Pharmaceuticals and Drug Development 15 years of Op Pangea: over 25 million illegally traded medicines and devices seized in the UK valued at more than £84m This year marks 15 years since the Medicines and Healthcare products Regulatory Agency (MHRA) launched Operation Pangea, an initiative cracking down on medicines crime. Pangea is now coordinated by Interpol, and the MHRA’s Criminal Enforcement Unit (CEU) joined 89 countries for this year’s operation. Working with law enforcement partners, the CEU seized over two million […] Written by Elsevier Ltd, The Boulevard, Langford Lane, Kidlington, Oxford, OX5 1GB, United Kingdom May 30, 2025May 30, 2025 Saving Bookmark this article Bookmarked
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Pharmaceuticals and Drug Development FDA Extends PDUFA Date of Biohaven's Troriluzole NDA for Rare Disease Spinocerebellar Ataxia NEW HAVEN, Conn., May 14, 2025 /PRNewswire/ — Biohaven Ltd. (NYSE: BHVN) (Biohaven or the Company), today announced that the Division of Neurology 1 within FDA’s Office of Neuroscience informed the Company that they are extending the PDUFA date for… Written by Admin May 18, 2025May 18, 2025 Saving Bookmark this article Bookmarked
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Pharmaceuticals and Drug Development How AI is Transforming Drug Discovery: Bio-IT World Europe Participants to Share Groundbreaking Advances 29-30 November in London LONDON, Nov. 6, 2023 — The life sciences profession is in the midst of a profound transformation, guided by the revolutionary force of artificial intelligence (AI), and especially predictive and generative AI models. These state-of-the-art technologies are leading the charge—expediting drug discovery and development, catalyzing innovation, and uncovering potential new therapies for cancer, heart disease, […] Written by Elsevier Ltd, The Boulevard, Langford Lane, Kidlington, Oxford, OX5 1GB, United Kingdom May 6, 2025May 6, 2025 Saving Bookmark this article Bookmarked
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Pharmaceuticals and Drug Development Aldeyra Therapeutics Receives Complete Response Letter from the U.S. Food and Drug Administration for the Reproxalap New Drug Application for the Treatment of Signs and Symptoms of Dry Eye Disease LEXINGTON, Mass.–(BUSINESS WIRE)–Apr. 3, 2025– Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated and metabolic diseases, today… Written by Admin April 24, 2025April 24, 2025 Saving Bookmark this article Bookmarked
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Pharmaceuticals and Drug Development MHRA authorises enzyme inhibitor Anastrozole to prevent breast cancer in post-menopausal women The Medicines and Healthcare products Regulatory Agency (MHRA) has today authorised this new indication for Anastrozole, a hormone treatment used for breast cancer in post-menopausal women. Anastrozole was already authorised for use in the treatment of breast cancer in post-menopausal women and has been used off-label for prevention. Today’s announcement confirms the authorisation for […] Written by Elsevier Ltd, The Boulevard, Langford Lane, Kidlington, Oxford, OX5 1GB, United Kingdom April 12, 2025April 12, 2025 Saving Bookmark this article Bookmarked
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AI-directed voxel extraction and volume EM identify intrusions as sites of mitochondrial contact Membrane contact sites (MCSs) establish organelle interactomes in cells to enable communication and exchange of materials. Volume EM (vEM) is ideally suited for MCS analyses, but semantic segmentation of large vEM datasets remains challenging. Recent adoption of artificial intelligence (AI) for segmentation has greatly enhanced our analysis capabilities. However, we show that organelle boundaries, which […] Written by Admin July 31, 2025July 31, 2025 Saving Bookmark this article Bookmarked
Plastics production ‘a global threat’ More than 60 leading scientists from around the world have issued an urgent call for governments to agree on ambitious, enforceable action to tackle plastic pollution, as the final round of UN negotiations on a global plastics treaty approaches. The letters, published today in Cambridge University Press journal Cambridge Prisms: Plastics in the run-up to the […] Written by brendan July 31, 2025July 31, 2025 Saving Bookmark this article Bookmarked
AI-directed voxel extraction and volume EM identify intrusions as sites of mitochondrial contact Membrane contact sites (MCSs) establish organelle interactomes in cells to enable communication and exchange of materials. Volume EM (vEM) is ideally suited for MCS analyses, but semantic segmentation of large vEM datasets remains challenging. Recent adoption of artificial intelligence (AI) for segmentation has greatly enhanced our analysis capabilities. However, we show that organelle boundaries, which […] Written by Admin July 31, 2025July 31, 2025 Saving Bookmark this article Bookmarked
Plastics production ‘a global threat’ More than 60 leading scientists from around the world have issued an urgent call for governments to agree on ambitious, enforceable action to tackle plastic pollution, as the final round of UN negotiations on a global plastics treaty approaches. The letters, published today in Cambridge University Press journal Cambridge Prisms: Plastics in the run-up to the […] Written by brendan July 31, 2025July 31, 2025 Saving Bookmark this article Bookmarked
pipeline drugs to watch in 2025 Newsletter Signup – Under Article / In Page “*” indicates required fields A consistent sleep schedule of going to bed and waking up each day allows the body to rest and helps maintain optimal brain function, physical health, and emotional stability. But for people with narcolepsy, staying awake can be a struggle. And as there […] Written by Roohi Mariam Peter July 31, 2025July 31, 2025 Saving Bookmark this article Bookmarked
Understanding PMDA Validation Rules v5.0 The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan has always led the charge in ensuring the safety and efficacy of drug development. Their latest update, the PMDA Validation Rules version 5.0, which took effect on April 1, 2024, marks another significant step in this mission. Let’s break down what these new rules mean and […] Written by Admin July 10, 2024July 10, 2024 Saving Bookmark this article Bookmarked
Enhance Your SEND Submissions! Join PointCross on May 29th, 2024, at 12 PM EST / 9 AM PST for a must-attend webinar: The Most Common Issues in Preparing SEND. Ideal for professionals in data submission and regulatory compliance, this webinar offers valuable insights from our seasoned experts. Why Attend? Why PointCross? With over 10 years of experience and more […] Written by Admin May 23, 2024May 23, 2024 Saving Bookmark this article Bookmarked