PharmaFocus Today – Page 310 – media

Lundbeck Pharmaceuticals’ “Anti-Parkinson’s Category 1 Chemical Drug” Submits Clinical Application in China

March 4), according to the CDE official website, Lundbeck’s clinical trial application for Class 1 chemical drug Lu AF28996 capsules has been accepted. Currently, the drug is undergoing Phase I clinical trials overseas. Parkinson’s disease is a neurological dysfunction disease with complex symptoms and difficult early diagnosis. It is common in middle-aged and elderly people. At present, the main treatment for Parkinson’s disease is drug therapy, with the purpose of reducing symptoms, delaying the progression, and improving the patient’s quality of life. Lu AF28996 is a dopamine D1/D2 receptor agonist developed by Lundbeck Pharmaceuticals. It is a relatively new anti-Parkinson therapy and is currently undergoing Phase I clinical trials overseas. Among them, a study to evaluate the safety, tolerability, etc. of Lu AF28996 in Parkinson’s patients is expected to be completed in 2025. This time, the approval of Lu AF28996’s clinical trial application in China is expected to bring a ...
- Source: drugdu
- 494
- March 7, 2024
FDA Clears First Over-the-Counter Continuous Glucose Monitor

Today, the U.S. Food and Drug Administration cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM). The Dexcom Stelo Glucose Biosensor System is an integrated CGM (iCGM) intended for anyone 18 years and older who does not use insulin, such as individuals with diabetes treating their condition with oral medications, or those without diabetes who want to better understand how diet and exercise may impact blood sugar levels. Importantly, this system is not for individuals with problematic hypoglycemia (low blood sugar) as the system is not designed to alert the user to this potentially dangerous condition. “CGMs can be a powerful tool to help monitor blood glucose. Today’s clearance expands access to these devices by allowing individuals to purchase a CGM without the involvement of a health care provider,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Giving more individuals valuable ...
- Source: drugdu
- 230
- March 7, 2024
Sinopharm and the University of Macau Signed Strategic Cooperation Framework Agreement

On February 26, Liu Jingzhen, Secretary of the Party Committee and Chairman of Sinopharm, and his delegation visited the University of Macau, where the two sides signed a strategic cooperation framework agreement and held talks on further deepening cooperation. President of the University of Macau Mr. Song Yonghua, Vice President Mr. Xu Jian, Vice President of Sinopharm Mr. Hu Jianwei, Vice President of Sinopharm Mr. Dong Zenghe, Vice President of Sinopharm and Vice President of Sinopharm Mr. Jin Bin attended the event. Before the meeting, the two sides held a signing ceremony for the strategic cooperation framework agreement, in which Sinopharm’s Vice General Manager Dong Zenghe and University of Macau’s Vice President Xu Jian signed the agreement on behalf of the two sides. Mr. Liu Jingzhen, Chairman of the Board of Directors of Sinopharm, introduced Sinopharm’s innovative development strategy and the key work it has done to help the development ...
- Source: drugdu
- 293
- March 7, 2024
Shuangcheng Pharmaceuticals Octreotide Acetate Injection Obtained Certificate of Drug Registration

Hainan Shuangcheng Pharmaceuticals was approved by the State Drug Administration to issue Drug Registration Certificate to Octreotide Acetate Injection. Basic drug information 1, drug name: octreotide acetate injection 2、Dosage form: Injection 3、Specifications: 1ml:0.1mg (C₄₉H₆₆₁₀O₁₀S₂) 4、Registration Classification: Class 4 chemical drugs 5、Drug Approval Number: State Drug License H20243223 6、Prescription drug/over-the-counter drug: prescription drug 7、Listed Licensee: Hainan Shuangcheng Pharmaceutical Co. 8、Manufacturer: Hainan Shuangcheng Pharmaceutical Co. 9, Production Address: Haikou City, Xiuying District, No. 16 Xingguo Road Approved indications Octreotide acetate injection is indicated for the control of symptoms and reduction of plasma levels of growth hormone (GH) and insulin-like growth factor-1 (IGF-1) in patients with acromegaly who are unable or unwilling to undergo surgery or radiation therapy. Treatment of patients with acromegaly who are unable or unwilling to undergo surgery, or treatment of patients with intermittent acromegaly for whom radiation therapy has not yet taken effect; alleviation of symptoms ...
- Source: drugdu
- 284
- March 7, 2024
Researchers develop brain-age prediction tool for diagnosis of neurological diseases

The non-invasive tool can also improve patient stratification and monitor disease progression Researchers from King’s College London (KCL) have developed a deep learning framework for a non-invasive brain-age prediction tool for the early diagnosis of neurological diseases. The study built and made available a set of models for clinical use after training multiple brain models from a variety of magnetic resonance image (MRI) types. Neurological disorders, such as Alzheimer’s disease, strokes, multiple sclerosis and Parkinson’s disease, are conditions that affect the brain as well as the nerves found throughout the human body and spinal cord. By comparing patients’ brain ages against their chronological ages, numerous neurological and psychiatric conditions can be identified, helping to predict future health outcomes for patients. Researchers collected over 81,000 patients’ head MRI examinations from Guy’s and St Thomas’ NHS Foundation Trust and King’s College Hospital NHS Foundation Trust between 2008 and 2019. After pre-training models, ...
- Source: drugdu
- 405
- March 7, 2024
Womb condition checks could reduce cancer risk in endometrial hyperplasia

