Search Results for “EC” – Page 260 – media

【EXPERT Q&A】How to apply for a Class III Medical Device Operation License?

Drugdu.com expert’s response: Here are the general steps for obtaining a Class III Medical Device Operation License: 1.Qualification Review: First, ensure that your enterprise meets the conditions specified in the “Measures for the Administration of Medical Device Operation Enterprise Licenses,” such as registered capital, premises, personnel, etc. 2.Prepare Application Materials: Prepare the required application materials, including the enterprise legal person business license, medical device operation enterprise filing certificate, medical device quality management system certification certificate, etc. 3.Submit Application: Submit the prepared application materials to the local provincial-level or above drug supervision and administration department or its authorized drug supervision and administration institution. 4.Acceptance Review: The relevant department will review the submitted application to verify the completeness and accuracy of the materials. 5.On-Site Inspection: In some cases, applicants may need to undergo on-site inspections to confirm that their operating premises meet the relevant requirements. 6.Approval Decision: The relevant department will make ...
- Source: drugdu
- 101
- April 22, 2024
GSK’s Five-in-One Meningococcal Vaccine Under Review by the FDA

Don Tracy, Associate Editor With a final decision expected next February, MenABCWY combines the protective elements of GSK’s existing vaccines to target the five primary serogroups of Neisseria meningitidis. GSK announced that the FDA has accepted for review an application for its five-in-one meningococcal vaccine MenABCWY. MenABCWY is a combination of GSK’s two existing vaccines, Bexsero and Menveo, and targets the five primary serogroups (A, B, C, W, and Y) of Neisseria meningitidis. These serogroups are credited with causing the majority of meningococcal disease (IMD) cases around the world. According to the company, a final decision is expected on February 14, 2025.1 “In the Phase III trial (NCT04502693), all primary endpoints were achieved for the MenABCWY vaccine candidate, including immunological non-inferiority to one dose of GSK’s Meningococcal Groups A,C,Y and W Vaccine, and non-inferior immune responses against 110 diverse MenB invasive strains (representing 95% of MenB strains circulating in the ...
- Source: drugdu
- 138
- April 20, 2024
GlobalData

Biopharmaceutical companies are regaining interest in metabolic dysfunction-associated steatohepatitis (MASH) innovator drug development. MASH innovator drugs witnessed over $2.5 billion increase in the total value of partnership deals from 2020 to 2024 year-to-date (YTD), with more than $2 billion forged in Q1 2024 alone, reveals GlobalData. MASH, previously known as nonalcoholic steatohepatitis (NASH), is a disease characteriSed by liver inflammation and damage caused by the accumulation of fat. Madrigal Pharmaceuticals’ Rezdiffra (resmetirom), a small molecule THRB agonist, was the first drug approved by the FDA for MASH in March 2024. Alison Labya, Business Fundamentals Analyst at GlobalData, comments, “Interest in MASH has returned in light of the FDA approval of Madrigal’s Rezdiffra, as well as the success of GLP-1 obesity drugs and their potential efficacy in MASH, as demonstrated by Eli Lilly’s Zepbound (tirzepatide; also known as Mounjaro for type 2 diabetes) in its Phase II SYNERGY-NASH trial readout.” However, ...
- Source: drugdu
- 123
- April 20, 2024
Chemomab touts study confirming CCL24 link to systemic sclerosis severity

Clinical-stage biotech Chemomab Therapeutics has announced the publication of a study highlighting that high serum CCL24 levels are linked to more severe forms of systemic sclerosis (SSc). SSc is a chronic autoimmune disease characterised by excessive collagen production, leading to thickening and hardening of the skin and various internal organs. Affecting the skin, blood vessels, muscles, and internal organs, the condition causes symptoms like joint pain, skin tightening, and organ dysfunction. The study, published in the Arthritis Care and Research journal and conducted at the University of Leeds in the UK, looked at 200 patients with SSc. It found that a quarter of them had high levels of CCL24 in their blood, even though they were receiving standard treatment. Higher CCL24 levels were linked to more severe forms of the condition, including worse skin problems and lung issues. Scientists identified that high CCL24 levels were predictive of lung problems worsening ...
- Source: drugdu
- 70
- April 20, 2024
Hengrui Pharmaceuticals Class 1 New Drug HRS8807 for ER-positive, HER2-negative Breast Cancer Combination Treatment Approved for Clinical Trial

Recently, Hengrui Pharmaceuticals and its subsidiary Shanghai Hengrui Pharmaceuticals Co., Ltd. received a Notice of Approval of Drug Clinical Trial from the State Drug Administration, approving the company to conduct an open, multi-center Phase I clinical study on the safety, tolerability and pharmacokinetics of HRS8807 combined with dalsylate hydroxyethanesulfonate in ER-positive, HER2-negative metastatic or locally advanced breast cancer patients. Breast cancer is the most common malignant tumor worldwide. According to the Global Cancer Epidemiology Report 2024, breast cancer ranks first among female malignant tumors in terms of incidence and mortality, with approximately 2.31 million new cases of breast cancer and 670,000 deaths per year globally, ranking first in terms of incidence and mortality of female malignant tumors. Among all breast cancer patients, about 70% are ER-positive, and the guideline-recommended standard treatment is endocrine drugs combined with CDK4/6 inhibitors. In contrast, the new generation of oral selective estrogen receptor down-regulators (SERDs) ...
- Source: drugdu
- 76
- April 20, 2024
Mouth Bacteria Test Could Predict Colon Cancer Progression

