Agency IQ

OCTOBER 27, 2023

In this new 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. and national regulators.

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Drug Discovery World

SEPTEMBER 14, 2023

As the second quarter of 2023 draws to a close, DDW’s Megan Thomas reviews key updates and results from three top pharmaceutical companies. Business updates Pfizer reported second quarter 2023 revenues totalling $12.7 billion, a decrease of $15.0 at CER and business EPS growth of 8.1% Specialty care grew 11.8% Vaccines were up 9.1%

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Agency IQ

AUGUST 9, 2024

By Scott Stephens, MPA The European Commission plans to implement exemptions introduced under the Stockholm Convention’s 2023 ban of UV-328, an ultraviolet-light absorbing persistent organic pollutant (POP).

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Regulations 59

KIF1A

SEPTEMBER 23, 2023

While we usually think of this cause as KIF1A mutations, upstream regulators of motor proteins can also disrupt traffic. In a recent pre-print*, the Holzbaur Lab at University of Pennsylvania investigated how a protein called LRRK2 regulates the traffic of synaptic vesicle precursors, a type of KIF1A cargo. What’s a pre-print?

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Drug Discovery World

JUNE 14, 2023

The International Society for Cellular Therapy (ISCT) is a global society of clinicians, regulators, technologists, and industry partners with a shared mission to drive the translation of all cell and gene (CGT) therapies for the benefit of patients worldwide. DDW’s Megan Thomas heard from attendees about key trends in the sector.

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Agency IQ

OCTOBER 27, 2023

What we expect European regulators to do in November 2023 In this new 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 Discovery World

JUNE 16, 2023

The International Society for Cellular Therapy (ISCT) is a global society of clinicians, regulators, technologists, and industry partners with a shared mission to drive the translation of all cell and gene (CGT) therapies for the benefit of patients worldwide. DDW’s Megan Thomas heard from attendees about key trends in the sector.

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KIF1A

OCTOBER 7, 2023

These molecules regulate neuronal growth and survival, and mice with insufficient KIF1A show NTRK1 transport defect and reduced pain sensitivity. WNK1: WNK1 is a kinase that interacts with KIF1A and may regulate its ability to unload cargo at axon tips. SCN9A/Nav1.7: Genetic mutations among HSAN/Congenital Insensitivity to Pain cohort.

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Agency IQ

DECEMBER 1, 2023

What we expect European regulators to do in December 2023 In this new 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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Regulations Clinical Trials Production Biosimilars 40

KIF1A

SEPTEMBER 16, 2023

But once a protein is made, it can still be regulated by making additions or modifications to its structure; these post-translational modifications could be useful tools for altering a protein’s behavior in a directed way, an approach closely related to structure-based therapeutics.

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Drug Discovery World

JUNE 12, 2023

The International Society for Cellular Therapy (ISCT) is a global society of clinicians, regulators, technologists, and industry partners with a shared mission to drive the translation of all cell and gene therapies for the benefit of patients worldwide. The ISCT 2023 Annual Meeting took place in Paris, France from May 31 to June 3 2023.

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thought leadership

NOVEMBER 14, 2023

On October 3rd, 2023, the U.S. If implemented, this rule would result in LDTs generally falling under similar enforcement regulations as other in vitro diagnostic (IVD) products, a significant change from existing policy.

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KIF1A

JUNE 10, 2023

CX32 likely regulates this cooperation, as knocking down CX32 weakened the connection between SFXN-1.2 From Barmaver and Wagner (pre-print, 2023) In the figure above we see KIF1A, SFXN-1.2, But this landmark in gene editing regulation will tell us more about the FDA’s approach to gene therapies.

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Clinical Trials FDA Regulations Disease 98

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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Drug Discovery World

JANUARY 2, 2024

Cancer Research Horizon’s Innovation Summit 2023 took place on 21 November 2023 at the Royal Society of Medicine, and included talks from researchers translating their research, as well as networking with members of the entrepreneurial ecosystem. DDW’s Megan Thomas spoke to a range of attendees. That’s exactly what we’ve done.

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Agency IQ

AUGUST 9, 2024

Commission proposes exemptions to UV-328 ban under POPs Regulation The European Commission plans to implement exemptions introduced under the Stockholm Convention’s 2023 ban of UV-328, an ultraviolet-light absorbing persistent organic pollutant (POP). Some Annex C entries are repeated from Annex A.

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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.

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KIF1A

JUNE 24, 2023

J Cell Biol 7 August 2023; 222 (8): e202208121. Rather than binding to kinesins directly, zinc binds to the microtubule, displacing other proteins that regulate the movement of kinesins. Read the Article The post #ScienceSaturday: June 24, 2023 appeared first on KIF1A. Minckley et al. How does zinc inhibit cargo transport?

