Drug Target Review

JULY 7, 2025

Non-human primates (NHPs), such as macaques and cynomolgus monkeys, have long served as a cornerstone in preclinical drug development due to their close genetic, anatomical and physiological resemblance to humans. Institutions must invest in secure housing, specialised veterinary care and rigorous training for handlers.

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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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The Premier Consulting Blog

APRIL 13, 2025

On April 10, 2025, the US FDA announced that it has a long-term plan to eliminate conventional animal testing in drug development, starting with monoclonal antibodies (mAbs).[ from approved products in other countries) to inform doses and development. 7] This was a landmark change in philosophy.

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SugarCone Biotech

JUNE 27, 2025

A post-ASCO update on tumor targets DLL3, B7H3 and Her3 June 2025 Paul D Rennert, SugarCone Biotech LLC Introduction: DLL3, B7H3 and Her3 are compelling tumor antigens to target with cancer therapeutics. As we’ll see, ASCO 2025 was a breakout conference for B7-H3-targeted therapies.

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ACTO

DECEMBER 17, 2024

A survey of healthcare and life science companies found that 93% of these companies expect to increase their spend in 2025. Such cross-functional collaboration ensures consistent implementation from drug development through commercialization. The stakes for AI adoption in the pharmaceutical industry have never been higher.

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BioPharma Drive: Drug Pricing

JULY 9, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Merck to buy Verona and its lung drug in $10B deal The New Jersey-based pharma has inked one of the biggest deals of the year in pursuit of a promising new way to treat COPD.

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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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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. While ICH E6(R3) was still in the development phase, the FDA released a draft guidance in May 2023 in the form of the draft ICH E6(R3).

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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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BioPharma Drive: Drug Pricing

JUNE 27, 2025

Published June 27, 2025 Ned Pagliarulo Lead Editor post share post print email license Bristol Myers Squibb sells two CAR-T cell therapies for cancer. On June 26, 2025, the Food and Drug Administration eased some of the medicines' reporting requirements. Hiroyuki Okuzawa is working to keep it that way. Can they keep it?

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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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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

MARCH 27, 2025

Deletion Vectors will be enabled by default in Delta Live Tables (DLTs) for materialized views and streaming tables starting April 28, 2025. Data privacy regulations such as GDPR , HIPAA , and CCPA impose strict requirements on organizations handling personally identifiable information (PII) and protected health information (PHI).

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BioPharma Drive: Drug Pricing

JULY 22, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from News roundup Replimune drug rejected by FDA; Omega raises $647M biotech fund The FDA raised issues that Replimune said hadn’t come up in meetings previously.

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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. Drug Policy There will be significant changes in clinical trials & drug development due to the Inflation Reduction Act.

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Perficient: Drug Development

JULY 24, 2025

In 2025, MedTech leaders are redefining innovation by architecting intelligent ecosystems that span the entire product lifecycle. Industry Insight: The FDA’s Total Product Life Cycle (TPLC) Advisory Program is expanding to accelerate innovation through early, strategic communication between device developers and regulators.

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BioPharma Drive: Drug Pricing

JUNE 23, 2025

Originally developed in the 1970s to treat diabetes, these drugs—such as Ozempic, Wegovy, and Mounjaro—have become headline-makers for their ability to induce significant weight loss. Understanding GLP-1 drugs GLP-1, or glucagon-like peptide-1 receptor modulators, mimic natural hormones that regulate insulin and appetite.

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Fierce BioTech

APRIL 28, 2025

Accelerating Time-to-Market: Balancing Speed, Compliance, and Operational Excellence jpiatt Mon, 04/28/2025 - 14:42 Tue, 06/24/2025 - 10:00 Resource Type Webinar Promotion Start Thu, 05/01/2025 - 08:30 Promotion End Sat, 11/01/2025 - 08:30 In the highly competitive world of drug development, few things matter more than getting to market first.

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Perficient: Drug Development

JULY 24, 2025

Increased data exposure and privacy vulnerability Service providers must comply with regulations, standards, and practices that prevent the misuse of user information. Retrieved July 24, 2025, from [link] This requires special attention to data governance and use; this is not the fault of artificial intelligence. Samsung.com.

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Alta Sciences

APRIL 8, 2025

43 Advancing Vision Care With Formulation and Manufacture of Ocular Therapeutics pmjackson Tue, 04/08/2025 - 15:28 According to the WHO, at least a billion people are currently living with vision impairment from a preventable or treatable source. billion in 2021 to an estimated $68.93 billion by 2030.

