Agency IQ

AUGUST 2, 2024

What we expect European regulators to do in August and September 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

SEPTEMBER 12, 2022

Chaired by Karin Blumer, Director of Global Patient Engagement at Novartis, the first event in this track, called ‘Patient Engagement: Driving Patient Advocacy to Inform Patient Centric Development’, looked into the multi-layered importance of involving patients in the drug development process, particularly in this case for gene therapy.

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Vial

JUNE 24, 2024

Contract research organizations (CROs) and pharmaceutical companies can leverage these cutting-edge technologies to streamline clinical trials and introduce automation in drug discovery. As clinical trials grow in complexity, the volume of data being gathered and utilized for these studies is expanding.

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Agency IQ

JULY 8, 2024

What we expect European regulators to do in July 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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Vial

FEBRUARY 21, 2024

Clinical trials are needed to determine whether a medical device can produce sufficient proof of its efficacy. However, medical device sponsors and developers are limited by the complex regulatory processes and the high costs associated with the design of running clinical trials for their products.

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Drug Discovery World

OCTOBER 2, 2024

The event explored how patient-derived organoids are revolutionising drug discovery by overcoming the limitations of traditional preclinical models. Before joining HUB, Dr Boj studied the role of TCF7L2 in regulating metabolism in the laboratory of Prof Hans Clevers at the Hubrecht Institute.

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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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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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Advarra

FEBRUARY 24, 2023

But what does “working” really mean when efficacy means something subjective, like quality of life, reduced psychiatric events, or less symptoms? In most cases, the results you are really looking for and trying to prove in a trial can be complex.

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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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Regulations Clinical Trials Production Biosimilars 40

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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The Pharma Data

NOVEMBER 10, 2020

Brazil’s National Agency for Sanitary Surveillance (ANVISA) has suspended Beijing, China-based Sinovac’s phase 3 trial of its COVID-19 vaccine, CoronaVac, halting the study Tuesday to evaluate a serious adverse event that occurred. Source link.

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Drug Discovery World

NOVEMBER 10, 2023

Topline results from a Phase I/II clinical trial have shown that Kiora’s light-restoring small molecule KIO-301 has the potential to meaningfully improve vision in patients with retinitis pigmentosa (RP). KIO-301 was safe and well tolerated with no ocular and non-ocular serious adverse events, nor any signs of retinal inflammation.

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Advarra

JUNE 14, 2024

A regulatory binder is essential for managing clinical trial documents, ensuring regulatory compliance, and facilitating audits. It organizes critical documents; provides easy access for trial monitors, auditors, and regulatory authorities; and serves as a reference for the research team.

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Crucial Data Solutions

MAY 31, 2023

Clinical trials continue to move closer to patients. Improvements to data collection technologies and processes, a robust high-speed internet infrastructure, and pressure from regulators to make research more inclusive are converging, making exclusively site-based study designs increasingly rare. Luckily, there is one solution.

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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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The Pharma Data

SEPTEMBER 1, 2020

Explore how emerging trends in clinical trial investigations are bringing patients closer to medicine making them more patient-centric. The patient experience is an important consideration in trial design. Innovative ways regulators are implementing new clinical practices to measure the patient perspective.

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Agency IQ

APRIL 19, 2024

Meet C3TI, FDA’s new clinical trial innovation hub On April 14, FDA announced that its Center for Drug Evaluation and Research (CDER) is launching a new clinical trial innovation hub, the CDER Center for Clinical Trial Innovation (C3TI). In particular, regulations in both the U.S.

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Drug Discovery World

AUGUST 21, 2023

Semaglutide manufacturer Novo Nordisk reported earlier this month that the drug reduces the risk of major adverse cardiovascular events by 20% in adults with overweight or obesity, as shown in the SELECT trial. However, these trials won’t be complete until 2026 at the earliest. It’s an exciting area,” he told The Guardian.

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The Strateos Blog: Drug Discovery

DECEMBER 5, 2022

The Alliance fosters pre-competitive collaboration with members working together as equals on projects that will benefit the industry as a whole—whether it is identifying the root causes of inefficiencies, working with regulators to adopt new standards, or helping researchers implement AI effectively—and more!  The

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Drug Discovery World

NOVEMBER 24, 2022

Despite the importance of the pharmaceutical industry to national economies and population health, the report paints a picture of falling competitiveness, with the global share of R&D investment, clinical trials and manufacturing output all decreasing. . Overall clinical trial activity in the region is also on the decline.

