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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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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FDA Law Blog: Drug Discovery

JANUARY 30, 2025

As a result of reforms enacted by the Food and Drug Omnibus Reform Act of 2022 (FDORA), FDAs authority to approve as well as withdraw an accelerated approval was given new regulatory teeth to ensure that confirmatory trials are conducted expeditiously.

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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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Drug Target Review

JUNE 11, 2025

Drug development is plagued by complex challenges, but multimodal AI is unlocking new opportunities. By integrating diverse data sources – from genomics to clinical insights – this approach is accelerating drug discovery, improving patient stratification and boosting success rates.

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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. 3-5 These layers of regulation, while essential for animal welfare, make NHP-based studies complex, expensive and time-consuming.

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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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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. Drawing from the brand-new 2025 Economic Report on U.S.

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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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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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The Pharma Data

JUNE 25, 2025

The drug’s mechanism also aims to delay the overall progression of disease severity—an urgent need in a patient population that often progresses to end-stage renal disease. In March 2025 , Regulus announced the successful completion of its Phase 1b multiple-ascending dose clinical trial for farabursen. Eastern Time on June 25, 2025.

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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. How will the imposition of tariffs and a burgeoning trade war affect domestic drug production and companies supply chain demands?

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LifeSciVC

MAY 14, 2025

In recent years, the renaissance in private space has rekindled interest in microgravity and spawned a more radical vision for the future: manufacturing drugs in space. Why Space, Why Drugs, and Why Now? Keytruda, which generates >$25B in annual sales, is among the most important and impactful oncology drugs of all time.

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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. That trial is in second-line NSCLC.

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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. Food & Drug Administration. The goal is not more complexity, but smarter, leaner operations grounded in relevance and accountability. link] MHRA UK.

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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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Drug Target Review

JUNE 16, 2025

G protein-coupled receptors (GPCRs) are a highly validated drug target family – accounting for 30-35 percent of all approved drugs. Despite this, the therapeutic potential of targeting most GPCRs remains untapped, as only 10 percent of GPCRs have been drugged.

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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. How regulators will interpret and enforce its provisions may not become clear for some time.

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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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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).[ One great example is the FDAs 505(b)(2) New Drug Application (NDA) pathway. Legislation with delayed implementation In 2021, the FDA Modernization Act 2.0

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FDA Law Blog: Biosimilars

MARCH 18, 2025

Koblitz Integral to the careful balance Congress struck when passing the Hatch-Waxman Amendments, the patent term extension (PTE) is intended to restore patent life that was consumed during regulatory review of an FDA-regulated product. On March 13, 2025, the Federal Circuit ventured into the world of reissued patents and PTE. (

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H1 Blog

DECEMBER 11, 2024

Drug Pricing, Global Diversity Strategies, & Emerging AI Applications Each year, we compile our predictions to provide life sciences, pharmaceutical, and healthcare organizations with a comprehensive look at emerging industry trends and dynamics to help them prepare for the year ahead.

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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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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. Fast Track and Orphan Drug Designations from FDA The U.S. John Stone, MD, MPH , Professor of Medicine at Harvard Medical School, the Edward A.

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FDA Law Blog: Biosimilars

MARCH 23, 2025

Livornese On Friday, March 21, 2025, FDA announced that it was further delaying the effective date for the ACNU final rule until May 27, 2025. Originally, the Nonprescription Drug Product with an Additional Condition for Nonprescription Use (ACNU) final rule was to become effective January 27, 2025. By Deborah L.

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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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The Pharma Data

JUNE 25, 2025

Additionally, the tablet form supports flexible dosing and simplifies dose reductions, which may be required due to drug interactions or adverse events, as guided by the product’s label. Food and Drug Administration (FDA) granted approval to the tablet formulation of BRUKINSA for all five of its approved indications.

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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. In fact, the priority designation for the final rule is labeled as “economically significant.”

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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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FDA Law Blog: Biosimilars

JUNE 25, 2025

To be clear, the minor changes are permitted only for OTC monograph drug products that are included in deemed final orders, and not for OTC monograph products that may remain on the market pending FDA monograph orders allowing or prohibiting such products.)

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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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Drug Patent Watch

JANUARY 13, 2025

The Rise of Biosimilars: A Healthcare Revolution Biosimilars, often referred to as the “generic equivalents” of biologic drugs, have been making waves in the pharmaceutical industry for over a decade. billion by 2025, growing at a CAGR of 34.2% from 2020 to 2025[1]. . billion by 2025, growing at a CAGR of 34.2%

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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. a walled garden of sorts), ensures data sovereignty and compliance with regional regulations.

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FDA Law Blog: Biosimilars

FEBRUARY 18, 2025

Lewis, , Principal Regulatory Device and Biologics Expert The FDA is currently funded through March 1st, 2025. The question that is always on the mind of folks in FDA-regulated industries is, what does that mean for my application/inspection/meeting? By Richard A. Once processing is complete, the staff are returned to furlough status.

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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

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. New roadmap sets out U.K.

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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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