Elrig

MARCH 25, 2025

After PhD and postdoctoral work in the UK and Singapore, Prof Johnson received a prestigious Ramn y Cajal fellowship at the Centre for Genomic Regulation (Barcelona). Back to Resources Find out more The post Therapeutic Oligos 2025 Keynote Speakers Announced appeared first on ELRIG.

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RNA Bioinformatics Science Pharmacokinetics 59

Drugs.com

MARCH 3, 2025

MONDAY, March 3, 2025 -- In a policy statement published today in the Federal Register, Robert F. Department of Health and Human Services, has rescinded the current policy of requiring new rules and regulations to. Kennedy Jr., secretary of the U.S.

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Regulations 246

Covalent Modifiers

JANUARY 9, 2025

Kjersti Julin, Franco Faucher, Marijn Hollander, Nichole Pedowitz, Daniel Abegg, Isabella Hammond, Ifeanyichukwu Eke, Sijie Wang, Shiyu Chen, John Bennett, Jeyun Jo, Christian Lentz, Alex Adibekian, Matthias Fellner Research Square Preprint 2025 [link] 10.21203/rs.3.rs-5494070/v1 aureus infections. We previously identified a group of S.

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Fragment Screening Regulations Research 147

Drugs.com

APRIL 2, 2025

WEDNESDAY, April 2, 2025 -- The U.S. Food and Drug Administration’s (FDA) top tobacco regulator, Brian King, has been placed on leave as part of a large wave of cuts across federal health agencies. King, who led the FDA's tobacco control.

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Covalent Modifiers

DECEMBER 21, 2024

Hsieh, Chin-Chung Wu, Wei-Jan Huang, European Journal of Medicinal Chemistry , 283, 2025 , 117169 [link] Protein disulfide isomerase (PDI) regulates multiple protein functions by catalyzing the oxidation, reduction, and isomerization of disulfide bonds. The enzyme is considered a potential target for treating thrombosis.

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Metabolic Stability Regulations 130

Perficient: Drug Development

FEBRUARY 12, 2025

Payments Trend #1: AI-Driven Payment Innovations The landscape of payments and financial services in 2025 will be marked by groundbreaking innovations and user-centric designs powered by Generative AI (GenAI). The fintech industry, once celebrated for its agility and innovation, now faces a future shaped by heightened regulation.

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Compliance Regulations Production Government 52

Drugs.com

FEBRUARY 13, 2025

13, 2025 -- A legal loophole is allowing marijuana ads to slip past regulations and land right in front of kids on social media, a new report shows.Although the federal Controlled Substances Act prohibits advertising the sale or use. THURSDAY, Feb.

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Regulations 200

BioPharma Drive: Drug Pricing

JANUARY 23, 2025

New documents clarify how the FDA plans to regulate AI-enabled devices, experts say, but several important questions remain around insurance coverage and generative AI.

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Regulations FDA 144

Conversations in Drug Development Trends

APRIL 29, 2025

On the last day of February every year is Rare Disease Day , a dedicated day to celebrate the rare disease community, including patients, families, caregivers, clinicians, researchers, regulators, and more. For any collaboration inquiries or questions about the 2025 Rally for Rare event, reach out to rare@worldwide.com.

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Perficient: Drug Development

NOVEMBER 15, 2024

Our experts are closely monitoring eight healthcare trends that are shaping industry leaders’ strategies in 2025. election results could significantly shift healthcare policy and impact healthcare access, affordability, regulation, and innovation. And this year is especially interesting, as 2024’s U.S. billion by 2030.

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Perficient: Drug Development

NOVEMBER 15, 2024

Our experts are closely monitoring eight healthcare trends that are shaping industry leaders’ strategies in 2025. election results could significantly shift healthcare policy and impact healthcare access, affordability, regulation, and innovation. And this year is especially interesting, as 2024’s U.S. billion by 2030.

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Regulations Compliance Production Nurses 52

BioPharma Drive: Drug Pricing

DECEMBER 19, 2023

A decision by European regulators to revoke approvals for five generic versions of Biogen's multiple sclerosis medicine helps cement the drug's monopoly there through early 2025.

