Drug Patent Watch

DECEMBER 30, 2024

This article aims to provide a comprehensive overview of the key aspects of the regulatory framework, highlighting the requirements and challenges faced by pharmaceutical companies seeking to introduce generic drugs into the Japanese market. Retrieved from [link] Japan Pharmaceutical Manufacturers Association. Freyr Solutions.

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Drug Patent Watch

FEBRUARY 12, 2025

Accelerating Generic Drug Development: Strategies for Success As a pharmaceutical professional, you know how crucial it is to navigate the complex landscape of generic drug development.

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Drug Patent Watch

FEBRUARY 27, 2025

Navigating the Complex World of Global Drug Patents: Strategies and Challenges Ahead As a pharmaceutical professional, you know how crucial it is to protect your innovative drug patents in the global market. This is a nightmare scenario for any pharmaceutical company, and it's a reality that many face every day.

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thought leadership

SEPTEMBER 9, 2024

On April 26, 2023 the Commission adopted a proposal for a new Directive and a new Regulation which revise and replace the existing general pharmaceutical legislation under the following documentation.

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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.

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ACTO

DECEMBER 17, 2024

The stakes for AI adoption in the pharmaceutical industry have never been higher. Yet, the critical question remains: How can pharmaceutical companies ensure responsible and compliant AI implementation while maximizing its potential for field teams? This approach provides better control over data access and security.

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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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thought leadership

SEPTEMBER 12, 2024

Introduction In the brightly lit corridors, clean rooms, and warehouses of pharmaceutical and medical device industries, a mystery lurks—a puzzle shrouded in regulations, veiled in risk, and cloaked in the shadows of compliance.

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Pharmaceutical Development Group

AUGUST 9, 2021

Formulation chemistry is the systematic and step-by-step approach to pharmaceutical development. Nowadays, as the usage of medicines is increasing, pharmaceutical companies are more eager to bring manufacturing a new look in quality and performance. There are different tests to assess the quality of a pharmaceutical product.

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biobide

DECEMBER 8, 2023

Qualification and validation are crucial processes in various industries, especially those involving R&D, manufacturing, and regulated sectors such as Pharmaceutical or Biotechnological. While these terms are often used interchangeably, they signify different procedures with unique purposes and methods.

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SCIENMAG: Medicine & Health

FEBRUARY 26, 2024

Another mystery is the regulation of cytochrome P450 enzymes (CYPs) in the central nervous system. DCM is the leading cause of heart failure in patients with chronic diabetes. However, the underlying mechanisms of DCM are poorly understood, and treatment options are limited.

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Disease Pharmaceuticals Regulations Treatment 75

thought leadership

MARCH 26, 2024

On April 26, 2023, the European Commission proposed a new package of pharmaceutical legislation 1 to revise many of the currently applicable Regulations.

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Agency IQ

APRIL 12, 2024

BY KIRSTEN MESSMER, PHD, RAC This week, the European Parliament voted to adopt the compromise texts of both the revised pharmaceutical directive and regulation presented by Parliament’s health committee in March 2024.

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PerkinElmer

MARCH 4, 2022

Early approaches focused on regulating intracellular aggregate formation by inhibiting tau kinases, tau aggregation, or improving microtubule stabilization. 1 “There is great interest in identifying targets that regulate the expression or degradation of tau,” explained the authors in Communications Biology. Communications Biology.

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DrugBank

APRIL 25, 2024

As the pharmaceutical industry is pushing to deliver new and better drugs while racing against time and budget constraints, it is becoming crucial to not just use artificial intelligence (AI) but truly maximize its potential. Invest in Your Tech Infrastructure A solid tech foundation is essential for AI to work in the pharmaceutical sector.

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DS in Pharmatics

JULY 7, 2023

As a supply chain expert in the biotech and pharmaceutical industry, I understand the unique challenges faced by companies operating in this highly regulated and complex sector.

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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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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. The Court thus explained that interpreting the patent in 35 U.S.C.

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Policy Prescription

AUGUST 25, 2022

This past June, during a debate in the Senate Health, Education, Labor and Pensions (HELP) Committee, Senator Richard Burr (R-NC), the committee’s Ranking Member, demonstrated that he does not understand very important developments in our nation’s approach to drug regulation and safety. It was almost as if Sen. Those are facts.

