Drug Target Review

JULY 24, 2023

Researchers from Tokyo Tech’s World Research Hub Initiative conducted a study to investigate the regulation of gene expression in the apicoplast of the malaria parasite Plasmodium falciparum. How is melatonin, the circadian signalling hormone, related to the regulation of gene expression in the apicoplast?

RNA 98

RNA Regulations Bioinformatics Laboratories 98

FDA Law Blog: Biosimilars

SEPTEMBER 11, 2023

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

Regulations 64

Regulations FDA Marketing Science 64

Drug Target Review

NOVEMBER 27, 2023

Because these proteins have such a profound effect on cells, there is typically a second hurdle of regulation that needs to be overcome to make the proteins. eFFECTOR Therapeutics has developed a novel class of cancer drugs known as Selective Translation Regulator Inhibitors (STRIs), which directly target the eIF4F complex.

Molecular Biology 86

Molecular Biology Therapies Pharmaceuticals Treatment 86

Perficient: Drug Development

AUGUST 16, 2023

In 2011, Hanes put together a local investment group that purchased the bank from its former holding company, and he became President and CEO of the new 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.

Regulations 52

Regulations International Compliance 52

Broad Institute

MARCH 14, 2024

In the new study, the researchers used a system called phage-assisted continuous evolution (PACE), first developed in Liu’s lab at Harvard in 2011, to generate a degron that might work with PT-179. Continuous evolution of compact protein degradation tags regulated by selective cereblon molecular glues. Paper cited Mercer JAM, et al.

Targeted Protein Degradation 141

Targeted Protein Degradation Small Molecule Medical Schools Science 141

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.

Regulations 40

Regulations Animal Testing Production Marketing 40

Drug Target Review

AUGUST 17, 2023

These antibodies are negatively regulated by the inhibitory IgG receptor, FcγRIIB (CD32B). Dogma suggests inhibition is mediated through the FcγRIIB immunoreceptor tyrosine-based inhibition motif (ITIM), negatively regulating immunoreceptor tyrosine-based activation motif (ITAM)-mediated signalling from activating FcγRs.

International 98

International Regulations Therapies Clinical Trials 98

FDA Law Blog: Biosimilars

MAY 23, 2023

Since then, the science and legal and regulatory framework for food allergens have evolved considerably: Congress enacted the Food Allergen Labeling and Consumer Protection Act (2004) and the Food Safety Modernization Act (2011), and FDA implemented the regulatory requirements set forth in 21 C.F.R.

FDA 45

FDA Compliance Regulations Production 45

Agency IQ

APRIL 12, 2024

Draft guidance on potency assays for CGT products garners extensive stakeholder input Late last year, the FDA published a draft update to its 2011 guidance on potency assays for cell and gene therapy products, unveiling a major shift in approach to the issue. As a result, the 2011 guidance was generally seen as basic and outdated.

Production 40

Production FDA Therapies Biochemical Assays 40

FDA Law Blog: Biosimilars

JULY 24, 2023

Jazz also argues that, notwithstanding the language that instructs FDA to promulgate regulations implementing the clinical superiority provisions at 21 U.S.C. 360cc(c), the statute does not permit FDA to promulgate regulations to use clinical superiority to break ODE.

FDA 52

FDA Regulations Clinical Trials Production 52

Drug Discovery World

DECEMBER 6, 2022

Detailed meta-data (the data about data) is a requirement of working in a regulated industry – enabling reproducibility and traceability. Stat Methods Med Res 2011; 20(6):613-22. 10 As a result, reported cumulative Covid-19 deaths reduced by 13% overnight. . Clinical Data Interchange Standards Consortium. Smith M, Marshall A.

Drug Development 246

Drug Development Vaccine Drugs Pharmaceuticals 246

Agency IQ

MAY 10, 2024

The proposal for a regulation on the sustainable use of pesticides (SUR), however, died in European Parliament in November 2023. However, pesticide regulation has remained a political flashpoint in France, where EU environmental regulations may be not only upheld, but sometimes supplemented with further domestic requirements.