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Marketing Regulations Drugs 167

FDA Law Blog: Drug Discovery

JANUARY 30, 2025

To this end, the December 2024 draft guidance and a companion guidance published January 7, 2025, Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway (the January 2025 draft guidance ) describe FDAs latest thinking on what it means to conduct a confirmatory trial with due diligence.

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FDA Trials Disease Drugs 105

PPD

FEBRUARY 19, 2024

The European Union Clinical Trial Regulation (EU CTR) brings the biggest change in the regulatory landscape since the implementation of the EU Clinical Trials Directive in 2004, requiring vast changes in the way organizations are structured and conduct their day-to-day activities. Ongoing trials must transition to the EU CTR by Jan.

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Clinical Trials Regulations Trials Clinical Research 96

Broad Institute

MARCH 12, 2025

New technology puts a spatial lens on CRISPR screening By Leah Eisenstadt March 12, 2025 Breadcrumb Home New technology puts a spatial lens on CRISPR screening Perturb-FISH reveals impacts of perturbations on gene expression and phenotype with single-cell, spatial resolution, allowing study of effects within and between cells.

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RNA Science Research Disease 99

Fierce BioTech

MARCH 25, 2025

How Japan and South Korea are Shaping the Next Era of Clinical Development Discover why Japan and South Korea are emerging as clinical trial powerhouses, offering cutting-edge infrastructure, streamlined regulations, and unique commercial advantages. CMIC Group Resource Type Whitepaper CMIC_ListingLogo_250x190.png

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Clinical Development Clinical Trials Regulations Trials 52

Advarra

MAY 21, 2025

The release of ICH E6(R3) in January 2025 marks the most significant evolution in Good Clinical Practice (GCP) guidelines in over a decade. Final Version, January 6, 2025. The goal is not more complexity, but smarter, leaner operations grounded in relevance and accountability. Learn more References: ICH Harmonised Guideline.

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Pharma Companies FDA Trials Government 52

Drug Channels

MARCH 4, 2025

Fein, president of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for DCIs new live video webinar: PBM Industry Update: Trends, Challenges, and What's Ahead This event will be broadcast live on Friday, April 4, 2025, from 12:00 p.m. This event is part of The Drug Channels 2025 Video Webinar Series.

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FDA Law Blog: Biosimilars

MARCH 31, 2025

Gonzalez On March 31, 2025, U.S. That Rule sought to codify FDAs view that LDTs are medical devices subject to FDA regulation under the Food, Drug, and Cosmetic Act (FDCA) and then phase out, over a four-year period, FDAs purported policy of enforcement discretion for such tests. By Steven J. District Judge Sean D.

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Laboratories FDA Regulations Drugs 111

Agency IQ

JANUARY 12, 2024

To kick off 2024, the British device regulator offered its medical device and IVD plans for this year and next, promising public action on the post-market surveillance regulation by mid-2024 and on the core regulations in late 2024 or early 2025. has done.

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Broad Institute

MAY 21, 2025

Scientists create next generation of tools in battle against brain disease By Corie Lok May 21, 2025 Breadcrumb Home Scientists create next generation of tools in battle against brain disease The findings contained in eight studies could lead to targeted gene therapies for brain disorders.

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Disease Medical Schools DNA Therapies 72

FDA Law Blog: Biosimilars

FEBRUARY 26, 2025

Claud The ongoing DOGE-led reductions to the federal workforce and recent sweeping policy changes have spawned many questions for compliance officers and quality managers in FDA-regulated companies. If a compliance or quality program exists only as bargaining chip to use with regulators, thats not a formula to instill good habits.

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Compliance Regulations FDA Government 66

Fierce BioTech

FEBRUARY 12, 2025

Join us for an exclusive webinar where well guide you through the essential steps of meeting Japans regulations and strict quality requirement. Join us for an exclusive webinar where well guide you through the essential steps of meeting Japans regulations and strict quality requirement.

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The Pharma Data

JUNE 6, 2025

As pharma companies grapple with mounting pressure from regulators, payers, and evolving market dynamics, the CSO model offers a compelling alternative to traditional, fully in-house sales forces. These markets are characterized by stringent pricing regulations and decentralized healthcare systems, making localized sales expertise essential.

