Search Results for “EC” – Page 395 – 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
- 105
- July 10, 2023
Takeda and F-star announce immunotherapy partnership worth over $1bn

Takeda and F-star Therapeutics have announced a strategic collaboration and licence agreement focused on developing next-generation multi-specific immunotherapies for patients with cancer, with the deal potentially worth over $1bn. Though few details of the partnership were disclosed, the two companies said they will jointly research and develop antibodies for new immuno-oncology targets using F-star’s proprietary fully-human Fcab and tetravalent mAb2 platforms. Takeda will then have an exclusive option to take select candidates arising from the collaboration forward, with F-star retaining the rights to research, develop,and commercialise antibodies incorporating certain other Fcab domains. F-star will receive an undisclosed upfront payment and research funding for the period of the collaboration and will also be eligible to receive future payments of up to $1bn “if all milestones across multiple programmes are reached during the term of the agreement” plus royalties. The agreement marks the third deal between the two companies, with licence agreements ...
- Source: drugdu
- 107
- 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
- 103
- July 10, 2023
Not eating enough of these six healthy foods is associated with higher cardiovascular disease and deaths globally

A study led by McMaster University and Hamilton Health Sciences researchers at the Population Research Health Institute (PHRI) has found that not eating enough of six key foods in combination is associated with a higher risk of cardiovascular disease (CVD) in adults. Consuming fruits, vegetables, legumes, nuts, fish and whole-fat dairy products is key to lowering the risk of CVD, including heart attacks and strokes. The study also found that a healthy diet can be achieved in various ways, such as including moderate amounts of whole grains or unprocessed meats. Previous and similar research has focused on Western countries and diets that combined harmful, ultra-processed foods with nutrient-dense foods. This research was global in scope and focused on foods commonly considered to be healthy. The World Health Organization estimates nearly 18 million people died from CVD in 2019, representing 32 percent of all global deaths. Of these deaths, 85 percent ...
- Source: drugdu
- 129
- July 9, 2023
FDA grants traditional approval for Eisai-Biogen’s Alzheimer’s therapy

The US Food and Drug Administration (FDA) has granted traditional approval for Eisai and Biogen’s Leqembi (lecanemab-irmb) 100mg/mL injection to treat Alzheimer’s disease (AD) in adults. With the approval of the supplemental biologics licence application (sBLA), Leqembi becomes the first therapy to slow disease progression rate and cognitive and functional decline in AD patients. This development is based on findings from the Phase III portion of Eisai’s Clarity AD clinical trial. Trial data showed that the product met the Leqembi primary endpoint and all crucial secondary endpoints, and also demonstrated clinical benefit. In January 2023, the regulatory agency granted accelerated approval for Leqembi. Leqembi is a humanised immunoglobulin gamma 1 (IgG1) monoclonal antibody that targets aggregated soluble (protofibril) and amyloid beta’s (Aβ) insoluble forms. Eisai CEO Haruo Naito stated: “The FDA approved Leqembi under the traditional approval pathway, making Leqembi the first and only approved anti-amyloid Alzheimer’s disease treatment shown ...
- Source: drugdu
- 105
- July 9, 2023
Antidepressant prescriptions continue to steadily grow in England

The number of antidepressant drugs being prescribed on the UK’s National Health Service (NHS) rose again, according to a quarterly report by the NHS Business Services Authority (NHSBSA). The report, which covers the months from October 2022 to December 2022, lists the number of mental health medicines prescribed in England according to the five British National Formulary (BNF) drug groups. This includes drugs that could have been dispensed in England, Scotland, Wales, Isle of Man of the Channel Islands. The British National Formulary classifies mental health medications into different groups based on their use. They are antidepressants, hypnotics and anxiolytics, central nervous system (CNS) stimulants and attention-deficit/hyperactivity disorder (ADHD) drugs, dementia medication, and antipsychotics. In the Q3 2022-2023, period antidepressant drugs were the most prescribed drug class, totalling nearly 22 million items, a 2.67% increase compared to the same period in the previous year. The rise is part of an ...
- Source: drugdu
- 110
- July 9, 2023
GSK’s ViiV explores novel pathway to bring long-acting HIV med Cabenuva to tough-to-treat patients

