Search Results for “EC” – Page 432 – media

Positive opinion for Gilead’s Hepcludex

The vital recommendation ensures marketing authorisation for treating the hepatitis delta virus Gilead Sciences has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has provided a positive opinion for Hepcludex. Also known as bulevirtide, the therapy concerns adults with chronic hepatitis delta virus (HDV) and compensated liver disease. Meanwhile, the recommendation grants full marketing authorisation (MA) which will no longer be subject to certain obligations. Initially, Bulevirtide was granted conditional marketing authorisation in 2020 in order to treat particular HDV patients who required urgent access to treatment. The CHMP recommendation for full MA of bulevirtide arrives after the submission of phase 3 MYR301 week 48 study data, which reinforces its safety and efficacy profile. HDV remains the most severe form of viral hepatitis and impacts around 5% of people living with hepatitis B (HBV). Furthermore, there is a prevalence of ...
- Source: drugdu
- 220
- May 9, 2023
The safety and efficacy of FINLAY-FR-2/1A, a new protein-based COVID-19 vaccine

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), responsible for the coronavirus disease 2019 (COVID-19) pandemic, has claimed more than 6.92 million lives and infected over 765 million individuals. Most COVID-19 vaccines target the SARS-CoV-2 spike glycoprotein receptor-binding domain (RBD) to prevent the binding of SARS-CoV-2 to the host angiotensin-converting enzyme 2 (ACE-2) receptor. Background Preclinical studies associated with FINLAY-FR-2 (Soberana 02), a protein subunit vaccine conjugated with the tetanus toxoid carrier protein, have confirmed its effectiveness, with similar results obtained in Phases I, II, and III clinical trials. These trials have shown that FINLAY-FR-1A (Soberana Plus), an RBD dimer without conjugation, has increased neutralization capacity in COVID-19 convalescent individuals. Additionally, when this protein-based vaccine was introduced as the third dose to FINLAY-FR-2, it induced the production of anti-RBD immunoglobulin G (IgG) antibodies. Several countries, including Iran, Cuba, Venezuela, Belarus, Mexico, and Nicaragua, have approved FINLAY-FR-2 and FINLAY-FR-1A vaccines ...
- Source: drugdu
- 124
- May 9, 2023
Manufacturing operations for Eli Lilly, Rentschler reprimanded by FDA

After FDA inspectors visited Eli Lilly and Rentschler Biopharma production sites in October 2022 and early 2023, respectively, the U.S.’ drug regulator is making concerns about the facilities public. In Form 483 filings posted this week, the FDA flagged Lilly’s site in Indianapolis for three manufacturing-related shortfalls and Rentschler’s Baden-Wurttemberg, Germany, site for five deficiencies. At Lilly’s site, the regulator said the company’s aseptic technique for an undisclosed drug’s filling operation was “deficient.” Specifically, operators “handled unprotected sterile components” in a way that “may introduce contaminants onto sterile surfaces” in certain areas, the FDA said. Aside from that observation, the FDA flagged “processing areas” for two filling lines as substandard. Again, the FDA flagged sanitization procedures as not meeting its standards. Inspectors visited Lilly’s Indianapolis site from Oct. 17-21, 2022. In parallel to the Indianapolis site inspection and filing, the FDA in April rejected Eli Lilly’s ulcerative colitis prospect mirikizumab over manufacturing-related shortfalls. It isn’t immediately clear whether the ...
- Source: drugdu
- 180
- May 8, 2023
Rise in UK measles cases causing concern

BBC By James Gallagher Health and science correspondent A “very concerning” rise in the number of people catching measles in the UK has been reported by health officials. The virus spreads incredibly easily and a fall in vaccination rates is leaving more children vulnerable to infection. There were 54 cases of measles in the whole of last year. However, there have already been 49 in the first four months of 2023. The UK Health Security Agency (UKHSA) is encouraging parents to ensure their children’s vaccinations are up to date. The main symptoms of measles are a fever and a rash. But it can cause more serious complications including meningitis, and an infection can be fatal. That is why the measles, mumps and rubella (MMR) vaccine is part of routine childhood immunisations. Vaccination rates had been falling in the UK before the Covid pandemic. However, the disruption caused by Covid has dented vaccination ...
- Source: drugdu
- 136
- May 8, 2023
People with Long COVID neurological symptoms found to have differences in immune cell profiles and autonomic dysfunction

Reviewed by Emily Henderson, B.Sc. Twelve people with persistent neurological symptoms after SARS-CoV-2 infection were intensely studied at the National Institutes of Health (NIH) and were found to have differences in their immune cell profiles and autonomic dysfunction. These data inform future studies to help explain persistent neurological symptoms in Long COVID. The findings, published in Neurology: Neuroimmunology & Neuroinflammation, may lead to better diagnoses and new treatments. People with post-acute sequelae of COVID-19 (PASC), which includes Long COVID, have a wide range of symptoms, including fatigue, shortness of breath, fever, headaches, sleep disturbances, and “brain fog,” or cognitive impairment. Such symptoms can last for months or longer after an initial SARS-CoV-2 infection. Fatigue and “brain fog” are among the most common and debilitating symptoms, and likely stem from nervous system dysfunction. Researchers used an approach called deep phenotyping to closely examine the clinical and biological features of Long COVID in 12 ...
- Source: drugdu
- 151
- May 8, 2023
People with Long COVID neurological symptoms found to have differences in immune cell profiles and autonomic dysfunction

