Drug Target Review

FEBRUARY 26, 2024

Our data demonstrate that the CoREST complex is a critical mediator of the distinct melanoma phenotypes, working through the regulation of both the phenotype-defining genes MITF and AXL as well as the master regulators of epithelial-to-mesenchymal transitions (EMT) and phenotype switching in melanoma and other cancers, SNAIL/SLUG/ZEB1/ZEB2.

Therapies 59

Therapies Molecular Biology Regulations Medical Schools 59

NIH Director's Blog: Drug Development

MARCH 11, 2014

But this approach doesn’t just provide predictions of risk; it may also provide a path to developing new ways of treating and preventing this serious, chronic disease that affects about 26 million Americans. Over time, this leads to heart disease, stroke, blindness, nerve damage, kidney damage, and amputations. Nat Rev Drug Discov.

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DNA Drugs Disease Research Laboratories 52

The Pharma Data

JANUARY 18, 2021

About Biophytis Biophytis SA is a clinical-stage biotechnology company specialized in the development of therapeutics that slow the degenerative processes associated with aging and improve functional outcomes for patients suffering from age-related diseases, including severe respiratory failure in patients suffering from COVID-19.

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Regulations Clinical Trials Disease Production 40

Agency IQ

JUNE 9, 2023

Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. BY KIRSTEN MESSMER, PHD, RAC JUN 5, 2023 10:14 PM CDT Regulatory Background: How things work now Regulation (EC) No 141/2000 (the Orphan Regulation) provides the legal framework for orphan drug designations and incentives.

Marketing 40

Marketing Regulations Biosimilars Drugs 40

Agency IQ

JUNE 7, 2024

The devil is in the details: a deep dive into the state of Notified Body designations While the European Commission has been laser-focused on the number of medical device and IVD certificates, AgencyIQ is taking a look at progress toward designating Notified Bodies to the European medical device and diagnostics regulations.

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Broad Institute

AUGUST 2, 2023

Known to be a regulator of metabolism, we have found that in addition it has profound behavioral effects in animals and humans, even evident in population-level economic behavior. The Sabatini Lab focuses on the development and regulation of synapses in the brain and the relationship of these processes to behavior and disease.

Medical Schools 52

Medical Schools Disease Science International 52

Agency IQ

NOVEMBER 27, 2023

The regulations also provided clarification regarding what does not constitute a “true statement,” including false or misleading information, failure to reveal important facts, and/or the lack of a fair balance between side effects/contraindications and effectiveness. 1) When required.

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Drug Target Review

AUGUST 9, 2024

Global efforts to standardise regulations could streamline development processes and eventually improve the likelihood of drug development success. While current and future innovations in drug development hold immense promise, there are potential dangers that have not yet been accounted for in regulatory standards. References Allen, L.

Science 59

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Agency IQ

JUNE 7, 2024

BY CHELSEY MCINTYRE, PHARMD | JUN 3, 2024 8:43 PM CDT Regulatory background: DSHEA and dietary supplements The Dietary Supplement Health and Education Act ( DSHEA ) of 1994 defines the FDA’s authority in the regulation of dietary supplement products and dietary ingredients. See AgencyIQ’s deep dive into kratom research and regulation here. ]

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New Drug Approvals

JANUARY 9, 2024

The present invention is directed to methods of preparation of compound of formula (I) that is useful for inhibiting Cyclin-dependent kinase 7 (CDK7) and for treating diseases or disorders mediated thereby. In addition to CDK7, other CDKs have been reported to phosphorylate and regulate RNA pol (II) CTD. Aug 26;78(4):713- 24, 1994).

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Production DNA RNA Regulations 62

Drug Target Review

AUGUST 9, 2023

Published on bit.bio’s website, this article authored by Dr Tony Oosterveen dives into the close relationship between FTD and ALS with a focus on mechanisms underlying the neuropathology of both diseases. ALS is the most common motor neuron disease and is estimated to affect more than 80,000 people worldwide.

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RNA Regulations Disease DNA 98

The Pharma Data

JULY 8, 2021

Today, access to the world’s largest browsable resource linking rare protein-coding genetic variants to human health and disease was launched through a genetic exome sequence analysis collaboration between AbbVie (NYSE: ABBV), Biogen Inc. Nasdaq: BIIB) and Pfizer (NYSE: PFE). The browser can be accessed via [link]. About AbbVie.

Disease 52

Disease Clinical Trials Government Research 52

The Pharma Data

MAY 14, 2021

Shockingly, in many cases, many medications have been found to progress the disease. And people who follow this kind of regime still have long term problems associated with heart disease, liver damage, kidney problems and more…. Often to the point of no return…. Just to be clear once again – I’m not saying you shouldn’t take your meds.

