KIF1A

JANUARY 13, 2024

Dylan Verden of KIF1A.ORG summarizes newly published KIF1A-related research and highlights progress in rare disease research and therapeutic development. This study indicates that KIF1A and KIF13B have different impacts on these angles, regulating the number of RGPs and neurons in the developing brain.

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DNA Regulations Drug Development Disease 105

Advarra

NOVEMBER 14, 2024

The February 2024 FDA draft guidance on DMCs highlights the necessity of incorporating diverse, global expertise into these critical oversight functions. A globally diverse DMC ensures the trial adheres to local regulations while maintaining high ethical standards.

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Clinical Trials Trials International Clinical Research 97

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.

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Clinical Research Research Clinical Trials Compliance 98

Covalent Modifiers

FEBRUARY 25, 2024

2024 , DOI: 10.1039/D3CB00230F N6-Methyladenosine (m6A) is the most prevalent mRNA modification and is required for gene regulation in eukaryotes. Gan-Qiang Lai, Yali Li, Heping Zhu, Tao Zhang, Jing Gao, Hu Zhou and Cai-Guang Yang RSC Chem. ALKBH5, an m6A demethylase, is a promising target, particularly for anticancer drug discovery.

RNA 157

RNA Cell Based Assays Regulations Research 157

Drug Patent Watch

DECEMBER 11, 2024

It is crucial to determine whether you will be working with a CDMO for discovery and drug development all the way through approvals and commercialization or if your work with a CDMO will begin with preclinical development or clinical research. 2024, March 13). References Ajinomoto Bio-Pharma Services. 2019, March 6). Contract Pharma.

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Pharmaceutical Companies Pharmaceuticals Compliance Drug Development 98

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.

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Regulations FDA Laboratories Disease 64

Broad Institute

MARCH 20, 2024

By Broad and Mass General Communications March 20, 2024 Credit: Chen JH et al. By Broad and Mass General Communications March 20, 2024 Credit: Chen JH et al. doi: 10.1038/s41590-024-01792-2 (2024) Scientists used a microscope to visualize an immunity hub (yellow and green) in human lung tumor tissue (blue). Nature Immunology.

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Immune Response Hospitals Research Treatment 131

Agency IQ

MAY 31, 2024

What we expect EU chemical regulators to do in June 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. Another consultation is closing this month on a draft implementing regulation that is amending the label format for fluorinated greenhouse gases (F-gases) under the new F-gas Regulation (EU) 2024/573.

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Regulations Production International Government 40

FDA Law Blog: Biosimilars

JUNE 12, 2024

The GAO Report provides an overview of the rulemaking process for OTC hearing aids, the resulting OTC hearing aid regulatory scheme, and FDA’s interaction with other agencies when regulating OTC hearing aids. But the GAO Report highlights the lack of research on OTC hearing aids thus far.

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FDA Regulations Treatment Licensing 111

Broad Institute

MARCH 14, 2024

By Leah Eisenstadt March 14, 2024 Credit: Courtesy of the authors. Related groups Liu lab Choudhary lab Fischer lab Researchers studying the role of proteins in health and disease use experimental tools that inactivate proteins, destroy them, or prevent them from being made in cells. The new study appears in Science.

Targeted Protein Degradation 141

Targeted Protein Degradation Small Molecule Medical Schools Science 141

Advarra

MARCH 19, 2024

The Food and Drug Administration’s (FDA’s) February 2024 draft guidance Use of Data Monitoring Committees in Clinical Trials signals a significant shift in approach. Open for public comment until April 15, 2024, this draft seeks to modernize and clarify the agency’s expectations for DMC oversight.

Clinical Trials 52

Clinical Trials Trials FDA Regulations 52

Agency IQ

AUGUST 2, 2024

What we expect EU chemical regulators to do in August 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. Other consultations ending in August include two addressing potential candidates for substitution and exemption conditions under the Biocidal Products Regulation (BPR), including for the substance DBNPA.

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Regulations Production Packaging International 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 Therapies Regulations Treatment 105

Agency IQ

JANUARY 4, 2024

What we expect EU regulators to do in January 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. ECHA plays a central role in this reassignment of duties, and it would make sense for the basic regulation to be introduced at the same time as these other proposals.

Regulations 40

Regulations Packaging Production Government 40

Broad Institute

JUNE 10, 2024

The advance, from the lab of Broad core institute member David Liu , could one day help researchers develop a single gene therapy for diseases such as cystic fibrosis that are caused by one of hundreds or thousands of different mutations in a gene.

