Agency IQ

NOVEMBER 3, 2023

regulatory landscape for probiotics and other microbiome-based therapies Probiotics, a type of microbiome-based therapy containing live micro-organisms, are broadly available on drug store and grocery store shelves, but the regulatory classifications for products containing the same micro-organism can differ dramatically.

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Conversations in Drug Development Trends

APRIL 3, 2024

By: Sue Batchelor, Executive Director, Oncology Project Management Radiopharmaceuticals represent a cutting-edge frontier in oncology treatment, offering the promise of highly targeted therapy with the potential to revolutionize cancer care. Are you aware of the challenges you must address for a successful radiopharmaceutical trial?

Trials 81

Trials Clinical Trials Compliance Treatment 81

Vial

APRIL 10, 2024

The strong commitment to innovation allows IQVIA to provide advanced analytics, technology solutions, and industry-specific expertise in the health information technologies and clinical research domains. This approach replaces paper sources, supports productivity-enhancing workflows, and ensures compliance with relevant regulations.

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Clinical Trials Trials Compliance Clinical Research 52

Olympian Clinical Research

SEPTEMBER 3, 2020

Eating a well balanced diet, full of fruits and vegetables, floods your body with antioxidants that then decrease the internal inflammation contributing to and/or caused by depression. . Sleep is especially important in regulating mood. Try to also exercise regularly, make time for meditation, and get plenty of sleep each night.

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Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. Read AgencyIQ analysis here for a detailed discussion of these issues. ].

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Drug Discovery World

SEPTEMBER 28, 2022

Yet despite this, the biggest players in the global pharma sector are increasingly opening their doors to partnerships with AI and machine learning companies, cognisant of the potential benefits these could provide across broad therapy areas such as oncology, autoimmune and rare diseases. . How AI can streamline drug discovery .

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Agency IQ

FEBRUARY 2, 2024

What We Expect the FDA to do in February and March 2024 (Updated) In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

MARCH 1, 2024

What We Expect the FDA to do in March and April 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. Read AgencyIQ’s analysis of a lower court’s ruling.

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The Pharma Data

JANUARY 7, 2021

As CEO of Freeline, a liver-directed gene therapy company, she scaled the company from preclinical stage to a fully integrated biotechnology organization, which included a broad, internally developed pipeline, two programs in clinical development and a commercial-scale, high-quality CMC and manufacturing platform.

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The Pharma Data

DECEMBER 17, 2020

Goater is CEO at Surface Oncology, an immuno-oncology company developing next-generation antibody therapies. Thérin is the president of Advanced Therapies at Siemens Healthineers. Prior to SpringWorks, Smith was the executive vice president of Gene Therapy at Bamboo Therapeutics. Immune Regulation – U.K.-based

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The Pharma Data

DECEMBER 14, 2020

“With the acquisition of this intellectual property, we have solved the problem that has plagued psychedelic therapies for so many decades. Our highly experienced clinical team will be placing 2-Bromo-LSD into multi-center United States clinical research locations without restriction.”.

Bioethics 40

Bioethics Clinical Research Regulations Compliance 40

The Pharma Data

DECEMBER 15, 2020

The Data Contribution Agreement between Diamyd Medical and C-Path will allow for this unique set of fully anonymized clinical trial data to be integrated into an ever-growing list of committed trial data sets within the TOMI-T1D project. For more information, please visit jdrf.org or follow us on Twitter: @JDRF.

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Drug Development Clinical Trials Vaccine Trials 40

Conversations in Drug Development Trends

MAY 1, 2024

For clinical research professionals, this journey often involves reconciling differing feedback from regulatory agencies, each with unique standards, priorities, and expectations. Maintaining open lines of communication helps address issues as they arise, allowing for real-time clarification and adjustments. Japan, and China.

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Clinical Research Trials Research Clinical Trials 69

The Pharma Data

NOVEMBER 10, 2020

We’re excited to be collaborating with Tiziana to support the development of a novel, oral therapy that could provide Crohn’s patients with another option in their repertoire of treatments to combat this devastating disease.”. This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

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Drug Discovery World

JULY 1, 2024

He thinks that the amount of money awarded in total is unique for research in this very specific field and that the research projects complement each other and the international research in this field. billion DKK ($11.97 He said: “A single study can never form the basis for recommendations.

Disease 162

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PPD

AUGUST 5, 2024

Food and Drug Administration (FDA)-approved therapies for treating PAH were primarily vasodilators, designed to overcome the imbalance between vasoactive and vasodilator mediators and to restore endothelial cell function. Complexity: PAH trial sites are complex and require highly experienced clinicians, researchers and support staff.

