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Novo Nordisk’s Awiqli receives CHMP recommendation to treat diabetes in adults

Novo Nordisk has announced that the European Medicine Agency’s advisory committee has recommended Awiqli (once-weekly basal insulin icodec) to treat diabetes in adults. The recommendation from the Committee for Medicinal Products for Human Use (CHMP) was based on positive results from the phase 3a ONWARDS clinical trial programme. Estimated to affect 415 million people worldwide, diabetes is a chronic disease that occurs when the pancreas does not produce enough insulin, a hormone that regulates glucose, or when the body cannot effectively use the insulin it produces. Awiqli works to cover the basal insulin requirements for a week with a single subcutaneous injection. Comprising six phase 3a global clinical trials involving more than 4,000 adults with type 1 or type 2 diabetes, the ONWARDS clinical development programme investigated the efficacy and safety of Awiqli. Results from the programme showed that Awiqli achieved a superior blood sugar reduction and superior time in ...
- Source: drugdu
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- March 27, 2024
【EXPERT Q&A】What is the QSR820 Quality System? What is the relationship with ISO13485?

Drugdu.com expert’s response: The US QSR820 quality system refers to the Quality System Regulation issued by the United States Food and Drug Administration (FDA) for medical devices. This regulation, also known as the Medical Device Quality System Standard, sets forth the quality management system requirements that medical device manufacturers must follow to ensure the safety and effectiveness of medical devices. QSR820 covers various aspects including design controls, production controls, equipment calibration, quality audits, record-keeping, etc. ISO13485 is the medical device quality management system standard published by the International Organization for Standardization (ISO). It bears some similarities to QSR820 as both are quality management system standards for the medical device industry aimed at ensuring product quality and safety. However, ISO13485 is an international standard applicable to medical device manufacturers globally, whereas QSR820 is a regulatory standard mandated by the FDA specifically for medical devices marketed in the United States.
- Source: drugdu
- 160
- March 27, 2024
CPhI South East Asia 2024

Organiser: Informa Markets Time:10 – 12 July 2024 address：60 New Ratchadapisek Road Klongtoey Bangkok 10110 Thailand Exhibition hall: Queen Sirikit National Convention Center 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 South East Asia ： Thailand Pharmaceutical Raw Materials Exhibition (CPhI South East Asia) is the most authoritative pharmaceutical raw materials exhibition in ...
- Source: drugdu
- 169
- March 26, 2024
Coin-Sized Device Rapidly Isolates Blood Plasma for Quicker and More Precise Clinical Diagnoses

Identifying biomarkers for various cancers and diseases often relies on cell-free DNA, RNA, and extracellular vesicles. Traditionally, separating blood plasma to detect these markers requires centrifugation, spinning blood to isolate cells from plasma. Yet, even after multiple centrifugation cycles, some cells and platelets remain in the blood plasma, potentially releasing unwanted biological materials that can affect diagnostic accuracy. Researchers have now developed a compact, coin-sized chip capable of extracting blood plasma directly from a sample within 30 minutes, resulting in a more convenient and user-friendly option than the currently laborious centrifugation method. The chip named ExoArc, developed by scientists at Nanyang Technological University (NTU, Singapore), offers a one-step solution to achieve over 99.9% purity by efficiently removing blood cells and platelets. This advance promises quicker and more reliable clinical analysis of critical biomarkers. To demonstrate its utility, the team developed a portable prototype device (measuring 30cm x 20cm x 30cm) ...
- Source: drugdu
- 147
- March 26, 2024
Testing Method Could Help More Patients Receive Right Cancer Treatment

Cancer treatment isn’t always a one-size-fits-all solution, but the field of cancer research is making strides in matching patients with the most effective treatments for their specific conditions. A groundbreaking study now points to a significant finding related to testing that could enable thousands of cancer patients to receive the precise treatment they need. The research led by the University of Oklahoma (Oklahoma City, OK, USA) compared the effectiveness of immunohistochemistry (IHC) and next-generation sequencing (NGS) tests in newly diagnosed cancer patients to guide their treatment plans. These tests target the detection of high levels of microsatellite instability, a condition indicating the DNA’s diminished capacity to correct replication errors. Identifying microsatellite instability is crucial, particularly in colon and endometrial cancer patients, as it marks a higher likelihood of a positive response to immunotherapy, which enhances the immune system’s ability to fight cancer, compared to other treatments. IHC detects the absence ...
- Source: drugdu
- 92
- March 26, 2024
Clinical Trial of Keytruda and Lynparza Combination Fails to Meet Primary Endpoint for Treatment of Metastatic Nonsquamous Non-Small Cell Lung Cancer

