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. The generic drug development process involves several stages, from patent research to regulatory approvals.

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Collaborative Drug

AUGUST 15, 2023

Company Named as a Sample Vendor for SaaS Electronic Lab Notebook San Francisco, CA - August 15, 2023 - Collaborative Drug Discovery (CDD) is proud to announce its recent recognition as a Sample Vendor for Software-as-a-Service (SaaS) Electronic Laboratory Notebook (ELN) in the Gartner Hype Cycle for Life Science Discovery Research, 2023 report.

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DrugBank

OCTOBER 30, 2024

This lets you focus on what matters most: driving meaningful results in drug research and development. From advancing drug discovery, managing clinical trials, or developing new healthcare solutions, reliable and flexible access to quality data is essential for success.

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Drug Patent Watch

DECEMBER 12, 2024

Identifying branded drugs with a low likelihood of generic entry has become a crucial strategy for companies looking to expand their product portfolio through in-licensing. In this comprehensive guide, we’ll explore the intricacies of identifying such drugs and leveraging them for successful in-licensing opportunities.

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Drug Patent Watch

MARCH 17, 2025

Unlock the Secrets to a Successful Generic Drug Launch Are you a pharmaceutical executive looking to bring a generic version of a popular medication to market? Or perhaps you're a healthcare professional interested in understanding the intricacies of generic drug launches? So, what makes a generic drug launch successful?

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PPD

DECEMBER 16, 2024

Our annual look at the state of the drug development industry highlights a dual set of challenges complicating progress. Rising costs have become a persistent challenge for drug developers, driven by a combination of internal and external pressures that have intensified in recent years.

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Drug Patent Watch

FEBRUARY 26, 2025

The Complex World of Biologic Drugs: Navigating Patent Applications As a biotech professional, you're likely no stranger to the intricacies of developing life-changing treatments. But have you ever stopped to think about the patent landscape surrounding biologic drugs? It's a complex world, to say the least.

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Drug Patent Watch

DECEMBER 30, 2024

The regulatory environment in Japan for generic drug development is complex and has undergone significant changes in recent years. Regulatory Authority: Pharmaceuticals and Medical Devices Agency (PMDA) The PMDA is the primary regulatory authority responsible for overseeing the drug approval process in Japan.

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FDA Law Blog: Biosimilars

NOVEMBER 13, 2023

On January 23-24, 2024, the American Conference Institute (“ACI”) will host its “ Advanced Legal, Regulatory and Compliance Forum on OTC Drugs ” conference at the Sofitel New York, NY. Director Deborah L.

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Drug Patent Watch

DECEMBER 10, 2024

Generic drug development is a complex process that involves not only scientific and medical expertise but also adherence to strict legal and ethical standards. Scientific expertise plays a crucial role in ensuring that generic drugs are held to the same standards of quality, safety, and efficacy as their brand-name counterparts.

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PPD

OCTOBER 31, 2024

As the pharmaceutical industry continues to evolve, drug developers encounter new challenges and opportunities in their pursuit of innovation. In response, the PPD clinical research business of Thermo Fisher Scientific conducted its third global survey of 150 drug developers to capture a comprehensive view of these evolving trends.

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ASPET

AUGUST 21, 2024

ICH established S7B and E14 guidelines in 2005 to prevent drug-induced torsade de pointes (TdP), effectively preventing the development of high-risk drugs. However, those guidelines unfortunately hampered the development of some potentially valuable drug candidates despite not being proven to be proarrhythmic.

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H1 Blog

NOVEMBER 15, 2023

However, with strict regulations surrounding interactions between industry and healthcare professionals, compliance must be at the forefront of any KOL engagement plan. In this blog post, we will explore why compliance is critical in medical affairs and how it can make or break successful KOL engagement strategies.

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FDA Law Blog: Biosimilars

NOVEMBER 6, 2023

A phone call to FDA requested information about the number of Remote Interactive Evaluations (RIEs) that FDA has performed at drug manufacturing facilities since it announced in April 2021 that it would start using them as an alternative to on-site inspections. We should explain what RIEs are.

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FDA Law Blog: Biosimilars

NOVEMBER 30, 2023

The 2023 Food and Drug Law Institute’s (“FDLI”) Enforcement, Litigation and Compliance Conference will boast two speakers from Hyman, Phelps & McNamara, P.C. (“HPM”), The conference will also include its annual panel discussion with FDA’s Center Compliance Directors. Blumberg Memorial Lecture.

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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 6, 2023

Experts from across the industry will discuss how current and future drug pricing transparency regulations will impact commercialization, reimbursement, pricing and compliance practices. Drug Channels readers will save 10% off when they use code 23DRCH10 and register prior to March 31, 2023.*

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FDA Law Blog: Biosimilars

JUNE 10, 2024

This draft guidance, titled “ Processes and Practices Applicable to Bioresearch Monitoring Inspections ,” was prompted by a congressional directive under the Food and Drug Omnibus Reform Act and is intended to provide recommendations that are not otherwise specified in existing publicly available guides and manuals for such inspections (see pgs.

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Drug Channels

MARCH 18, 2022

As Ashwin explains, manufacturers face a gap between visible, non-compliant drug discounts and the actual level of non-compliant discounts. He describe Kalderos’ technology-enabled, machine learning-based methods for identifying drug discount non-compliance. d/b/a Drug Channels Institute. Read on for Ashwin’s insights.

