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.

Regulations 40

Regulations Production Compliance Pharmaceuticals 40

KIF1A

MAY 4, 2024

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 in Brazil identified a KIF1A mutation in a cohort of patients with congenital ataxia.

Science 116

Science Medical Schools RNA Research 116

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.

Regulations 40

Regulations Production Biosimilars Clinical Trials 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.

Regulations 40

Regulations Biosimilars Clinical Trials Production 40

Drug Discovery World

JANUARY 2, 2024

Cancer Research Horizon’s Innovation Summit 2023 took place on 21 November 2023 at the Royal Society of Medicine, and included talks from researchers translating their research, as well as networking with members of the entrepreneurial ecosystem. As for Infinitopes, the company’s trials will begin in 2024.

Research 147

Research Vaccine Science Trials 147

Drugs.com

SEPTEMBER 26, 2024

27, 2024 -- Laws that ban assault weapons do indeed protect children from dying in mass shootings, but the same can't be said for more common types of gun restrictions and regulations, new research shows.“Mass FRIDAY, Sept. Mass shootings are horrific e.

Regulations 98

Regulations Research 98

Drugs.com

AUGUST 8, 2024

8, 2024 -- That vape pen might contain something even worse than nicotine, new research warns.Tobacco companies may be trying to duck federal restrictions on vaping products by replacing nicotine with “nicotine analogs” -- related che. THURSDAY, Aug.

Regulations 52

Regulations Production Research 52

KIF1A

FEBRUARY 18, 2024

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 Overarching pathomechanisms in inherited peripheral neuropathies, spastic paraplegias, and cerebellar ataxias What causes KAND?

Therapies 52

Therapies DNA Clinical Trials Trials 52

FDA Law Blog: Biosimilars

MARCH 31, 2024

Gibbs — On March 21, 2024, the House Energy and Commerce held a subcommittee hearing titled “Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule.” By Ana Loloei & Jeffrey N. FDA, which was not invited to participate, would surely have concurred.

Regulations 64

Regulations FDA Laboratories Hospitals 64

Agency IQ

MAY 31, 2024

What we expect the EPA to do in June 2024 The top line: In this returning feature, AgencyIQ looks at public data to determine what the EPA is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more. This is what OIRA is currently reviewing.

Regulations 40

Regulations Engineering International Research 40

Agency IQ

MAY 3, 2024

What we expect the EPA to do in May 2024 In this returning feature, AgencyIQ looks at public data to determine what the EPA is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more. TSCA new chemicals procedural regulations. TSCA risk management rules.

Regulations 40

Regulations Government Engineering International 40

Advarra

AUGUST 8, 2024

Artificial intelligence (AI) has taken the world by storm – and regulators are paying attention. The EU AI Act’s implications extend into clinical research, where AI is increasingly utilized for tasks like medical image analysis, natural language process for endpoint analysis, and generating/analyzing data for synthetic control arms.

Clinical Research 52

Clinical Research Research Compliance Clinical Trials 52

Drug Discovery World

OCTOBER 3, 2024

In total, clinical researchers will receive approximately $17.2 The Sloan-Kettering Institute Cancer Research received $1 million to fund a Phase II study of avutometinib and defactinib for the treatment of RAF dimer-driven thyroid cancer, as well as $2.6 The regulator also provided an additional $4.1

130

130

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.

FDA 40

FDA Science Regulations Biosimilars 40

Drug Discovery World

AUGUST 13, 2024

Animal models (AMs) have generally been seen as useful for drug development and biomedical research for many years. There are serious ethical and scientific questions about the use of these models that need addressing and discussing amongst regulators, researchers, scientists and others involved in drug development.

Drug Development 162

Drug Development Animal Testing Regulations Drugs 162

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. We’re about to find out.

FDA 40

FDA Science Regulations Production 40

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. 2022 Dec 12 [cited 2024 Sep 4];22(3):213–34. 2019 Dec 13 [cited 2024 Sep 4];122(4):465–72.

Small Molecule 105

Small Molecule Regulations Therapies Treatment 105

Perficient: Drug Development

FEBRUARY 1, 2024

The conference will take place on February 11-14, 2024, in Orlando, Florida. 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. Still not registered?

Science 59

Science Clinical Research Clinical Trials Trials 59

Fierce BioTech

OCTOBER 26, 2023

Are you struggling to keep track of privacy and compliance regulations across multiple countries and grant types? Join a team of medical grants experts to learn about common grantmaking challenges and tools for tackling them in 2024. Why common medical grants complexities exist and how to effectively tackle them.