Don Tracy, Associate Editor Despite not having a positive outcome, safety profiles for Keytruda and Lynparza were consistent with previous findings. Merck revealed that its Phase III KEYLYNK-006 clinical trial, which tested a combination of Keytruda and Lynparza for the treatment of a subset of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), failed to meet the primary endpoint of improving overall survival (OS) and progression-free survival (PFS). According to the company, its trial compared Keytruda combined with chemotherapy with an additional round of Keytruda plus Lynparza vs. Keytruda with chemotherapy followed by maintenance chemotherapy. However, the safety profiles for both treatments were reported to be consistent with previous findings. Moving forward, Merck said that it plans on continuing to analyze data to share at a later date.1 “As lung cancer continues to be the leading cause of cancer death worldwide, we are committed to exploring Keytruda-based combinations and ...
- Source: drugdu
- 138
- March 26, 2024
FDA Nod in Duchenne Helps Wider Swath of Patients With the Rare Muscle Disease

Corticosteroids are a standard first-line treatment for Duchenne muscular dystrophy, but these drugs have many side effects. FDA approval of Italfarmaco’s Duvyzat is the first nonsteroidal drug to pass the agency’s regulatory bar for treating this rare disease. By FRANK VINLUANDuchenne muscular dystrophy has several approved drugs, including a gene therapy that provides children who have the rare, inherited muscle-wasting disease the option of a one-time treatment. But each of these therapies only treats certain defined patient groups. While corticosteroids can reach more Duchenne patients, they introduce many side effects. The FDA just approved the first nonsteroidal Duchenne drug. The late Thursday approval of Italfarmaco drug givinostat covers patients age 6 and older and spans all genetic variants that drive the inherited disease. The twice-daily oral suspension will be marketed under the brand name Duvyzat. In an email, Italfarmaco said Duvyzat’s price has not yet been set. The Milan, Italy-based ...
- Source: drugdu
- 169
- March 26, 2024
Evive Biotech’s Ryzneuta (Efbemalenograstim alfa Injection) approved in the EU

Recently, the innovative biologic drug Efbemalenograstim alfa Injection (Chinese trade name “Ryzneuta”), independently developed by Evive Biotech and for which Chia Tai Tianqing has exclusive commercialization rights in China, received the “COMMISSION IMPLEMENTING DECISION” issued by the European Commission, approved for sale in the EU. The decision is based on a positive review by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). So far, Efbemalenograstim alfa Injection has become the first domestic innovative biological drug that has been approved for marketing in China, the United States and the European Union. It has also become the first innovative drug approved by the European Union by a Chinese pharmaceutical company in 2024. Previously, Chia Tai Tianqing had signed a commercial cooperation agreement with Evive Biotech and obtained all intellectual property rights and exclusive commercialization rights of Yilisu® in China. Efbemalenograstim alfa Injection is currently the only G-CSF ...
- Source: drugdu
- 165
- March 26, 2024
New antibiotic to fight infections caused by multidrug-resistant bacteria

EMA has recommended granting a marketing authorisation in the European Union (EU) for Emblaveo (aztreonam-avibactam), indicated for the treatment of complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia and infections caused by certain types of bacteria (aerobic Gram-negative) where treatment options are limited. Infections due to Gram-negative bacteria that are resistant to many currently available antibiotics are a serious public health problem since patients have limited or sometimes no treatment options. Infections due to multidrug-resistant bacteria are estimated to cause 35,000 deaths in the EU every year. Emblaveo is a fixed-dose combination of two active substances, aztreonam and avibactam. Aztreonam is already authorised for use in the EU on its own and avibactam is authorised for use in combination with another antibiotic (ceftazidime). Aztreonam is an antibiotic that belongs to the group ‘beta-lactams’. It works by attaching to proteins on the surface of the bacteria. This prevents the bacteria from ...
- Source: drugdu
- 112
- March 26, 2024
The Results of Phase II Clinical Study of KN046 Plus Chemotherapy as First-line Treatment for Metastatic NSCLC were Published in Cell Reports Medicine

SUZHOU, China, March 22, 2024 /PRNewswire/ — Alphamab Oncology (stock code: 9966.HK) announced that the phase II clinical research results of anti- PD-L1/CTLA-4 bispecific antibody KN046 plus chemotherapy as first-line treatment for metastatic non-small cell lung cancer (NSCLC) were published online in the renowned journal Cell Reports Medicine (IF: 14.3). Professor Li Zhang from Sun Yat-Sen University Cancer Center is the corresponding author of this paper, and Professor Yuanyuan Zhao is the first author. Lung cancer is one of the most common cancers in the world, and it is the malignant tumor with the highest morbidity and mortality in China. According to the latest national cancer statistics released by the National Cancer Center, there are 1.06 million new cases of lung cancer, with a total death toll of 0.73 million in year 2022, far exceeding other tumor types. NSCLC accounts for about 80% – 90% of all lung cancers, and ...
- Source: drugdu
- 125
- March 26, 2024

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