Search Results for “EU” – Page 39 – media

EU grants full marketing authorisation for Novavax’s Covid-19 vaccine

US-based Novavax received its first full marketing authorisation for its Covid-19 vaccine Nuvaxovid (NVX-CoV2373) in the EU. Nuvaxovid is now fully authorised as a primary series vaccine for general Covid-19 prevention for individuals aged 12 years and older and as a booster dose in adults aged 18 years and older. The approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in May 2023, surrounding the vaccine’s full approval. The full authorisation comes a few years after the European Medicines Agency (EMA) granted the prophylactic a conditional marketing authorisation, in December 2021. At the time, Nuvaxovid was the fifth vaccine recommended for Covid-19 prevention in the EU. Novavax has authorised its vaccine in more than 40 markets worldwide. Nuvaxovid is a novel Matrix-M adjuvant protein-based vaccine that has received a US Food and Drug Administration (FDA) emergency use authorisation but has not yet received full ...
- Source: drugdu
- 109
- July 10, 2023
BrainTale Has Presented at the European Academy of Neurology and the World Parkinson Congress the Interest of Its Digital Biomarker Platform for the Early and Differential Diagnosis of Parkinson’s Disease

STRASBOURG, France–(BUSINESS WIRE)– BrainTale, a medtech deciphering white matter to enable better brain care, spin-off of the Paris Region Greater Hospitals, presented preliminary results during the European Academy of Neurology (Budapest, July 1 – 4, 2023) and the World Parkinson congress (Barcelona, July 4 – 7, 2023) demonstrating the interest of its digital biomarker platform for the early and differential diagnosis of Parkinson’s disease. Vincent Perlbarg, co-founder, scientific director and president of BrainTale, has presented the results supporting the interest of BrainTale’s digital biomarker platform for the care of patients suffering from the disease and the development of new therapies. Long underestimated in neuroscience, white matter, which represents 60% to 80% of the human brain, plays a key role in its proper functioning, development, and aging, whether normal or pathological. Accordingly, since its creation in 2018, BrainTale has been developing non-invasive, accessible, effective and clinically validated measurement and prediction tools ...
- Source: drugdu
- 108
- July 10, 2023
Horizon shares positive results for Uplizna in neuromyelitis optica spectrum disorder

Horizon Therapeutics has shared positive new MRI data from a late-stage study of Uplizna (inebilizumab-cdon) in patients with neuromyelitis optica spectrum disorder (NMOSD). Approximately one to ten per 100,000 people are affected by NMOSD, a rare and debilitating autoimmune disease characterised by inflammatory lesions that primarily damage the optic nerve and spinal cord. Most patients experience unpredictable relapses that reoccur after days, months or even years and may lead to further disability. Uplizna is the first and only CD19+ B-cell-depleting therapy approved by the US Food and Drug Administration and European Commission to treat NMOSD in adults who are AQP4-IgG positive. Around 80% of all patients with NMOSD test positive for anti-AQP4 antibodies. A new analysis of MRI data from the phase 3 N-MOmentum trial, presented by Horizon at this year’s Congress of the European Academy of Neurology in Budapest, shows that Uplizna effectively reduced the formation of subclinical (asymptomatic) ...
- Source: drugdu
- 121
- July 9, 2023
Researcher reach milestone in the treatment of anemia in chronic lymphocytic leukemia

In people with myelodysplastic neoplasms (MDS), a usually benign form of chronic lymphocytic leukemia, the body produces too few functional blood cells. Affected individuals suffer from anemia—a lack of red blood cells or hemoglobin—which can be a precursor to acute leukemia. Compared to the standard treatment, luspatercept can increase hemoglobin levels in MDS patients and help them to avoid blood transfusions. These are the findings of an international clinical trial led by Professor Uwe Platzbecker from Leipzig University and the University of Leipzig Medical Center in collaboration with a large international research team. Every year, around 4,000 people in Germany alone are diagnosed with myelodysplastic neoplasms (MDS). In these patients, the healthy maturation of blood cells is disrupted, which can lead to anemia, infections and an increased risk of bleeding. High-risk MDS is characterized by rapid progression, severe symptoms and often a transition to acute leukemia that results in a ...
- Source: drugdu
- 105
- July 6, 2023
FDA approves Skyline Therapeutics’ IND for macular degeneration trial

Chinese gene therapy company Skyline will initiate a global trial investigating a gene therapy to treat neovascular age-related macular degeneration (nAMD), after receiving clearance from the US Food and Drug Administration (FDA). The FDA granted the company’s investigational new drug (IND) application for a Phase I/IIa trial of SKG0106 – a one-time intravitreally delivered adeno-associated virus (AAV) gene therapy. Skyline has not disclosed when it expects to initiate the trial. Skyline Therapeutics’ candidate encompasses a new AAV capsid and unique transgene genome encoding an anti-VEGF protein. Vascular endothelial growth factor (VEGF) is a protein that promotes the growth of new blood vessels and also makes vessels more permeable or leaky. Patients with macular degeneration secrete too much of this protein. The company’s anti-angiogenic treatment is able to suppress neovascular lesions at a low dose with durable effects from a single injection. The prevention of neovascularisation provides relief of vascular leakage ...
- Source: drugdu
- 113
- July 6, 2023
Has COVID-19 changed the future of pharmaceutical regulation?

