Codon

APRIL 2, 2023

This is Codon Digest, a weekly roundup of research papers, news articles, and industry highlights about engineered biology. Read Biological Engineering mScarlet3: a brilliant and fast-maturing red fluorescent protein. Read Inhalable nanoparticles, packaged with mRNA or CRISPR systems, efficiently edit lung cells. Gungabeesoon J.

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Vial

FEBRUARY 23, 2024

A number of factors are contributing to this increase in popularity of digital patient portals, including the surge in telemedicine needs following the COVID-19 pandemic, technological advances enabling better integration of mobile-based health platforms, as well as federal regulations shifting to accommodate remote data accessibility.

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Clinical Trials Clinical Research Trials Hospitals 52

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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Agency IQ

JUNE 26, 2023

Regulation (EC) No 141/2000 (the Orphan Regulation) provides the legal framework for orphan drug designations and incentives.The Orphan Regulation entered into force in January, 2000, outlining requirements for orphan designation and incentives, and establishing the EMA Committee for Orphan Medicinal Products (COMP). regulators.

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Drug Target Review

DECEMBER 5, 2024

2,3 Engineering both the capsid and DNA cargo improves the safety and efficacy of rAAV vectors and expands their clinical applications. Access to fast, high-throughput tools during the manufacturing process will accelerate the development of therapeutics while adhering to regulations and stringent quality standards. Labcompare.

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Agency IQ

MARCH 7, 2024

BY WALKER LIVINGSTON, ESQ | MAR 5, 2024 6:33 PM CST Background: Food chemical safety at the FDA The FDA has primary authority over the chemicals used in food, including those used as food additives, colorants, in food packaging and more. A former EPA assistant administrator, Jones has focused much of his career on chemical regulation.

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Codon

JULY 27, 2023

But for a recent paper out of Nanjing, China, researchers engineered another enzyme and showed that, when mixed with FAST-PETase, the two worked together to break down plastic twice as fast as the Texas enzyme alone. These protein:RNA duos seem to regulate gene expression in a way that we don’t really understand. No longer.

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Codon

JULY 27, 2023

But for a recent paper out of Nanjing, China, researchers engineered another enzyme and showed that, when mixed with FAST-PETase, the two worked together to break down plastic twice as fast as the Texas enzyme alone. These protein:RNA duos seem to regulate gene expression in a way that we don’t really understand. No longer.

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Codon

APRIL 2, 2024

A gene encoding green fluorescent protein was placed alongside one of the three promoters, and as the engineered cells cycled from one gene to the next, they blinked between green—dark—green—dark. So we engineered a system that allows the cell to package up RNAs and then secrete them in extracellular vesicles.

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RNA Engineering Molecular Biology Synthetic Chemistry 55

Agency IQ

NOVEMBER 3, 2023

The prebiotic may either feed the probiotic that it is packaged with, or it may feed another beneficial microbe that is intended to complement the activity of the probiotic. However, the term synthetic biotic is typically reserved for genetically engineered bacteria that intend to target a specific condition.

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Agency IQ

JUNE 17, 2024

These are the lists of national and international standards the Commission plans to harmonize with its device and diagnostics regulations. But standards harmonized under the directives may not be used to show compliance with the new Medical Device Regulation, which replaced the MDD. This is similar to the situation in the U.S.,

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The Pharma Data

OCTOBER 14, 2020

Horsepox and vaccinia are closely related orthopoxviruses that are believed to share a common ancestor. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements.

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Vaccine Pharmaceuticals Small Molecule Virus 40

LifeSciVC

APRIL 27, 2023

Fourteen years on, this corporate experiment has gone far beyond the initial idea, and has established an R&D engine more effective than most big pharma R&D groups at producing best-in-class small molecules against targets that matter in human disease biology.

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Codon

JUNE 26, 2023

I’m writing long essays for Asimov every other week and my work at MIT, where I’m helping to design a genetic engineering curriculum for undergraduates, has reached its crescendo. Anyone who has tried to engineer a cell knows how tedious it can be. And it’s been my life for the last few weeks. A Mycoplasma cell.

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DNA Therapies Engineering Clinical Trials 52

Codon

JUNE 26, 2023

I’m writing long essays for Asimov every other week and my work at MIT, where I’m helping to design a genetic engineering curriculum for undergraduates, has reached its crescendo. Anyone who has tried to engineer a cell knows how tedious it can be. And it’s been my life for the last few weeks. A Mycoplasma cell.

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DNA Therapies Engineering Clinical Trials 52

The Pharma Data

MAY 15, 2021

You can think of it like the difference between hammering the gas for more acceleration, and fine-tuning your engine for greater horsepower. So much so that studies have shown your brain can regulate force production without you ever having to move a muscle. In ways that most guys are normally NOT aware of. If it doesn’t however….

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Agency IQ

JANUARY 19, 2024

The History of the ICH Q5A(R1) Guideline The International Council on Harmonization (ICH) Q5A(R1) Guideline, Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin , was first adopted by regulators in 1999. This bulk product contains both the final product (e.g., Why might this be the case?