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Agency IQ

DECEMBER 1, 2023

Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. This ongoing feature compiles information from across EU agencies and institutions to deliver an overview of chemicals-related regulatory actions likely to happen in the month ahead, including planned legislation, consultations, webinars, meetings, and more.

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Regulations 59

Broad Institute

AUGUST 7, 2023

A surprising new role for a major immune regulator By Tom Ulrich August 7, 2023 Breadcrumb Home A surprising new role for a major immune regulator By Anne Trafton, MIT News August 7, 2023 Credit: RCSB Protein Data Bank A model of the human STING protein. Online August 3, 2023. Paper Cited Liu B, Carlson R, et al.

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Agency IQ

OCTOBER 27, 2023

Welcome to AgencyIQ’s roundup of upcoming regulatory activities in the EU chemicals sector. This ongoing feature compiles public information from across the EU to deliver an overview of all the chemical policy-related actions in the month ahead, including planned legislation, consultations, webinars, meetings, and more.

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Regulations 59

Covalent Modifiers

MARCH 1, 2024

CHANG Science 2023 382, 6670 DOI: 10.1126/science.abp9201 INTRODUCTION One-carbon metabolism manages cellular carbon pools by detoxifying highly reactive carbon species, such as aldehydes, and diverting their carbon toward the biosynthesis of useful products, including amino acids and nucleotides. DINGLER, CHRISTOPHER L. GARCIA-PRIETO MIA C.

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Agency IQ

MARCH 29, 2024

National PFAS water regulations imminent The White House Office of Information and Regulatory Affairs has cleared a final rule that will implement the first national drinking water regulations for per- and polyfluoroalkyl substances. The rule, once released, will set the tone for future PFAS regulation in the U.S. with the U.S.

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Agency IQ

JUNE 16, 2023

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond.

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KIF1A

OCTOBER 28, 2023

Other genes with potential links to KIF1A were also identified: LRRK2 is a Parkinson’s Disease-associated regulator of KIF1A cargo binding; and NEFH ‘s C. See the Tournament Page The post #ScienceSaturday: October 28, 2023 appeared first on KIF1A. elegans counterpart may stabilize KIF1A transport along microtubules.

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Perficient: Drug Development

SEPTEMBER 6, 2023

The regulators feel that this proposed LTD rule would: Improve the resolvability of these banking organizations in case of failure, Potentially reduce costs to the Deposit Insurance Fund, and Mitigate financial stability and contagion risks by reducing the risk of loss to uninsured depositors.

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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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KIF1A

JUNE 17, 2023

They will be presenting at our 2023 Family and Scientific Engagement Conference ! Read the Article The post #ScienceSaturday: June 17, 2023 appeared first on KIF1A. Want to learn more about NeuCyte’s work?

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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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Regulations Pharmaceuticals Production Compliance 40

KIF1A

NOVEMBER 20, 2023

The survey is available here: [link] Please complete the survey by December 18, 2023. Donate The post November 2023 Highlights appeared first on KIF1A. Dr. Dylan Verden at conferences~ Dr. Dylan Verden attended the Society for Neuroscience conference this year on behalf of our community! KIF1A’s C.

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Agency IQ

SEPTEMBER 1, 2023

EU’s PIC Regulation adds 35 new entries The European Commission’s latest update to the export and import of hazardous chemicals regulation – which implements the Rotterdam Convention on prior informed consent in the EU – includes 27 pesticides and eight industrial chemicals in the list of substances requiring export notification.

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Perficient: Drug Development

FEBRUARY 29, 2024

Perficient is excited to announce we’ve won the 2023 Acquia Partner Advocate of the Year Award for North America ! 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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Drug Channels

FEBRUARY 21, 2023

On March 14, 2023, Drug Channels Institute will release The 2023 Economic Report on U.S. We are providing you with the opportunity to preorder this thoroughly updated, revised, and expanded 2023 edition at special discounted prices. Special preorder and launch pricing discounts will be valid through April 3, 2023.

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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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Agency IQ

NOVEMBER 10, 2023

BY KIRSTEN MESSMER, PHD, RAC | NOV 3, 2023 3:47 PM CDT Regulatory Background on EMA fees Since it became operational in 1995 as the European Medicines Evaluation Agency, the EMA has depended on fees. There are other fee-related regulations as well. literature monitoring), since national regulators charge their own fees.

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FDA Law Blog: Biosimilars

NOVEMBER 9, 2023

Gaulkin & Riëtte van Laack — On October 31, 2023, the U.S. Food and Drug Administration (FDA) issued a proposed rule that would amend its prior notice regulations to add new information requirements and deadlines. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it.

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Agency IQ

MAY 31, 2024

What we expect European regulators to do in June 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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