DNA 144

DNA Engineering Therapies Disease 144

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.

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Regulations Disease Research 80

Drug Target Review

MARCH 12, 2024

The study’s findings offer new insights into the biochemical language microbes use to influence distant organ systems, which could revolutionise the way researchers approach disease. The diversity and range of functions of these secondary bile acids has been greatly underappreciated by researchers until now.

Disease 111

Disease Biochemical Pharmacology FDA Approval Pharmacy 111

Agency IQ

MARCH 1, 2024

What we expect EU regulators to do in March 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. ECHA consultations under the CLP Regulation closing in March CLP: Harmonized classification and labeling (CLH) Consultations on classification and labeling harmonization (CLH) are open for 60 days.

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Regulations Production Packaging Science 40

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 Clinical Trials DNA Trials 52

Broad Institute

MARCH 6, 2024

Schizophrenia and aging may share a common biological basis By Allessandra DiCorato March 6, 2024 Breadcrumb Home Schizophrenia and aging may share a common biological basis Tightly synchronized genetic changes in two types of brain cells may underlie cognitive impairment in both conditions, offering potential therapeutic clues.

Medical Schools 134

Medical Schools RNA Science Research 134

Broad Institute

JUNE 25, 2024

In T2D, the body gradually loses its ability to regulate blood sugar effectively. Research over the last decade has linked changes in the gut microbiome — the collection of bacteria, fungi, and viruses that inhabit our intestines — to the development of T2D. Online June 24, 2024. Paper cited Mei Z, Wang F, et al.

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Virus Hospitals Disease Nurses 135

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 Treatment 52

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

Broad Institute

FEBRUARY 7, 2024

However, researchers lack efficient ways to explore how these genetic variants are molecularly connected to cardiovascular disease, limiting efforts to develop therapeutics. In a study published in Nature , the researchers applied this technique to endothelial cells, which line blood vessels.

Disease 105

Disease Hospitals Medical Schools Therapies 105

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

Broad Institute

JANUARY 22, 2024

By Allessandra DiCorato January 22, 2024 Bill Sellers is the head of Broad's Cancer Program. At the Broad Institute of MIT and Harvard and elsewhere, researchers are also learning how dependencies affect cancer cells and how they influence each other and contribute to drug resistance.

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Drugs Therapies Regulations RNA 128

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 Trials Regulations Pharmaceutical Companies 52

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

National Institute on Drug Abuse: Nora's Blog

SEPTEMBER 25, 2024

BRAIN at 10: A View from the National Institute on Drug Abuse mfleming Wed, 09/25/2024 - 19:31 Nora's Blog October 1, 2024 By Nora Volkow, MD, Director, and Rita Valentino, Ph.D., The BRAIN Initiative is marking a milestone—10 years of& advancing neuroscience and neurotechnology research by funding innovative projects.

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Drugs Science Research Regulations 100

Broad Institute

AUGUST 7, 2024

Six scientists named as new core institute members at Broad By Corie Lok August 7, 2024 Breadcrumb Home Six scientists named as new core institute members at Broad As leaders in their fields, the new core members have also all demonstrated deep commitment to the community and intellectual life at Broad. She is a professor at the Harvard T.H.

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Medical Schools Hospitals Bioinformatics Vaccine 90

Broad Institute

JANUARY 19, 2024

In the new study, the researchers examined samples from 256 patients in the collection whose infections lasted at least 30 days. To investigate the effect of the mutated genes on the host’s immune response, the researchers infected mouse immune cells called macrophages in a dish with Salmonella with barA or sirA mutations.

Immune Response 119

Immune Response Treatment Disease Research 119

PPD

DECEMBER 16, 2024

The drug development industry faces rising costs and increasingly complex protocols as top challenges, with 49% of developers citing costs as their primary concern and 39% pointing to protocol complexity as a key hurdle, according to a recent survey of 150 drug developers worldwide by the PPD clinical research business of Thermo Fisher Scientific.

Drug Development 52

Drug Development Clinical Trials Compliance Trials 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

FDA Law Blog: Biosimilars

JUNE 10, 2024

Walsh — Among FDA-regulated establishments and stakeholders, there is one word that makes everyone go on edge – the dreaded FDA “inspection.” Maintain accurate and detailed records of all research activities, including raw data, test results, and correspondence. By Sarah Wicks & Anne K.

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FDA Compliance Laboratories International 111

Agency IQ

JUNE 16, 2023

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. The anticipated date of publication is June 2023, meaning we should see this regulation imminently.

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Regulations FDA Science Production 40

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.

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