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SynaptixBio awarded £2m BioMedical Catalyst grant from Innovate UK

Oxford-based SynaptixBio has been awarded a £2m BioMedical Catalyst grant from Innovate UK to support first-in-human clinical trials of its therapeutic targeting H-ABC, the most severe form of TUBB4A leukodystrophy. In November 2023, SynaptixBio received an earlier grant from Innovate UK to expand its search for rare disease therapies. The company was given a second Orphan Drug Designation from the US FDA in February this year for a therapy targeting Isolated Hypomyelination – a less severe form of TUBB4A leukodystrophy. In the UK, a rare disease is defined as a condition that affects fewer than one in 2,000 in the population and SynaptixBio is the only company licensed to commercialise a treatment for this rare, deadly and currently incurable disease. Currently, there is no cure for TUBB4A-related leukodystrophies, a group of rare neurodegenerative caused by mutations in the TUBB4A gene. The diseases result in disruption to the signals between nerve ...
- Source: drugdu
- 68
- August 28, 2024
Celltrion’s SteQeyma receives EC approval for chronic inflammatory diseases

The European Commission (EC) has approved Celltrion‘s SteQeyma (CT-P43), a biosimilar to Stelara (ustekinumab), for treating various chronic inflammatory conditions. This approval, which encompasses gastroenterology, dermatology, and rheumatology indications, follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in June this year. SteQeyma, previously known as CT-P43, acts as an antagonist to human IL-12 and IL-23, addressing multiple immune-mediated diseases. It is available in subcutaneous and intravenous formulations, with the subcutaneous injection offered in 45mg/0.5ml or 90mg/1ml strengths in a single-dose, prefilled syringe. The intravenous infusion is available as a 130mg/26ml (5mg/ml) solution in a single-dose vial. Stelara, the reference product for SteQeyma, is a biologic therapy targeting interleukin (IL)-12 and IL-23 cytokines, crucial in inflammatory and immune responses. The EC’s decision is grounded on comprehensive evidence, including a Phase III trial in adults with moderate to severe plaque ...
- Source: drugdu
- 118
- August 28, 2024
MSD snags European approval for pulmonary arterial hypertension therapy

The European Commission (EC) has granted approval to Merck & Co’s (MSD) Winrevair (sotatercept) to be used as a combination therapy for the treatment of adults with functional class II or III pulmonary arterial hypertension (PAH). The approval was awarded based on data from STELLAR, a Phase III study (NCT04576988) that evaluated 323 adult participants with functional class II or III PAH, as determined by the World Health Organization (WHO), as per the 26 August press announcement, The European approval for the subcutaneously administered therapy follows one from the US Food and Drug Administration (FDA) in March 2024 for the same group of PAH patients. According to GlobalData’s consensus forecasts, Winrevair is expected to generate total sales of $6.3bn in 2030. GlobalData is the parent company of Pharmaceutical Technology. Notably, a day before the approval of Winrevair, the FDA granted approval to Johnson & Johnson’s (J&J) Opsynvi (macitentan + tadalafil). ...
- Source: drugdu
- 95
- August 28, 2024
【EXPERT Q&A】What are the advantages of MDSAP medical device system certificate?

Drugdu.com expert’s response: The MDSAP (Medical Device Single Audit Program), also known as the “Medical Device Single Audit Program,” is an audit process recognized and joined by five medical device regulatory agencies from the United States FDA, Australia TGA, Brazil ANVISA, Canada HC, and Japan MHLW. This system certification brings numerous benefits and advantages to medical device manufacturers, primarily in the following aspects: I. Streamlining the Audit Process Reducing Redundant Audits: MDSAP employs a one-time audit process that encompasses the regulatory requirements of multiple countries. Manufacturers need to undergo a single audit to meet market access requirements across participating nations, eliminating the duplication of effort and time waste associated with multiple audits. Unifying Audit Standards: MDSAP certification ensures that a manufacturer’s quality management system and products align with the audit standards and requirements of the five participating countries and regions, facilitating consistency in quality and compliance and simplifying audit procedures ...
- Source: drugdu
- 68
- August 28, 2024
KIHE 2025

Organiser: ITE Group Time: 21 – 23 May 2025 Address：42 Timiryazev str., Almaty, 050057 Almaty, Kazakhstan Exhibition hall: Atakent International Exhibition Centre Product range: Medical equipment: Medical technology equipment, laboratory equipment, medical electronic equipment, medical diagnostic equipment, ophthalmic equipment and protective products, surgical instruments, first aid and emergency equipment, hospital & Dental & medical equipment, dental service equipment and disposable medical products, hospital and home disposable medical products, hospital dentistry, medical data processing systems, dental plastic surgery, rehabilitation equipment Drugs: foreign prescription drugs, herbal preparations, mineral supplements and vitamin and other nutritional health drugs, dietary nutritional products, homeopathic preparations, dermatological preparations, maternal and infant medical care products and baby food, personal hygiene products, incontinence products, medical consumer products, cosmetics Pharmaceutical Industry: Pharmaceutical production equipment and technology, pharmaceutical packaging equipment, pharmaceutical packaging materials, pharmaceutical production, cleaning and disinfection configuration system, pharmaceutical industry raw materials and ingredients, intermediates, pharmaceutical equipment, pharmaceutical packaging, laboratory equipment ...
- Source: drugdu
- 260
- August 27, 2024
Roche Joins Fight Against Mpox Outbreak with High-Quality PCR Diagnostic Tests

