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Submission of Nidlegy marketing authorisation application validated by EMA

Philogen and Sun Pharmaceutical Industries (“Sun Pharma”) announces that on June 20 the European Medicines Agency (EMA) validated the submission of the Marketing Authorisation Application (MAA) for Nidlegy , which was finalised on June 3 2024. “The validation of the dossier by EMA represents the first important milestone for the MAA review process,” commented Dario Neri, chief executive officer and chief scientific officer at Philogen. “Our group is committed to working with EMA throughout the review process with the goal of making Nidlegy available to patients in need.” Nidlegy is partnered with Sun Pharma for the treatment of Skin Cancers in Europe, New Zealand and Australia. The data of the Phase III Nidlegy trial are expected to be published in a peer-reviewed scientific journal in 2024. https://sunpharma.com/wp-content/uploads/2024/07/Press-Release-Validation-of-Nidlegy%E2%84%A2-Marketing-Authorization-Application-Submission-by-EMA.pdf
- Source: drugdu
- 102
- July 6, 2024
FDA approves Eli Lilly’s alzheimer’s drug

The U.S. Food and Drug Administration has approved Eli Lilly’s Kisunla (donanemab-azbt) injection, a new treatment for Alzheimer’s disease. Targeted at adults in the mild cognitive impairment or mild dementia stage, Kisunla has shown significant promise in slowing clinical decline, offering a new beacon of hope for patients and their families. The approval comes after a double-blind, placebo-controlled, parallel-group study (Study 1, NCT04437511) in patients with Alzheimer’s disease. The patients had confirmed the presence of amyloid pathology and mild cognitive impairment or mild dementia stage of disease. 1736 patients were randomised 1:1 to receive 700 mg Kisunla every four weeks for the first 3 doses, and then 1400 mg every four weeks (N = 860) or placebo (N = 876) for a total of up to 72 weeks. The treatment was switched to placebo based on a prespecified reduction in amyloid levels measured by positron emission tomography (PET) at Week ...
- Source: drugdu
- 154
- July 6, 2024
GSK Pays CureVac €400M to Pick Up Clinical-Stage mRNA Vaccines for Infectious Diseases

GSK is taking over development of an avian influenza vaccine candidate as a bird flu outbreak continues in U.S. dairy cows. Meanwhile, CureVac is restructuring and returning its attention to cancer vaccines, which was the initial focus of the mRNA company. By Frank VinluanGSK and CureVac forged their relationship during the Covid-19 pandemic, setting out to develop vaccines that could protect against the novel coronavirus and other infectious diseases. The collaboration has advanced two vaccine candidates into clinical testing, and now GSK is taking over both, one of them in development for an infectious disease target that’s particularly hot right now. Under terms of the restructured agreement announced Wednesday, GSK will now have full control of developing and manufacturing the avian influenza vaccine, currently in Phase 1 testing, and a Covid-19 vaccine in Phase 2 testing. GSK is paying €400 million (about $431.4 million) up front to obtain global rights ...
- Source: drugdu
- 100
- July 5, 2024
Moderna Awarded $176 Million from the Biomedical Advanced Research and Development Authority to Expedite Development of mRNA-Based Influenza Vaccines

By Don Tracy, Associate Editor Funding from the Biomedical Advanced Research and Development Authority (BARDA) is expected to support the late-stage development and licensure of a pre-pandemic vaccine targeting the H5 influenza virus. The Biomedical Advanced Research and Development Authority (BARDA) has granted Moderna a $176 million project award under the Rapid Response Partnership Vehicle (RRPV) Consortium, with the goal of expediting the development of mRNA-based pandemic influenza vaccines. Reportedly, the award is expected to support the late-stage development and licensure of a pre-pandemic vaccine targeting the H5 influenza virus, a subtype known for causing severe avian influenza and posing a potential risk to humans.1 “mRNA vaccine technology offers advantages in efficacy, speed of development, and production scalability and reliability in addressing infectious disease outbreaks, as demonstrated during the COVID-19 pandemic,” said Stéphane Bancel, CEO, Moderna, in a press release. “We are pleased to continue our collaboration with BARDA to ...
- Source: drugdu
- 147
- July 5, 2024
Liver Biopsy Reveals Early Signs of Rapid Metastasis in Pancreatic Cancer Patients

Only 10% of individuals diagnosed with pancreatic cancer will live beyond two years post-diagnosis. The ability to predict the timing and location of metastases could dramatically transform the treatment approach for pancreatic cancer, especially for those at high risk of metastasis. Now, researchers have employed liver biopsies—a small tissue sample taken for laboratory analysis—to identify cellular and molecular markers that might predict if and when pancreatic cancer will metastasize to the liver or other areas like the lungs. A study conducted by Weill Cornell Medicine (New York, NY, USA) and an international research group suggests that data from liver biopsies obtained at the time of pancreatic cancer diagnosis could inform personalized treatment plans, such as liver-targeted immunotherapies, to preempt the spread of cancer cells. The research team discovered in 2015 that pancreatic cancer cells emit substances that primarily target the liver to create a pre-metastatic niche that promotes the growth ...
- Source: drugdu
- 104
- July 5, 2024
Pharmaconex

