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New Blood Test Enables Accurate Diagnosis of Dementia and Neurological Diseases

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 ...
- Source: drugdu
- 180
- June 26, 2024
CPHI & PMEC China

Organiser：Informa Markets Time：September 9th – 11th, 2024 address：Shenzhen Convention and Exhibition Center, Fuhua 3rd Road, Futian District, Shenzhen Exhibition hall：Shenzhen Futian Convention and Exhibition Center Product range: Active Pharmaceutical Ingredients (APIs) and Intermediates, Biopharmaceuticals, Pharmaceuticals, Pharmaceutical Excipients, CDMO, Natural Extracts, Third-party Services, Pharmaceutical Machinery, API Equipment, Packaging Equipment, Cleanroom Equipment and Engineering, Laboratory Construction and Systems, etc. About CPHI & PMEC China： CPHI & PMEC China (Shenzhen) continues to focus on the pharmaceutical industry development in the Guangdong-Hong Kong-Macao Greater Bay Area, radiating the Asian market, and concentrating on the transformation and upgrading of new drug development, technological innovation, and other fields. It aims to create a more precise, professional, and technology-driven industrial upgrading platform, deeply connecting the industrial exchanges and cooperation in the Guangdong-Hong Kong-Macao Greater Bay Area and even Asia.
- Source: drugdu
- 206
- June 26, 2024
FDA Approves Harmony Biosciences’ Wakix to Treat Excessive Daytime Sleepiness in Pediatric Patients with Narcolepsy

Don Tracy, Associate Editor Approval of Wakix marks the first time a non-scheduled treatment option for excessive daytime sleepiness has been approved for patients ages 6 years and older. The FDA has approved Harmony Biosciences’ Wakix (pitolisant) tablets for the treatment of excessive daytime sleepiness (EDS) in pediatric patients aged 6 years and older with narcolepsy. The FDA based the approval on results from a Phase III study conducted by Bioprojet, which evaluated the safety and efficacy of the treatment in patients over 6 years of age. Additionally, Wakix is the first non-scheduled treatment to be approved for EDS in pediatric patients.1 “Following the FDA’s decision to grant priority review, we are very pleased with the Agency’s timely review and approval of Wakix for pediatric narcolepsy patients with excessive daytime sleepiness,” said Jeffrey M. Dayno, MD, president, CEO, Harmony Biosciences, in a press release. “EDS is the primary symptom experienced ...
- Source: drugdu
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- June 26, 2024
FDA Approves Argenx Drug as First New Treatment in Decades for Rare Nerve Disease CIDP

Argenx’s Vyvgart Hytrulo is now approved to treat chronic inflammatory demyelinating polyneuropathy (CIDP), a rare autoimmune disease that affects nerves and impairs muscle function. The drug, an FcRn inhibitor, is the first in its class to win FDA approval in CIDP. By Frank VinluanA blockbuster Argenx therapy now has an additional FDA approval as a treatment for a rare autoimmune disorder affecting nerves, marking the first new treatment for this condition in decades and a new blockbuster opportunity for this pipeline-in-a-product drug. The disease, chronic inflammatory demyelinating polyneuropathy, or CIDP, develops as the immune system attacks myelin, the protective covering of nerve fibers. CIDP leads to weakness and impairment of motor function, numbness and tingling, and difficulty walking. In many cases, the loss of muscle function requires patients to rely on a wheelchair for mobility. The FDA’s late Friday approval of the Argenx product, Vyvgart Hytrulo, covers the treatment of ...
- Source: drugdu
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- June 26, 2024
【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
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- 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
- 122
- 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
- 128
- 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
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- 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
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- 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
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- June 25, 2024

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