DrugBank

OCTOBER 30, 2024

At DrugBank, we’re dedicated to empowering pharmaceutical researchers with data that drives impactful results. Your Need for Accessible, High-Quality Data—Solved Pharmaceutical research and healthcare innovation demand timely access to comprehensive, up-to-date data. In fact, poor data quality is estimated to cost U.S.

Production 98

Production Clinical Trials Packaging Compliance 98

DrugBank

OCTOBER 4, 2024

Deal Structuring Deal structuring in pharmaceutical M&A requires a balance of financial, legal, and strategic considerations. However, ensuring that these structures comply with applicable tax laws and regulations is essential to avoid potential legal and reputational risks.

Pharmaceuticals 98

Pharmaceuticals Pharmaceutical Companies Therapies Marketing 98

ProRelix Research

APRIL 17, 2025

Indiaprovidesanidealsettingforsuchcost-savingstrategiesduetoseveralkeyfactors: Economic Benefits Conducting trials in India can reduce costs by up to 60%comparedtoWesterncountries.Labor costs,participantrecruitment,hospitalinfrastructure,andadministrativefeesaresignificantly lower. […] The post Outsourcing Clinical Trials to India: Global Regulation, (..)

Clinical Trials 52

Clinical Trials Regulations Trials Pharmaceuticals 52

Drug Patent Watch

APRIL 8, 2025

"5 Key Considerations for Valuing Pharma Companies As the pharmaceutical industry continues to evolve, accurately valuing pharma companies has become increasingly complex. Consider the impact of new regulations, such as those related to biosimilars or generic drugs. Evaluate revenue growth, profitability, and cash flow.

Pharma Companies 77

Pharma Companies Biosimilars Pharmaceuticals Regulations 77

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.

Drug Development 52

Drug Development Clinical Pharmacology Clinical Trials Pharmaceutical Companies 52

Advarra

DECEMBER 17, 2024

As the harmonization effort advances, the focus will likely shift toward refining guidelines and regulations for vulnerable populations, including children, pregnant women, and prisoners. There are many ways in which being a small biotech company, small CRO, or individual site is absolutely wonderful for this industry.

Clinical Research 98

Clinical Research Clinical Trials Trials Hospitals 98

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.

Marketing 52

Marketing Drugs Regulations Pharmaceutical Companies 52

thought leadership

APRIL 4, 2025

Pharmaceutical tariffs of 25% have been forecasted causing many global organizations to investigate the consequences of the tariffs on their overall product portfolio. The US Government recently modified their policy to utilize tariffs to in an effort to support the US economy.

Pharmaceuticals 52

Pharmaceuticals Regulations Government Production 52

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.

Pharmaceuticals 52

Pharmaceuticals Regulations Compliance 52

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.

Regulations 52

Regulations Marketing Compliance Production 52

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.

Government 52

Government Compliance Pharmaceutical Companies Pharmaceuticals 52

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.

Drug Development 66

Drug Development Drugs Compliance Regulations 66

Drug Target Review

NOVEMBER 7, 2024

Agonist antibodies of immune checkpoint regulators These represent a groundbreaking class of immunotherapeutic agents that mimic the natural function of endogenous ligands by binding to specific cell-surface receptors. This approach augments the strength of achieving immune homeostasis.

Disease 52

Disease Immune Response Regulations Engineering 52

Drug Patent Watch

FEBRUARY 19, 2025

The Unsung Heroes of Generic Drugs: The Importance of Quality Assurance As we navigate the complex world of pharmaceuticals, it's easy to overlook the behind-the-scenes efforts that ensure the quality and safety of the medications we rely on.

Drugs 83

Drugs Packaging Compliance Regulations 83

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.

Compliance 91

Compliance Regulations Pharmaceuticals 91

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.

Pharmaceuticals 52

Pharmaceuticals Pharmaceutical Companies FDA Approval Production 52

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.

Disease 75

Disease Pharmaceuticals Regulations Treatment 75

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.

Regulations 99

Regulations Pharmaceuticals Research Drugs 99

LifeSciVC

MAY 14, 2025

1,2,3 Among a long list of innovations, the lowest hanging fruit for commercialization is the use of microgravity-based crystallization to enhance high-value pharmaceuticals. Pharmaceuticals are among the worlds most valuable materials by weight leading branded drugs, particularly biologics, carry list prices that often exceed $1M per kg.

Science 95

Science Production Research Drugs 95

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.

Regulations 52

Regulations Pharmaceutical Companies International Pharmaceuticals 52

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.

Pharmaceuticals 52

Pharmaceuticals Packaging Regulations Science 52

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.

Pharmaceuticals 59

Pharmaceuticals Regulations Research 59

Drug Patent Watch

MARCH 24, 2025

Navigating the Complex World of CDMO Contracts: What to Look Out For As a pharmaceutical professional, you're likely no stranger to the importance of finding the right Contract Development and Manufacturing Organization (CDMO) partner. Regulatory Compliance Regulatory compliance is a top priority in the pharmaceutical industry.

Compliance 69

Compliance Pharmaceuticals Laboratories Production 69

Drug Patent Watch

FEBRUARY 20, 2025

The Unseen Heroes of the Pharmaceutical Industry: Achieving High-Quality Standards in Generic Drugs As we navigate the complex world of healthcare, it's easy to overlook the unsung heroes who work tirelessly behind the scenes to bring affordable, high-quality medications to the masses.

Drugs 91

Drugs Compliance Regulations FDA 91

Conversations in Drug Development Trends

OCTOBER 29, 2024

Increasingly, patients and patient-led organizations are playing a pivotal role in shaping drug development, underscoring the importance of collaboration between patient organizations, CROs, and pharmaceutical and biotechnology companies.

Clinical Research 72

Clinical Research Disease Research Clinical Trials 72

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.

Regulations 52

Regulations Disease Research Engineering 52

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.

Pharmaceuticals 52

Pharmaceuticals Compliance Regulations Production 52

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.]

Regulations 40

Regulations International Production Government 40

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.

Pharmaceutical Companies 59

Pharmaceutical Companies FDA Production Regulations 59

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.

Drugs 89

Drugs FDA Regulations Pharmaceuticals 89

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.

Clinical Trials 98

Clinical Trials Regulations Compliance Government 98

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.

Government 59

Government FDA Pharmaceuticals FDA Approval 59

Drug Patent Watch

MARCH 26, 2025

The Unseen Hurdles of Generic Drug Development: Lessons Learned As the pharmaceutical industry continues to evolve, one thing remains constant: the pursuit of affordable, high-quality medications for patients worldwide. However, the journey to bringing a generic drug to market is often fraught with challenges.

Compliance 52

Compliance Drug Development Drugs Clinical Trials 52

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?

FDA 75

FDA Regulations Pharmaceuticals Drugs 75

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

Clinical Development 52

Clinical Development Pharmaceuticals Clinical Trials Trials 52

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.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceuticals Clinical Trials Therapies 98

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.

Regulations 40

Regulations Clinical Trials Production Biosimilars 40