- April 24, 2024
Focusing on China, Novartis Helps Promote the Development of the Radiopharmaceutical Industry

Today, the 2024 Conference on Innovative Development of Radiopharmaceuticals, organized by China Isotope and Radiation Industry Association (CIRIA), was held in Beijing. During the conference, China Isotope and Radiation Industry Association (CIRIA) established the Radiopharmaceutical Branch and held the first meeting of the First Council of the Branch, which was attended by leaders and representatives from research institutes, universities, medical institutions and enterprises in the field of radiopharmaceuticals in China. As a pioneer and “frontrunner” in the field of global radiopharmaceuticals, Novartis not only takes the lead in occupying the R&D plateau of radioligand therapy (RLT) and leading the domestic and international R&D track of RLT, but also actively promotes the construction and improvement of the industry in the field of radiopharmaceuticals based on its own industrial status and international influence. Ms. Luo Ya, Head of Value Access Department of Novartis China, participated in the meeting as Vice Chairman of ...
- Source: drugdu
- 519
- April 24, 2024
CureVac and MD Anderson Cancer Center partner to develop new cancer vaccines

Both will develop cancer vaccine candidates in selected haematological and solid tumour indications CureVac and the University of Texas’s MD Anderson Cancer Center have announced a co-development and licensing agreement to develop novel messenger ribonucleic acid (mRNA)-based cancer vaccines. The strategic collaboration will focus on the development of differentiated cancer vaccine candidates in selected haematological and solid tumour indications with high unmet medical needs. Solid tumour cancer, such as sarcoma, carcinoma and lymphoma, is characterised by an abnormal mass of tissue that usually does not contain cysts or liquid areas. Haematologic cancer, otherwise known as blood cancer, including leukaemia, lymphoma and multiple myeloma, begins in blood-forming tissues such as the bone marrow or in the cells of the immune system. Under the terms of the agreement, MD Anderson will be responsible for conducting phase 1/2 studies of the selected promising validated cancer vaccine candidates and the completion of investigational new ...
- Source: drugdu
- 622
- April 24, 2024

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