Government 40

Government Regulations Production Marketing 40

The Pharma Data

APRIL 7, 2023

The FDA approved Makena under the accelerated approval pathway in 2011 based on a determination that the sponsor had demonstrated a drug effect on an intermediate clinical endpoint that was reasonably likely to predict clinical benefit. The agency’s approval included a requirement that the sponsor conduct a post marketing confirmatory study.

FDA 40

FDA FDA Approval Production Vaccine 40

Common Sense for Drug Policy Blog

JUNE 6, 2024

Analogous substances like post-cycle therapy drugs and human growth hormone, on the other hand, are generally produced in licit pharmaceutical laboratories in jurisdictions with more lax regulations and subsequently imported or removed from domestic pharmaceutical supply chains by illicit actors (Fink et al. 2014 ; Begley et al.

Marketing 40

Marketing Drugs Production Pharmaceuticals 40

Common Sense for Drug Policy Blog

JANUARY 1, 2024

Regulations limiting clean needle and syringe distribution are important operational issues to consider if policy changes supporting harm reduction for PWID are to have optimal impact." M for Philadelphia, $46.8 M for Baltimore). dwf_admin Mon, 01/01/2024 - 15:59 Source Ruiz, Monica S.

Treatment 40

Treatment Government Regulations Disease 40

FDA Law Blog: Drug Discovery

JANUARY 4, 2023

The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. The next town hall will focus on the clinical development of gene therapy products for rare diseases in February 2023.

Therapies 59

Therapies Engineering Production FDA 59

NIH Director's Blog: Drug Development

SEPTEMBER 20, 2018

That includes those involved in regulating our appetites and our moods, via a class of G proteins known as inhibitory G proteins (G i ). 2011 Jul 19;477(7366):549-55. For years, rhodopsin has served as an important structural model for understanding GPCRs.

Laboratories 52

Laboratories Research Regulations Drugs 52

Agency IQ

MARCH 1, 2024

What we expect EU regulators to do in March 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. ECHA consultations under the CLP Regulation closing in March CLP: Harmonized classification and labeling (CLH) Consultations on classification and labeling harmonization (CLH) are open for 60 days.

Regulations 40

Regulations Production Packaging Science 40

Drug Target Review

SEPTEMBER 4, 2023

2018): Silent Information Regulator 2 from Trypanosoma cruzi is a potential target to infection control, IntechOpen. 2011): State of the Art in African Trypanosome Drug Discovery, Current topic of medical chemistry. 2018): Insights into antitrypanosomal drug mode-of action from cytology-based profiling, PLOS Neglected Tropical disease.

Drugs 111

Drugs RNA DNA Disease 111

Agency IQ

DECEMBER 1, 2023

What we expect EU regulators to do in December 2023 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. Highlights of chemical regulatory activities Consultations open under the REACH and CLP regulations are coming to an end in December. Events happening next month include two ECHA meetings (i.e.,

Regulations 40

Regulations Production International Marketing 40

Agency IQ

MARCH 1, 2024

What we expect the EPA to do in March 2024 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.

Regulations 40

Regulations Compliance Government Production 40

Agency IQ

SEPTEMBER 15, 2023

BY AMANDA CONTI SEP 13, 2023 1:58 PM CDT Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs. The FDA will follow these procedures for both agency-initiated operations (e.g.,

Science 40

Science FDA Clinical Trials Pharmacy 40

The Pharma Data

MAY 15, 2023

Before joining Solvias Group, Karen held various senior leadership roles at Novartis, including global head investor relations from 2000 to 2006, head M&A and Executive Committee member, as well as site head for the Vaccines & Diagnostics division between 2006 and 2011.

Science 40

Science Doctors Government Compliance 40

Agency IQ

FEBRUARY 2, 2024

What we expect EU regulators to do in February 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. BY SCOTT STEPHENS, MPA | JAN 26, 2024 10:22 PM CST Highlights of upcoming chemical regulatory activities Consultations under the REACH and CLP regulations are coming to an end in February.