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ACTO

DECEMBER 17, 2024

A survey of healthcare and life science companies found that 93% of these companies expect to increase their spend in 2025. Such cross-functional collaboration ensures consistent implementation from drug development through commercialization. The stakes for AI adoption in the pharmaceutical industry have never been higher.

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Perficient: Drug Development

OCTOBER 15, 2024

Lets talk about data governance in banking and financial services, one area I have loved working in and in various areas of it … where data isn’t just data, numbers aren’t just numbers … They’re sacred artifacts that need to be protected, documented, and, of course, regulated within an inch of their lives.

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Perficient: Drug Development

OCTOBER 1, 2024

However, rather than the same sign to be put online, the December 2023 rule established a new black and navy blue official digital sign shown below: Beginning on New Year’s Day 2025, banks will be required to display the FDIC official digital sign near the name of the bank on all bank websites and mobile applications.

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Conversations in Drug Development Trends

MAY 23, 2024

The CRO landscape is rapidly evolving with the recent implementation of the EU Clinical Trials Regulation No 536/2014 (EU-CTR) and the launch of the Clinical Trials Information System (CTIS). These designs allow for evaluating multiple drugs or treatments simultaneously, offering a more flexible and efficient approach to drug development.

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Agency IQ

FEBRUARY 2, 2024

Diagnostics landscape analysis: Key issues and a look ahead at 2024 Diagnostic regulation in the U.S. Following significant policy proposals in recent years, 2024 is gearing up to be a profoundly impactful year for diagnostics developers and the policymakers who regulate them. is a constantly evolving topic. In the U.S.,

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Agency IQ

JULY 7, 2023

This study was developed to help establish a workable framework for using real-world evidence (RWE) for regulatory cases within the E.U., building off the EMA’s Strategy through 2025. Regulators have been investing in ways to understand better how RWE can be used and how RWD is generated.

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Agency IQ

JULY 22, 2024

While the agency has been working to implement its rule, which has broad-reaching impacts for diagnostics and drug developers, other moves by the Supreme Court and legislators could impact the agency’s next steps. AgencyIQ provides a status update for regulated industry. diagnostic products are regulated as medical devices.

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Perficient: Drug Development

OCTOBER 7, 2024

Introduction A quick summary of the new official digital sign requirement of the FDIC is that effective January 1, 2025, this logo: must be replaced by this logo: For readers who missed part 1 of this series or want to reread the original blog can find it here. 12 CFR § 328.5(a).

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Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. This study is planned to start in late 2024 and conclude in late 2025.

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Perficient: Drug Development

NOVEMBER 14, 2023

My son’s part of Generation Alpha, a cohort that includes children born between 2010 and 2025. And games like Mightier combine biofeedback with emotional regulation to teach kids how to control their anger and anxiety. That’s where you as a healthcare marketer come in. The oldest of the Gen Alpha kids are only 13.

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Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

AUGUST 9, 2024

EMA’s psychedelic workshop leaves stakeholders with as many questions as answers Earlier this year, the EMA hosted a multi-stakeholder workshop to discuss regulatory issues surrounding drug development of psychedelic products. EMA has now published a report on the workshop; read on for AgencyIQ’s analysis. Although the E.U.

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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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Alta Sciences

MAY 16, 2025

Consultants CornerReflections from a Study Monitor and Director: A Career in Toxicology, by Bill Brock pmjackson Fri, 05/16/2025 - 18:40 Some might say a reflective piece like this could come across as sounding preachy. This article was published in May 2025. Maybe it is. I often rely on toxicologists from Altasciencessuch as Drs.

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Alta Sciences

JULY 31, 2024

Food and Drug Administration (FDA) published a draft guidance to ensure greater diversity in clinical trials, which is expected to become a final guidance by June 2025. Discover how drug developers, researchers, and regulators are ensuring this happens. Tags Clinical Trials Weight 15

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FDA Law Blog: Drug Discovery

JULY 9, 2024

Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & Sarah Wicks & Deborah L. Another question is the impact on rare disease drug development, where broader populations are small and there may be limited knowledge about differential impacts of disease. 355(z)(3) and 21 U.S.C. 360j(g)(9)(A)).

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Agency IQ

JULY 28, 2023

FAR regulations require contracting officers to “promote and provide for full and open competition in soliciting offers and awarding Government contracts.” Industry wants its products reviewed quickly, efficiently and predictably. Without sufficient resources, the FDA is unable to do so.

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