Drug Target Review

OCTOBER 17, 2023

The liver is an essential organ that has a variety of crucial functions in the body, including metabolising nutrients, storing energy, regulating blood sugar levels and detoxifying and removing harmful substances. This promotes tumour growth by regulating the expression of metabolic genes. 2017 July [cited 2023 October 9]; 3(2):45-51.

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Agency IQ

JUNE 17, 2024

Swiss regulators align with EU on chemicals, biocides The Swiss Notification Authority for Chemicals has announced new adaptations are in the offing that will harmonize parts of the Swiss Chemicals and Biocidal Products ordinances with recent updates to corresponding EU legislation.

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Agency IQ

MAY 28, 2024

regulator lays out proposal for international device and diagnostics recognition The British medical device regulator just issued its promised framework on international recognition. law as the Medical Devices Regulation 2002 (UK MDR 2002). law as the Medical Devices Regulation 2002 (UK MDR 2002).

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FDA Law Blog: Biosimilars

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

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Laboratories FDA Regulations Licensing 81

Agency IQ

JULY 22, 2024

The 103 regulations the EPA is currently working on 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.

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Advarra

JUNE 12, 2023

Gene therapy research is exciting and full of promise, but because of the risks involved, it’s also highly regulated, requiring an institutional biosafety committee (IBC) to provide additional oversight and risk assessment. What do the Regulations Say about IBC Review? The post IBC vs. IRB: What’s the Difference?

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Agency IQ

SEPTEMBER 15, 2023

PFAS regulation in California (late 2023 edition) California consistently maintains its status as both one of the most important economies in the world as well as one of the most regulated states in the United States. In 2019, the state began to significantly ramp up its PFAS regulation and research.

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Agency IQ

JULY 8, 2024

What we expect European regulators to do in July 2024 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.

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Agency IQ

AUGUST 18, 2023

A deep dive into MDR and IVDR implementation: Where we are and where we’re going Late last summer, AgencyIQ took a close look at how the European Commission had been meeting its goals in implementing the medical device and IVD regulations (MDR and IVDR, respectively). Fill out the form to read the full article.

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Drug Target Review

AUGUST 9, 2023

14 TDP-43 is a DNA and RNA binding protein that regulates the expression and splicing of several target transcripts. Stathmin-2 is one of many proteins that appear critical for the growth and stabilisation of axons, most likely by regulating the dynamics of axonal microtubules.

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Agency IQ

AUGUST 2, 2024

What we expect European regulators to do in August and September 2024 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.

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Drug Target Review

SEPTEMBER 26, 2023

2017 Jan;155(1):234–47. 2017 Jul 6;21(1):14–7. Ther Innov Regul Sci. Regul Toxicol Pharmacol RTP. 2017 Feb;16(2):115–30. Comprehensive Translational Assessment of Human-Induced Pluripotent Stem Cell Derived Cardiomyocytes for Evaluating Drug-Induced Arrhythmias. Toxicol Sci. Cell Stem Cell. 2018;53(4):519–25.

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FDA Law Blog: Biosimilars

DECEMBER 4, 2023

But in addition to imposing civil penalties for alleged failure to comply with their obligations under the federal Controlled Substances Act and DEA regulations, the courts mandated how those registrants must handle controlled substances going forward. 6, 2023 ( DOJ Press Release ). Complaint ¶ 55.

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The Pharma Data

APRIL 6, 2021

persons outside the United States in reliance on Regulation S under the Securities Act. In member states of the European Economic Area, this announcement is directed only at persons who are “qualified investors” within the meaning of the Prospectus Regulation.

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Regulations Biosimilars Government Production 52

FDA Law Blog: Biosimilars

MAY 27, 2024

Jennifer was with the firm from 2011-2017, before leaving for in-house roles at Apple, Abbott Laboratories, and Cognito Therapeutics. At Apple, she led executive-level meetings, including with the Chief Operating Officer, regarding regulatory and legal challenges associated with shipping regulated health features.

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Laboratories Compliance FDA Regulations 59

Perficient: Drug Development

FEBRUARY 29, 2024

Since 2017, our Acquia practice has demonstrated consistent expertise with Acquia products and cloud hosting services. Our engagements range from implementing Drupal websites and portals to strategizing personalization and customer journeys, including clients in regulated industries like healthcare and financial services.

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Agency IQ

MARCH 25, 2024

AgencyIQ Guidance Tracker: European medical device and diagnostics guidance documents With the many moving parts of the European medical device and IVD regulations, it can be difficult to keep up on planned guidance and other publications, published documents and document revisions. Our new resource aims to help make this a little bit easier.

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The Pharma Data

APRIL 8, 2021

persons outside the United States in reliance on Regulation S under the Securities Act. In member states of the European Economic Area, this announcement is directed only at persons who are “qualified investors” within the meaning of the Prospectus Regulation.

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Regulations Biosimilars Government Production 52

FDA Law Blog: Biosimilars

DECEMBER 11, 2023

1] Yet FDA’s conclusions about the Agency’s ability to regulate the entire laboratory industry are based on fundamentally flawed assumptions about the number of entities and tests that will be subject to FDA regulation. 5] This stratification, though, assumes that LDTs will follow the same pattern as IVDs currently regulated by FDA.

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Eye on FDA

FEBRUARY 8, 2024

The last time the agency issued less than 200 releases to the public was back in 2017. The communications about legal actions (Consent Decrees, Warnings, Seizures, e.g.) was up while announcements about new rules (Guidances, Regulations and Policy announcements) were nearly flat. Did They Speak Spanish?

