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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
- 141
- April 25, 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
- 118
- 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
- 86
- April 24, 2024
Use of Popular Pain Reliever During Pregnancy Not Linked to Neuro Disorders in Kids

Questions about whether acetaminophen use during pregnancy can lead children to develop neurological problems have sparked scientific inquiry and litigation. Lawsuits are continuing, but a new National Institutes of Health-sponsored study has results that show no causal link between acetaminophen and neurodevelopmental disorders. By Frank Vinluan When women experience pain or fever during pregnancy, many clinicians recommend acetaminophen for relief. But concerns about a possible link between these medicines and neurodevelopmental disorders have lingered. A multi-year study sponsored by the National Institutes of Health has results that add to the scientific consensus that these medicines aren’t the cause of neurodevelopmental problems. Acetaminophen is the active pharmaceutical ingredient in some prescription products and popular over-the-counter pain relievers, notably Tylenol and Excedrin. While nonsteroidal anti-inflammatory drugs offer an alternative approach to pain relief, these drugs aren’t recommended during pregnancy because they can cause low levels of amniotic fluid among other problems. The ...
- Source: drugdu
- 116
- April 23, 2024
Hengrui Pharmaceuticals Class 1 New Drug HRS8807 for ER-positive, HER2-negative Breast Cancer Combination Treatment Approved for Clinical Trial

Recently, Hengrui Pharmaceuticals and its subsidiary Shanghai Hengrui Pharmaceuticals Co., Ltd. received a Notice of Approval of Drug Clinical Trial from the State Drug Administration, approving the company to conduct an open, multi-center Phase I clinical study on the safety, tolerability and pharmacokinetics of HRS8807 combined with dalsylate hydroxyethanesulfonate in ER-positive, HER2-negative metastatic or locally advanced breast cancer patients. Breast cancer is the most common malignant tumor worldwide. According to the Global Cancer Epidemiology Report 2024, breast cancer ranks first among female malignant tumors in terms of incidence and mortality, with approximately 2.31 million new cases of breast cancer and 670,000 deaths per year globally, ranking first in terms of incidence and mortality of female malignant tumors. Among all breast cancer patients, about 70% are ER-positive, and the guideline-recommended standard treatment is endocrine drugs combined with CDK4/6 inhibitors. In contrast, the new generation of oral selective estrogen receptor down-regulators (SERDs) ...
- Source: drugdu
- 83
- April 20, 2024
Kind Pharmaceuticals Announces Settlement

HANGZHOU, China, April 17, 2024 /PRNewswire/ — Today, Hangzhou Andao Pharmaceutical Ltd. and Kind Pharmaceuticals LLC (“Kind Pharmaceuticals”), together with its Chief Executive Officer Dr. Dong Liu and Chief Scientific Officer Dr. Shaojiang Deng, announced a resolution of their recent dispute with FibroGen, Inc. regarding Kind Pharmaceuticals’ hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF- PHI) technology. The parties have agreed to withdraw all pending legal proceedings between them regarding this HIF-PHI technology, without payment by either party. HIF-PHIs are a class of compounds that can be used to treat anemia. Kind Pharmaceuticals’ HIF-PHI drug candidate, AND017, is currently being studied in a clinical trial for the treatment of anemia in chronic kidney disease (CKD) patients. As a result of the settlement, Kind Pharmaceuticals remains free to develop AND017 and other HIF-PHIs in its pipeline. Dr. Liu, Chief Executive Officer of Kind, commented: “Kind is pleased that these disputes have been fully ...
- Source: drugdu
- 72
- April 18, 2024
Preclinical Safety Signal Prompts FDA Clinical Hold on Neumora Schizophrenia Drug

