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.

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Regulations Research 246

Drugs.com

APRIL 29, 2024

MONDAY, April 29, 2024 -- Laboratory tests used by millions of Americans are soon to be classified as medical devices, and as such be regulated by U.S. Food and Drug Administration, the agency announced Monday.The new rule does not apply to tests.

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Laboratories FDA Regulations Drugs 245

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.

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Regulations Production Research 130

KIF1A

MAY 4, 2024

During her time as an undergraduate student, she conducted research on proline metabolism and its effects on ATF4 regulation. program in Chemistry in the fall of 2024). The post #ScienceSaturday: May 4, 2024 appeared first on KIF1A. She obtained her Bachelor’s degree in Life Sciences from Fudan University in 2023.

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Science Medical Schools RNA Research 116

FDA Law Blog: Drug Discovery

NOVEMBER 10, 2024

In October, FDA announced seven new clinical trial grants awarded in fiscal year (FY) 2024 – including one for a Phase 3 trial – totaling $17.2 Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field. million over the next four years.

Clinical Development 69

Clinical Development Production Clinical Trials Treatment 69

Drug Target Review

JULY 9, 2024

For the first time, scientists at UCL and University Medical Center Utrecht have observed bowel cancer cells’ ability to regulate their growth using a genetic on-off switch to increase their likelihood of survival. cited 2024 July 5] Available from: [link] 2 Bowel cancer statistics. 2018 June 6 [cited 2024 July 8]; 8.

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Regulations DNA Treatment Research 106

KIF1A

JANUARY 13, 2024

This process is regulated so we end up with the right number of neurons, which we can imagine with some simplified math: If you start with one progenitor and need eight neurons, it isn’t efficient for that progenitor to make a single neuron eight times. Read the Article The post #ScienceSaturday: January 13, 2024 appeared first on KIF1A.

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DNA Regulations Drug Development Disease 105

Common Sense for Drug Policy Blog

OCTOBER 1, 2024

New regulations governing methadone treatment for opioid use disorder go into effect in the US on October 2, 2024. 20, 2024 ("US will let more people take methadone at home"): As reported by the Associated Press on Sept.

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Regulations Government Treatment 52

Drugs.com

JUNE 27, 2024

THURSDAY, June 27, 2024 -- As psilocybin mushrooms become the most popular psychedelic in the United States, some states have started to ease regulations on its recreational use. Now, a new report warns that the federal government will have to.

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Government Regulations 162

Covalent Modifiers

JUNE 29, 2024

Commun Chem 7 , 144 (2024). Phosphorylation of their C-terminal RS domains by SR protein kinases (SRPKs) regulates their localization and diverse cellular activities. link] Serine–arginine (SR) proteins are splicing factors that play essential roles in both constitutive and alternative pre-mRNA splicing.

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Regulations Disease 200

Agency IQ

MAY 31, 2024

and national regulators. Given the expansive and complex European life sciences regulatory landscape, we’ll be including updates from key E.U. Fill out the form to read the full article.

Regulations 59

Regulations Science 59

Agency IQ

JULY 8, 2024

BY SEBASTIAN GODOY, MPH , KIRSTEN MESSMER, PHD, RAC , COREY JASEPH, MS, RAC , KARI OAKES 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 59

Regulations Science 59

Agency IQ

MARCH 29, 2024

and national regulators. Given the expansive and complex European life sciences regulatory landscape, we’ll be including updates from key E.U. The goal: to allow regulatory professionals to better anticipate and prepare for upcoming events and catalysts.

Regulations 59

Regulations Science 59

Perficient: Drug Development

MAY 30, 2024

Health insurers from every corner of the country are set to assemble in Las Vegas for the 2024 AHIP conference —and here at Perficient, we’re excited to have two of our colleagues attending as well. Mike Porter : There is both a technical point of view here as well as very specific discussions on what’s happening with trends and regulations.

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Regulations Science Marketing 88

Drug Patent Watch

DECEMBER 9, 2024

This involves working closely with regulators to ensure that the analytical characterization and clinical trial design meet the necessary standards for approval. 2024, June 19). 2024, May 17). References Bilea, A. Overcoming Regulatory Hurdles in the Development of Biosimilars. link] KBDNA. link] Lawless, L. 2016, November 11).

Biosimilars 97

Biosimilars Clinical Trials Immune Response Trials 97

Covalent Modifiers

SEPTEMBER 22, 2024

Andrew D Huber, Taosheng Chen eLife 2024, 13 :e101446. Topics include the role of PPARγ in regulating fatty tissue and glucose levels; and the effects of covalent inhibitors on PPARγ's ligand-binding site and its interaction with co-activators and co-repressors.

Regulations 162

Regulations 162

Covalent Modifiers

MAY 9, 2024

Hopkins Journal of Medicinal Chemistry 2024 DOI: 10.1021/acs.jmedchem.4c00220 4c00220 Multiple sclerosis (MS) is a chronic disease with an underlying pathology characterized by inflammation-driven neuronal loss, axonal injury, and demyelination.