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FDA Law Blog: Biosimilars

SEPTEMBER 28, 2023

Richard Marschall, a “naturopathic doctor,” had been convicted in 2017 for a misdemeanor violation of the FDC Act for selling misbranded drugs. While Marschall was convicted of a felony based on one earlier 2017 FDC Act conviction, in a footnote, the 9th Circuit notes that this was actually Marschall’s third FDC Act conviction.

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KIF1A

JUNE 17, 2023

Research to develop new rare disease therapies underway at The Jackson Laboratory In the rare disease space, it takes a village – only through collaboration between clinicians, researchers, regulators, and patients can we develop effective treatments for devastating disorders.

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Laboratories Therapies Disease Research 98

Broad Institute

JUNE 14, 2023

A trailblazer in cancer research, Glimcher's research identified key transcriptional regulators of protective immunity and the origin of pathophysiologic immune responses underlying autoimmune, infectious, and malignant diseases. She has also received the 2017 George M. degree, cum laude , from Harvard Medical School.

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Perficient: Drug Development

AUGUST 16, 2023

In 2017, the bank was converted from its National Charter to a Kansas state-chartered bank and renamed Heartland Tri-State Bank. 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.

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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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Drug Patent Watch

JANUARY 9, 2025

In 2017, small and medium-sized biotech companies accounted for 51% of FDA market approvals, while large pharma companies were the originators in only 28% of approvals[4]. Q: How can I ensure my CDMO is staying compliant with evolving regulations? A: Regular audits and open communication are key.

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Agency IQ

JULY 26, 2024

reference laboratories for high-risk diagnostics The newly available May 2024 meetings of the Medical Device Coordination Group provide insight into the European Commission’s efforts to fully implement the European medical device and diagnostic regulations. Top IVDR Notified Body concern: Lack of E.U. Some news on E.U.

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Laboratories Regulations Virus Production 40

The Pharma Data

DECEMBER 10, 2020

The Company’s ordinary shares are listed on the regulated market of Euronext Paris under the ticker symbol “NANO.”. Any stabilization action or over-allotment shall be carried out in accordance with all applicable rules and regulations and may be undertaken on the regulated market of Euronext in Paris and on the Nasdaq Global Select Market.

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Marketing Regulations Treatment Clinical Trials 52

The Pharma Data

JANUARY 19, 2021

This announcement is not a prospectus within the meaning of the Regulation (EU) n°2017/1129 of 14 June 2017 as amended by Regulations Delegated (EU) n°2019/980 of 14 March 2019 and n°2019/979 of 14 March 2019. This press release is provided “as is” without any representation or warranty of any kind.

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Drug Target Review

MAY 18, 2023

Specifically, the study will assess the effects of Panobinostat on non-histone proteins such as NFkB, a regulator of innate immunity, and p53, a protein that plays a critical role in controlling cell division and apoptosis. Additionally, not all patients respond to every drug. It helps safeguard red blood cells from damage.

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Broad Institute

AUGUST 31, 2023

Through the imposition of a user-defined GRN in its architecture, GRouNdGAN simulates steady-state and transient-state single-cell datasets where genes are causally expressed under the control of their regulating transcription factors (TFs).

RNA 40

RNA Regulations 40

FDA Law Blog: Biosimilars

JUNE 28, 2023

Baumhardt, Senior Medical Device Regulation Expert & Philip Won — The Center for Devices and Radiological Health’s (CDRH) Standards and Conformity Assessment Program (S-CAP) encourages medical device sponsors to use FDA-recognized voluntary consensus standards in their product submissions.

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Drug Target Review

MAY 23, 2023

The algae-derived non-digestible oligosaccharides can also influence the expression of cytokines that regulate the immune system. Regulation (EU) 2017/2470 maintains this list within the novel food catalogue. It contains all authorised novel foods permitted for sale within the EU. References: Linschoten et al.

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Drugs Small Molecule Production Disease 75

Advarra

DECEMBER 15, 2022

Policies and Regulations Affecting Single IRB Review. Health and Human Services (HHS) regulations as much as practicable, which includes sIRB requirements. This requirement entered the regulations as part of a broader update in 2017, commonly referred to as the Revised Common Rule.

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Clinical Trials Regulations FDA Trials 52

Policy Prescription

JANUARY 31, 2022

state boards of pharmacy to properly regulate pharmacies that irresponsibly and too often illegally profited from opioid drug sales to patients. So pharmacies could order scores of powerful painkillers at will with no scrutiny — at least from state regulators. Last year, the state ranked 5th in the rate of drug overdose deaths.

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Pharmacy Regulations Doctors Drugs 52

Agency IQ

AUGUST 18, 2023

A deep dive into MDR and IVDR implementation: Where we are and where we’re going Late last summer, AgencyIQ took a close look at how the European Commission had been meeting its goals in implementing the medical device and IVD regulations (MDR and IVDR, respectively). regulators. reference laboratories. reference laboratories.

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Science Regulations Laboratories Production 40

Agency IQ

JULY 22, 2024

Updated EUDAMED roadmap projects mandatory use of some processes as early as December 2025 The new EUDAMED roadmap includes updates accounting for the recent amendments to the European medical device and diagnostics regulations, which allow for a phased rollout of the different functional modules of the database.

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