Search Results for “EC” – Page 206 – media

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
- 60
- 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
- 58
- 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
- 74
- 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
- 73
- 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
- 53
- August 27, 2024
Eli Lilly doubles down on Oblique partnership for antibody generation

Eli Lilly is strengthening its ties with Oblique Therapeutics, as the two companies announced an expansion to their collaboration agreement to include a second “high-value target”. Building on the existing agreement from November 2023, Eli Lilly will continue to use Oblique’s AbiProt platform to discover antibodies. Specifically, Sweden-based Oblique will partner with Lilly Catalyze360-ExploR&D, an arm of the company that offers clinical development capabilities for partnered biotechs and drug developers, as per a 22 August press release. The financial terms of the expanded deal were not disclosed, and neither was the target of its application. Oblique did state that if treatments are developed successfully, the partnership will “generate milestones and royalties”. Abiprot identifies therapeutic antibodies that can be programmed to have a specific pharmacological function. Oblique states its technology can help develop effective medicines against difficult-to-drug target proteins. The biotech’s platform uses microfluidics and proteases as molecular probes and provides ...
- Source: drugdu
- 75
- August 27, 2024
【EXPERT Q&A】Do I need to apply for Import License in Germany when exporting insulin apis to Germany?

Drugdu.com expert’s response: Regarding the question of whether an Import License is required for exporting insulin Active Pharmaceutical Ingredients (APIs) to Germany, I will address this from both international trade and pharmaceutical regulatory perspectives. Hopefully, this will provide you with valuable insights. Firstly, it is crucial to note that Germany, as a member of the European Union (EU), subjects the import and sale of pharmaceutical products, including APIs, to stringent regulatory frameworks. Typically, the import of pharmaceuticals (APIs included) must comply with the relevant EU and German laws and regulations. Whether an Import License is necessary for insulin APIs exported to Germany depends on several factors: I. EU and German Pharmaceutical Regulatory Policies: The EU’s pharmaceutical regulatory system may require prior import authorization or certification for certain pharmaceuticals or APIs. Therefore, it is essential to consult the latest EU and German pharmaceutical regulations to determine if insulin APIs are subject ...
- Source: drugdu
- 78
- August 26, 2024
Q&A with Oren Gilad, CEO of Aprea Therapeutics

By Mike Hollan Gilad discusses the ways that this method can be used to treat various cancers without putting patients through the side effects of chemotherapy. Precision medicine is gaining momentum in the life sciences industry. It’s also changing the way that researchers are approaching new treatments and therapies. Pharmaceutical Executive spoke with Oren Gilad, PhD, president and CEO of Aprea Therapeutics, about some of the ways that the company is approaching cancer treatment with this new mindset. Pharmaceutical Executive: Can you discuss the concept of synthetic lethality and how it relates to your work? Oren Gilad: Synthetic lethality is a concept where the combination of two genetic mutations leads to cell death, whereas each mutation on its own would not be lethal. Cancer cells often have specific genetic mutations that normal cells do not carry, generally because they exist because a normal mutated to become cancer. So, there’s already ...
- Source: drugdu
- 57
- August 26, 2024
GLP-1 Therapy Significantly Increases Visceral Adipose Tissue Metabolic Activity in Patients with Obesity, Obstructive Sleep Apnea

By Don Tracy, Associate Editor Findings from a study published in the Journal of the Obesity Society may significantly advance the understanding of GLP-1 analogues and their role in treating obesity.In recent years, glucagon-like peptide-1 (GLP-1) analogues, such as Ozempic, have demonstrated promising weight loss results by promoting satiety and delaying gastric emptying, thus reducing energy intake. However, a number of studies conducted in animals suggest that GLP-1 therapies may also influence energy expenditure by increasing metabolic activity in visceral adipose tissue (VAT), a more metabolically active and harmful fat depot compared to subcutaneous fat. The study’s primary objective was to determine whether VAT metabolic activation also occurs in humans and how it contributes to the weight loss effect of GLP-1 analogues.1 “This study challenges the main narrative about these newer treatments which is that they simply make you eat less, and that any action on energy burn is minimal. ...
- Source: drugdu
- 71
- August 26, 2024
【EXPERT Q&A】What is a passive medical device?

Drugdu.com expert’s response: Passive medical devices refer to those that do not rely on external energy sources (such as electricity or batteries) to perform their intended functions. These devices typically utilize physical principles like mechanics, optics, acoustics, and thermodynamics to achieve their functions, with their energy primarily derived from the human body itself or gravitational forces. I. Characteristics of Passive Medical Devices Energy Source: Passive medical devices do not depend on external power sources or other forms of energy. Instead, they operate directly using natural forces such as the human body or gravity. Function Realization: They achieve their intended medical functions through physical principles like mechanical force, pressure, optical properties, etc. Safety: Since they do not rely on external power, these devices generally do not generate electromagnetic interference or radiation during use, making them safer for the human body. II. Classification of Passive Medical Devices Passive medical devices can be ...
- Source: drugdu
- 67
- August 26, 2024

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