Twelve people with persistent neurological symptoms after SARS-CoV-2 infection were intensely studied at the National Institutes of Health (NIH) and were found to have differences in their immune cell profiles and autonomic dysfunction. These data inform future studies to help explain persistent neurological symptoms in Long COVID. The findings, published in Neurology: Neuroimmunology & Neuroinflammation, may lead to better diagnoses and new treatments. People with post-acute sequelae of COVID-19 (PASC), which includes Long COVID, have a wide range of symptoms, including fatigue, shortness of breath, fever, headaches, sleep disturbances, and “brain fog,” or cognitive impairment. Such symptoms can last for months or longer after an initial SARS-CoV-2 infection. Fatigue and “brain fog” are among the most common and debilitating symptoms, and likely stem from nervous system dysfunction. Researchers used an approach called deep phenotyping to closely examine the clinical and biological features of Long COVID in 12 people who ...
- Source: drugdu
- 235
- May 8, 2023
ckWomen with a history of domestic abuse may have higher risk of atopic diseases

Women who have suffered domestic abuse may have a higher risk of developing atopic diseases including asthma, new research has found. Published today in the Journal of Allergy and Clinical Immunology: In Practice, the research led by the University of Birmingham found that in analysis of patient records, there were a significantly larger percentage of women who had atopic diseases and had a history of being exposed to domestic abuse and violence compared to those who hadn’t. After adjusting for possible cofounders, our results show women with a recorded exposure to domestic violence and abuse had a 52% increased risk of developing atopic diseases. “Domestic violence and abuse is a global issue that disproportionately affects women. We set out to deepen our understanding of the health impacts of domestic violence so evidence-based public health policies can be further developed to address not only domestic violence, but secondary effects like the development ...
- Source: drugdu
- 112
- May 8, 2023
Early smoking cessation associated with higher survival rates following a lung cancer diagnosis

Quitting smoking early was associated with higher survival rates following a lung cancer diagnosis, according to a new study led by researchers at Harvard T.H. Chan School of Public Health. Compared to those who never smoked and were being treated for non-small cell lung cancer (NSCLC), current smokers had 68% higher mortality and former smokers had 26% higher mortality. Our participants’ smoking histories varied, with some having stopped smoking a few years before their diagnosis and others having stopped several decades before. This wide range gave us confidence in our results—that the benefit of pre-diagnosis smoking cessation persists even after lung cancer is diagnosed.” David Christiani, Senior Author, Elkan Blout Professor of Environmental Genetics The study was published online in JAMA Network Open on May 5, 2023. While most similar research has compared mortality among current smokers and never smokers, the majority of the study’s participants were former smokers, ...
- Source: drugdu
- 130
- May 7, 2023
Neogap, Cellerys partner for study of multiple sclerosis therapy

Biopharmaceutical company Neogap Therapeutics has partnered with Swiss company Cellerys for a Phase II study of the latter’s RED4MS therapy for multiple sclerosis. Under the collaboration, Neogap will provide its EpiTCer technology for Cellerys’ upcoming Phase II study of an innovative cell therapy to fight multiple sclerosis. The RED4MS therapy is being studied for the induction of antigen-specific immune tolerance in multiple sclerosis patients. The Neogap EpiTCer technology will be used for the identification of rare autoreactive T cells in the patients, utilising them as biomarkers of tolerance in patients. Neogap CEO Samuel Svensson said: “We are thrilled to contribute to and be a part of Cellerys upcoming Phase II study, where EpiTCer will be a key aspect in monitoring autoreactive T cells. “The collaboration with Cellerys opens up opportunities for Neogap to use our technology platform in several disease fields, including autoimmune diseases and other immune-related conditions. “Our ...
- Source: drugdu
- 169
- May 7, 2023
Eli Lilly’s Alzheimer’s drug shown to significantly slow disease progression in phase 3 trial

Eli Lilly’s experimental Alzheimer’s drug, donanemab, has been shown to significantly slow cognitive and functional decline in patients with early-stage disease. The phase 3 TRAILBLAZER-ALZ 2 study met its primary endpoint, with the drug slowing the progression of the disease by 35% compared to placebo in 1,182 patients with early symptomatic Alzheimer’s disease and intermediate levels of tau protein. All secondary endpoints of cognitive and functional decline were also met and showed highly statistically significant clinical benefits, the company said. Results from the trial demonstrated that 47% of patients who received donanemab showed no disease progression a year after starting treatment, compared with 29% on placebo. Additionally, 52% of patients completed their course of treatment by one year, and 72% completed by 18 months as a result of achieving amyloid plaque clearance. Patients receiving donanemab also experienced a 39% lower risk of progressing to the next stage of disease, and ...
- Source: drugdu
- 133
- May 7, 2023

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