Broad Institute

AUGUST 27, 2024

Prior to founding TESARO, Hedley served as CSO and EVP of operations at Abraxis prior to its acquisition by Celgene and EVP of Eisai Inc, a role she assumed following the acquisition in January 2008, of MGI PHARMA by Eisai for $3.9 At MGI, Hedley was EVP & CSO, responsible for R&D. Prior to her role at MGI, she was a co-founder of ZYCOS Inc.,

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Perficient: Drug Development

AUGUST 16, 2023

He was promoted to President and CEO in 2008. Bank Closed By Regulators Almost all bank closures happen on a Friday so that regulators can work all weekend to reopen the bank on Monday. In 2017, the bank was converted from its National Charter to a Kansas state-chartered bank and renamed Heartland Tri-State Bank.

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Common Sense for Drug Policy Blog

JANUARY 5, 2024

Melatonin, the hormone involved in the regulation of our biological clock, is released when we are exposed to daylight. As Crary ( 2013 , p. But working at night is not necessarily good for us. Adverse effects of caffeine, if taken in high amounts, include disturbed sleep, increased blood pressure, and physical addiction.

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Perficient: Drug Development

JUNE 25, 2024

Learning from history, he referenced the lack of regulatory controls in derivatives and financial engineering before the 2008 financial crisis, and more recently, the unregulated growth of cryptocurrencies leading to the “Crypto Winter” of 2022.

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Drug Target Review

SEPTEMBER 19, 2023

This major shift to the orthodox tradition of using animal experiments in drug testing dates back the Aristotle’s time and cemented 80 years ago with initial federal mandate of drug safety regulation of 1938. To this end, the FDA’s newly created iSTAND initiative drives the path toward regulatory approval for devices like organ-on-chips.

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Perficient: Drug Development

FEBRUARY 22, 2024

Many said it couldn’t be done, but after its successful launch of the Roadster in 2008, Tesla became a household name. At that time, their industry was driven by government regulations and tariffs. This has allowed them to retain a successful niche within a competitive market. Now several U.S. We did amazing work together.

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Agency IQ

AUGUST 18, 2023

and internationally Establishing and communicating a substance’s potential to cause cancer is a cornerstone of chemical regulation worldwide. Many entries in category 2B are only weakly associated with carcinogenicity and are generally unlikely to be regulated for causing cancer. For more on the regulation of glyphosate in the E.U.,

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Agency IQ

JULY 26, 2024

EU executive consults on proposed update to PIC chemical lists Regulation (EU) 649/2012 (PIC Regulation) is the main act on the export and import of hazardous chemicals between the European Union and third countries. Part 1 of the annex lists substances that carry the obligation to submit an export notification.

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Drug Target Review

SEPTEMBER 26, 2023

Ther Innov Regul Sci. Regul Toxicol Pharmacol RTP. 2008 Mar;153 Suppl 2(Suppl 2):S1-209. Strauss DG, Gintant G, Li Z, Wu W, Blinova K, Vicente J, et al. Comprehensive In Vitro Proarrhythmia Assay (CiPA) Update from a Cardiac Safety Research Consortium / Health and Environmental Sciences Institute / FDA Meeting. Rockley KL.

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Agency IQ

AUGUST 30, 2024

An introduction to EU chemicals guidance In the internet age, meeting regulatory obligations starts with knowing where to pinpoint the right resources in the vast ocean of information to guide you successfully through the often-labyrinthine processes of EU chemicals regulation. REACH, CLP, BPR, PIC), scopes (e.g.,

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Drug Target Review

FEBRUARY 28, 2024

Regulation of cutaneous malignancy by gammadelta T cells. J Immunol 180(9):6044-6053 (2008). Increased frequency of TCR gamma delta + T cells in disease-free survivors following T cell-depleted, partially mismatched, related donor bone marrow transplantation for leukemia. J Hemotother 5(5):503-9 (1996). Liu Z, Eltoum I-E, Guo B, et al.

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NIH Director's Blog: Drug Discovery

MAY 9, 2019

If successful, such efforts could revolutionize biology by helping us better understand how allosteric proteins reconfigure themselves in the right shapes at the right times to regulate cell signaling, metabolism, and many other important biological processes. 2008 Sep;33(9):420-425. [2] What exactly is an allosteric protein?

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Agency IQ

JUNE 7, 2024

Almost 10 years late, the new framework’s arrival will represent significant changes in the regulation of these pesticide substances. Active substances that have been approved for use in the EU are listed in the Annex of Regulation (EU) No 540/2011; currently, approximately 450 entries are listed.

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Agency IQ

SEPTEMBER 22, 2023

It appears the issue is largely the result of unclear labeling for biocidal disinfectants, an aspect French regulators may flag in future market authorization evaluations for these products. Article 69 of the BPR regulates the labeling of all biocides, including biocidal disinfectants.

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Agency IQ

NOVEMBER 27, 2023

Its latest report serves as a powerful indicator for what EU chemical regulation is likely to resemble in the coming years should the agency receive sufficient scientific support to meet four regulatory challenges ECHA just can’t solve without further progress from the scientific community.

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Agency IQ

SEPTEMBER 15, 2023

The SCP Regulations define a candidate chemical as a chemical that exhibits a “hazard trait and/or an environmental or toxicological endpoint” and is found on one or more of the authoritative lists specified in section 69502.2(A) A) , or listed by DTSC using the criteria specified in section 69502.2(B). Chapter 54.

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Agency IQ

AUGUST 23, 2024

ECHA issues guidelines for enforcing mixture classification based on bridging principles ECHA has issued a new guide for national enforcement authorities (NEAs), clarifying the tiered approach to mixtures classification under the CLP Regulation and strategies for reviewing duty holders’ classifications of hazardous mixtures.

