Agency IQ

OCTOBER 27, 2023

What we expect European regulators to do in November 2023 In this new recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Agency IQ

DECEMBER 1, 2023

What we expect European regulators to do in December 2023 In this new recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Drug Discovery World

JUNE 16, 2023

The International Society for Cellular Therapy (ISCT) is a global society of clinicians, regulators, technologists, and industry partners with a shared mission to drive the translation of all cell and gene (CGT) therapies for the benefit of patients worldwide. DDW’s Megan Thomas heard from attendees about key trends in the sector.

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Drug Discovery World

JUNE 12, 2023

The International Society for Cellular Therapy (ISCT) is a global society of clinicians, regulators, technologists, and industry partners with a shared mission to drive the translation of all cell and gene therapies for the benefit of patients worldwide. The ISCT 2023 Annual Meeting took place in Paris, France from May 31 to June 3 2023.

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KIF1A

JUNE 10, 2023

Each week, Dr. Dylan Verden of KIF1A.ORG summarizes newly published KIF1A-related research and highlights progress in rare disease research and therapeutic development. In this week’s pre-print, researchers found evidence for KIF1A’s role in transporting a very important type of cargo: Mitochondria.

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Drug Target Review

NOVEMBER 3, 2023

Organoid group (Hubrecht Institute) researchers, collaborating with researchers at the Princess Máxima Center and Maastricht University, used gut organoids to perform a systematic CRISPR screening of 1800 human transcription factors. 2018 February 8 [2023 November 1];172(4):650-65. The study was published in Science.

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Broad Institute

AUGUST 7, 2023

A surprising new role for a major immune regulator By Tom Ulrich August 7, 2023 Breadcrumb Home A surprising new role for a major immune regulator By Anne Trafton, MIT News August 7, 2023 Credit: RCSB Protein Data Bank A model of the human STING protein.

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KIF1A

JUNE 24, 2023

Each week, Dr. Dylan Verden of KIF1A.ORG summarizes newly published KIF1A-related research and highlights progress in rare disease research and therapeutic development. In this week’s article, researchers investigated how zinc on microtubules acts like a roadblock for kinesins. Minckley et al.

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Drug Discovery World

DECEMBER 18, 2023

Digital biomarkers promise to transform preventive medicine and clinical trials, but also raise issues of security, regulation and potential disparities in access. They mark a significant shift in clinical research, utilising technology to capture real-time patient data. Digital biomarkers could be the cornerstone of this evolution.

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KIF1A

OCTOBER 28, 2023

Each week, Dr. Dylan Verden of KIF1A.ORG summarizes newly published KIF1A-related research and highlights progress in rare disease research and therapeutic development. KIF1A-Related Research Genetic overlap between ALS and other neurodegenerative or neuromuscular disorders How do you define a disease?

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Drug Discovery World

MAY 25, 2023

Following the Scottish Research and Drug Development Forum meeting, DDW’s Diana Spencer provides a snapshot of drug discovery in Scotland. Introduction to the CRUK Beatson Institute The first speaker was Professor Owen Sansom, Director of the Cancer Research UK Beatson Institute, who gave two presentations.

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Drug Discovery World

APRIL 17, 2023

Cancer research has always been a team sport. We all need to think much more broadly,” said Lisa M Coussens, Deputy Director for Basic & Translational Research, Knight Cancer Institute, Oregon Health & Science University. Lisa M Coussens “This is an old story with new components.

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KIF1A

JUNE 17, 2023

Dylan Verden of KIF1A.ORG summarizes newly published KIF1A-related research and highlights progress in rare disease research and therapeutic development. The researchers assessed KIF1A’s speed, distribution, and ability to transport both small and large cargo across these 16 mutations. What’s a pre-print? .

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KIF1A

NOVEMBER 20, 2023

Join Professor Angela Morgan, co-Director of the Royal Children’s Hospital’s Speech Genomics Clinic and Lead of the Speech and Language team at Murdoch Children’s Research Institute in Melbourne, to discuss genetic speech pathologies, family experiences with communication in KAND, and how speech studies can benefit our community.

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Agency IQ

MAY 31, 2024

What we expect European regulators to do in June 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Drug Discovery World

NOVEMBER 10, 2023

With the first DDW Turning Science into Business Summit taking place next week on the theme of Cancer Research, this dynamic area of drug discovery is my round-up focus again. The post This week in drug discovery (6-10 November) appeared first on Drug Discovery World (DDW).

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PPD

APRIL 30, 2024

31, 2022, the EU Clinical Trial Regulation (EU CTR) 536/2014 became applicable, heralding a new era for clinical trials in the European Union (EU). Our PPD FSP regulatory affairs solutions teams, part of the PPD clinical research business of Thermo Fisher Scientific, regularly gather, assess and determine the impact of CTR intelligence.

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Agency IQ

APRIL 12, 2024

Landscape analysis: A look at the regulation of decentralized trials and what’s coming soon In the past few years, regulators and researchers have shown increased interest in leveraging decentralized trial methods – especially following the pandemic.