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Pharmaceutical Companies Compliance Pharmaceuticals International 40

Fierce BioTech

JANUARY 23, 2025

What Youll Learn: How contract sales models can help you stay ahead, amid shifting trends + evolving regulations. On Demand Start Date Wed, 03/05/2025 - 13:00 End Date/Time Wed, 03/05/2025 - 13:00 Ways to use smart tech + data insights to supercharge your teams effectiveness.

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Government Regulations Marketing 52

Fierce BioTech

OCTOBER 31, 2024

The tools developed function entirely post-translationally, enabling synergistic strategies with engineerable regulation across multiple levels of the central dogma. The tools developed function entirely post-translationally, enabling synergistic strategies with engineerable regulation across multiple levels of the central dogma.

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DNA Regulations 64

FDA Law Blog: Drug Discovery

FEBRUARY 27, 2025

Livornese As anticipated, the International Council for Harmonization (ICH) published the Good Clinical Practice (GCP) guideline E6(R3) Principles and Annex 1 on January 6, 2025. How regulators will interpret and enforce its provisions may not become clear for some time.

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Clinical Trials Trials Clinical Research Government 88

Agency IQ

NOVEMBER 10, 2023

The European Commission has proposed a regulation to revise the fees regulation governing the cost of compensating the European Medicines Agency (EMA) for its regulatory activities, with the aim of streamlining the fee structure and increasing fees in line with the cost of services and inflation.

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Regulations Government 59

Fierce BioTech

OCTOBER 15, 2024

A Pharma Marketers' Roadmap to Data Privacy Compliance : Are You Ready for 2025? swheeler Tue, 10/15/2024 - 19:53 Thu, 11/21/2024 - 13:00 Resource Type Webinar Ben Chapman Duration 60 minutes Join for an insightful webinar on the evolving privacy landscape impacting pharma marketers in 2025.

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Compliance Marketing Regulations 52

Alta Sciences

FEBRUARY 19, 2025

Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development pmjackson Wed, 02/19/2025 - 21:30 The unique physicochemical properties of oligonucleotides require the use of specialized bioanalytical approaches, with key considerations including selectivity and specificity, sensitivity, stability, and matrix effects.

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H1 Blog

DECEMBER 11, 2024

In this edition, our CEO and co-founder, Ariel Katz, along with Regional VP of Trial Landscape, Ryan Brown, share their top predictions for 2025. Ryan Brown , Regional VP, Trial Landscape Global standards for diversity plans will emerge in 2025. Ariel Katz , CEO & Co-Founder AI will be used to combat rare diseases.

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Clinical Trials Trials Pharma Companies Treatment 52

FDA Law Blog: Biosimilars

JUNE 2, 2025

Mullen At midnight on Friday, May 30, 2025, the governments deadline to notice an appeal from the U.S. That being said, we have no doubt that as the door to regulating LDTs directly has closed, absent new legislation, FDA is likely to look for a new door to open. By Steven J. Gonzalez & Allyson B. Stay tuned.

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Drug Target Review

JUNE 11, 2025

Multimodality however can detect and connect trends (and in future generate content) across different modalities and therefore allows for better interpretability, which builds trust between regulators, researchers and industry stakeholders. The Rise of Multimodal Language Models in Drug Development (2025).

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FDA Law Blog: Biosimilars

FEBRUARY 27, 2025

The American Conference Institutes popular FDA Boot Camp now in its 43rd iteration is scheduled to take place from March 19-20, 2025, at the NY Bar Association in New York, NY. This is achieved through firsthand insights, real-world examples, and case studies from FDA-regulated products. And it is exactly that!

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FDA Clinical Trials Regulations Production 59

The Pharma Data

JUNE 12, 2025

Foundation, explained during the EULAR 2025 presentation: “IgG4-related disease is a progressive, immune-mediated condition with a significant unmet patient need. John Stone, MD, MPH , Professor of Medicine at Harvard Medical School, the Edward A. Fox Chair in Medicine at Massachusetts General Hospital, and Executive Chairman of The IgG4ward!

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Disease Clinical Development Treatment Medical Schools 40

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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Regulations Production Engineering International 40

FDA Law Blog: Biosimilars

JULY 6, 2023

By Véronique Li, Senior Medical Device Regulation Expert — Earlier this year, neither the Quality System Regulation (QSR) nor the Quality Management System Regulation (QMSR) were referenced in the semiannual regulatory agenda.

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Regulations FDA Drugs 52