Women with atypical endometrial hyperplasia have an increased risk of developing cancer Researchers from the University of Edinburgh have revealed that improved patient care is needed to reduce cancer risk among women with endometrial hyperplasia in a new study. The study compared the treatment that patients living with the condition received before and after the introduction of national guidance. Grouped into two types, atypical endometrial hyperplasia is a precancerous condition that carries an increased risk, and non-atypical endometrial hyperplasia occurs when the womb lining is thicker than normal but less likely to become cancerous. Currently, in the UK, the national guidance for this condition recommends a hysterectomy, a surgical procedure that removes the womb, for patients with atypical endometrial hyperplasia. For those with non-atypical endometrial hyperplasia, guidance recommends a trial of a hormone treatment given directly into the womb, with regular follow-up monitoring to track progress. The study analysed patient ...
- Source: drugdu
- 268
- March 7, 2024
Highly Reliable Cell-Based Assay Enables Accurate Diagnosis of Endocrine Diseases

The conventional methods for measuring free cortisol, the body’s stress hormone, from blood or saliva are quite demanding and require sample processing. The most common method, therefore, involves collecting urine over several days. However, this method requires great perseverance from patients, as collecting every drop of urine over several days can be nearly impossible, even if the patients are hospitalized. This often leads to up to 60% variation in urine-free cortisol measurements in individual patients. Now, researchers have developed a new method for measuring cortisol levels directly from a blood sample, marking a significant advancement in the diagnosis and treatment of various diseases. Researchers from Aarhus University (Aarhus, Denmark) have discovered a groundbreaking method for measuring levels of free cortisol directly from a blood sample. This new method is simple and quick, requiring only a few drops of blood. This contrasts sharply with current practices, which are both cumbersome and ...
- Source: drugdu
- 311
- March 6, 2024
Groundbreaking Blood Test Offers Early Pancreatic Cancer Diagnosis

Pancreatic cancer ranks as the third leading cause of cancer-related deaths, primarily due to its late detection. Early discovery of the disease, while it’s still treatable, could significantly impact survival rates. For more than a century, scientists have sought to link cancer with cellular energy production and metabolism. The advent of quantitative mass spectrometry has enabled the testing of many such theories. Now, for the first time, researchers have utilized targeted mass spectrometry to demonstrate that pancreatic cancer stems from changes in cellular metabolism that are detectable using a simple blood test. This method could lead to more precise and earlier diagnoses of pancreatic cancer than currently possible with tumor markers or imaging techniques, potentially paving the way for more timely and appropriate therapeutic interventions. In contrast to genomic approaches that measure DNA for early detection and often struggle with false positives and negatives, mass spectrometry can measure extremely low ...
- Source: drugdu
- 456
- March 6, 2024
FDA Clears Quoin Pharmaceuticals to Employ Teens for Netherton Syndrome Clinical Trials

Don Tracy, Associate Editor Teens to be included in both placebo and open label studies for QRX003, a potential treatment for Netherton syndrome. Today, Quoin Pharmaceuticals announced that the FDA has given approval to include teenagers aged 14 years and older in two ongoing clinical trials for QRX003, a potential treatment for Netherton syndrome (NS). According to a press release, this marks the first time that teen patients with NS will have the opportunity to participate in clinical trials under an Investigational New Drug Application (IND). Additionally, the studies will accommodate teens currently on off-label systemic therapy, with the focus of generating comprehensive data for QRX003’s development.1 “We are very pleased to announce this exciting development, not just for Quoin’s clinical program, but for the Netherton community as a whole,” said Michael Myers, BSc, PhD, CEO, Quoin, in a press release. “We are frequently petitioned by parents and caregivers that ...
- Source: drugdu
- 229
- March 6, 2024
Longer Treatment Leads to More Liver Benefit

Akero Therapeutics’ preliminary Phase 2b data show that treatment with its MASH drug, efruxifermin, continued to distance itself from a placebo measured at nearly two years of treatment. The latest Akero data build on six-month results reported in 2022. By FRANK VINLUAN Longer treatment with an Akero Therapeutics drug in development for the liver disease MASH led to better results, including improvement in fibrosis, the liver scarring that is a hallmark of the chronic disorder. Metabolic dysfunction-associated steatohepatitis, or MASH, causes deteriorating liver function that can reach the point of requiring an organ transplant. The fibrosis that develops with MASH is classified in four stages. Stage 4, the most severe, is liver cirrhosis. On Monday, South San Francisco-based Akero reported preliminary results at 96 weeks showing that 75% of patients treated with the highest dose of its drug, efruxifermin, showed improvement of at least one stage of fibrosis without worsening ...
- Source: drugdu
- 294
- March 6, 2024

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