media – Page 171 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

【EXPERT Q&A】Simaglutide API is exported to Thailand, which registration qualifications need to be met and the registration process for drug registration in Thailand (preparation manufacturers are local enterprises in Thailand)

Drugdu.com expert’s response: 1.Registration Qualification Requirements ①Pharmaceutical Business License: To export Semaglutide API to Thailand, it is first necessary to ensure that your enterprise possesses a Pharmaceutical Business License, which is the basic qualification for drug export. ②GMP Certification: GMP certification refers to the certification of a pharmaceutical production quality management system. For the export of Semaglutide API to Thailand, your enterprise must also obtain GMP certification to ensure the quality and safety of the product. ③Pharmaceutical Quality Management System Certification: In addition to the above two qualifications, pharmaceutical quality management system certification is also necessary. This will help guarantee the quality of product sales and service in the Thai market. ④Pharmaceutical Liability Insurance: To safeguard the rights and interests of consumers, your enterprise should also consider purchasing pharmaceutical liability insurance. 2.Thai Drug Registration Process (Assuming the Formulation Manufacturer is a Local Enterprise in Thailand) ①Submission of Registration Application: ...
- Source: drugdu
- 209
- June 26, 2024
Portable Device Analyzes White Blood Cell Activity to Monitor Cancer Patients’ Health

Chemotherapy and similar treatments aimed at eliminating cancer cells often adversely affect patients’ immune cells. Each year, this results in tens of thousands of cancer patients suffering from weakened immune systems, making them susceptible to potentially fatal infections. Physicians are tasked with balancing the dosage of chemotherapy—enough to kill cancer cells but not so much as to dangerously reduce the patient’s white blood cell count, leading to neutropenia. This condition not only impacts health but can also lead to social isolation between chemotherapy sessions. Traditionally, monitoring of white blood cells has been limited to blood tests. Now, a new at-home white blood cell monitor offers doctors the ability to remotely monitor their patients’ health more comprehensively. This device, which avoids blood draws, uses light to scan the skin at the top of the fingernail and employs artificial intelligence (AI) to identify critically low levels of white blood cells. Based on ...
- Source: drugdu
- 184
- June 25, 2024
AI-Powered Blood Test Predicts Parkinson’s Seven Years before Symptoms Appear

Parkinson’s disease is currently the fastest-growing neurodegenerative disorder worldwide, affecting nearly 10 million people globally. It is a progressive disease caused by the deterioration and death of nerve cells in a part of the brain known as the substantia nigra, which is essential for movement control. These nerve cells diminish or become damaged, losing their ability to produce a crucial chemical, dopamine, often due to the accumulation of a protein called alpha-synuclein. Presently, treatments for people with Parkinson’s, such as dopamine replacement therapy, are initiated after symptoms like tremors, slow movements, gait issues, and memory problems have already appeared. However, there is a consensus among researchers that early prediction and diagnosis could lead to discoveries of treatments capable of slowing or halting the progression of Parkinson’s by protecting dopamine-producing brain cells. Now, a simple blood test employing artificial intelligence (AI) can predict the onset of Parkinson’s up to seven years ...
- Source: drugdu
- 237
- June 25, 2024
Tectonic bets on GPCR heart failure drug following reverse merger with Avrobio

Tectonic Therapeutic has completed a reverse merger with AVROBIO and will begin trading on the Nasdaq global market as Tectonic Therapeutic (ticker symbol ‘TECX’) on 21 June. Coinciding with the merger, the new company also completed a private placement of $130.7m with multiple US and European investors. Following the placement, Tectonic reported total cash reserves of $181m, before payment of final transaction-related expenses, which is expected to fund operations until mid-2027. As part of the merger, Avrobio enacted a 1-for-12 reverse stock split of its common shares, along with an issuance of a non-transferable contingent value right. Under that, shareholders will have the rights to cash payments received by Tectonic, if any, related to Avrobio’s pre-transaction legacy assets. Avrobio’s stockholders will own approximately 24.8% of the new company while old Tectonic shareholders, including the investors in the private placement, will hold 75.2% of the combined company’s outstanding common stock. The ...
- Source: drugdu
- 195
- June 25, 2024
Sarepta’s Elevidys secures US label expansion for DMD

Just a week after Pfizer revealed a Phase III trial failure for its mini-dystrophin gene therapy for Duchenne muscular dystrophy (DMD), Sarepta has announced that it has scored a US label expansion for its DMD gene therapy Elevidys (delandistrogene moxeparvovec-rokl). As per the 20 June press release, the US Food and Drug Administration (FDA) has expanded Elevidys’ label to include DMD patients with a confirmed mutation in the DMD gene who are at least four years of age. Based on its functional benefits, Elevidys was granted traditional approval for ambulatory patients and accelerated approval for the non-ambulatory population. However, according to the announcement, which drove Sarepta’s shares up 36%, further progression on the approval track hinges on validated clinical benefits from a confirmatory study. When the therapy’s durability came into question, particularly in a non-ambulatory population, Sarepta CEO Douglas Ingram said in an investor call held on 21 June, that ...
- Source: drugdu
- 231
- June 25, 2024
Researchers reveal genetic makeup could identify treatment options for sepsis

