Search Results for “EC” – Page 270 – media

March 29, 2024

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA made several updates to the Mammography Quality Standards Act and Program section on the FDA Website to enhance user experience and provide the most up-to-date information, including reordering and renaming the landing pages so the information is easier to find and updating and deleting old data to provide the public with current information. On Thursday, the FDA launched the Searchable Tobacco Products Database, a new user-friendly list of tobacco products—including e-cigarettes—that may be legally marketed in the United States. The database is designed to serve the public—especially retailers—by providing this key information in a single location, with easy-to-use search capabilities. The database, which can be accessed here. The database will be updated on a monthly basis. On Wednesday, the FDA authorized marketing of the Medline Autologous Regeneration of ...
- Source: drugdu
- 97
- April 2, 2024
Altamira Therapeutics partners with Univercells Group on nanoparticle-delivered mRNA vaccines

Under the terms of the agreement, Univercells will test in vitro and in vivo a proprietary mRNA vaccine delivered with Altamira’s SemaPhore nanoparticle platform Altamira Therapeutics, a company providing nanoparticle-based technology for efficient RNA delivery to extrahepatic targets has announced that it has entered into a collaboration agreement with Univercells Group to evaluate the use of the Company’s proprietary SemaPhore platform for the delivery of mRNA vaccines. Univercells is a global life sciences company creating platforms for developing and manufacturing biologics, including mRNA vaccines and therapeutics, in a simple, scalable and cost-efficient way. Under the terms of the agreement, Univercells will test in vitro and in vivo a proprietary mRNA vaccine delivered with Altamira’s SemaPhore nanoparticle platform. Should the experiments prove successful, Univercells and Altamira intend to discuss and negotiate a commercial agreement for the development and manufacturing of nanoparticle-based mRNA vaccines using Univercells’ production platform. Covadonga Pañeda, PhD, Altamira’s ...
- Source: drugdu
- 75
- April 2, 2024
Novo Nordisk to acquire Cardior Pharmaceuticals to strengthen pipeline in cardiovascular disease

The agreement includes Cardior’s lead compound CDR132L, currently in phase 2 clinical development for the treatment of heart failure Novo Nordisk and Cardior Pharmaceuticals has announced that Novo Nordisk has agreed to acquire Cardior for up to 1.025 billion Euros, including an upfront payment and additional payments if certain development and commercial milestones are achieved. The agreement includes Cardior’s lead compound CDR132L, currently in phase 2 clinical development for the treatment of heart failure. Martin Holst Lange, executive vice president for Development at Novo Nordisk said, “By welcoming Cardior as a part of Novo Nordisk, we will strengthen our pipeline of projects in cardiovascular disease where we already have ongoing programmes across all phases of clinical development. We have been impressed by the scientific work carried out by the Cardior team, especially on CDR132L, which has a distinctive mode of action and potential to become a first-in-class therapy designed to ...
- Source: drugdu
- 90
- April 2, 2024
Cambodia Phar-Med Expo 2024

Organiser: Minh Vi Exhibition & Advertisement Services Co., Ltd. Time:28 – 30 August 2024 address：Diamond Island Phnom Penh Cambodia Exhibition hall: Diamond Island Convention & Exhibition Center Product range: Medical equipment and equipment: medical aid equipment, rehabilitation physiotherapy equipment, medical vehicle, bed, table, medical aid equipment, surgical equipment, preventive medical equipment, examination equipment, monitoring equipment, treatment equipment, inspection and analysis equipment, special surgical equipment, first aid equipment, surgical equipment, diagnostic equipment and supplies, analysis and control, Monitoring equipment, corrective equipment, ophthalmic instruments and equipment, ENT equipment, dental supplies and equipment, radiological medicine equipment, medical reagents and equipment, prosthetics and rehabilitation equipment, medical and health products and equipment, disinfection and sterilization equipment, traction, diagnostic equipment, treatment equipment, inspection and analysis equipment, etc Medical institutions and laboratory technical equipment: laboratory furniture, laboratory automation and accessories, optical instruments and equipment, dressings, wound care materials, catheters, medical experimental analysis and diagnostic instruments, biopharmaceutical instruments, cell biology ...
- Source: drugdu
- 160
- April 2, 2024
FDA hits Renovo with warning letter over reprocessed medical devices

Dive Brief Renovo received a warning letter in October for supplying reprocessed medical devices without seeking 510(k) clearance from the Food and Drug Administration. The letter, which the FDA published Tuesday, accuses Renovo of providing reprocessed models other than the ones covered by its 510(k) clearances. Renovo failed to evaluate how cleaning and re-sterilization of the additional models could affect performance and reliability. FDA inspectors also identified problems with Renovo’s approach to air particulate sampling that prompted warnings about the failure to establish control procedures. Dive Insight Renovo cleans medical devices that have been used in procedures such as the ablation of soft tissue for reuse. Renovo has multiple 510(k) clearances that permit the company to supply reprocessed versions of devices such as Depuy Mitek Ablation Wands and Ethicon Bladeless Trocars. The problem, according to the FDA, is that Renovo has reprocessed models that are outside of the scope of ...
- Source: drugdu
- 122
- April 1, 2024
University of Liverpool to lead £125m research facility supported by UKRI investment

Set to open in 2032, the RUEDI facility is funded by the UKRI’s recent infrastructure fund worth £388m The University of Liverpool has announced that it will be leading a national research facility worth £125m to drive scientific discovery and advance technologies as part of the UK Research and Innovation’s (UKRI) infrastructure fund worth £388m. The Relativistic Ultrafast Electron Diffraction and Imaging (RUEDI) facility will benefit areas of research including quantum technologies and personalised medicine. The UKRI recently announced five new infrastructure projects with new funding to equip the UK’s research and innovation bases, with an additional £85m for the UKRI’s Digital Research Infrastructure Programme. In collaboration with the University of Liverpool’s Science and Technology Facilities Council and the Rosalind Franklin Institute, the new facility will allow researchers to explore changes in living cells as they happen to develop more personalised treatments for patients in a more renewable and sustainable ...
- Source: drugdu
- 78
- April 1, 2024
Innovent Dosed First Participant in Phase 3 Clinical Study (Neoshot) of IBI310 (Anti-CTLA-4 Monoclonal Antibody) in Combination with Sintilimab for MSI-H/dMMR Colon Cancer Neoadjuvant Therapy

ROCKVILLE, Md. and SUZHOU, China, March 27, 2024 /PRNewswire/ — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, announces that the first participant has been successfully dosed with IBI310 (anti-CTLA-4 monoclonal antibody) in combination with sintilimab (PD-1 inhibitor) in a randomized, controlled, multicenter Phase 3 clinical trial (Neoshot), for resectable MSI-H/dMMR[1] colon cancer (stage cT4 or cN+) neoadjuvant therapy. Neoshot is the first Phase 3 clinical trial (NCT05890742) in China to investigate MSI-H/dMMR colon cancer neoadjuvant immunotherapy. The study will evaluate the safety and efficacy of IBI310 combined with sintilimab for neoadjuvant therapy, compared with adjuvant chemotherapy after radical surgery for MSI-H/dMMR colon cancer. The primary endpoints are pathologic complete response (pCR) rate and event-free survival (EFS). Previously, in a randomized, controlled, multicenter Phase 1b study for neoadjuvant ...
- Source: drugdu
- 124
- 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
- 144
- 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

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