Search Results for “cancer” – Page 97 – media

Gilead’s Tecartus gets revised safety demand amid FDA’s push for CAR-T boxed warnings

The FDA’s letter demanding a labeling change for Gilead Sciences’ Tecartus temporarily went missing on the agency’s website Tuesday. Turns out, the FDA didn’t drop the CD19 CAR-T from a classwide safety alert list. Instead, the agency has adjusted the wording of a proposed boxed warning. In a revised letter (PDF) dated Jan. 23, the FDA is still pressing Gilead’s cell therapy unit Kite Pharma to include new language about the risk of T-cell malignancies in the black-box warning section of Tecartus’ label. But unlike its proposed boxed warning for other commercial CAR-T therapies, the FDA’s updated letter for Tecartus no longer names Tecartus patients specifically as having experienced T-cell malignancies. The FDA apparently took some time before uploading the new letter after taking down the original one, dated Jan. 19. The missing letter for Tecartus caused a brief period of confusion because the FDA says in all letters to ...
- Source: drugdu
- 87
- January 26, 2024
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
- 87
- 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
- 85
- 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 ...
- Source: drugdu
- 77
- 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
- 178
- 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
- 125
- January 25, 2024
New Liquid Biopsy Approach Improves Blood Tests’ Ability to Detect Circulating Tumor DNA

Tumors continuously release DNA from dying cells into the bloodstream, which is rapidly broken down. This makes it difficult for existing blood tests to detect the minute amounts of tumor DNA present at any given time. Now, a team of researchers has developed an innovative method to amplify the detection of tumor DNA in blood, a breakthrough that could enhance cancer diagnosis and treatment monitoring. Researchers at Massachusetts Institute of Technology (MIT, Cambridge, MA, USA) have created “priming agents,” injectable molecules that temporarily slow the clearance of circulating tumor DNA from the bloodstream. These priming agents target the body’s two main mechanisms for removing circulating DNA: DNases, enzymes that break down DNA in the blood, and macrophages, immune cells that absorb cell-free DNA during blood filtration through the liver. The researchers developed two types of priming agents. The first is a monoclonal antibody that attaches to circulating DNA, shielding ...
- Source: https://www.labmedica.com/molecular-diagnostics/articles/294799968/new-liquid-biopsy-approach-improves-blood-tests-ability-to-detect-circulating-tumor-dna.html
- 132
- January 24, 2024
Data from 11 studies of CHIATAI TIANQING’s class 1 innovator anilotinib, pembrolizumab, and bemosulbemab unveiled

The American Society of Clinical Oncology Gastrointestinal Oncology Symposium (ASCO GI) 2024 has been successfully concluded. CHIATAI TIANQING Pharmaceutical Group’s Class 1 innovative drugs Anrotinib (small molecule multi-targeted receptor tyrosine kinase inhibitor), Paianprilizumab (PD-1 inhibitor) and Behmosubaisumab (TQB2450, PD-L1 inhibitor) have been selected to be presented at the poster session this time with a total of 11 studies, which are related to the field of GI tumors with liver metastasis, esophageal cancer, hepatocellular carcinoma, tumors of the biliary tract system, and colorectal cancer. ALTER-G-001 is a multi-cohort, multi-center phase II study, and updated results from Cohort A were presented at this ASCO GI meeting. Patients in Cohort A were treated with 6 cycles (3 weeks each) of anilotinib (12 mg, po, qd, d1-14, q3w) + oxaliplatin (130 mg/m2, iv, d1, q3w) + capecitabine (850 mg/m2, po, bid, d1-14, q3w), and if liver metastases were not converted to resectable on ...
- Source: drugdu
- 159
- January 24, 2024
RecA protein skips “unwinding” step in DNA repair

Researchers from Tokyo Metropolitan University have been studying DNA repair by homologous recombination, where the RecA protein repairs breaks in double-stranded DNA by incorporating a dangling single-strand end into intact double strands, and repairing the break based on the undamaged sequence. They discovered that RecA finds where to put the single strand into the double helix without unwinding it by even a single turn. Their findings promise new directions in cancer research. Homologous recombination (HR) is a ubiquitous biochemical process shared across all living things, including animals, plants, fungi, and bacteria. As we go about our daily lives, our DNA is subjected to all kinds of environmental and internal stress, some of which can lead to breakage of both strands in the double helix. This can be disastrous, and lead to imminent cell death. Luckily, processes like HR are continuously repairing this damage. During HR, one of the two exposed ...
- Source: drugdu
- 179
- January 23, 2024
FDA Approves Balversa for Locally Advanced, Metastatic Urothelial Carcinoma

Today’s FDA approval amends a previously granted accelerated approval for Balversa (erdafitinib) to treat patients with metastatic urothelial carcinoma whose tumors harbor FGFR3 or FGFR2 alterations following prior platinum-based chemotherapy. The FDA has approved Balversa (erdafitinib) for adults with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic mutations whose disease progressed on or following one line of systemic therapy.1 The regulatory action amends the accelerated approval granted by the FDA in April 2019 for patients with metastatic urothelial carcinoma with susceptible FGFR2 or FGFR3 alterations following prior treatment with platinum-containing chemotherapy. Balversa, a fibroblast growth factor (FGFR) inhibitor, is not recommended for patients who are eligible for, and were not previously administered, prior treatment with a PD-1 or PD-L1 inhibitor, according to the FDA.The FDA based the approval on data from Study BLC3001 cohort 1, which evaluated data from 266 patients with metastatic urothelial carcinoma harboring selected FGFR3 alterations and who previously received ...
- Source: drugdu
- 261
- January 23, 2024

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