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FDA Approves Johnson & Johnson’s Edurant PED for Pediatric Patients With HIV

Davy James Expanded indication for Edurant in combination with other antiretroviral therapies includes treatment-naïve children with HIV-1 RNA <100,000 copies/mL aged at least 2 years and weighing between 14 kg and 25 kg. The FDA has approved an expanded indication for Johnson & Johnson’s Edurant PED (rilpivirine) in combination with other antiretroviral therapies (ART) to treat HIV-1 in treatment-naïve children (with HIV-1 RNA <100,000 copies/mL) aged at least 2 years and weighing between 14 kg and 25 kg.1 Edurant is an HIV-1 specific, nonnucleoside reverse transcriptase inhibitor previously approved in combination with ART in treatment-naïve patients 12 years of age and older who weigh at least 35 kg with HIV-1 RNA less than or equal to 100,000 copies/mL. “Decades of experience with the global HIV epidemic have made it clear that new and improved treatment options are needed to support the diverse population of people living with HIV on their ...
- Source: drugdu
- 147
- March 23, 2024
CPhI India 2024

Organiser: Informa Markets Time:26 – 28 November 2024 address：Plot No.23 -25 & 27- 29 Knowledge Park – I Gautam Budh Nagar Greater NOIDA一201306 Exhibition hall: INDIA EXPO CENTRE&MART Product range: Apis: vitamins, hormones, sulfonamides, antipyretic analgesics, tetracycline, amino acids and their derivatives, chloramphenicol, digestive system drugs, other anti-infective drugs, penicillins, aminoglycosides, lincomycin, cardiovascular system drugs, anti-parasitic diseases drugs, cephalosporins, macrolides, respiratory system drugs, central nervous system drugs, other Western drugs Ingredients Packaging equipment: pharmaceutical machinery, packaging machinery, packaging materials, pharmaceutical production equipment and technology, pharmaceutical packaging equipment, pharmaceutical packaging materials, pharmaceutical production, cleaning, disinfection configuration and laboratory instrument system Pharmaceutical products: various proprietary Chinese medicines, Western medicines, new drugs, various raw materials, chemical pharmaceuticals, pharmaceutical intermediates, biopharmaceuticals, traditional medicines, Chinese medicine, herbs, animal and plant extracts, veterinary drugs, food ingredients and additives, etc About CPhI India ： CPhI India is the most influential pharmaceutical raw material machinery exhibition in ...
- Source: drugdu
- 157
- March 22, 2024
【EXPERT Q&A】What is FDA Food grade certification?

Drugdu.com expert’s response: FDA food-grade certification typically refers to the certification or approval by the U.S. Food and Drug Administration (FDA) for food-related products. This certification generally includes two types: 1.Food Additive Approval: FDA’s certification of food additives involves the FDA approving a substance for use in food processing to improve the quality, freshness, taste, or other characteristics of food. These food additives may include preservatives, sweeteners, colorants, thickeners, etc. Once FDA approval is obtained, these additives can be legally used in food processing. 2.Food Contact Material Certification: FDA’s certification of food contact materials refers to the FDA approving a material for use in the manufacture or processing of food or potable water. These materials may include food packaging, containers, manufacturing equipment, etc., used to protect food from contamination or pollution. FDA-certified food contact materials typically comply with FDA regulations, ensuring that they do not pose a hazard to food ...
- Source: drugdu
- 120
- March 22, 2024
POC Finger-Prick Blood Test Determines Risk of Neutropenic Sepsis in Patients Undergoing Chemotherapy

Neutropenia, a decrease in neutrophils (a type of white blood cell crucial for fighting infections), is a frequent side effect of certain cancer treatments. This condition elevates the risk of infections, including neutropenic sepsis—a potentially fatal reaction to infection and a severe complication of chemotherapy. Identifying the signs of neutropenic sepsis can be challenging, leading to a stressful and expensive treatment process. Consequently, all chemotherapy patients feeling ill are advised to seek emergency care to check for neutropenic sepsis. Unfortunately, half of these patients do not receive antibiotics quickly enough, while the other half, not at risk of neutropenic sepsis, unnecessarily visit the emergency department. 52North Health Ltd. (Cambridge UK) has developed NeutroCheck, a groundbreaking approach aimed at enhancing the safety and well-being of cancer patients. This innovation combines a finger-prick blood test with an AI-powered digital platform, allowing patients to evaluate their neutropenic sepsis risk at home. This affordable, ...
- Source: drugdu
- 94
- March 22, 2024
Cells Harvested From Urine to Enable Earlier Kidney Disease Detection

Detecting kidney disease late can lead to severe and even life-threatening issues. Now, new research has found that the genes expressed in human cells harvested from urine closely match those in the kidney, suggesting that these cells could offer a non-invasive approach to better understanding kidney health. This discovery could allow the diagnosis of kidney problems without doing biopsies, making it possible to detect kidney disease earlier and more easily. A team of scientists led by the University of Manchester (Manchester, UK) used a method called transcriptomics to measure the levels of about 20,000 genes in each cellular sediment sample of urine. Transcriptomics helps scientists see which genes are active or inactive, providing insights into how cells adapt to changes in their environment. This molecular-level understanding can lead to more accurate diagnoses and better patient outcomes. The team also had access to the world’s largest collection of human kidney samples ...
- Source: drugdu
- 103
- March 22, 2024
FDA Approves Idorsia’s Tryvio for Once-Daily Treatment of Difficult-to-Control Hypertension