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Drug Target Review

SEPTEMBER 25, 2024

BRAF and downstream mitogen-activated extracellular signal-regulated kinase (MEK) inhibitors are combined to treat BRAF-mutated melanoma, for example. Inhibiting KDM5A, a regulator of cell proliferation, poses another interesting approach.

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Advarra

SEPTEMBER 23, 2022

In other words, the FDA also regulates whether investigational products may be manufactured, shipped, and administered to human subjects who participate in clinical investigations. . There are three types of amendments specified in these regulations: . The sponsor of the investigation submits an IND to the FDA; . 21 CFR 312.40(a)

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Perficient: Drug Development

FEBRUARY 1, 2024

The SCOPE (Summit for Clinical Ops Executives) conference is a premier event in the field of clinical operations, providing a comprehensive platform for professionals to explore the latest trends and innovations in clinical research. The conference will take place on February 11-14, 2024, in Orlando, Florida. Still not registered?

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Advarra

SEPTEMBER 14, 2023

In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials.

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The Pharma Data

NOVEMBER 8, 2020

FDA authorizes restart of AstraZeneca’s Covid-19 phase 3 trial. The US Food and Drug Administration (FDA) has authorized the restart of AstraZeneca ’s clinical trial for the Oxford coronavirus vaccine AZD1222 in the US, after regulators in the UK, Brazil, South Africa and Japan had already confirmed it was safe to proceed. .

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The Pharma Data

NOVEMBER 29, 2020

AstraZeneca’s COVID-19 vaccine candidate is facing another potential delay as the company plans to undertake a new global clinical trial to confirm the vaccine’s 90 percent efficacy based on a one-and-a-half-dose regimen. An additional trial could further delay AZ’s efforts to earn an EUA in the U.S., James Miessler. Source link.

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Vial

MARCH 15, 2024

The decision to outsource to a CRO is more than a strategic move; outsourcing to a CRO has multiple benefits , including access to streamlined expertise and risk mitigation in clinical trials. Breakdown of CROs Roles Initially, CROs primarily concentrated on overseeing clinical trial site operations and data management.

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Drug Target Review

JULY 4, 2023

1 Regulators invest significant consideration balancing quality-of-life measures with overall survival when assessing novel oncology treatments. 2 However, when dosed at the MTD, ADCs display improved efficacy over small molecules in oncology trials. 3D rendering of Antibody Drug Conjugate Molecules.

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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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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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Advarra

DECEMBER 15, 2022

As the research community continues to seek clinical trial efficiencies designed to bring therapies to patients faster, more governing bodies are pushing for single institutional review board (single IRB) review as one way to streamline efforts. Policies and Regulations Affecting Single IRB Review. Common Rule Single IRB Policy.

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Drug Discovery World

APRIL 11, 2023

Endogena Therapeutics has completed the dose-escalation stage of its Phase I/IIa study of EA-2353 in retinitis pigmentosa (RP) with no clinically relevant or dose-limiting adverse events. We have the best people working tirelessly to bring this novel treatment to the patients who need it as fast as possible.”

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The Pharma Data

DECEMBER 17, 2020

COVID-19 vaccine developers are faced with an ethical quandary — whether to let phase 3 trial participants become “unblinded” and to receive authorized vaccines as they become available, which could hinder the collection of meaningful trial data. Pfizer, which has received emergency approvals in the U.S.

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Agency IQ

AUGUST 2, 2024

What We Expect the FDA to do in August and September 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.

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Drug Discovery World

MAY 15, 2024

One of several other events associated with NPDR is the emergence of centre-involved diabetic macular edema (ci-DME), a similarly vision threatening condition that can arise independently of the transition to PDR. Currently in a Phase Ib/IIa study, it is believed to stabilise GAP-junction activity through regulation of connexin-43.

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Agency IQ

JULY 8, 2024

What We Expect the FDA to do in July and August 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.

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