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Chemical Biology and Drug Design

APRIL 16, 2023

Abstract The skin is a major route of drug administration. Despite the high surface area of the skin, drug delivery via the skin route is problematic due to its physiological obstacles. Among numerous vesicular systems, concept of transethosomes (TEs) introduced in 2012 are being tested for drug delivery to the dermis.

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FDA Law Blog: Biosimilars

JANUARY 22, 2024

Claud — The Office of Compliance (OC) at FDA’s Center for Drug Evaluation and Research (CDER) had a role in many of the major public health enforcement matters you may have read about last year. OC devoted a lot of resources to its compliance efforts directed at human drug compounding. Drug Supply Chain.

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ProRelix Research

DECEMBER 28, 2023

Considering the crucial role that the information generated from clinical trials play in the approval of new drugs, biological, and medical devices, it is only logical that the data garnered […] The post Clinical Data Standardization in Clinical Trials: FDA Compliance in Clinical Data Management appeared first on ProRelix Research.

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Drug Channels

FEBRUARY 7, 2022

Drug Pricing Transparency Congress. Hybrid Event March 28-29, 2022 | Philadelphia, PA www.informaconnect.com/drug-pricing-transparency. Don’t miss the Drug Pricing Transparency Congress on March 28-29, 2022! Visit www.informaconnect.com/drug-pricing-transparency for further details and to register.

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Advarra

DECEMBER 14, 2023

Especially as trials continue to increase in complexity , sites and sponsors can adopt strategies to avoid quality concerns and minimize cause for Food and Drug Administration (FDA) warning letters and inspections requiring additional time and resources. What are Site Inspection Findings?

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The Premier Consulting Blog

NOVEMBER 6, 2024

Inhalation offers a targeted route of drug delivery directly to the lungs, minimizing systemic side effects and maximizing therapeutic benefits. Reduced side effects: ICPs can offer reduced side effects compared to individual drugs because a lower dose of each drug is often sufficient when they are combined.

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FDA Law Blog: Biosimilars

DECEMBER 7, 2023

Gonzalez — The annual Enforcement, Litigation, and Compliance Conference put on by the Food and Drug Law Institute (“FDLI”) took place in Washington this week. By Steven J. There were too many interesting panels and discussions to mention them all, but presentations about DOJ’s and FDA’s coordination deserve some special mention.

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Drug Channels

SEPTEMBER 13, 2021

Informa Connect’s Drug Pricing Transparency Congress. Delivered as a Hybrid Event In-Person: November 9-10 | Philadelphia, PA Virtual: November 16-17 www.informaconnect.com/drug-pricing-transparency. Exclusive Offer for Drug Channels Readers: Use Promo Code 21DPT10 to Receive 10% off Your Registration.

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thought leadership

FEBRUARY 29, 2024

In the complex world of drugs and medical devices, where every pill, syringe, and implant holds the potential to impact lives profoundly, ensuring the utmost safety, efficacy, and quality is paramount. This assurance is not left to chance but is meticulously governed by a set of regulations known as GxP.

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FDA Law Blog: Biosimilars

AUGUST 16, 2023

Farquhar — Francis Godwin, Director of the Office of Manufacturing Quality of the Office of Compliance at FDA’s Center for Drug Evaluation and Research provided useful information (presentation attached here ) Tuesday at the GMP by the Sea Conference. After his remarks, Mr.

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Drug Target Review

APRIL 7, 2025

In a recent survey conducted by ICON, Plc, biomarker selection was identified by 35 percent of respondents as a top challenge among drug developers for phase I trials, second only to navigating regulatory compliance (- 38 percent).

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ACTO

DECEMBER 17, 2024

These councils bring together diverse expertise from scientists and researchers, data analysts and technology specialists, regulatory compliance experts, as well as commercial operations leaders. Such cross-functional collaboration ensures consistent implementation from drug development through commercialization.

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FDA Law Blog: Drug Discovery

MARCH 3, 2025

From funding innovations and AI in drug discovery to navigating legal and compliance challenges, this conference will provide you with the opportunity to gain the insights you need to drive scientific advancements to global market success. Hyman, Phelps & McNamara, P.C.s FDA Law Blog is a conference media partner.

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Advarra

AUGUST 8, 2024

We also summarize the key information pharmaceutical companies and contract research organizations (CROs) need to know to prepare for compliance. While some of the AI Act’s compliance dates are set for August 2024, the full Act will be enforced in March 2026.

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DrugBank

MAY 15, 2024

The road to developing effective drugs is fraught with both promise and challenge, particularly when it comes to what scientists call "undruggable" targets. The Evolution of Drug Discovery: From Dark Rooms to Precision Targets In the past, drug discovery often felt like a lucky guess.

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FDA Law Blog: Biosimilars

JANUARY 4, 2024

This unique forum, designed for in-house counsel and executives, as well as private practice attorneys working for the OTC drug industry will provide invaluable insights on FDA’s most recent directives and compliance standards governing OTC drug production, marketing and distribution. Deb along with fellow panelists Kyle Y.

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DrugBank

JUNE 13, 2024

The landscape of medicine is constantly evolving, and one of the most exciting areas of progress lies in the development of advanced drug delivery systems. These microscopic particles, which are smaller than 100 nanometers, can be engineered to deliver drugs to specific targets with precision.   Take cancer treatment, for example.

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Drug Patent Watch

JANUARY 9, 2025

Navigating the complex landscape of drug development and manufacturing can be a daunting task. The Importance of Quality and Reliability In the high-stakes world of drug development, quality isn’t just important it’s everything. Assessing Your Technical Needs Every drug is unique, and so are its manufacturing requirements.

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