Has COVID-19 revolutionized the future of regulation of medicine development and authorization or are we simply responding to an unprecedented global pandemic? Our Head of Regulatory Affairs and Enhanced Services, Harriet Edwards, delves deep on how the pandemic changed the industry we work in today. COVID-19, or SARS-CoV-2, has undoubtedly changed the world as we know it, affecting daily life, health, and economics to an unprecedented degree. Due to the widespread and devastating impact of this previously unknown virus, there has been a massive effort from the pharmaceutical industry to rapidly develop a vaccine to protect the population. As a consequence of the increasingly evolving threat of COVID-19, developers and regulators have had to respond accordingly, learning about the virus while attempting to develop and regulate treatments concurrently. This article aims to examine whether COVID-19 (SARS-CoV-2) has changed the future of regulation through identifying and discussing the notable regulatory milestones ...
- Source: drugdu
- 147
- July 2, 2023
Generics to Novartis’ leukemia drug Tasigna to reach poor countries under 4 MPP licenses

More than a year ago, eight pharma giants partnered to provide cancer medicines to many of the world’s most needy nations where oncology treatments often are non-existent.On Thursday, the effort took a major step toward fruition as the United Nations-backed Medicines Patent Pool (MPP) signed up four generic drugmakers to produce copycat versions of Novartis’ myeloid leukemia blockbuster Tasigna (nilotinib). The agreement allows BrightGene of Indonesia and three Indian manufacturers—Dr. Reddy’s, Eugia and Hetero—to produce generic nilotinib, even though it remains on patent in the U.S. The generic companies plan to make their copycats in six countries—Egypt, Guatamala, Morocco, Pakistan, the Philippines and Tunisia—and supply it to 44 territories. “We have seen great gains in cancer survival in the richest countries over the last decade, however, the benefit of our innovation is not reaching everyone,” Lutz Hagemann, Novartis’ president of global health and sustainability, said in a release. “Through public-private ...
- Source: drugdu
- 193
- June 28, 2023
Initiative helps neurosurgical infections drop more than 80% in two years at Pittsburgh hospital

When excess surgical site infections (SSIs) were detected among neurosurgery patients at University of Pittsburgh Medical Center (UPMC) Mercy in 2019, infection preventionist Katie Palladino, MPH, CPH, CIC, partnered with a hospital neurosurgeon on a multidisciplinary quality and process improvement initiative that led to a steep drop in infection rates over a two-year period. Their successful initiative is being presented at the Association for Professionals in Infection Control and Epidemiology’s (APIC’s) Annual Conference in Orlando Florida, June 26-28. Palladino and the surgeon began the initiative by reviewing the path of a surgical patient—from the first pre-op meeting to the surgery, to the patient’s discharge from the hospital—observing practices and looking for opportunities where infections could arise. They also reviewed pre-surgical instructions for patients and found ways to improve information about chlorhexidine gluconate (CHG) bathing, nasal decolonization, and other important infection prevention practices. The next step was a literature review of ...
- Source: drugdu
- 111
- June 27, 2023
Empress Therapeutics emerges with $50m to fund small molecule development

Life sciences venture capital firm Flagship Pioneering has unveiled Empress Therapeutics, a small molecule drug development startup. The Moderna-backed venture fund has launched Empress with a $50m investment. This will support development of its proprietary Chemilogics platform and drug discovery pipeline. So far, Empress claims to have generated 15 drug leads across multiple indications. These span multiple structural classes and target several classes of proteins, including cytokines, enzymes, G protein-coupled receptors (GPCRs), and ion channels. With this pipeline, Empress hopes to address unmet clinical needs in immune and inflammatory conditions, and metabolic, neurologic, oncologic, and pain disorders. The company expects to file multiple IND applications in these areas over the next couple of years. Empress benefits from a wealth of clinical data, and recent advances in genomics, artificial intelligence (AI) and synthetic biology. This allows the company’s platform to read genetic code and use biosynthetic instructions to find, make and ...
- Source: drugdu
- 122
- June 23, 2023
ADVANZ PHARMA and Veeva Systems link for digital operations in Europe

ADVANZ PHARMA has collaborated with Veeva Systems to set up a unified digital-first commercial foundation in Europe. ADVANZ intends to drive a unified field strategy across all markets and strengthen field engagement with healthcare professionals (HCPs) using Veeva Commercial Cloud, a family of data, software and services for advancing commercial excellence in life sciences. ADVANZ is also using Veeva OpenData and Veeva CRM Suite to consolidate its operations and to gain a clear understanding of customers throughout the healthcare ecosystem, with a focus on products within oncology, anti-infectives, critical care, endocrinology and rare diseases. This allows the company’s newly merged field teams to coordinate more effectively with HCP touchpoints across channels and regions. Veeva Europe commercial strategy vice-president Philipp Luik stated: “With Veeva Commercial Cloud, ADVANZ now has a digital foundation to sustain growth as it expands operations in Europe. “By reaching the right people sooner and leading more impactful ...
- Source: drugdu
- 116
- June 23, 2023

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