Search Results for “Clinical Trial” – Page 65 – media

FDA Hands Expanded Indication to Gilead’s Vemlidy for Chronic HBV Infection in Pediatric Patients

Don Tracy, Associate Editor Phase II clinical study showed that children as young as six years of age with hepatitis B virus could benefit from treatment with Vemlidy. The FDA has approved an expanded indication for Gilead’s Vemlidy (tenofovir alafenamide), to treat chronic hepatitis B virus (HBV) infection in pediatric patients aged six years and older who weigh at least 25 kg and have compensated liver disease. In 2016, the medication was initially approved for adults with chronic HBV and compensated liver disease, with an extended use approved in 2022 for children aged 12 years and above. Approval for the expanded indication was based on positive results stemming from Gilead’s Phase II clinical trial (Trial 1092) after 96 weeks, showing safety and efficacy in younger children. According to the study data, participants experienced progressive increases in the rates of virological suppression compared to those administered a placebo.1 “Chronic hepatitis B ...
- Source: drugdu
- 84
- April 2, 2024
Innovative Blood Collection Device Overcomes Common Obstacles Related to Phlebotomy

The discomfort associated with traditional blood draws leads to a significant issue: approximately 30% of diagnostic tests prescribed by physicians are never completed by patients. This avoidance is often due to the fear of pain from needle sticks and a reluctance to visit medical facilities where there’s a perceived risk of encountering illness. Now, a virtually pain-free, low-cost, easy-to-use, whole blood and plasma collection and dispensing system solves the problem of the physical pain of a traditional blood draw, making it easier, cheaper, and faster to potentially receive a diagnosis. RedDrop Dx’s (Fort Collins, CO, USA) innovative blood collection device, RedDrop One, aims to enhance blood collection technology and patient care practices. With its user-centric design, RedDrop One eliminates many of the drawbacks associated with traditional blood collection methods, allowing for the collection of larger blood volumes more efficiently and with significantly less discomfort for the patient. This device is ...
- Source: drugdu
- 86
- April 2, 2024
Strand Therapeutics develops new class of mRNA molecules for cancer

The self-replicating mRNA molecule could be used in cancer and potentially a broad range of other diseases Strand Therapeutics, a Massachusetts Institute of Technology (MIT) spinout, has developed a new class of advanced mRNA molecules for more targeted and powerful treatments for cancer. The new class of mRNA molecules is designed to sense what type of cells they encounter in the body and express therapeutic proteins once they have entered diseased cells. Most next-generation cancer immunotherapies are based on recombinant proteins, which are challenging to deliver to specific targets in the body and do not remain active for long enough to create a durable response. Strand has developed the world’s first mRNA programming language to improve mRNA molecules’ ability to sense their environment and generate targeted responses where needed most, allowing the company to specify the tissues its mRNAs express proteins in. In addition, the company uses techniques such as ...
- Source: drugdu
- 77
- April 1, 2024
BioDuro-Sundia’s Partner, DigmBio Announced IND Clearance from Korea MFDS for its Selective PARP1 Inhibitor DM5167

SHANGHAI, March 26, 2024 /PRNewswire/ — BioDuro-Sundia’s partner, DigmBio, a South Korean biotechnology company, announced its selective PARP1 inhibitor for the treatment of triple-negative breast cancer has been approved by Korea Food and Drug Administration (MFDS) for Investigational New Drug (IND) application. Founded in April 2020, DigmBio is a pioneering biotech company discovering and developing novel therapies to treat oncology, neurodegeneration, and fibrosis. The lead program DM5167 is the 2nd generation PARP1 selective inhibitor. According to preclinical study results, DM5167, a novel selective PARP1 inhibitor, exhibits superior in vivo safety, particularly in terms of hematotoxicity and demonstrates enhanced selectivity in enzyme assays, and possesses a more efficient DNA trapping capability. Notably, DM5167 showcases excellent brain permeability, rendering it suitable for treating brain metastasis and brain cancer. DigmBio CEO Kim Jung-min stated, “We are pleased to receive official approval from the Food and Drug Safety Department without the need for any ...
- Source: drugdu
- 77
- April 1, 2024
Agile, responsive regulation helps early breast cancer patients to benefit from a study to potentially improve survival outcomes

Breast cancer is the most common cancer and is one of the leading causes of cancer-related deaths worldwide. Data published between 2016 to 2018 suggests that close to 56,000 new cases of breast cancer are diagnosed in the UK, mostly affecting females, and with 86% presenting with early disease. Most breast cancers have proteins (receptors). These include oestrogen receptor-positive (ER+), where breast cancers have receptors for the hormone oestrogen, and HER2-negative, where the protein is absent – human epidermal growth factor 2. Hormones, particularly oestrogen, can attach to these receptors and encourage the cells to grow. A pathologist can identify the receptors during biopsy or surgery, helping to determine treatment. Recent research has led to the development of new candidate drugs known as SERDS (selective oestrogen receptor degraders). These drugs are designed to attach to and disrupt these oestrogen receptors, preventing the growth of cancer. A new SERD molecular entity, ...
- Source: drugdu
- 108
- April 1, 2024
FDA Approves Akebia’s Vafseo for Anemia in Adults with Chronic Kidney Disease on Dialysis

