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Gilead’s Trodelvy Falls Short of Phase III Trial Primary Endpoint of Improved Overall Survival in NSCLC

January 23, 2024 Pharmaceutical Executive Editorial Staff The EVOKE-01 trial compared Trodelvy with docetaxel for the treatment of patients with metastatic or advanced non-small cell lung cancer who progressed on or following platinum-based chemotherapy and checkpoint inhibitor therapy.Image credit: Dr_Microbe | stock.adobe.com Data from the Phase III EVOKE-01 trial (NCT05089734) show that Gilead Sciences, Inc’s Trodelvy (sacituzumab govitecan-hziy) did not achieve the primary endpoint of overall survival (OS) in patients with previously treated, metastatic non-small cell lung cancer (NSCLC).EVOKE-01 was comparing Trodelvy with docetaxel for the treatment of patients with metastatic or advanced NSCLC who progressed on or following platinum-based chemotherapy and checkpoint inhibitor therapy. “The totality of our data gives us continued confidence in Trodelvy’s potential in metastatic NSCLC, and in our broader lung cancer clinical development program,” said Gilead Sciences Chief Medical Officer Merdad Parsey, MD, PhD, in a press release. “Treating metastatic NSCLC that has progressed on or ...
- Source: drugdu
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- January 25, 2024
Novel Urinary Biomarkers with Improved Diagnostic Performance to Enable Early Detection of Lupus Nephritis

Systemic Lupus Erythematosus (SLE), widely known as lupus, is an autoimmune condition where the body’s immune system mistakenly attacks its own tissues and organs. This disease can lead to inflammation affecting various body parts, including joints, skin, kidneys, blood cells, brain, and heart. Among its manifestations, lupus nephritis stands out as one of the most severe and common, often resulting in significant morbidity and mortality. Early detection of kidney involvement in lupus patients and prompt intervention are critical in mitigating the associated pain, suffering, and potential fatality. Now, researchers have discovered new biomarkers with improved diagnostic performance for the early detection of lupus nephritis. In a significant advancement, a research team from the University of Houston (Houston, TX, USA) employed Proximity Extension Assay (PEA) proteomics—a method focused on the study of proteins in terms of their interactions, functions, compositions, and structures—on urine samples from lupus patients. This approach led to ...
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- January 25, 2024
AI Leverages Tumor Genetics to Predict Patient Response to Chemotherapy

Understanding tumor responses to drugs becomes challenging due to the complex nature of DNA replication, a critical target for many cancer treatments. All cells, including cancer ones, depend on a sophisticated system for DNA replication during cell division. Most chemotherapies aim to disrupt this replication process in rapidly multiplying tumor cells. Given the diverse genetic mutations in tumors, predicting drug resistance remains a formidable challenge. Now, scientists have developed a machine learning algorithm capable of predicting when cancer will resist chemotherapy. This model was specifically tested on cervical cancer, accurately predicting responses to cisplatin, a widely used chemotherapy drug. It efficiently identified tumors likely to resist treatment and shed light on the molecular mechanisms driving this resistance. Developed by the University of California San Diego School of Medicine (La Jolla, CA, USA; ), the algorithm assesses how various genetic mutations collectively impact a tumor’s response to DNA replication-inhibiting drugs. The ...
- Source: drugdu
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- January 25, 2024
Recbio Enters a License and Strategic Cooperation with SPIMACO

January 23 , 2024 – Jiangsu Recbio Technology Co., Ltd. (“Recbio” , HKEX:02179) is pleased to announce that the company has recently reached a License and strategic cooperation with the Saudi Arabian pharmaceutical company SPIMACO for the recombinant HPV-9 vaccine REC603. According to the agreement, Recbio exclusively authorizes SPIMACO to develop, register and commercialize the HPV-9 vaccine REC603 in 15 Middle East and North African countries, including Saudi Arabia. This strategic cooperation covers a total population of approximately 380 million in the Middle East and North African countries. Cervical cancer is the eighth most common cancer in Saudi Arabia and the eighth most common chronic cancer among women aged 15-44. The nine-valent HPV vaccine is widely regarded as the most effective vaccine against HPV and can prevent about 90% of cervical cancer and 90% of anal and genital warts. SPIMACO is one of the largest listed pharmaceutical companies in Saudi ...
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- January 25, 2024
Deep Cooperation Agreement Between Beijing Hemophilia Association and Shanghai RAAS in Rare Disease Care

In January 2024, the Beijing Hemophilia Association Rare Disease Care Center and Shanghai RAAS Blood Products Co., Ltd., after negotiations, reached a deep cooperation agreement in the field of hemophilia charity and public welfare. They will work together to promote the development of charitable and public welfare activities related to hemophilia in China. Shanghai RAAS Blood Products Co., Ltd. was established in 1988 and went public on the Shenzhen Stock Exchange in June 2008. It is a leading domestic blood products enterprise that integrates the collection of raw plasma, research and development, production, and sales of blood products. Their main products include human albumin, intravenous human immunoglobulin (PH4), human coagulation factor VIII, human fibrinogen, human prothrombin complex, human thrombin, and human fibrin sealant. Shanghai RAAS is one of the few domestic blood product manufacturers capable of extracting six components from plasma and has the most comprehensive range of coagulation factor ...
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- January 25, 2024
Harbour BioMed Announces Positive Profit Alert