Researchers from the Wellcome Sanger Institute, the University of Oxford and collaborators have revealed that genetic makeup could help determine the best treatment options for sepsis patients. Published in Cell Genomics, findings from the study could potentially lead to the development of targeted therapies to treat the condition. Responsible for 11 million deaths globally every year, sepsis is a serious condition in which the body responds improperly to an infection, causing the organs to work poorly. Depending on patients’ immune responses, which can be difficult to identify based on symptoms alone, treatment for sepsis can vary. Built on previous studies that identified different subgroups of patients with sepsis, researchers analysed data from the UK Genomic Advances in Sepsis study, involving 1,400 sepsis patients due to community-acquired pneumonia and faecal peritonitis, to investigate the impact of genetic variants that regulate expression quantitative trait locus (eQTLs), a type of gene expression. After ...
- Source: drugdu
- 133
- June 25, 2024
Researchers design genetic mole reversal therapy for rare skin condition

Researchers from the Francis Crick Institute, University College London (UCL) Great Ormond Street Institute for Child Health and Great Ormond Street Hospital for Children (GOSH) have created a new genetic therapy to alleviate debilitating moles in a rare skin condition. Published in the Journal of Investigate Dermatology, the treatment could help prevent affected children and adults from developing cancer. Covering up to 80% of children’s bodies at birth, congenital melanocytic naevus syndrome (CMN) is caused by progenitor-cell mutations during embryonic development that appear as large, painful or itchy moles, which can develop into severe melanoma. Funded by the National Institute for Health and Care Research (NIHR), the Caring Matters Now Charity, the Patient Support Group, LifeArc and the NIHR Great Ormond Street Hospital Biomedical Research Group Centre, researchers used a genetic therapy known as silencing RNA, which works to block the action of the mutation NRAS, which is mutated in ...
- Source: drugdu
- 128
- June 25, 2024
【EXPERT Q&A】What is the business process of exporting raw materials of Chinese companies to Indonesia to make medicines, health products and food raw materials?

Drugdu.com expert’s response: 1.Pre-preparation Stage ①Understanding Indonesian Market and Regulations: Firstly, Chinese companies need to understand Indonesia’s import regulations, regulatory requirements, and market demand for pharmaceuticals, healthcare products, and food ingredients, ensuring that exported products comply with Indonesian standards and regulations. ②Signing Trade Contracts: After clarifying market demand and regulatory requirements, Chinese companies should sign trade contracts with Indonesian importers or buyers, clarifying product specifications, quantity, price, delivery method, and other terms. 2.Export Declaration Stage ①Preparing Export Documents: Chinese companies need to prepare necessary export documents, including commercial invoices, packing lists, certificates of origin, export licenses (if required), etc. These documents must accurately reflect information such as product names, quantities, specifications, prices, etc. ②Export Declaration: Chinese companies submit export declaration forms and related documents to customs authorities for export declaration procedures. Customs authorities will review the information and documents to ensure they are complete and valid, and verify the ...
- Source: drugdu
- 224
- June 24, 2024
【EXPERT Q&A】How does the law regulate the production and sale of medical devices?

Drugdu.com expert’s response: In the production and sales of medical devices, countries have strict laws and regulations to regulate them. Taking China as an example, the Measures for the Supervision and Administration of Medical Device Production are formulated to strengthen the supervision and administration of medical device production, standardize medical device production activities, and ensure the safety and effectiveness of medical devices. The measures clarify the laws, regulations, rules, mandatory standards and quality management specifications that should be observed in medical device production activities, and require medical device registrants and filers to be responsible for the safety and effectiveness of listed medical devices. At the same time, according to the different levels of medical device risks, China also implements classified management for medical device production, requiring enterprises engaged in different types of medical device production to obtain corresponding production licenses or make filings according to law. In addition, the country ...
- Source: drugdu
- 233
- June 21, 2024
API China

Organizer: Reed Sinopharm Exhibitions Date: October 16-18, 2024 Venue: No. 1399 Huizhan 1st Road, Baqiao District, Xi’an, Shaanxi Province Exhibition hall：Xi’an International Convention and Exhibition Center Product range: Pharmaceutical APIs, Pharmaceutical Excipients, Natural Extracts, Chemical Reagents, Intermediates, Fine Chemical Raw Materials, Key Raw Materials, Food Ingredients and Additives, Veterinary Drug Raw Materials, Feed Ingredients and Additives, Health Product Ingredients and Additives, Biotechnology, Pharmaceutical R&D Services, Contract Manufacturing Services, Registration and Pharmaceutical Services, Training Services Exhibition Introduction: As the longest-running exhibition in China’s pharmaceutical industry, API China – China International Pharmaceutical API Exhibition was first held in 1968. The exhibits cover more than 50,000 types of APIs in 24 categories, as well as all auxiliary materials, functional ingredients, internal and external packaging materials, production and testing equipment required for the production of pharmaceuticals and health products.
- Source: drugdu
- 237
- June 19, 2024

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