The flurry of Trodelvy developments accentuates what Gilead CEO Dan O’Day called “a time of focused execution” at the California biotech. (Jim Watson/AFP/Getty Images) After a negative phase 3 readout, Gilead Sciences is taking a $2.4 billion impairment charge on Trodelvy, which serves as the cornerstone of the company’s solid tumor ambition. Gilead has cut the carrying value of Trodelvy to $3.5 billion in its first-quarter report, from $5.9 billion at the end of 2023, CFO Andrew Dickinson told investors during a call Thursday. The move comes after a January report of a phase 3 trial that the TROP2-directed antibody-drug conjugate failed to significantly extend the lives of patients with previously treated non-small cell lung cancer compared with chemotherapy. The bad news at that time caused a 10% slide in Gilead’s stock price. The write-off reflects a “smaller addressable market that Trodelvy could serve among second-line-plus metastatic non-small cell lung ...
According to the World Health Organization (WHO), an estimated 354 million individuals globally are afflicted with chronic hepatitis B or C. These viruses are the leading causes of liver cirrhosis, liver cancer, and deaths related to viral hepatitis, affecting hundreds of millions. Early detection plays a crucial role in initiating timely treatments that improve long-term health outcomes. The detection of the hepatitis B virus surface antigen (HBsAg) in serum or plasma is an early indicator of infection. HBsAg is the first serological marker to appear in the progression of the disease, emerging in the blood two to three weeks before symptoms become apparent. Traditional testing protocols typically require retesting and subsequent confirmatory tests for reactive samples. Now, two newly introduced hepatitis assays use advanced technology to elevate efficiency and confidence in hepatitis testing. Beckman Coulter Diagnostics (Brea, CA, USA) has extended the menu of DxI 9000 Immunoassay Analyzer assays with ...
Researchers from the universities of Oxford, Nottingham and King’s College London (KCL) have shown that a new heart disease calculator can accurately predict an individual’s ten-year risk of cardiovascular diseases and identify high-risk patients. Published in Nature Medicine, the QR4 tool could save over 2,500 chronic obstructive pulmonary disease (COPD) patients a year, promoting earlier recognition of the disease and its associated cardiovascular risk. Currently the leading cause of death globally, CVDs are responsible for an estimated 17.9 million deaths each year, according to the World Health Organization. They are disorders of the heart and blood vessels. Researchers from KCL, along with the QRISK team based at the universities of Oxford and Nottingham, conducted a large-scale epidemiological study involving over 13 million UK citizens, which revealed an increased risk of severe cardiovascular events in female patients with COPD. The team identified seven new unique risk factors common to all genders ...
Tonghua Dongbao Pharmaceutical Co. (hereinafter referred to as the “Company”, “Tonghua Dongbao”), a wholly-owned subsidiary of Tonghua Dongbao Zixing (Hangzhou) Biomedicine Co., Ltd. has recently obtained the clinical trial approval for THDBH120 for weight loss indication from the Center for Drug Evaluation (CDE) of the State Drug Administration. THDBH120 for injection for the indication of weight loss drug clinical trial approval notice. The approval of the clinical application for THDBH120 for weight loss indication for injection signifies that the company’s GLP-1 pipeline in the field of overweight and obesity treatment has also stepped into the phase of clinical trials, which is of milestone significance. In the future, the Company will accelerate the research and development progress of THDBH120 for injection in diabetes indication and weight loss indication, and further explore and tap the potential of other indications to maximize the value of the product. THDBH120 for injection has a huge ...
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 ...
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. ...
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 ...
Mike Hollan BrandShield states that it has identified sites selling counterfeit versions of Wegovy and Ozempic, among other drugs. It’s important to always be careful whenever buying anything from a website, especially medication. In recent years, it’s become much more common for patients and other consumers to find online sources where they can directly access medications without having to visit a pharmacy. This provides clear benefits for patients, such as limiting the burden placed upon them and potentially helping to reduce the cost of some medications. As is the case with most things, however, there are also risks. A new report from Reuters details one company’s work to take down sites selling fake medications.1 Not surprisingly, a significant percentage of these sites were selling counterfeit weight-loss drugs, such as fake versions of Ozempic. The report does note, however, that the number of sites selling these counterfeit weight-loss drugs has significantly ...
Shanghai, China, April, 17th, 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the investigational new drug application (IND) for the clinical trial of HLX53, an anti-TIGIT Fc fusion protein, in combination with HANSIZHUANG (serplulimab, HLX10) and HANBEITAI (bevacizumab, HLX04) for the first line treatment of locally advanced or metastatic hepatocellular carcinoma, has been approved by the National Medical Products Administration (NMPA). A phase 2 clinical trial will be initiated to evaluate the safety, tolerance and efficacy of the multiple immunotherapy-based treatment combinations in patients with advanced or metastatic hepatocellular carcinoma. Liver cancer is one of the most prevalent malignancy in the world. According to GLOBALCAN 2022, there are about 870,000 new cases diagnosed and 760,000 deaths for the tumour in the globe. Meanwhile, primary liver cancer (PLC) is the fourth most common cause and the second mortality cancer in China, with about 370,000 new cases and 320,000 deaths in ...
Bio-Rad Laboratories and Oncocyte Corporation have partnered to develop and commercialise solid tissue transplant monitoring products for researchers and laboratories to “advance science and save lives”. The collaboration will utilise Bio-Rad’s Droplet Digital Polymerase Chain Reaction (ddPCR) technology. Solid organ transplantation is a medical procedure to treat end-stage organ failure of the kidneys, liver, pancreas, heart and lung. Currently the most commonly transplanted organ worldwide, kidney transplantation was performed more than 42,800 times in 2022, according to the United Network for Organ Sharing. Under the terms of the agreement, Bio-Rad has agreed to participate in a private placement of Oncocyte’s equity and has secured exclusive commercial rights in certain markets to commercialise the precision diagnostics company’s assay for transplant monitoring research using the QX600 ddPCR system. When organs are transplanted, cell-free DNA, otherwise known as donor-derived cell-free DNA (dd-cfDNA), a sensitive biomarker for organ health that requires a simple blood ...
Go to Page Go
your submission has already been received.
OK
Please enter a valid Email address!
Submit
The most relevant industry news & insight will be sent to you every two weeks.