Drug Target Review

JULY 7, 2025

3-5 These layers of regulation, while essential for animal welfare, make NHP-based studies complex, expensive and time-consuming. However, the last decade has seen a gradual reduction in their use, driven by tightening animal welfare regulations and scientific advances. Are we nearing a post-NHP future?

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The Pharma Data

JUNE 25, 2025

BeOne Medicines Receives Positive CHMP Opinion for New Film-Coated Tablet Formulation of BRUKINSA® (zanubrutinib), Paving the Way for European Market Approval BeOne Medicines Ltd. This dual regulatory progress signals strong global confidence in the new formulation and sets the stage for expanded availability in key markets.

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The Pharma Data

JUNE 6, 2025

The data underscored the significant clinical benefits associated with cystic fibrosis transmembrane conductance regulator (CFTR) modulators—particularly its next-generation triple therapy, ALYFTREK® (vanzacaftor/tezacaftor/deutivacaftor).

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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).[ We remain ingrained in the regulations to ensure sponsors can optimize their programs and leverage the benefits that might be available to them via new initiatives.

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Drug Patent Watch

JANUARY 13, 2025

As we delve into the intricate world of biosimilar market dynamics, we’ll explore how these complex molecules are reshaping treatment paradigms across diverse patient populations. ”[1] The global biosimilars market is experiencing exponential growth, with projections indicating it will reach $69.4 from 2020 to 2025[1].

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The Pharma Data

JULY 2, 2025

INZ-701 is designed to replace deficient ENPP1 enzyme activity, with the aim of restoring normal regulation of mineralization processes in the body. Timeline of the Transaction The acquisition process began on May 16, 2025, when BioMarin and Inozyme jointly announced the signing of a definitive merger agreement. per share in cash.

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The Pharma Data

JUNE 9, 2025

Food and Drug Administration, with additional filings planned in other markets.” The results were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting , where they generated significant attention among oncologists, rheumatologists, and musculoskeletal disease experts. Source link

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The Pharma Data

JUNE 27, 2025

Understanding the Medications Involved: Semaglutide’s Growing Role in Global Health Semaglutide is a glucagon-like peptide-1 receptor agonist (GLP-1RA) , a class of drugs that has gained substantial popularity over recent years for its efficacy in blood glucose regulation, weight reduction, and cardiovascular risk management.

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The Pharma Data

JUNE 13, 2025

This opinion paves the way for the eventual authorization of Zenrelia for marketing across the European Union (EU) — a crucial step forward in delivering much-needed treatment options for dogs suffering from pruritic skin disorders.

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The Pharma Data

JUNE 13, 2025

The results of this study were presented at the American Association for Cancer Research (AACR) annual meeting on April 27, 2025, and show a dramatic improvement in event-free survival (EFS) for patients treated with KEYTRUDA alongside standard care. 0.89; p = 0.00140).

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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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The Pharma Data

JUNE 6, 2025

Global Pharmaceutical Contract Sales Outsourcing Market to Reach $24.8 Billion by 2030: Strategic Insights, Regional Trends, and Technological Shifts Reshaping the Landscape The global pharmaceutical contract sales outsourcing (CSO) market is entering a transformative phase, with its value expected to grow from $17.3 In the U.S.,

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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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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. BCMA and CD19 are the protein targets of the seven approved CAR-T therapies.

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FDA Law Blog: Biosimilars

MARCH 6, 2025

Lenz, Principal Medical Device Regulation Expert & Lisa M. Here, we will describe the recommendations in FDAs guidance documents for collection and processing of data that will be used for training, tuning, and testing AI models and what to include in a marketing submission for AI-enabled software. By Adrienne R.

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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: Biosimilars

JANUARY 5, 2025

Livornese As promised in the Fall Unified Regulatory Agenda, FDA issued the final rule to establish the pathway to obtain marketing approval of a nonprescription drug product with an additional condition for nonprescription use (ACNU) on December 26, 2024, before the end of the calendar year. By Deborah L. 105288 (Dec.

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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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Codon

JUNE 12, 2025

At Activate and Cyclotron Road, he built fellowships that served as perches for researchers working on societally important ‘ hard’ technologies that might not yet be VC-fundable find their feet and begin developing technologies into market-ready products. ” Asimov Press (2025). Join Asimov Press. Cite: Gilliam, E.

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FDA Law Blog: Biosimilars

FEBRUARY 20, 2025

Gibbs The multi-decade battle over FDAs power to regulate Laboratory Developed Tests (LDTs) had its day in court earlier this week. Many of the fired employees were within the Center for Devices and Radiological Healththe Center that is tasked with regulating all devices, including in vitro diagnostics, which FDA argues includes LDTs.

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Drug Channels

MAY 20, 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: Whats Next for Retail Pharmacy: Data, Debate, and Disruption This event will be broadcast live on: Friday, June 20, 2025 12:00 p.m. It is part of The Drug Channels 2025 Video Webinar Series.

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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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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. Register now to secure your spot.

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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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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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Fierce BioTech

JANUARY 23, 2025

What Youll Learn: How contract sales models can help you stay ahead, amid shifting trends + evolving regulations. Get actionable insights for staying competitive in todays market. On Demand Start Date Wed, 03/05/2025 - 13:00 End Date/Time Wed, 03/05/2025 - 13:00

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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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BioPharma Drive: Drug Pricing

JUNE 23, 2025

Understanding GLP-1 drugs GLP-1, or glucagon-like peptide-1 receptor modulators, mimic natural hormones that regulate insulin and appetite. By Jacob Bell • May 6, 2025 Keep up with the story. © 2025 TechTarget, Inc. The balance is complex, as obesity carries its own serious health risks. or its subsidiaries.

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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. While this approach aims to improve ROI before potential price controls kick in, it complicates trial design and recruitment, increasing the time it takes to get treatments to market.

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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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PPD

MAY 7, 2024

The European Union (EU) is on the verge of a significant shift as it prepares to implement new health technology assessment (HTA) regulations in 2025. Challenges and opportunities of the new EU HTA regulation The implementation of centralized HTA presents both opportunities and challenges for pharmaceutical companies.

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Agency IQ

JANUARY 12, 2024

device regulation timelines 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. both pre- and post-market.

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Agency IQ

MARCH 7, 2024

British regulators tease new device regulations in informative live session This week, the British regulator MHRA offered a new peek into its planned medical device regulations. BY COREY JASEPH, MS, RAC | MAR 5, 2024 11:10 PM CST Quick background on medical device regulation in the U.K. post-market regulation here.]

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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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thought leadership

MAY 7, 2024

Are You Ready for Mandatory EU Health Technology Assessment Regulation (HTAR) Implementation Beginning January 2025? Pharmaceutical companies need to be prepared for the new European Health Technology Assessment Regulation (HTAR), which will take effect in January 2025.

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PPD

APRIL 30, 2024

31, 2022, the EU Clinical Trial Regulation (EU CTR) 536/2014 became applicable, heralding a new era for clinical trials in the European Union (EU). Transitioning to EU CTR requirements for existing studies Under the regulation, clinical trial applications submitted before Jan.

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FDA Law Blog: Biosimilars

JULY 15, 2025

The American Conference Institute’s 3rd Annual West Coast Forum on Legal, Regulatory, and Compliance for Cosmetics & Personal Care Products is scheduled to take place from October 8-9, 2025 in Santa Monica, California. FDA Law Blog is a conference media partner. As such, we can offer our readers a special 10% discount.

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