Doctors 52

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Codon

FEBRUARY 27, 2024

Most square centimeters of our built environments transmit next to no disease (think of walls, which we rarely so much as brush in passing), but some are touched with extraordinary frequency. Diarrheal diseases—attributed to viruses, such as noroviruses, which are spread via fomite transmission—killed about 1.5

Virus 70

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Codon

JUNE 18, 2024

For more than a century, scientists thought of gas vesicles as little more than a natural curiosity and, later, as a way for microbes to regulate buoyancy. Dr. Karl Dussik, an Austrian physician, was among the first to suggest that ultrasound could be used to diagnose diseases within the body in 1941. But ultrasound is different.

Engineering 67

Engineering Laboratories International Clinical Trials 67

Agency IQ

JULY 5, 2023

What we expect the EPA to do in July 2023 In this returning feature, AgencyIQ looks at public data to determine what the Environmental Protection Agency (EPA) is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more.

Regulations 40

Regulations Compliance International Engineering 40

The Pharma Data

NOVEMBER 5, 2020

The resumed session will discuss a 10-year-plan for addressing neglected tropical diseases, as well as efforts to address meningitis, epilepsy and other neurological disorders, maternal infant and young child nutrition, digital health, and the WHO Global Code of Practice on the International Recruitment of Health Personnel, adopted in 2010.

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The Pharma Data

AUGUST 3, 2021

end-stage renal disease (ESRD) bundled payment system, dialysis clinics rapidly implemented new treatment protocols, switching patients from Parsabiv to generic oral cinacalcet. A Phase 2 study continues to enroll patients with chronic obstructive pulmonary disease. With Parsabiv’s inclusion in the U.S. Bemarituzumab.

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Biosimilars Production Treatment FDA 52

The Pharma Data

OCTOBER 14, 2020

It was granted orphan drug designation for the treatment of narcolepsy in 2010. WAKIX is not recommended in patients with end-stage renal disease (ESRD). WAKIX is not recommended in patients with end-stage renal disease. since Q4 2019. WAKIX is a selective histamine 3 (H?) receptor antagonist/inverse agonist. Adverse Reactions.

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FDA Approval FDA Treatment Clinical Trials 40

The Pharma Data

APRIL 27, 2021

Cardiovascular diseases are responsible for 17.9 These gold standard biomarkers³ have proven to be successful in supporting cardiovascular disease management and can help clinicians diagnose heart attacks? are at higher risk of developing cardiovascular disease?. and are at higher risk of developing cardiovascular disease.

Treatment 40

Treatment Disease Pharmaceuticals Therapies 40

Codon

JULY 27, 2023

CNGA3-achromatopsia is a hereditary disease that causes people to see in shades of gray. They’re talking about a patient who has a rare genetic disease. These protein:RNA duos seem to regulate gene expression in a way that we don’t really understand. ” Gene-edited poplar tree stems appear red. From Sulis D.B.

Therapies 52

Therapies RNA DNA Engineering 52

Codon

JULY 27, 2023

CNGA3-achromatopsia is a hereditary disease that causes people to see in shades of gray. They’re talking about a patient who has a rare genetic disease. These protein:RNA duos seem to regulate gene expression in a way that we don’t really understand. ” Gene-edited poplar tree stems appear red. From Sulis D.B.

Therapies 52

Therapies RNA DNA Engineering 52

Codon

MARCH 24, 2024

This was the founding ethos of Moderna, the mRNA vaccine developer, when it was launched in 2010 by Noubar Afeyan and Doug Cole at Flagship Pioneering. In response to this hysteria, regulation was aggressively tightened. An alternative approach is to make molecules not in tubes, vials, or cells, but inside the body itself.

Engineering 86

Engineering Vaccine Production RNA 86

Agency IQ

JUNE 16, 2023

Highlights of the EPA’s Unified Agenda for Spring 2023 The Office of Management and Budget has released the Unified Agenda for Spring 2023, which outlines the regulations that agencies expect to release in 2023 and 2024. This information would be used in considering the regulation of asbestos.

Regulations 40

Regulations Compliance Production Science 40

Codon

APRIL 24, 2025

The reason for this shift is relatively simple: Chinese regulators have passed reforms that lower barriers to market entry and streamline approvals. regulators hoping to speed up drug development, too. Those reforms could hold lessons for U.S. Sign up for Asimov Press. It will always be free. Here’s what the data shows.