Colon cancer, a relatively common but challenging disease to diagnose, requires confirmation through a colonoscopy or surgery. Recently, there has been a worrying increase in colon cancer rates among younger populations, heightening the need to understand more about the disease’s mechanisms and preventive measures. Fusobacterium nucleatum, a bacterium typically linked with dental plaque and gingivitis, is found more frequently in colon cancer tissues than in normal colon tissues, suggesting its involvement in cancer progression and its association with adverse outcomes after treatment. Now, researchers have identified a specific subtype of this bacterium that can migrate to the gut and proliferate within colorectal cancer tumors. The finding could help improve early screening methods for colorectal cancer by paving the way for a test to screen for the presence of this bacterium with a mouth swab or stool sample. In the study, a team of researchers at Fred Hutch Cancer Center (Seattle, ...
- Source: drugdu
- 87
- April 19, 2024
Eli Lilly Shows Obesity Drug Zepbound Can Treat Sleep Apnea Too

Eli Lilly drug tirzepatide, marketed as Zepbound for weight management, has results from two Phase 3 studies showing reductions in the breathing problems caused by obstructive sleep apnea. Lilly is now preparing regulatory submissions to add this indication to the drug’s label. By Frank Vinluan Sleep apnea could be the next new indication for an Eli Lilly drug that’s already a blockbuster seller in metabolic indications. The pharmaceutical giant has preliminary Phase 3 data showing that treatment with the drug reduced the breathing interruptions characteristic of the common sleep disorder. With the positive data in hand, Lilly said it is now planning for regulatory submissions seeking to expand the label of tirzepatide, which is marketed as Mounjaro for type 2 diabetes and as Zepbound for weight management. Those submissions are expected in the middle of this year. Obstructive sleep apnea (OSA) is the collapse or partial collapse of the upper ...
- Source: drugdu
- 111
- April 19, 2024
FDA Approves Stelara Biosimilar Selarsdi to Treat Psoriasis, Psoriatic Arthritis

Davy James Alvotech’s and Teva’s Selarsdi (ustekinumab-aekn), the second FDA-approved biosimilar to Stelara, is indicated to treat patients aged 6 years and above with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and for patients aged 6 years and above with active psoriatic arthritis. Image credit: Maria | stock.adobe.com Alvotech’s and Teva Pharmaceuticals’ Selarsdi (ustekinumab-aekn) has been approved by the FDA as a biosimilar to Stelara (ustekinumab), which represents the second approval for a Stelara biosimilar.1 Selarsdi is indicated to treat patients aged 6 years and above with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; and for patients aged 6 years and above with active psoriatic arthritis. “The approval of Selarsdi—which is our second biosimilar approval this year—underscores Teva’s commitment to expanding the availability, access and uptake of this important treatment option to patients in the US,” Thomas Rainey, ...
- Source: drugdu
- 72
- April 19, 2024
ELRIG UK and SRG collaborate to advance life sciences professionals in drug discovery

Both companies will facilitate career progression while advancing the life sciences industry The European Laboratory Research and Innovation Group (ELRIG) UK has announced its partnership with SRG to support life sciences professionals in advancing their careers in drug discovery. Both will help facilitate career progression as well as support the growth of the life sciences industry. As part of the collaboration, ELRIG UK’s community will gain access to career opportunities, while SRG’s specialist talent solutions will be provided to organisations of all sizes to help grow the life sciences sector. More specifically, early career professionals (ECPs) in industry and academia will be able to attend forums and networking events to meet new people and learn the skills needed to help them progress their careers in drug discovery. The volunteer-led community for drug discovery unites academic and biopharma industry experts and thought leaders to share ideas and information through free-to-attend scientific ...
- Source: drugdu
- 74
- April 19, 2024
IND Application for the Clinical Trial of Novel Anti-TIGIT Fc Fusion Protein HLX53 in Combination with HANSIZHUANG Plus HANBEITAI for the First-Line Treatment of Locally Advanced or Metastatic Hepatocellular Carcinoma Patients Approved by NMPA

Shanghai, China, April, 17th, 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the investigational new drug application (IND) for the clinical trial of HLX53, an anti-TIGIT Fc fusion protein, in combination with HANSIZHUANG (serplulimab, HLX10) and HANBEITAI (bevacizumab, HLX04) for the first line treatment of locally advanced or metastatic hepatocellular carcinoma, has been approved by the National Medical Products Administration (NMPA). A phase 2 clinical trial will be initiated to evaluate the safety, tolerance and efficacy of the multiple immunotherapy-based treatment combinations in patients with advanced or metastatic hepatocellular carcinoma. Liver cancer is one of the most prevalent malignancy in the world. According to GLOBALCAN 2022, there are about 870,000 new cases diagnosed and 760,000 deaths for the tumour in the globe. Meanwhile, primary liver cancer (PLC) is the fourth most common cause and the second mortality cancer in China, with about 370,000 new cases and 320,000 deaths in ...
- Source: drugdu
- 80
- April 19, 2024

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