Search Results for “EC” – Page 231 – media

Hengrui’s Innovative Drug Henagliflozin Approved for New Indications, Providing New Treatment Options for Type 2 Diabetes Patients

Recently, Henagliflozin Pharmaceuticals received the Certificate of Drug Registration approved by the State Drug Administration, approving the new indication of Henagliflozin (Ruichin®), a Class 1 new drug, sodium-glucose cotransporter protein 2 inhibitor (SGLT2i) proline, which was independently researched and developed by the company: the product, 5mg or 10mg, combined with Regliflozin Phosphate and Metformin is used in patients with type 2 diabetes mellitus whose blood glucose is not yet reached after receiving Metformin monotherapy. adults with type 2 diabetes. This is the second indication for which Henagliflozin has been approved for marketing. Henagliflozin has thus become the only SGLT2i approved for combination therapy with dipeptidyl peptidase-IV inhibitors and metformin in China, which will provide a new therapeutic option for rational drug use in adult patients with type 2 diabetes mellitus. The approval of this indication for marketing is based on a multicenter, randomized, controlled, double-blind phase III clinical study [1]. ...
- Source: drugdu
- 113
- July 3, 2024
FDA Approves New Drug Application for Shorla Oncology’s Tepylute, a Ready-to-Dilute Formulation for the Treatment of Breast and Ovarian Cancer

By Don Tracy, Associate Editor Reportedly, the liquid formulation of Tepylute eliminates the need for complex and time-consuming reconstitution, providing consistent dosing accuracy and allowing for timely preparation. The FDA has approved Shorla Oncology’s Tepylute, a ready-to-dilute formulation designed to treat breast and ovarian cancer. According to the company, the formulation is an easier to prepare injectable product that enables dosing accuracy, addressing the shortcomings and handling complexities associated with the current lyophilized powder formulation. Additionally, Shorla stated that the new formulation eliminates the need for complex and time-consuming reconstitution, enabling consistent dosing accuracy.1 ‘’This approval fulfills an unmet need by addressing the shortcomings and handling complexities of the current lyophilized powder formulation,” said Sharon Cunningham, CEO, co-founder, Shorla Oncology, in a press release. “We have taken a vital oncology drug and made it easier for oncology clinics and hospitals to use, while also reducing medical personnel exposure to a ...
- Source: drugdu
- 81
- July 3, 2024
CIPM

Organiser：China Association for Pharmaceutical Equipment Time：November 17-19, 2024 Address：No. 198, Huizhan Road, Siming District, Xiamen City Exhibition hall： Xiamen International Convention and Exhibition Center Product range: Raw Material Pharmaceutical Equipment & Machinery: Reaction equipment, tower equipment, crystallization equipment, separation machinery & equipment, extraction equipment, heat exchangers, evaporation equipment, distillation equipment, drying machinery & equipment, storage equipment, sterilization equipment, etc. Pharmaceutical Preparation Machinery: Granule machinery, tablet machinery, capsule machinery, powder injection machinery, small-volume injection machinery & equipment, large-volume injection machinery & equipment, pill machinery, suppository machinery, ointment machinery, oral liquid preparation machinery, aerosol machinery, ophthalmic preparation machinery, pharmaceutical film machinery, etc. Pharmaceutical Packaging Machinery & Materials: Direct packaging machinery for pharmaceuticals, outer packaging machinery for pharmaceutical packaging materials, pharmaceutical packaging material manufacturing machinery, pharmaceutical packaging materials, packaging production lines, packaging software products, integrated packaging solutions, etc. Pharmaceutical Water (Gas) Equipment: Pharmaceutical process gas (steam) equipment, purified water equipment, water for injection equipment, ...
- Source: drugdu
- 147
- July 3, 2024
Magnolia Medical Announces New Platform to Reduce Misdiagnosis of Sepsis

By Mike Hollan The platform utilizes standards set forth in a recently published document from the CDC. After years of collaborating with hospitals, Magnolia Medical has launched a new digital platform designed to prevent sepsis misdiagnosis.1 The platform, Magnolia Analytics, was designed with the CDC’s recently published Blood Culture Contamination guidelines in mind. The main addition to the guidelines is a new step utilizing initial specimen diversion devices, which Magnolia specializes in. CDC notes that reducing sepsis misdiagnosis is important as it can play a key role in reducing the amount of needlessly prescribed antibiotics, which can then further play a role in reducing instances of antibiotic resistance. In a press release, Magnolia Medical co-founder and CEO Greg Bullington said, “In response to our customer’s clear unmet needs, we developed Magnolia Analytics as a custom, exclusive solution to support our hospitals in achieving and sustaining their blood culture contamination rates ...
- Source: drugdu
- 74
- July 3, 2024
【EXPERT Q&A】How long does it take to register three types of medical devices in Russia?