Treatment 208

Treatment Clinical Development Disease Regulations 208

Agency IQ

AUGUST 2, 2024

By Sebastian Godoy, MPH , Kirsten Messmer, PhD, RAC, Corey Jaseph, MS, RAC , Kari Oakes 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 59

Regulations 59

Agency IQ

MARCH 1, 2024

and national regulators. Given the expansive and complex European life sciences regulatory landscape, we’ll be including updates from key E.U. The goal: to allow regulatory professionals to better anticipate and prepare for upcoming events and catalysts.

Regulations 59

Regulations Science 59

Agency IQ

AUGUST 30, 2024

By Sebastian Godoy, MPH , Corey Jaseph, MS, RAC , Kari Oakes 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 and comment periods.

Regulations 52

Regulations 52

Agency IQ

MAY 3, 2024

Fill out the form to read the full article.

Regulations 52

Regulations 52

Drugs.com

FEBRUARY 19, 2024

19, 2024 -- Raw milk cheese tainted with E. coli bacteria has sickened 10 people in four states, hospitalizing four, federal regulators warn. MONDAY, Feb. The cases have been tied to Raw Farm brand raw cheddar cheese, the U.S. Centers for Disease.

Hospitals 147

Hospitals Regulations Disease 147

Agency IQ

JANUARY 12, 2024

To kick off 2024, the British device regulator offered its medical device and IVD plans for this year and next, promising public action on the post-market surveillance regulation by mid-2024 and on the core regulations in late 2024 or early 2025. has done.

Regulations 59

Regulations Marketing 59

Agency IQ

JULY 22, 2024

BY WALKER LIVINGSTON, ESQ On July 5, 2024, the EPA published its Spring 2024 Unified Agenda, which reveals what regulations the agency is planning on releasing by the end of the year and beyond.

Regulations 59

Regulations 59

Agency IQ

JUNE 21, 2024

BY KIRSTEN MESSMER, PHD, RAC This week, the newly finalized Variations Regulation was published in the Official Journal of the E.U. An updated guideline implementing the changes from the new regulation is now open for public consultation until August 23, 2024. Fill out the form to read the full article.

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Regulations Production 59

Agency IQ

JULY 12, 2024

BY ALEXANDER GAFFNEY, MS, RAC The FDA on Friday unveiled its much-anticipated Spring 2024 Unified Agenda, a document outlining the regulations the agency plans to release in 2024 and beyond.

Regulations 59

Regulations FDA 59

FDA Law Blog: Drug Discovery

JANUARY 30, 2025

Valentine We recently blogged about a new December 2024 draft guidance about accelerated approval (the December 2024 draft guidance). While the first topic is addressed primarily in the December 2024 draft guidance, the considerations and policies FDA articulates in the January 2025 draft guidance are also relevant.

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FDA Trials Disease Drugs 105

Covalent Modifiers

JANUARY 17, 2024

Maciag Journal of Biological Chemistry , 2024 [link] Individual oncogenic KRAS mutants confer distinct differences in biochemical properties and signaling for reasons that are not well understood. Nissley,Frank McCormick,Anna E.

Small Molecule 195

Small Molecule Regulations Drugs 195

Covalent Modifiers

OCTOBER 15, 2024

Weizhi Weng, Ping Zhang, and Zhengying Pan Journal of the American Chemical Society 2024 DOI: 10.1021/jacs.4c06459 4c06459 Naturally, kinases exert their activities in a highly regulated fashion.

Regulations 147

Regulations Drugs 147

Fierce BioTech

OCTOBER 31, 2024

The tools developed function entirely post-translationally, enabling synergistic strategies with engineerable regulation across multiple levels of the central dogma. The tools developed function entirely post-translationally, enabling synergistic strategies with engineerable regulation across multiple levels of the central dogma.

DNA 64

DNA Regulations 64

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

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.

Clinical Trials 97

Clinical Trials Trials International Clinical Research 97

Agency IQ

AUGUST 2, 2024

By Scott Stephens, MPA Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities.

Regulations 59

Regulations 59

Agency IQ

MAY 31, 2024

BY SCOTT STEPHENS, MPA Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities.

Regulations 59

Regulations 59

Agency IQ

MAY 3, 2024

BY SCOTT STEPHENS, MPA Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities.

Regulations 59

Regulations 59

Covalent Modifiers

MAY 25, 2024

Backus Journal of the American Chemical Society 2024 DOI: 10.1021/jacs.3c12240 3c12240 Caspases are a highly conserved family of cysteine-aspartyl proteases known for their essential roles in regulating apoptosis, inflammation, cell differentiation, and proliferation. Desai, Oliver I. Fregoso, Robert Damoiseaux, and Keriann M.

Small Molecule 162

Small Molecule DNA Virus Regulations 162

Drug Patent Watch

DECEMBER 11, 2024

Pharmaceutical companies should evaluate a CDMOs compliance with industry standards and regulations, ensuring that they have a robust quality assurance system in place. 2024, March 13). Regulatory Compliance and Quality Assurance Regulatory compliance and quality assurance are essential aspects of CDMO selection. 2019, March 6).

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Pharmaceutical Companies Pharmaceuticals Compliance Drug Development 98