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The Pharma Data

FEBRUARY 22, 2021

1,7-14 It was engineered to have greater inhibitory potency for JAK1 versus JAK2, JAK3 and TYK2. RINVOQ (upadacitinib) [Package Insert]. Discovered and developed by AbbVie scientists, RINVOQ is an oral, once daily, selective and reversible JAK inhibitor studied in several immune-mediated inflammatory diseases. ClinicalTrials.gov.

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The Pharma Data

AUGUST 3, 2021

The company confirmed the tirzepatide SURPASS program has met global regulatory submission requirements for evaluating cardiovascular risk and its intention to submit the registration package to regulatory authorities by the end of 2021. The company announced the acquisition of Protomer Technologies Inc.,

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Agency IQ

APRIL 12, 2024

The regulations also explain that this trait can be demonstrated via appropriate laboratory tests or adequately controlled clinical data. The International Society for Pharmaceutical Engineering (ISPE) took a more nuanced approach, requesting that the language be tweaked to indicate that multiple assays are often optional.

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Agency IQ

DECEMBER 15, 2023

The 174 regulations the EPA is currently working on The Environmental Protection Agency has unveiled its Fall 2023 Unified Agenda, which provides a look into the agency’s regulatory agenda for the upcoming year. The expected release dates of the agendas rarely line up exactly with the actual dates when the agency releases the regulation.

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Agency IQ

OCTOBER 20, 2023

In the United States, the Environmental Protection Agency (EPA) has developed a PFAS Roadmap and proposed numerous regulations for managing the effects PFAS has on the environment and human health. carpets, fabrics, and food packaging) and in specialty chemicals (i.e. BY PATRICIA ISCARO, ESQ. | OCT 11, 2023 7:05 PM CDT What are PFAS?

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Agency IQ

MARCH 29, 2024

What we expect the EPA to do in April 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. PFAS regulations for drinking water.

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Regulations Compliance Production Government 40

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.

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Agency IQ

OCTOBER 27, 2023

What we expect the EPA to do in November 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. TSCA risk management rules.

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The Pharma Data

JANUARY 5, 2021

The Company is an emerging personalized/precision medicine leader in the field of cellular therapies and tissue engineering, with a focus on bone, skin, and cartilage regeneration. Lattice Biologics maintains all necessary licensures to process and sell its tissue engineered products within the U.S. and internationally.

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The Pharma Data

MAY 13, 2021

Then these hormones can’t regulate your metabolism like they should…. Along with the amount of estrogen-regulating DIM that he added as well. To a fat-burning engine…. So go ahead and choose your discounted package of HB5 right now…. And the answer is to simply click on one of the packages you see below right now….

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Codon

MAY 2, 2023

Once the mosquito factory has made all these insects, they are packaged into boxes or cups and then released in “strategic” areas within a city, like near swampy water or in dengue-ridden neighborhoods. But I do know this: Genetic engineering has endowed us with a radical ability to control our environments.

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Codon

MAY 2, 2023

Once the mosquito factory has made all these insects, they are packaged into boxes or cups and then released in “strategic” areas within a city, like near swampy water or in dengue-ridden neighborhoods. But I do know this: Genetic engineering has endowed us with a radical ability to control our environments.

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Engineering Packaging Licensing Licensing 52

Codon

MARCH 14, 2023

The engineered T-cells were infused back into the rodents. had already done much the same T-cell engineering on 106 patients at the National Cancer Institute. There are even differences in how their genomic DNA is packaged inside of neurons. ” About 6% of all mouse genes are regulated in sex-specific ways.

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Codon

NOVEMBER 1, 2024

Making a computer-designed protein in the laboratory requires, first, that scientists synthesize a string of DNA encoding the protein, insert that DNA into living cells, and then isolate the proteins churned out by the engineered cells. The world’s supply of insulin is now made by engineered microbes.

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Agency IQ

FEBRUARY 2, 2024

What we expect the EPA to do in February In this returning feature, AgencyIQ looks at public data to determine what the Environmental Protection Agency is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more. The Agency expects to issue a final rule later in 2023.

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Codon

APRIL 23, 2023

Most people would take the two CRISPR gene-editing components (a Cas9 protein and guide RNA), package them up inside of a virus, and then inject the viruses into the skulls of mice. Genetic engineering can be used to eradicate mosquitoes in two ways: Through gene drives or the “sterile insect technique.” Stahl et al.

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Codon

APRIL 23, 2023

Most people would take the two CRISPR gene-editing components (a Cas9 protein and guide RNA), package them up inside of a virus, and then inject the viruses into the skulls of mice. Genetic engineering can be used to eradicate mosquitoes in two ways: Through gene drives or the “sterile insect technique.” Stahl et al.

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Vaccine DNA Virus Engineering 52

Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. Smith rejected plaintiff’s analogy between books and drug package inserts. May 13, 2015) (contract involving multiple, identical “software package[s]” governed by UCC). Page Engineering Co. , In United States v.

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Drug & Device Law

DECEMBER 19, 2022

2019), it simply misconstrued the FDA’s rather (that’s an understatement) complicated supplemental application/changes being effected regulation, 21 C.F.R. Sub-sub-sub-subsection (C) references the “highlights” part of the FDA’s general drug labeling regulation, 21 C.F.R. Albrecht , 139 S. Mensing , 564 U.S. a) of this chapter. . . .

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