Mpox, formerly known as monkeypox, is a viral disease that can spread easily between people and from infected animals. The mpox virus was first detected in laboratory monkeys in 1958. The virus is, however, assumed to be transmitted from wild animals such as rodents to people — or from human to human. Symptoms of mpox include fever, chills, headaches, muscle aches, fatigue, swollen lymph nodes, and a painful rash that characteristically appears as raised bumps on the skin and tends to be distributed on the face, extremities and genitals. As the disease progresses, these bumps fill with pus and fluid and become umbilicated. They will eventually ulcerate, scab, and fall off. Mpox was declared a Public Health Emergency of International Concern by the World Health Organization (WHO) on August 14, 2024. Roche (Basel, Switzerland) has announced that it is supporting the international response to the mpox global health emergency with ...
- Source: drugdu
- 64
- August 27, 2024
Machine Learning-Powered Blood Test Estimates Age-Related Disease Risk

Age is a significant factor for many common chronic diseases, yet it does not perfectly represent the actual biological aging processes that drive multimorbidity and mortality. Biological aging can be more accurately assessed by using ‘omics data, which reflects an individual’s biological functions relative to their chronological age. Traditionally, biological aging clocks have relied on DNA methylation, but protein levels might offer deeper insights into the mechanisms of aging. Researchers have now created a machine learning-based blood test that evaluates over 200 proteins to determine a person’s biological aging rate. This test is designed to predict the risk of developing 18 major age-related diseases and the likelihood of premature death. The machine learning model that uses blood proteomic information to estimate a proteomic age clock was developed by researchers at Massachusetts General Hospital (Boston, MA, USA) in a large sample of participants from the UK Biobank. Its validity was further ...
- Source: drugdu
- 62
- August 27, 2024
FDA Approves Updated COVID-19 Vaccines

By Mike Hollan The updated formulas should provide better protection against the currently circulating strains. FDA approved and authorized updated COVID-19 vaccines that research shows will provide better protection against the current strains circulating amongst the population.1 According to the federal agency, the mRNA vaccines have been updated with a monovalent component that makes them more effective against the Omicron variant KP.2 strain of the virus. In a press release, director of FDA’s Center for Biologics Evaluation and Research Peter Marks, MD, PhD, said, “Vaccination continues to be the cornerstone of COVID-19 prevention. These updated vaccines meet the agency’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality. Given waning immunity of the population from previous exposure to the virus and from prior vaccination, we strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants.” In June of this ...
- Source: drugdu
- 79
- August 27, 2024
FDA Grants Fast Track Designation to Clarity Pharmaceuticals’ Novel Treatment for PSMA-Positive Prostate Cancer Lesions

By Don Tracy, Associate Editor 64Cu-SAR-bisPSMA has demonstrated advantages over current diagnostic tools, such as higher tumor uptake, next-day imaging, and a longer half-life in PET imaging of PSMA-positive prostate cancer lesions, Clarity says. The FDA has granted Fast Track designation to Clarity Pharmaceuticals’ 64Cu-SAR-bisPSMA, a novel imaging agent designed for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA)-positive prostate cancer lesions with suspected metastasis. According to the company, the agent, which was supported by promising clinical results, has demonstrated advantages over current diagnostic tools, such as higher tumor uptake, next-day imaging, and a longer half-life, allowing for centralized production and flexible patient scheduling.1 “Receiving Fast Track Designation for 64Cu-SAR-bisPSMA is a significant milestone, especially as we are actively recruiting into our first registrational Phase III trial, CLARIFY, and preparing for an End of Phase meeting with the FDA for a second pivotal Phase III trial with ...
- Source: drugdu
- 75
- August 27, 2024
SynaptixBio awarded £2m BioMedical Catalyst grant from Innovate UK

Oxford-based SynaptixBio has been awarded a £2m BioMedical Catalyst grant from Innovate UK to support first-in-human clinical trials of its therapeutic targeting H-ABC, the most severe form of TUBB4A leukodystrophy. In November 2023, SynaptixBio received an earlier grant from Innovate UK to expand its search for rare disease therapies. The company was given a second Orphan Drug Designation from the US FDA in February this year for a therapy targeting Isolated Hypomyelination – a less severe form of TUBB4A leukodystrophy. In the UK, a rare disease is defined as a condition that affects fewer than one in 2,000 in the population and SynaptixBio is the only company licensed to commercialise a treatment for this rare, deadly and currently incurable disease. Currently, there is no cure for TUBB4A-related leukodystrophies, a group of rare neurodegenerative caused by mutations in the TUBB4A gene. The diseases result in disruption to the signals between nerve ...
- Source: drugdu
- 57
- August 27, 2024

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