Davy James Tryvio (aprocitentan) approved in combination with other antihypertensive drugs to lower hypertension in adults whose blood pressure is not adequately controlled by other therapies. The FDA has approved Idorsia Ltd’s Tryvio (aprocitentan) to reduce hypertension in combination with other antihypertensive drugs in adults whose blood pressure is not adequately controlled by other therapies. Tryvio is an endothelin receptor antagonist that interferes with the binding of endothelin (ET)-1 to ETA and ETB receptors.1 “Today, there are millions of Americans whose blood pressure is not well-controlled despite existing therapies. This is a major public health issue leading to a high incidence of cardio- and cerebrovascular events,” Jean-Paul Clozel, MD, CEO of Idorsia said in a press release. “In order to help address this issue, Idorsia developed aprocitentan, an endothelin receptor antagonist suited to the treatment of these patients. Idorsia conducted an ambitious clinical program in patients remaining hypertensive despite a ...
- Source: drugdu
- 100
- March 22, 2024
Startup Lands $150M for Delicate Dance Between Cancer Cells & Immune Cells

Clasp Therapeutics’ novel T cell engagers could offer advantages over others in this class of cancer immunotherapies. The startup is based on the research of Johns Hopkins University scientist Bert Vogelstein. By FRANK VINLUANCancer immunotherapy comes in several forms, and one area of growing research interest is a type of drug called a T cell engager. These drugs bind to a cancer cell and a T cell simultaneously, bringing both of them together to spark a therapeutic effect. Robert Ross, CEO of Clasp Therapeutics, likens T cell engagers to the chaperone at a middle school dance who grabs a boy and a girl in each hand, getting them to dance together. But in cancer drugs, just as in school dances, sometimes the pairing just isn’t right. The wrong pairing in cancer happens when a drug that’s targeted to a tumor also hits healthy cells, causing toxic effects. Clasp is developing ...
- Source: drugdu
- 88
- March 22, 2024
Henlius’ Trastuzumab Approved in Brazil, a Semi-Exclusive License Area, in Latin America

Recently, HANQUYOU (trastuzumab, trade name in Europe: Zercepac®), independently developed and manufactured by Henlius, has been approved to be marketed in Brazil for the treatment of HER2-positive breast cancer and gastric cancer. To date, the product has been approved for marketing in more than 40 countries and regions worldwide. Following the commercialization of HANQUYOU in Argentina, the approval of HANQUYOU in Brazil, the largest economy and the most populous country in Latin America, has become another anchor point for Henlius’ continuous global commercial expansion. Latin America and the Caribbean comprises 33 countries and regions with a total population of close to 660 million as of 2022 and a per capita GDP of close to $10,000 per capita [1]. In Latin America, breast and gastric cancers are the most and fifth most prevalent malignancies, respectively. The total number of new cases of breast and gastric cancer in the region in 2022 ...
- Source: drugdu
- 96
- March 22, 2024
WuXi Biologics Breaks Ground on CRDMO Center in Singapore

Singapore, March 19, 2024, WuXi Biologics (“WuXi Bio”) (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), today announced that it has broken ground on its new 13.5-hectare CRDMO center in Tuas Biomedical Park, Singapore. The center will provide integrated biologics research, development and manufacturing services. WuXi Biologics announced a USD$1.4 billion (S$2 billion) investment in Singapore in 2022. The CRDMO center will be the first-of-its-kind in Singapore, offering end-to-end biologics research, development and manufacturing solutions upon completion. It will add 120,000L of manufacturing capacity to WuXi Biologics’ global network, and is expected to employ 1,500 staff. The site will be equipped with WuXi Biologics’ proprietary technical platforms, along with industry-leading technologies such as single-use technology to provide clients with time-and cost-efficient services. In line with WuXi Biologics’ Environmental, Social and Governance strategy, the site will implement sustainable concepts in the design and construction of the center, deploy ...
- Source: drugdu
- 173
- March 22, 2024
Researchers suggest treatments for rare diseases could reduce burden of kidney disease

Rare kidney diseases are a group of conditions which account for over 5% of people living with chronic kidney disease A new study led by University College London (UCL) and the UK Kidney Association has suggested that treatments for rare diseases could significantly reduce the burden of kidney disease for patients and the NHS. Published in The Lancet in alignment with World Kidney Day (14 March 2024), the study draws on the largest kidney disease dataset ever created, the UK’s National Registry of Rare Kidney Disease (RaDaR). Affecting over seven million adults, according to Kidney Research UK, chronic kidney disease (CKD) is characterised by the gradual loss of kidney function over a period of months to years. Rare kidney diseases such as cystinosis and Fabry disease are a group of conditions that affect less than one in 2,000 people, accounting for over 5% of people with CKD. Researchers charted the ...
- Source: drugdu
- 75
- March 22, 2024

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