Regulations 40

Regulations Production Government Marketing 40

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 International Doctors Science 52

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. ppm since 2011 ( Figure 2- 27 ). BY PATRICIA ISCARO, ESQ.,

Regulations 40

Regulations Science Government Research 40

The Pharma Data

NOVEMBER 4, 2020

From 2003 to 2014, Mr. Thoresen was the managing director of Nycomed Pharma AS acquired by Takeda Pharmaceutical Company Limited in 2011 as part of an acquisition transaction with a total value of approximately USD $14B. SOURCE: XPhyto Therapeutics Corp. View source version on accesswire.com: [link].

Pharmaceutical Companies 40

Pharmaceutical Companies International Pharmaceuticals Production 40

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. Smiley currently serves as president and CEO of VMS BioMarketing and is a member of the board of directors of life science company, Assertio. He spent 27 years at Merck & Co.

Small Molecule 52

Small Molecule Engineering Pharmaceuticals Clinical Development 52

Agency IQ

OCTOBER 27, 2023

What we expect EU regulators to do in November 2023 Welcome to AgencyIQ’s roundup of upcoming regulatory activities in the EU chemicals sector. Regulation on detergents and surfactants The expert working group on detergents is scheduled to hold a meeting on November 17.

Regulations 40

Regulations Production Packaging International 40

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. ECHA plays a central role in this reassignment of duties, and it would make sense for the basic regulation to be introduced at the same time as these other proposals.

Regulations 40

Regulations Packaging Production Government 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.

Regulations 40

Regulations Compliance Packaging Production 40

Agency IQ

APRIL 8, 2024

FDA updates set the stage for broader use of harmonized standards for safety reporting Though long considered a top priority by regulators, the process to standardize and harmonize the submission of individual case safety reports (ICSRs) has been slow. Periodic Benefit-Risk Evaluation Reports ).

FDA 40

FDA Production Regulations Vaccine 40

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.

Regulations 40

Regulations Compliance Production Government 40

Agency IQ

JANUARY 19, 2024

With the publication of three proposed legal acts, this concept is one step closer to streamlining the way the bloc regulates chemicals. The ensuing Chemicals Strategy expounded upon the 1S1A concept further, presenting it as the definitive approach to heighten the efficiency, consistency, and transparency of European chemical regulation.

Packaging 40

Packaging Regulations Laboratories Animal Testing 40

NIH Director's Blog: Drug Development

MARCH 11, 2014

3] National Diabetes Education Program: Snapshot of Diabetes [4] National Diabetes Statistics, 2011. NIH/NIDDK) [5] The diabetes-susceptible gene SLC30A8/ZnT8 regulates hepatic insulin clearance. Nat Rev Drug Discov. 2013 Aug;12(8):581-94. [3]

DNA 52

DNA Drugs Research Laboratories Disease 52

New Drug Approvals

JANUARY 9, 2024

In addition to CDK7, other CDKs have been reported to phosphorylate and regulate RNA pol (II) CTD. Genes Dev.Oct 15;25(20):2158-72, 2011). Genes Dev.Oct 15;25(20):2158-72, 2011). CDK7, which primarily phosphorylates Ser-5 (PSS) of RNAP-II at the promoter as part of transcriptional initiation (Gomes et ah, Genes Dev. Konig et al.,

Production 62

Production DNA RNA Regulations 62

The Pharma Data

APRIL 28, 2021

2011 Nov;43(7):503-11. ClinicalTrials.gov. Available at: [link]. Accessed on April 1, 2021. Duvallet, E., Sererano, L., Assier, E., Interleukin-23: a key cytokine in inflammatory diseases. SKYRIZI (risankizumab) [Package Insert]. North Chicago, Ill. AbbVie Inc.

FDA 40

FDA Disease Therapies Treatment 40