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Clinical Trials Trials Pharmaceutical Companies Licensing 100

The Pharma Data

JUNE 18, 2021

The study met its primary endpoint of superior progression-free survival (PFS) as assessed by an independent review committee (IRC) with a HR 0.216 (95% CI, 0.131-0.357; p < 0.0001), demonstrating a reduction in the risk of disease progression or death for I+V of approximately 78% compared to C+O. . About the GLOW Study.

Treatment 52

Treatment Therapies FDA FDA Approval 52

The Pharma Data

MAY 13, 2021

Non-alcoholic fatty liver disease and fructose: bad for us, better for mice. Grading scale of visceral adipose tissue thickness and their relation to the nonalcoholic fatty liver disease. Exposure to non-nutritive sweeteners during pregnancy and lactation: Impact in programming of metabolic diseases in the progeny later in life.

Disease 52

Disease Production Testimonials Science 52

The Pharma Data

JUNE 18, 2021

Undetectable minimal residual disease (uMRD) was achieved in 77% of patients in peripheral blood and 60% of patients in bone marrow. 2,3 CLL is predominately a disease of the elderly, with a median age at diagnosis of 70 years and is more common among men than women.

Treatment 40

Treatment FDA Therapies FDA Approval 40

New Drug Approvals

APRIL 23, 2025

“Studies on the effect of probenecid (benemid) in gout” Annals of the Rheumatic Diseases. Ho RH (January 2010). Experimental Properties Property Value Source melting point (C) 195 C PhysProp water solubility 27.1 mg/L Not Available logP 3.21 HANSCH,C ET AL. 1995) pKa 3.4 after filtering, being dried, yield 86.2%(is

Pharmacokinetics 62

Pharmacokinetics FDA Production Regulations 62

Codon

DECEMBER 12, 2024

In 2010, researchers at the J. In 2001, in an outbreak that had nothing to do with a lab leak, foot-and-mouth disease in the U.K. A study of fox rabies in Europe found that the disease spreads at a rate of roughly 50 kilometers per year. 14 But scientific efforts continue to bear fruit. Not all pathogens spread quickly.

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RNA DNA Vaccine Virus 103

Drug Target Review

NOVEMBER 27, 2024

Advanced techniques like liquid chromatography tandem mass spectrometry (LC-MS/MS) and Meso Scale Discovery (MSD) provide the kind of comprehensive and reliable data increasingly favoured by regulators, yet many researchers continue to rely exclusively on enzyme-linked immunosorbent assay (ELISA). This is a misconception.

Drug Development 52

Drug Development Regulations Laboratories FDA 52

Codon

JANUARY 21, 2024

Today, refined versions of these human challenge studies have become standard practice in testing vaccines for vector-borne diseases (e.g., yellow fever, malaria, and dengue), evaluating new drugs or treatments, and studying pathogenesis, the process by which a disease develops. How are disease targets selected for challenge trials?

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New Drug Approvals

MARCH 31, 2025

g/mol SCHEME Tisolagiline ( INN Tooltip International Nonproprietary Name; developmental code names KDS-2010 , SeReMABI ) is a potent , highly selective , and reversible monoamine oxidase B (MAO-B) inhibitor which is under development for the treatment of Alzheimer’s disease and obesity. [1] 1] [2] [3] [4] It is taken by mouth.

Disease 62

Disease Clinical Trials Treatment International 62

Codon

AUGUST 10, 2023

Nature Reviews Genetics (2010). Link The second decade of synthetic biology: 2010–2020 , by Meng F. & Link Gene Expression & Regulation →Genetic regulatory mechanisms in the synthesis of proteins , by Jacob F. & Gene Expression and Regulation. Drug Discovery Today: Disease Models (2008).

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DNA Cell Biology Molecular Biology Engineering 98

Agency IQ

JULY 12, 2024

The 53 regulations that FDA is currently working on 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. Of those 53, seven are new to the Agenda, having never before been included in prior agendas.

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Regulations FDA Science Production 40

Codon

FEBRUARY 9, 2025

” Indeed, Gage’s case initiated a standard practice in neuroscience in which diseased or damaged brains are used to examine the connection between behavior and neuroanatomy — a method referred to as “ lesion studies.” Amazingly, Gage not only survived but is remembered as “the man who began neuroscience.”

Research 108

Research Disease Engineering Regulations 108

Codon

AUGUST 10, 2023

Nature Reviews Genetics (2010). Link The second decade of synthetic biology: 2010–2020 , by Meng F. & Link Gene Expression & Regulation →Genetic regulatory mechanisms in the synthesis of proteins , by Jacob F. & Gene Expression and Regulation. Drug Discovery Today: Disease Models (2008).

DNA 52

DNA Cell Biology Engineering Molecular Biology 52