On June 25, Chiatai Tianqing received the Certificate of Drug Registration approved by the State Drug Administration, and the company’s liraglutide injection was approved to be listed in the market, which is used for controlling blood glucose in adult patients with type 2 diabetes mellitus. This is the ninth new product (including new indications) approved by Chiatai Tianqing since this year. The approval of this product also marks Chiatai Tianqing’s formal entry into the field of biopharmaceutical glycemic control. Liraglutide is a long-acting analog of glucagon-like peptide-1 (GLP-1) with 97% homology to natural GLP-1, an endogenous enteric insulinotropic hormone that enhances glucose-dependent insulin secretion from pancreatic β-cells. In addition to pancreatic islet cells, GLP-1 receptors are widely present in gastrointestinal, lung, brain, kidney, cardiovascular system and other organs and tissues. Liraglutide prolongs the half-life of GLP-1 on the basis of retaining the physiological action characteristics of GLP-1, and needs to ...
Frontotemporal dementia (FTD), amyotrophic lateral sclerosis (ALS), and progressive supranuclear palsy (PSP) represent a group of neurodegenerative diseases with symptoms that include dementia, behavioral changes, paralysis, muscle wasting, and movement impairments. These diseases are rare but have severe health impacts, and currently, there are no cures. Presently, conclusive diagnosis of the molecular pathology of these diseases during a patient’s lifetime is challenging because it typically requires examination of brain tissue. However, accurate diagnosis is essential for developing therapies and for patient stratification, which is necessary for testing targeted disease-modifying treatments. Now, researchers have demonstrated that the most common forms of FTD, as well as ALS and PSP, can be detected through blood tests, though these tests are not yet ready for routine clinical use. In the long term, they could significantly improve disease diagnosis and accelerate the development of new treatments. This research, led by the German Center for Neurodegenerative ...
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: ...
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 ...
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 ...
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 ...
Dive Brief Philips has launched its Duo Venous Stent System in the U.S. to treat patients with blockages in their veins, the company said Wednesday. The implant, which won approval in December, is designed to address the root cause of chronic deep venous disease and comes in two forms for use in different types of veins. Philips acquired the device in its 2022 takeover of Vesper Medical. The company paid 227 million euros upfront for Vesper to expand its image guided therapy business. Dive Insight The Duo Venous Stent System is a portfolio of self-expanding stents mounted on disposable delivery devices. Vesper designed the stents to increase the diameter of obstructed veins. Restoring blood flow could improve quality of life by alleviating symptoms of venous disease, which include pain, swelling and discoloration of skin. Philips tracked improvements on observational quality-of-life endpoints in a trial of the device. Using data from ...
The amyotrophic lateral sclerosis (ALS) market across the 8MM (8MM: the US, France, Germany, Italy, Spain, the UK, Japan, and Canada) is projected to grow at a compound annual growth rate (CAGR) of 15 per cent from $317 million in 2019 to $1.28 billion in 2029, forecasts drugdu. The key opinion leaders (KOLs) interviewed by drugdu identified the greatest unmet needs within the ALS space. These entail earlier diagnosis, disease-modifying therapies (DMTs), identification of biomarkers, and efficacious first-line treatment options. However, the consensus amongst them is that the need to diagnose ALS early and the development of DMTs is imperative for any change to take place within the treatment space. Momna Ali, Healthcare Analyst at drugdu, comments, “Due to the variety in the presentation of ALS development and symptoms, there have been historical difficulties in diagnosing patients in a timely manner. Pharmaceutical companies have an opportunity to educate physicians both ...
Avidity Biosciences’ RNA therapy for facioscapulohumeral muscular dystrophy has preliminary clinical data showing it knocked down expression of a gene that causes this rare disease. More details will be presented at a medical conference this week. By Frank VinluanAn experimental RNA therapy from Avidity Biosciences has early clinical trial results showing it reduced by half the expression of a gene at the root of a rare, inherited form of muscular dystrophy with no FDA-approved therapies. Furthermore, patients in the study are showing signs of regaining muscle function. Based on these initial results announced Wednesday, Avidity said it plans to accelerate the start of additional cohorts in the Phase 1/2 study that could support an application seeking regulatory approval in this disease, facioscapulohumeral muscular dystrophy (FSHD). More details about the data are coming soon. Avidity plans to present the preliminary results during the Annual FSHD Society International Research Congress meeting, which ...
Lucy Therapeutics (LucyTx) has announced it has raised $12.5m in additional funding to develop potentially new drugs and advance the company’s research programmes for neurological diseases. The funding, provided by existing investors, Engine Ventures and Safar Partners, with recent participation from the Bill & Melinda Gates Foundation, the Michael J. Fox Foundation and £1.6m from Parkinson’s UK’s Biotech programme, brings the company’s total funding to $36m. The new project aims to develop novel therapies that are based on mitochondrial small-molecule treatments and diagnostic biomarkers for Alzheimer’s (AD) and Parkinson’s disease (PD), as well as continue the development of a novel drug target for Rett syndrome, a rare genetic neurological and developmental disorder that affects brain development. AD and PD are the two most common neurodegenerative diseases worldwide, affecting around 24 million and ten million people, respectively. Using LucyTx’s platform, the team will analyse a variety of disease drivers central to ...
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