Compliance 52

Compliance Regulations Science Production 52

Agency IQ

MAY 3, 2024

What We Expect the FDA to do in May and June 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.

FDA 40

FDA Science Regulations Clinical Trials 40

Drug Discovery World

OCTOBER 3, 2023

The programme will be open to sponsors of products currently in clinical trials under an active Investigational New Drug application (IND), regulated by the Center for Biologics Evaluation and Research (CBER) and/or the Center for Drug Evaluation and Research (CDER).

FDA 130

FDA Disease Therapies Clinical Trials 130

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.

Regulations 40

Regulations Clinical Trials Production Biosimilars 40

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.

FDA 40

FDA Science Clinical Trials Regulations 40

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.

Clinical Trials 52

Clinical Trials Regulations Trials Pharmaceutical Companies 52

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.

FDA 40

FDA Science Clinical Trials Regulations 40

Drug Discovery World

APRIL 24, 2024

The AI Act, which bans certain AI applications that it feels threaten citizens’ rights, was approved in the European Parliament in March 2024. Significantly for drug discovery, ‘scientific research and development’ is excluded from the scope of the Act, though this will be defined further in future guidance.

Pharma R&D 130

Pharma R&D Government Regulations Drug Development 130

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.

Regulations 40

Regulations Pharmaceuticals Production Packaging 40

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.

Regulations 40

Regulations Trials Science Clinical Trials 40

Agency IQ

FEBRUARY 12, 2024

What’s going on in the world of PFAS – early 2024 edition This feature from AgencyIQ focuses on the wide world of per- and polyfluoroalkyl substance regulation, legislation, and litigation around the United States. This edition reviews developments that occurred in late 2023 and early 2024.

Regulations 40

Regulations Packaging Production Doctors 40

Drug Discovery World

AUGUST 20, 2024

Research shows that companies could shorten this cycle by up to 30 months 2 over the course of the small molecule drug discovery process by applying AI. However, as with any application of AI in the life sciences, research organisations must follow guidelines to ensure AI models deliver accurate and trustworthy results.

Small Molecule 275

Small Molecule Pharmaceutical Companies Drugs Pharmaceuticals 275

Perficient: Drug Development

MARCH 19, 2024

Our experts are closely monitoring nine healthcare trends that are shaping industry leaders’ strategies in 2024. Recommended Approach : Experience is key, especially as a growing number of consumers research care options within a competitive marketplace.

Pharmacy 52

Pharmacy Nurses Marketing Engineering 52

Drug Discovery World

MARCH 16, 2023

Additionally, a pledge to reform the regulation and approval of medicines, could see rapid approval for companies whose products have already gone through the US or European system and quickly open the UK as a new market.” The new R&D tax credits scheme will be welcomed by small and medium sized companies.

Science 243

Science Government Regulations Pharmaceuticals 243

Agency IQ

MARCH 1, 2024

What we expect the EPA to do in March 2024 In this returning feature, AgencyIQ looks at public data to determine what the EPA is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more. PFAS regulations for drinking water.

Regulations 40

Regulations Compliance Government Production 40

SCIENMAG: Medicine & Health

JANUARY 10, 2024

10, 2024 – University of Pittsburgh Schools of Medicine researchers uncovered a fundamental mechanism that controls the body’s response to limited oxygen and regulates blood vessel disease of the lung. PITTSBURGH, Jan. Credit: Johnathan Wright PITTSBURGH, Jan.

Regulations 80

Regulations Disease Research 80

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.

Clinical Trials 162

Clinical Trials Trials Regulations Compliance 162

Drug Discovery World

MAY 17, 2024

Deepika Khedekar , Associate Centralized Clinical Trial Lead at IQVIA Inc, looks at the challenges of utilising artificial intelligence (AI) in oncology clinical research. MIT research 4 tells us a hard truth: about 95% of these trials fall short, leaving behind a trail of broken hopes for cancer patients each year.

Trials 147

Trials Clinical Trials Treatment Research 147

Agency IQ

AUGUST 30, 2024

FDA AdComm to discuss patient-centric informed consent The FDA’s Center for Devices and Radiological Health (CDRH) will soon convene its Patient Engagement Advisory Committee to discuss “patient-centered informed consent” policies – notably, not just for medical devices but for “FDA regulated medical products” writ large.

FDA 40

FDA Regulations Clinical Trials Production 40