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KIF1A

APRIL 29, 2023

Dylan Verden of KIF1A.ORG summarize newly published KIF1A-related research and highlight progress in rare disease research and therapeutic development. Kaur is an integral member of our Research Network whose transparency and collaboration underlie her success.

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FDA Law Blog: Biosimilars

JANUARY 22, 2024

Claud — The Office of Compliance (OC) at FDA’s Center for Drug Evaluation and Research (CDER) had a role in many of the major public health enforcement matters you may have read about last year. This is another area in which FDA works with industry to try to ensure voluntary compliance from regulated entities. By John W.M.

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Agency IQ

MARCH 1, 2024

What we expect European regulators to do in March 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Agency IQ

MARCH 29, 2024

What we expect European regulators to do in April 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Drug Discovery World

MAY 8, 2024

This new era of digitalisation is exciting and promises great opportunity, but it does introduce questions as to how regulators can keep up to combat concerns around how AI should be monitored, data ethics, data privacy, and safety with appropriate supporting legislation. There is now growing pressure for regulators to take action.

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Drug Discovery World

JUNE 30, 2023

The company’s research data was presented during the 2023 European Academy of Allergy and Clinical Immunology (EAACI) Congress, in Hamburg, Germany. The research highlights the need for long-term studies to determine autism’s underlying causes.

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KIF1A

APRIL 22, 2023

Each week, Dr. Dominique Lessard and Dr. Dylan Verden of KIF1A.ORG summarize newly published KIF1A-related research and highlight progress in rare disease research and therapeutic development. Follow up research might involve testing if we can improve symptoms in creatine deficient mice directly by decreasing KIF1A levels.

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Drug Discovery World

APRIL 26, 2024

Researchers have found that vitamin D encourages the growth of a type of gut bacteria in mice which improves immunity to cancer. This microbe gave mice better immunity to cancer as the transplanted tumours didn’t grow as much, but the researchers are not yet sure how. To investigate this, the researchers analysed a dataset from 1.5

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Conversations in Drug Development Trends

NOVEMBER 10, 2023

 Instead, the medical community and regulating agencies need to balance all aspects when making decisions, working in partnership with their patients. Collaborating If you’re interested in learning more about pain therapeutics research, check out our pain expertise.

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Drug Discovery World

OCTOBER 16, 2023

The company was launched in 2019, initially to build on research from the Alzheimer’s Research UK UCL Drug Discovery Institute (UCL DDI). ” In July 2023, AstronauTx announced a partnership with Saniona, a Danish biotechnology company, to identify new treatments by modulating a novel, undisclosed ion channel target.

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Vial

MAY 20, 2024

Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research Randomized clinical trials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drug development pipeline. What is a Pre-Clinical CRO? The global preclinical CRO market was estimated to be valued at US$5.7

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Agency IQ

AUGUST 25, 2023

BY SCOTT STEPHENS, MPAAUG 23, 2023 10:15 PM CDT Background on PFAS Per- and polyfluoroalkyl substances (PFAS) are a large class of man-made organic chemicals, numbering upwards of 10,000, used in many different industrial, commercial, and consumer applications. PFAS regulation in the E.U. are currently underway.

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Agency IQ

JUNE 2, 2023

What We Expect the FDA to do in June 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. An updated Unified Agenda: The Unified Agenda is the U.S.

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Agency IQ

NOVEMBER 27, 2023

ECHA issues research wish list to aid in its regulatory endeavors The European Chemicals Agency is attempting to guide scientific research toward topics with regulatory relevance. Second , ECHA is requesting further research addressing chemical pollution in the natural environment.

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Drug Discovery World

OCTOBER 24, 2023

While attending Life Science Baltics 2023, Diana Spencer spoke to Monika Paule , CEO and Co-founder of Caszyme, about creating a company based on CRISPR gene editing and some of the challenges of operating in this dynamic area of research. Caszyme was founded in 2017 by the pioneers of CRISPR gene editing technologies.

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Drug Discovery World

FEBRUARY 6, 2024

Technologies like artificial intelligence (AI), machine learning (ML) and robotics/automation are enabling researchers to process enormous data sets and conduct preclinical investigations in record time, speeding up the process and offering greater accuracy. Universities are also using these digital technologies to advance their research.

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Drug Discovery World

DECEMBER 21, 2023

billion in the US in 2023. Innovative clinical options for IBD Research shows that PHD 1/2 plays a critical role in regulating the stability and transcriptional activity of the hypoxia-inducible factor-1α (HIF-1α), which drives the expression of barrier protective genes.

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The Pharma Data

APRIL 11, 2023

Bayer is progressing novel research around its prostate cancer treatment darolutamide. Both small molecule inhibitors in Immuno-Oncology are being jointly developed in a strategic research alliance with the German Cancer Research Center (DKFZ) in Heidelberg, Germany.

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Advarra

FEBRUARY 28, 2023

In an effort to accelerate the sharing of biomedical research results, the National Institutes of Health (NIH) issued its finalized Data Management and Sharing (DMS) policy , effective January 25, 2023. What is the 2023 NIH Data Management and Sharing Policy?

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