Organiser：Informa Markets Time： September 8-10, 2024 Address：El-Nasr Rd, Al Estad, Nasr City, Cairo Governorate Exhibition hall：Cairo International Convention Centre Product range: Vitamins, Hormones, Antipyretic Analgesics, Digestive System Medications, Anti-infective Drugs, Antiparasitic Drugs, Cardiovascular System Medications, Intermediates Pharmaceutical Packaging Materials: PVC/PVDC Laminates, PVC Rigid Sheets, PS Sheets, Anti-Counterfeiting Technology for Packaging, Label Sleeve Technology, Labeling Machines, Packaging Containers, Form-Fill-Seal Machines, Wrapping Machines, Paper Film Packaging Machinery, Bag Packaging Machines, etc. Infusion Equipment Production Lines, Dryers, Water Treatment Equipment, Refrigeration Compressors, Distillation Equipment, Sterilization Equipment, Tablet Presses, Coating Machines About Pharmaconex： Pharmaceutical Ingredients & Technology Exhibition in Cairo, Egypt, is the most renowned exhibition for pharmaceutical ingredients and technology in Egypt. Hosted by the renowned British exhibition company Informa Markets, with extensive experience and strong capabilities in organizing exhibitions, Pharmaconex plays a significant role in exploring the markets of Egypt and Africa.
- Source: drugdu
- 169
- July 5, 2024
New Lab Test Detects Persistent HIV Strains in Africa

Most research on the human immunodeficiency virus (HIV) has concentrated on the virus variants prevalent in Western nations, primarily impacting men who have sex with men, with a focus on subtype B. However, less attention has been given to the variants in Africa, where the virus significantly affects women. To develop a universally effective cure, it’s crucial to investigate viral variants not only in developed regions but across different global demographics. Researchers have now developed a test to measure HIV persistence in individuals predominantly affected by African viral strains—a critical step towards finding a cure that can aid patients globally. This research, published in Nature Communications on July 2, addresses a significant shortfall in HIV research. The findings of the study by a multinational team led by investigators at Weill Cornell Medicine (New York, NY, USA)—similar to findings in the developed world—revealed that African HIV strains form viral reservoirs in ...
- Source: drugdu
- 117
- July 5, 2024
Study reveals cardiovascular health could be biggest risk factor for dementia

Dementias, including Alzheimer’s disease, are estimated to affect 944,000 people in the UK Researchers from University College London (UCL) have revealed that cardiovascular health could be the biggest risk factor associated with future dementia. Published in the Lancet Public Health, the study was funded by the National Institute for Health and Care Research’s Three Schools’ Dementia Research Programme. Estimated to affect 944,000 people in the UK, dementia is a general term for the impaired ability to remember, think, or make decisions that affects everyday life. The most prevalent dementias include Alzheimer’s disease, vascular dementia, Lewy body dementia and frontotemporal dementia. Researchers analysed and extracted data from 27 papers involving people with dementia worldwide, with data collected between 1947 and 2015 and the latest paper published in 2020. The extracted information from each paper about dementia risk factors was then used to calculate what proportion of dementia cases were attributable to ...
- Source: drugdu
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- July 5, 2024
Study finds headache drug could prevent overuse of acute migraine medications

Chronic migraine is a neurological condition estimated to affect up to 2.2% of people globally A study led by researchers at King’s College London (KCL) and funded by AbbVie has revealed that a headache drug helps to prevent the overuse of acute migraine medication. Published in Neurology, AbbVie’s Qulipta (atogepant) was shown to be effective in decreasing migraine days in adults living with chronic migraine. Estimated to affect up to 2.2% of the global population, chronic migraine is a debilitating neurological disease where people regularly experience at least 15 days a month of headaches. Most often, headaches can be intensified by the overuse of acute migraine medications such as triptans, ergots and simple analgesics, leading to worse pain relief outcomes over a 24-hour period. Funded by AbbVie, the study assessed the efficacy of Qulipta in preventing chronic migraine in patients who met the criteria for acute medicine overuse as well ...
- Source: drugdu
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- July 5, 2024
Beacon secures $170m to advance ophthalmic gene therapies

Beacon Therapeutics has raised $170m in a Series B funding round to accelerate the development of its lead asset AGTC-501, for X-linked retinitis pigmentosa (XLRP). The financing round was led by life sciences venture capital firm Forbion, alongside existing investors Syncona Limited, Oxford Science Enterprises and the University of Oxford, and also featured initial investments from TCGX and Advent Life Sciences. The British investment trust Syncona previously acquired Applied Genetic Technologies Corporation (AGTC) for $23.5m in October 2023. AGTC inherited a portfolio of ophthalmic pipeline candidates, including AFTC-501, an adeno-associated virus (AAV) gene therapy. XLRP is a genetic disorder that causes progressive vision loss, primarily in males, due to retinal degeneration. AFTC-501, now transferred to Beacon, has been investigated in several clinical trials for XLRP. Promising interim data from the Phase II SKYLINE trial (NCT03316560) was announced in February 2024, showing that 63% of eyes treated with high-dose AGTC-501 experienced ...
- Source: drugdu
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- July 5, 2024

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