Cambridge, MA, Rotterdam, NL, Suzhou, CN – Jan 19, 2023 Harbour BioMed (the “Company”; HKEX: 02142), a global biopharmaceutical company committed to the discovery, development, and commercialization of novel antibody therapeutics focusing on oncology and immunology, announces a positive profit alert for the year ended December 31, 2023. As disclosed before, there was a turnaround from a loss of US$73.1 million for the six months ended June 30, 2022 to a profit of US$2.9 million for the six months ended June 30, 2023. Based on the preliminary review of the unaudited consolidated management accounts, it is expected that there will be a profit of approximately US$18 million for the year ended December 31, 2023, as compared to a loss of approximately US$137 million for the year ended December 31, 2022. This is the first time that the Company has recorded a net profit on its annual financial statements. The anticipated ...
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- January 25, 2024
MHRA introduces new restrictions for fluoroquinolone antibiotics

From today, fluoroquinolone antibiotics given systemically (by mouth, injection, or inhalation) must only be administered when no other antibiotics are appropriate for use, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced. This means that fluoroquinolones should only be prescribed when other recommended antibiotics have failed, will not work due to resistance, or are unsafe to use in an individual patient. This is a strengthening of the previous regulations which stated that fluoroquinolones should not be prescribed for mild to moderate or self-limiting infections, or non-bacterial conditions.The MHRA conducted a thorough review into the effectiveness of current measures to reduce the risk of potentially long-term adverse reactions to fluoroquinolone antibiotics and sought advice from the Commission on Human Medicines (CHM). The review process considered available evidence, including Yellow Card reports submitted by patients and healthcare professionals, and the experiences of people affected by these side effects. The restrictions have ...
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- January 25, 2024
//www.fiercepharma.com/pharma/johnson-johnson-settles-talc-consumer-protection-claims-42-states-700m

For more than 2 years, Johnson & Johnson has been plotting its future as a two-sector company. In the wake of the company’s consumer healthcare spinoff last summer, the company’s fourth-quarter results offer plenty of signs of life from the new-look J&J.After wrapping up 2023 with a total haul of $85.2 billion, the company is heading into 2024 with “multiple catalysts for growth,” CEO Joaquin Duato said on J&J’s fourth-quarter and full-year earnings conference call. Across J&J’s innovative medicines portfolio, the company’s oncology and immunology medicines generated the lion’s share of sales in 2023’s fourth quarter, helping the unit achieve operational growth in the U.S. of 9.5% during the period. Worldwide, J&J’s pharma business reeled in $13.72 billion during the fourth quarter, a 4% increase from the same period in 2022.On the immunology front, J&J’s antibody blockbuster Stelara grew its market share and demonstrated continued strength in inflammatory bowel disease (IBD), J&J said in ...
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- January 25, 2024
Johnson & Johnson inks $700M deal to resolve talc consumer protection claims from 42 states

After failing to resolve a mountain of talcum-powder lawsuits through two unsuccessful bankruptcy attempts, Johnson & Johnson has agreed to a $700 million settlement that would free the company from some consumer protection claims—and a small part of the talc litigation that it faces. J&J plans to pay $700 million to 42 states and the District of Columbia to settle claims that the company did not warn of the potential health risks posed by its talcum-based products, including its iconic Johnson’s Baby Powder.Bloomberg first revealed the agreement two weeks ago, with the company confirming the news to the Wall Street Journal on Tuesday. “Consistent with the plan we outlined last year, the company continues to pursue several paths to achieve a comprehensive and final resolution of the talc litigation,” J&J litigation chief Erik Haas said in an emailed statement confirming the report. “We will continue to address the claims of those who do not ...
- Source: drugdu
- 193
- January 25, 2024
【EXPERT Q&A】Which in vitro diagnostic medical devices are required to be assessed by EURLs for export to the EU, and what are the specific reference laboratories involved?

Drugdu.com expert’s response: For the export of in vitro diagnostic (IVD) medical devices to the European Union, certain types of products may require assessment or testing by designated European Union Reference Laboratories (EURLs). These reference laboratories mainly focus on high-risk in vitro diagnostic medical devices, particularly those closely related to public health. The types of IVD products typically evaluated by EURLs include: Infectious Disease Diagnostic Devices: For detecting major infectious diseases such as HIV, Hepatitis B, and Hepatitis C. Blood Screening Devices: Used for blood safety testing, such as devices for detecting pathogens in blood. High-Risk Cancer Biomarker Diagnostic Devices: For detecting high-risk biomarkers of certain types of cancer. Genetic Disease Diagnostic Devices: For detecting specific genetic diseases or susceptibilities. The EU designated reference laboratories include: ECDC (European Centre for Disease Prevention and Control): Responsible for the detection and control of infectious diseases. EURL for Blood Borne Infections: Specifically responsible ...
- Source: drugdu
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- January 25, 2024

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