GSK’s Cabenuva made history in 2020 as the world’s first complete, long-acting HIV regimen. But the injectable drug is approved in various countries only as a switch therapy for patients who already have undetectable HIV levels in the blood. Trying to reach tough-to-treat patients who have difficulty controlling the virus with existing daily oral therapies, GSK’s ViiV Healthcare is getting creative. To seek an approval for Cabenuva in patients who aren’t virologically suppressed while on oral drugs, GSK’s ViiV is exploring running a clinical trial using a historical control group. This would replace the standard practice of randomizing some patients in the study to receive standard-of-care oral meds, ViiV’s R&D head Kimberly Smith, M.D., said during a recent interview. The FDA in February unveiled draft guidance laying out the considerations for the use of external control groups in clinical trials to prove a drug’s safety and efficacy. The gist is, ...
- Source: drugdu
- 100
- July 9, 2023
Immunotherapy significantly improves overall survival for advanced NSCLC patients

A global study, led by UCL and UCLH and sponsored by Roche, has shown that the cancer immunotherapy atezolizumab significantly improved the overall survival of advanced stage non-small cell lung cancer patients who were not able to be treated with platinum-containing chemotherapy, when compared to single-agent chemotherapy. The trial results, published today in The Lancet, are good news for non-small cell lung cancer patients who are not eligible for standard of care platinum-based chemotherapy, due to concerns about their ability to withstand the treatment. Lung cancer is the leading cause of cancer death worldwide, with around 2.2 million new cases and 1.8 million deaths a year. The majority of patients present with advanced stage non-small cell lung cancer (NSCLC) . For the fittest patients with advanced stage NSCLC, first-line immunotherapy with or without platinum-based doublet chemotherapy (PDC) is now established as the standard of care treatment. This follows several randomized ...
- Source: drugdu
- 124
- July 9, 2023
New AI system could revolutionize the diagnosis of valvular heart disease

AI (artificial intelligence) may sound like a cold robotic system, but Osaka Metropolitan University scientists have shown that it can deliver heartwarming-;or, more to the point, “heart-warning”-;support. They unveiled an innovative use of AI that classifies cardiac functions and pinpoints valvular heart disease with unprecedented accuracy, demonstrating continued progress in merging the fields of medicine and technology to advance patient care. The results will be published in The Lancet Digital Health. Valvular heart disease, one cause of heart failure, is often diagnosed using echocardiography. This technique, however, requires specialized skills, so there is a corresponding shortage of qualified technicians. Meanwhile, chest radiography is one of the most common tests to identify diseases, primarily of the lungs. Even though the heart is also visible in chest radiographs, little was known heretofore about the ability of chest radiographs to detect cardiac function or disease. Chest radiographs, or chest X-Rays, are performed in ...
- Source: drugdu
- 109
- July 9, 2023
Safety Concerns About New Weight Loss Drugs Brew as Demand Soars

By Heather McKenzie Pictured: Physician with notepad/iStock, Everyday better to do everything you love The European Medicines Agency recently flagged a safety signal regarding the potential for glucagon-like peptide-1 receptor agonists to cause thyroid cancer. The documentation—the first step taken by the regulator toward investigation of potential adverse events in approved products—comes as demand for the popular diabetes and weight loss drugs reaches a fever pitch. The safety signal reported by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) in April covers a range of glucagon-like peptide-1 receptor (GLP-1) agonists, including semaglutide, the key ingredient in Novo Nordisk’s Wegovy, Ozempic and Rybelsus. Supplemental information was also requested from Eli Lilly, Sanofi and AstraZeneca, all of which manufacture drugs in this class. GLP-1 is a hormone that stimulates insulin secretion after eating, enabling a feeling of fullness and regulating blood sugar. GLP-1 agonists mimic the effects of this hormone, making them an ...
- Source: drugdu
- 109
- July 9, 2023

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.