Don Tracy, Associate Editor Approval of Vafsen (vadadustat) based on promising results from the INNO2VATE program and additional safety data from use in Japan in adults with chronic kidney disease.Akebia Therapeutics announced that the FDA has approved Vafsen (vadadustat) for the treatment of anemia in adults with chronic kidney disease (CKD) who are on dialysis. According to a company press release, the once-daily, oral tablet works as a hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, activating the physiologic response to hypoxia to stimulate endogenous production of erythropoietin to manage anemia. In other words, it copies the body’s response to low oxygen levels. The FDA based the approval was on positive outcomes from the INNO2VATE program and additional safety data from its use in Japan, where it was launched in August 2020. Now approved in 37 countries, Akebia stated that Vafsen has the potential to improve overall outcomes for patients struggling with ...
- Source: drugdu
- 142
- March 30, 2024
Boundless Bio’s ‘BOLD’ IPO Reels In $100M for a New Kind of Cancer Drug

Cancer drug developer Boundless Bio is a pioneer in therapies that target extrachromosomal DNA. The IPO cash will support its pipeline, including a lead program on track to report preliminary data later this year. By FRANK VINLUAN Targeted therapies and immunotherapies offer new treatment options for more types of cancer, but these drugs are less helpful when tumors produce multiple copies of a gene. This gene amplification contributes to drug resistance. Boundless Bio’s research into the what drives this phenomenon has yielded new understanding of cancer biology. The company now has $100 million in IPO cash to support two programs in early clinical development and more in its pipeline. Boundless Bio late Wednesday priced its offering of 6.25 million shares at $16 each, which was the midpoint of the preliminary $15 to $17 price range the San Diego-based company set last week. Those shares will trade on the Nasdaq under ...
- Source: drugdu
- 152
- March 30, 2024
Jacobio Pharma Announces 2023 Annual Results

Beijing, Shanghai & Boston, Mar. 28, 2024 — Jacobio Pharma (1167.HK), a clinical-stage oncology company drugging the undruggable targets, today announced its 2023 annual results. The revenue was RMB63.5 million, the R&D investment was RMB372 million, the cash and cash equivalent at the end of 2023 was RMB 1.2 billion. Jacobio Pharma also announced its recent business progress and expected milestones. Dr. Wang Yinxiang, Chairman and CEO of Jacobio Pharma, said: “In the past year, Jacobio continued to make progress in our projects. We received approval for registrational phase III clinical trial of the combination therapy between our SHP2 inhibitor JAB-3312 and KRAS G12C inhibitor glecirasib. Our JAB-3312 became the first SHP2 inhibitor to enter into registrational trial. This milestone is consistent with our mission of ‘drugging the undruggable’. Meanwhile, the patient enrollment for pivotal trial of our core product glecirasib has been completed, and the NDA application expected to ...
- Source: drugdu
- 88
- March 30, 2024
【EXPERT Q&A】What is the content of the MDR technical document that EU CE needs to submit for medical device registration?

Drugdu.com expert’s response: The MDR technical documentation required for medical device registration in the European Union typically includes the following components: 1.General Information: Basic product information, manufacturer details, product classification, and product description. 2.Design and Manufacturing Information: Details about the product’s design process, manufacturing process, material selection, assembly process, etc. 3.Performance and Functionality: Expected use of the product, performance indicators, technical specifications, functional descriptions, etc. 4.Risk Analysis: Analysis and assessment of potential risks associated with the product, including descriptions of control measures and risk management plans. 5.Clinical Evaluation: Clinical trial data and assessment results for the product, including trial design, results, safety, and efficacy data. 6.Summary of Technical Documentation: Comprehensive summary and explanation of the above content to ensure the integrity and consistency of the documentation. Additionally, depending on the specific characteristics and classification of the product, other relevant information and documents may be required to ensure compliance with the ...
- Source: drugdu
- 105
- March 30, 2024
Novo Nordisk Acquires Cardior Pharmaceuticals for $1.112B in Effort to Bolster Cardiovascular Disease Pipeline

Don Tracy, Associate Editor Deal includes the novel treatment CDR132L, which is currently in Phase II clinical trials for heart failure. Novo Nordisk announced that it has acquired Cardior Pharmaceuticals in hopes of improving its pipeline in cardiovascular disease management. The acquisition includes Cardior’s top drug candidate, CDR132L, which is currently in Phase II of clinical development for treating heart failure. Under terms of the agreement, Cardor has the potential to earn up to $1.112 billion, including an upfront payment and the opportunity for more payments pending the completion of certain development and commercial milestones.1 “By welcoming Cardior as a part of Novo Nordisk, we will strengthen our pipeline of projects in cardiovascular disease where we already have ongoing programs across all phases of clinical development,” said Martin Holst Lange, EVP, development, Novo Nordisk, in a press release. “We have been impressed by the scientific work carried out by the ...
- Source: drugdu
- 112
- March 29, 2024

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