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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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Clinical Trials Trials Regulations Pharmaceutical Companies 52

Agency IQ

MAY 3, 2024

What we expect European regulators to do in May 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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The Premier Consulting Blog

APRIL 13, 2025

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. 4] ICH = International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. link] [7] H.R.2565

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FDA Law Blog: Biosimilars

OCTOBER 1, 2024

Karst — If you monitor Regulations.gov dockets and litigation dockets on PACER like we do, then you know that one company name—more than any other over the past several years—pops up: Vanda Pharmaceuticals, Inc. VANDA PHARMACEUTICALS, INC. VANDA PHARMACEUTICALS, INC. 24-270 VANDA PHARMACEUTICALS, INC. 23-5200 (D.C.

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thought leadership

NOVEMBER 18, 2024

A Risk Evaluation and Mitigation Strategy (REMS) is a critical component of modern pharmaceutical regulation, designed to ensure that medications with serious safety risks are used safely and effectively. What is REMS?

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The Premier Consulting Blog

AUGUST 21, 2024

Phase-appropriate information and data to support CMC content, such as specifications, analytical methods, analytical method validation, pharmaceutical development, and stability, should be developed as clinical development progresses. QOS – optional Module 3.2.S QOS – optional Module 3.2.S

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DrugBank

MARCH 7, 2024

Pharmaceutical researchers, in particular, have a keen interest in understanding the unfolding dynamics of this market. Inspired by its success, pharmaceutical companies are pursuing the development of drugs with similar therapeutic profiles, aiming to expand treatment options.

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Drug Target Review

NOVEMBER 27, 2023

Because these proteins have such a profound effect on cells, there is typically a second hurdle of regulation that needs to be overcome to make the proteins. eFFECTOR Therapeutics has developed a novel class of cancer drugs known as Selective Translation Regulator Inhibitors (STRIs), which directly target the eIF4F complex.

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Molecular Biology Therapies Pharmaceuticals Treatment 86

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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Agency IQ

NOVEMBER 10, 2023

The adoption of a “fees payable” regulation, Council Regulation (EC) No 297/95 , permitted (and continues to permit) the regulator to assess fees for many of the services it provides to medicines developers. There are other fee-related regulations as well.

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Drug Target Review

JULY 4, 2023

1 Regulators invest significant consideration balancing quality-of-life measures with overall survival when assessing novel oncology treatments. Author bios: Dr Petra Dieterich Petra has 30 years’ experience of drug development in the Pharmaceutical industry with a focus on supporting CMC activities.

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thought leadership

AUGUST 6, 2024

Why Does Pharmaceutical Product Labeling Matter? Do you know what’s in your product’s labeling and what it is saying about your product? More importantly, do you know why that matters?

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Advarra

MARCH 6, 2025

Over the years, Advarra has reviewed a wide range of clinical research studies and worked every day alongside leading pharmaceutical manufacturers, medical researchers, and healthcare institutions. Advarra ensures that clinical trials comply with the U.S.

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DrugBank

MARCH 15, 2024

Eli Lilly's Triumph: Pioneering Solutions in Weight Management Eli Lilly's remarkable achievement with its drug Mounjaro (tirzepatide) in the fourth quarter of 2023 has sent ripples of excitement through the pharmaceutical industry. This has caused a great deal of hesitation from pharmaceutical companies in the past.

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Agency IQ

MARCH 15, 2024

California publishes draft regulations for landmark plastic pollution reduction act CalRecycle has launched the formal rulemaking process for Senate Bill 54, which will implement a sweeping plan to reduce plastic waste in the state by 2032. However, a producer may also choose to apply for independent compliance with the requirements.

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thought leadership

MAY 8, 2024

How ProPharma Can Help You Ensure Compliance with the New HTAR Requirements The new Health Technology Assessment Regulation (HTAR) will set new requirements for pharmaceutical companies seeking registration and market access in the European Union (EU) for their products.

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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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Drug Patent Watch

FEBRUARY 26, 2025

Unlocking the Secrets to Patenting Drug Combinations: Strategies and Challenges As a pharmaceutical professional, you know how crucial it is to stay ahead of the curve when it comes to patenting innovative treatments.

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