The FDA clinical hold keeps Neumora Therapeutics from catching up to the field of biopharmaceutical companies pursuing the same target for schizophrenia. But Neumora remains on track with its lead program, a different drug in late-stage clinical testing for major depressive disorder. A Neumora Therapeutics drug candidate addressing a promising and competitive target for schizophrenia has been placed under an FDA clinical hold after new preclinical data emerged showing convulsions in rabbits that received the experimental treatment. The Neumora drug, NMRA-266, began Phase 1 testing last November. The clinical hold announced Monday pauses the study, which had dosed about 30 healthy participants so far. Watertown, Massachusetts-based Neumora said no convulsions have been observed in any of the study participants. The company added that it is working with the FDA to resolve the clinical hold and will provide an update on the program’s status when new information becomes available. “We are ...
- Source: drugdu
- 82
- April 17, 2024
Dr Reddy’s launches drug-free migraine management device Nerivio in Europe

Dr Reddy’s Laboratories announced the launch of the drug-free non-invasive migraine management wearable device Nerivio in Germany through its step-down subsidiary betapharm. The launch marks the company’s entry into digital therapeutics in Europe. Nerivio is approved by the United States Food and Drug Administration (USFDA), and is CE-mark certified in Europe. Nerivio was presented in 2023 by Dr Reddy’s at the DGN Kongress organised by the German Association of Neurology in Berlin, and the 17th European Headache Congress held in Barcelona, Spain. Dr Reddy’s will present and launch Nerivio during the Neurological Association of South Africa annual congress on April 17, 2024, in the presence of Dr Stewart Tepper, Professor of Neurology at the Geisel School of Medicine – Dartmouth, and Vice President, New England Institute for Neurology and Headache. In May 2024, Nerivio will also be presented at International Headache Society 2024 iHEAD meeting in Berlin, Germany. In subsequent ...
- Source: drugdu
- 119
- April 15, 2024
Invenra, Astellas Launch Partnership Focused on Discovering Therapeutic Bispecific Antibodies

Don Tracy, Associate Editor Joint venture aims to implement Invenra’s B-Body bispecific antibody platform to enhance Astellas’ research and development efforts. Invenra Inc. and Astellas Pharma announced that they have agreed to terms on a collaboration that seeks to utilize Invenra’s B-Body bispecific antibody platform to bolster Astellas’ research and development efforts in bispecific therapeutic research. Per the agreement, Astellas will acquire full access to the B-Body platform, with the opportunity for further license negations upon the completion of this initiative. Both teams stated that they remain dedicated to pushing the boundaries of healthcare through innovative research, with the ultimate goal of providing new, effective treatments to patients worldwide.1 “We are honored to partner with the Astellas team, one of the world’s foremost developers of therapeutics,” said Roland Green, PhD, CEO, Invenra, in a press release. “We are excited by the potential of this partnership to yield profound benefits to ...
- Source: drugdu
- 140
- April 15, 2024
Lonza, NeuroSense Strike Deal Focused on Exploring Biological Markers for Neurodegenerative Diseases

Don Tracy, Associate Editor Collaboration aims to advance the development of treatments for multiple neurodegenerative conditions, including amyotrophic lateral sclerosis. Lonza and NeuroSense Therapeutics have announced a collaboration focused on evaluating biological markers in neurodegenerative diseases, such as amyotrophic lateral sclerosis (ALS). According to both companies, the joint venture intends to utilize Lonza’s expertise in extracellular vesicles in combination with NeuroSense’s experience in biomarker utilization for neurodegenerative diseases. The overall goal of this partnership is to enhance development of neurodegenerative disease treatments. This deal comes amid NeuroSense revealing positive results from the Phase IIb PARADIGM trial for PrimeC, focused on treating adults living with ALS. Under terms of the agreement, Lonza will focus on utilizing neuron-derived exosomes (NDEs) for assimilation into the development of PrimeC.1 “We believe this collaboration could be a game-changer for the ALS and neurodegeneration field, as findings in such biomarkers may advance early diagnosis and treatment, ...
- Source: drugdu
- 106
- April 12, 2024

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