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. The Commission may be close to delivering this proposal , given that the EU executive recently adopted a package of related draft legislation in support of the CSS’s one substance-one assessment (1S1A) ambition.

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NIH Director's Blog: Drug Development

MARCH 11, 2014

ZnT8 is responsible for packaging zinc ions with insulin crystals, which are then secreted from the beta cells in the pancreas. NIH/NIDDK) [5] The diabetes-susceptible gene SLC30A8/ZnT8 regulates hepatic insulin clearance. 2010 Jan-Feb;2(1):49-50. [7] Nat Rev Drug Discov. 2013 Aug;12(8):581-94. [3] J Clin Invest.

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The Premier Consulting Blog

APRIL 27, 2023

However, the ICH M8 EWG/IWG was reestablished in November 2010 to oversee the next eCTD update and create a more robust, more flexible, and longer-term messaging system between sponsors and regulatory agencies. Sponsors should prepare by reviewing implementation packages from the ICH and applicable regions. Implementation Package v1.5

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Codon

JANUARY 21, 2024

With hepatitis C, what changed within the last 10 years was the development of direct-acting antivirals , or DAAs, which are packaged into pills that you can take once a day for a few months. Hepatitis C used to be really difficult to treat, and those treatments had high failure rates, but DAAs revolutionized the field.

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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

SEPTEMBER 29, 2023

The Commission has prepared a draft implementing regulation for the active substance that is expected to be presented for a final vote at PAFF’s upcoming meeting. Proposal for a regulation Initiative entry Chemicals – making best use of E.U. Proposal for a regulation Initiative entry E.U. CLP revision.

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The Pharma Data

AUGUST 3, 2021

The Company has initiated discussions with regulators on the Phase 3 study design for bemarituzumab, a first-in-class anti-fibroblast growth factor receptor 2b (FGFR2b) antibody for the treatment of patients with human epidermal growth factor receptor 2 (HER2) negative, FGFR2b-positive gastric and gastroesophageal junction cancer.

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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.

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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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Agency IQ

JUNE 2, 2023

Within the realm of FDA-required labeling, there are currently a few different types of information a sponsor might develop specifically for patient use: medication guides, instructions for use (IFU), consumer medical information (CMI) and patient package inserts (PPI). The FDA recently concluded its work on a proposed rule focused on PMI.

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Codon

JULY 27, 2023

These protein:RNA duos seem to regulate gene expression in a way that we don’t really understand. A new paper from Michael Elowitz’s group at Caltech reports engineered RNA exporters that “efficiently and specifically package and secrete target RNA molecules from mammalian cells within protective nanoparticles.”

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Codon

JULY 27, 2023

These protein:RNA duos seem to regulate gene expression in a way that we don’t really understand. A new paper from Michael Elowitz’s group at Caltech reports engineered RNA exporters that “efficiently and specifically package and secrete target RNA molecules from mammalian cells within protective nanoparticles.”

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Codon

MARCH 24, 2024

In the case of semaglutide, those cells are Saccharomyces cerevisiae— also known as Baker’s yeast — engineered to secrete a peptide precursor that is later purified, chemically modified, packaged into an injectable or tablet form, and then shipped around the world. Continuing this method may not scale.

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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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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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The Pharma Data

MAY 15, 2021

So much so that studies have shown your brain can regulate force production without you ever having to move a muscle. This is an unbelievably exciting package… designed you so don’t risk a single cent putting it to the test in your own home. They understand that your mind drives your movement. Not in some airy-fairy “woo woo” sense.

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The Pharma Data

JUNE 18, 2021

2010; 116(20): 4777–4787. 9 VENCLEXTA (venetoclax) [Package Insert].?North Cancer Stat Facts: Leukemia – Chronic Lymphocytic Leukemia (CLL). Accessed May 2021. 4 Shanafelt, et al. Age at Diagnosis and the Utility of Prognostic Testing in Patients with Chronic Lymphocytic Leukemia (CLL). 5 Burger JA et al. 2020;34:787-798.

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The Pharma Data

JUNE 18, 2021

2010; 116(20): 4777–4787. 8 VENCLEXTA (venetoclax) [Package Insert].?North?Chicago, Cancer Stat Facts: Leukemia – Chronic Lymphocytic Leukemia (CLL). Accessed May 2021. 3 Shanafelt, et al. Age at Diagnosis and the Utility of Prognostic Testing in Patients with Chronic Lymphocytic Leukemia (CLL). 4 Genetics Home Reference.

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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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Agency IQ

JANUARY 4, 2024

What we expect the EPA to do in January 2024 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.

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Regulations Compliance Government Science 40

Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. Dental Organization for Conscious Sedation, LLC , 2010 WL 5146603, at *2-3 (E.D. 13, 2010) (whether “education, information, and protocols” were products could not be decided on the pleadings). In United States v.

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