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Agency IQ

FEBRUARY 15, 2024

The regulation of BPA in the EU today BPA has been jointly registered (as a full registration) under REACH with over 60 registrants manufacturing or importing the substance in the tonnage band at or above 1,000,000 metric tons per year. B1) BPA’s regulation across so many sectors affecting different parts of the supply chain (i.e.,

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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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The Premier Consulting Blog

APRIL 27, 2023

the current default version internationally, was established in 2008. Technical Conformance Guide HL7 Version 3 Implementation Guide: Regulated Product Submission, Release 1 In 2003, the original eCTD was adopted by health authorities and sponsors both in the U.S. and around the world, and eCTD v3.2.2, Implementation Package v1.5

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Metabolite Tales Blog

APRIL 4, 2023

Tapinarof is a topical aryl hydrocarbon receptor–modulating agent approved for the treatment of psoriasis by downregulating proinflammatory interleukin-17 and regulating expression of the skin-barrier proteins filaggrin and loricrin. 2008 Mar;153 Suppl 1(Suppl 1):S82-9. Dermavant’s tapinarof is one such friend. Br J Pharmacol.

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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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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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Agency IQ

JUNE 2, 2023

Proposal for a regulation Initiative entry Chemicals – making best use of EU agencies to streamline scientific assessments Adoption is planned for second quarter of 2023 The European Green Deal aims to move towards a ‘one substance, one assessment’ process for chemical safety assessments.

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The Pharma Data

DECEMBER 17, 2020

She joined VMS BioMarketing in 2008 and has served as its president and CEO since 2011. Immune Regulation – U.K.-based based Immune Regulation Ltd. Rockwell Medical — Andrea Heslin Smiley was appointed to the board of directors at Rockwell Medical. He spent 27 years at Merck & Co.

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FDA Law Blog: Biosimilars

APRIL 30, 2023

110-316 (2008) and by Section 1135 of the FDA Safety and Innovation Act (“FDASIA”), Pub. It does so by amending FDC Act § 505(q), the current statutory subsection regarding citizen petitions. Subsection 505(q) initially was added by Section 914 of the 2007 FDA Amendments Act (“FDAAA”), Pub. 110-85 (2007), as amended by Section 301 of Pub.

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Agency IQ

APRIL 19, 2024

The conduct and infrastructure of clinical trials is heavily regulated, and updates to the methods, approaches, designs, or technologies employed can have regulatory implications. In particular, regulations in both the U.S. In particular, regulations in both the U.S. KEVIN BUGIN will serve as C3TI Director.

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The Pharma Data

OCTOBER 15, 2020

John Hospital, researchers compared 649 patients from two cohorts: a recent cohort (2017–2019) from the RECOVER III post-market approval (PMA) study, after the widespread adoption of the best practice of placing Impella pre-PCI, and a cohort from before PMA (2008–2014) when the practice of placing Impella pre-PCI was not yet widely adopted.

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FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

And with 2024 (September 24th) being the 40th anniversary of the enactment of the 1984 Hatch-Waxman Amendments—the statute that amended Title 35 of the United States Code to create PTEs for certain FDA-regulated products—and a recent spate of PTE-related items posted on regulations.gov, we thought we would peruse some decisions to see what’s up at (..)

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DrugBank

JUNE 27, 2023

14 As an unbiased method for genetic variant detection, GWAS holds the promise of identifying new genes and gene regulation mechanisms underlying a variety of conditions, including complex diseases. 9 , 477–485 (2008). 12 , 713230 (2021).  Slatkin, M.  The 1000 Genomes Project Consortium et al.  McInnes, G.,

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Agency IQ

JANUARY 19, 2024

WALKER LIVINGSTON, ESQ | JAN 17, 2024 8:30 PM CST Background: Clean Air Act and NAAQS Under the Clean Air Act (CAA), the Environmental Protection Agency (EPA) must issue a cornucopia of air quality-related regulations to protect the environment and public health of the country. BY PATRICIA ISCARO, ESQ.,

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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.

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Agency IQ

AUGUST 23, 2024

By Laura DiAngelo, MPH | Aug 22, 2024 10:13 PM CDT Intro: Pre-Determined Change Control Plans in medical device regulation Post-market updates to authorized medical devices may, or may not, require a new submission to the FDA. In late 2022, the FDA gained new authority related to PCCPs.

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Codon

JULY 17, 2024

In 2008, I began to lurk on do-it-yourself biology forums. I want to see amateur biology thrive, and while a lot of regulations exist for a reason, I’m unconvinced that molecular biology requires all the crazy expensive equipment that has become associated with it.

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BMG Labtech

DECEMBER 20, 2024

The ACU provides a complete solution to fully and independently regulate both O2 and CO2 gas levels within the microplate reader chamber. Online corrected version: (2008) "Absorbance". Online corrected version: (2014) "BeerLambert law (or BeerLambertBouguer law)". the "Gold Book") (1997).

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Agency IQ

JUNE 21, 2024

Commission proposes guidelines to flesh out the newly finalized Variations Regulation 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.

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New Drug Approvals

DECEMBER 3, 2022

2] The Bcl-2 family is most notable for their regulation of apoptosis , a form of programmed cell death, at the mitochondrion ; Bcl-2 and Bcl-xL are anti-apoptotic proteins. 2008): 360–367. Hann CL, Daniel VC, Sugar EA, Dobromilskaya I, Murphy SC, Cope L, Lin X, Hierman JS, Wilburn DL, Watkins DN, Rudin CM (April 2008).

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