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Clinical Trials Trials Clinical Research Disease 98

The Pharma Data

DECEMBER 13, 2020

AMPK is a master regulator of several important metabolic pathways, including lipid metabolism, glucose control and inflammation, and is a novel target for NASH and additional chronic and rare metabolic diseases. . Harrison, MD, Director, Summit Clinical Research. Currently no curative or specific therapies are available.

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Trials Disease Treatment Pharmacokinetics 52

Drug Discovery World

AUGUST 24, 2023

Of course, while the regulation remains a continuous battle, this does not hinder the research being undertaken. Moreover, the US Food and Drug Administration (FDA) granted breakthrough therapy status to psilocybin in 2018 for treatment-resistant depression, and in 2019 for major depressive disorder 4.

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Vial

MAY 15, 2024

Vial | Pros and Cons The unprecedented consequences of the COVID-19 pandemic gave rise to the advent of decentralized clinical trials (DCTs), which are studies that use telemedicine and remote or local healthcare professionals to enable participants to join from different locations. billion and now functions as a subsidiary.

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Clinical Trials Trials Clinical Research Compliance 52

The Pharma Data

DECEMBER 29, 2020

It is believed that the advantage of this nanomedicine-based therapy is not solely the ability to deliver the therapeutic directly to the lungs of the patient, but also the induction of virus aggregation leading to patient immunity, in effect, simultaneous generation of a vaccination response. en/research. About TU/e.

Therapies 52

Therapies Virus Engineering International 52

Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 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.

FDA 40

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PPD

DECEMBER 12, 2023

Navigating the Intricacies of the Follow-the-Sun Model in Clinical Research The implementation of a follow-the-sun model, which leverages global resources in different time zones to assure continuous operations, requires a thoughtful approach to cultures, communication and collaboration for effective results.

Compliance 52

Compliance Clinical Research Trials Clinical Trials 52

Drug Target Review

SEPTEMBER 26, 2023

Human derived induced pluripotent stem cells (hiPSCs) have revolutionised research and are increasingly used for toxicology screening and disease modelling. Early detection of neurotoxicity induced by potential new therapies is a major challenge, and hiPSC-neuronal cells may provide a solution. Ther Innov Regul Sci. Rockley KL.

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The Pharma Data

NOVEMBER 10, 2020

While the world is facing a severe shortage of specific antiviral drugs, a new treatment developed by Asclepius Meditec highlights the potential of hydrogen-oxygen therapy in tackling COVID-19. The paper has been contributed and under review. History of Application of Molecular Hydrogen in Medicine.

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Hospitals Clinical Trials Treatment Therapies 52

The Pharma Data

JANUARY 13, 2021

Optimum Strategic Communications (International Media and European Investor Enquiries). Ensifentrine also activates the Cystic Fibrosis Transmembrane Conductance Regulator (“CFTR”), which is beneficial in reducing mucous viscosity and improving mucociliary clearance. . .

Hospitals 52

Hospitals Clinical Trials Therapies Treatment 52

The Pharma Data

OCTOBER 14, 2020

Pre-clinical and clinical proof-of-concept data from a first-in-human single dose DSR study demonstrated that single dose DSR therapy was safe and well-tolerated and the positive results were published in the high impact peer-reviewed cardiovascular journal, Circulation. About Dr. Udelson James E.

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Clinical Trials Clinical Research Therapies Marketing 40

The Pharma Data

DECEMBER 23, 2020

Marketing Authorization was based on the pivotal phase III ATLAS (Antiretroviral Therapy as Long-Acting Suppression), FLAIR (First Long-Acting Injectable Regimen) and ATLAS-2M studies. Ilya Pharma – Sweden’s Ilya Pharma announced it extended its research collaboration in immunophysiology with Uppsala University.

Licensing 52

Licensing Licensing Vaccine Compliance 52

Agency IQ

AUGUST 9, 2024

has adopted some measures to spur Member States to harmonize their approach towards regulating the possession and research use of narcotics, the specifics nonetheless vary from jurisdiction to jurisdiction. Although the E.U. Notably, in addition to five academic presentations , the workshop featured presentations from the U.S.

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Agency IQ

MAY 28, 2024

With “numerous public reports of FDA actions that delay approvals well beyond these timelines, often due to bureaucratic limbo or last-minute internal decisions,” he said he is concerned that FDA’s reports don’t tell the whole story. It’s happening too often,” said Hudson. Read AgencyIQ’s analysis of the rule here.] Thank you.

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