Drugdu.com expert’s response: The registration process for Class III medical devices in Russia typically requires a period of 24 months or more. Based on official requirements and information from reference articles, here is a detailed explanation and summary of the registration timeline: Medical Device Classification: According to the Russian medical device classification standards, Class III medical devices fall into the high-risk category, requiring a more stringent registration and review process. Registration Process: The registration process includes appointing a Russian authorized representative, product classification identification, submitting technical documentation for medical devices, conducting system audits (if applicable), and undergoing RZN evaluation. Registration Timeline: Initial Review: Once the application materials are complete, the registration agency will submit the application to the Russian Federal Service for Surveillance in Healthcare (Roszdravnadzor). The initial review may take several weeks to several months to confirm the completeness and compliance of the application documents. Detailed Review and Evaluation: ...
- Source: drugdu
- 99
- July 3, 2024
Parkinson’s UK awards ICL £100,000 to develop small drugs for Parkinson’s disease

Parkinson’s UK has awarded nearly £100,000 to researchers at Imperial College London (ICL) to develop a new drug for Parkinson’s disease (PD) through the charity’s drug accelerator award grant scheme. Researchers will use a computer-based programme to simulate good targets for new drugs to slow the progression of the neurological disease and improve the success of clinical trials. Affecting around 153,000 people in the UK, PD is a neurodegenerative condition in which parts of the brain become progressively damaged, causing problems such as shaking and stiffness. In the process of drug development, the more information that researchers have when planning a clinical trial, including simulating how a drug might work, the more likely it is to be successful when being trialled in people and compared to other available treatments. Using simulation, researchers aim to test the best way to target GPNMB, a protein that has been linked to PD. Previous ...
- Source: drugdu
- 75
- July 2, 2024
UK study reveals persistent challenges in heart health and cardiovascular diseases

A study conducted by European researchers from the University of Glasgow, the University of Oxford, KU Leuven and the University of Leicester has revealed the shifting trends and persistent challenges in heart health and cardiovascular disease (CVD) in the UK. Published in the BMJ, researchers analysed the electronic health records of 22 million people from the Clinical Practice Research Datalink, CPRD GOLD and Aurum. CVD affects around seven million people in the UK and is a significant cause of disability and death. Affecting around 2.3 million people in the UK, coronary heart disease is the most common form of heart and circulatory disease and occurs when coronary arteries become narrowed by a build-up of fatty material within their walls. In the last 20 years, the study found a 19% reduction in the overall incidence of heart-related disease, including significant reductions in heart attacks and stroke, between 2000 and 2019, with ...
- Source: drugdu
- 91
- July 2, 2024
US Justice Dept cracks down on healthcare fraud schemes linked to $2.75bn loss

The US Justice Department has charged 193 people in a major enforcement action, accusing them of participating in healthcare fraud schemes worth $2.75bn. The two-week crackdown involved 76 doctors, nurses, and other medical professionals. The defendants are accused of several scams, such as illegally distributing millions of Adderall (amphetamine) pills and other stimulants. This also included fraudulent activity that involved corporate executives distributing tainted and misbranded HIV medication, which amounted to $90m in losses. Ruthia He, founder and CEO of San Francisco-based digital technology company Done Global, was arrested on 13 June. He has been charged with participating in a scheme to distribute Adderall (amphetamine / dextroamphetamine) over the internet and conspired to commit healthcare fraud in connection with the submission of fraudulent claims for reimbursement for the drug and other stimulants. Adderall is a drug used to treat attention deficit hyperactivity disorder (ADHD). Also included in this crackdown were ...
- Source: drugdu
- 70
- July 2, 2024
Dexcom to lay off 535 employees in California

Dive Brief Dexcom will lay off 535 employees in California, adding to the medical device industry’s long list of job cuts this year. The expected first date of separation is July 26, and the layoffs are connected to one site in San Diego, according to a Worker Adjustment and Retraining Notification filing with California. “Dexcom has decided to centralize its [U.S.] manufacturing operations in Mesa, Arizona, and refocus our San Diego operations as a Global Center of Excellence for Product Innovation,” company spokesperson James McIntosh wrote in an emailed statement. He added that Dexcom is offering support for employees, such as allowing them to apply for similar roles at another U.S. site with relocation assistance. Dive Insight The layoffs continue the consistent stream of job cuts in the medtech industry over the past 18 months. This year alone has seen numerous layoffs from top medical technology companies, including Medtronic, Zimmer ...
- Source: drugdu
- 59
- July 2, 2024
Eating baby carrots three times a week raises skin carotenoid levels in young adults

A new study found that eating a snack of baby carrots just three times a week significantly increased skin carotenoids in young adults. Levels of these phytonutrients were boosted even more when this healthy snack was combined with a multivitamin containing the carotenoid beta carotene. Carotenoids, which are responsible for the bright red, orange and yellow colors of many fruits and vegetables, can be measured in the skin to gauge fruit and vegetable consumption since diet is the only source of these pigments. Higher levels of skin carotenoids are associated with increased antioxidant protection and a lower risk of chronic diseases such as heart disease and certain cancers. This marker also reflects improved skin health and immune function. Mary Harper Simmons, Master of Science in Nutrition student at Samford University, said, “Previous studies have demonstrated that skin carotenoid levels can be increased by consuming three times the recommended serving of ...
- Source: drugdu
- 76
- July 2, 2024

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