Drug Patent Watch

DECEMBER 10, 2024

” These dense webs of overlapping patent rights can significantly impact innovation, market entry, and competition across various industries and countries. Easier market entry: Less dense thickets may make it easier for new players to enter markets. may create higher barriers to entry for new innovators.

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PPD

DECEMBER 16, 2024

Addressing these underlying factors is essential; only by tackling the complexities of recruitment, timelines and regulatory compliance can sponsors achieve cost-effective and efficient trials, paving the way for long-term success in todays demanding market. With trials facing a median delay of 12.2

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Drug Channels

JULY 15, 2025

Among them: manufacturers’ evolving market access strategies, which increasingly aim to offset—or circumvent—growing pricing pressure from both commercial and government payers. Yet despite this record total, the bubble expanded at the slowest rate in at least a decade.

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Government Drugs Marketing 52

The Pharma Data

JUNE 16, 2025

The Extel survey, which assesses companies’ performance across financial expertise, shareholder communications, operational excellence, and market credibility, is recognized as a benchmark for understanding which firms are delivering the greatest value to their stakeholders.

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Government Pharmaceuticals Marketing Compliance 40

Drug Target Review

JUNE 19, 2025

With government and grant funding tightening,” Atwood adds, “labs are under pressure to do more with less, especially in resource-intensive areas like antibody discovery.” “With government and grant funding tightening, labs are under pressure to do more with less, especially in resource-intensive areas like antibody discovery.”

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Analytical Chemistry Engineering Science Government 52

Drug Patent Watch

JANUARY 21, 2025

By increasing access to affordable medications, biosimilars can also help to reduce healthcare costs for employers, insurers, and governments. As more and more biosimilars come to market, we can expect to see a significant reduction in the cost of biologics. So, what's the future hold for biosimilars?

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Drug Target Review

MAY 21, 2025

At the forefront of this mission is Senior Vice President of Vitalant, Becky Butler Cap, whose career has been long defined by a passion for building new services and treatment options in emerging markets. Building new services and treatment options for patients are a passion for me.

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The Premier Consulting Blog

OCTOBER 30, 2024

Innovation can also lead to faster time to market by accelerating drug development timelines, strengthening the supply chain, and providing better responsiveness during a public health emergency. The process for an advanced manufacturing technologies designation is outlined below in Figure 2.

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FDA Law Blog: Biosimilars

FEBRUARY 26, 2025

With all the change we are witnessing in the American model of regulation and governance, it might be tempting to ask if we are suddenly living in a post-compliance word. How will the imposition of tariffs and a burgeoning trade war affect domestic drug production and companies supply chain demands?

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Compliance Regulations FDA Government 66

PPD

JUNE 17, 2025

In the past decade alone, the time needed to complete a clinical trial has increased by 20–30%, and the cost to bring a new drug to market has risen to an average of about $2.6 Backed by more than 30 years of support for clinical and marketed products, we know what it takes to solve your specific challenges.

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Clinical Development International Drug Development Clinical Research 52

Perficient: Drug Development

MARCH 18, 2025

Government Citizen Services Assists citizens with information about services. Sales and Marketing Sales Qualification Agent Focuses on high-priority sales opportunities. Employee Self-Service Agent Answers policy questions and performs HR/IT tasks. Career Coach Personalized career advice and action plans.

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Production Research Government Marketing 52

Drug Patent Watch

FEBRUARY 26, 2025

However, the patentability of biologics is governed by specific laws and regulations, such as the Biologics Price Competition and Innovation Act (BPCIA). This requires a deep understanding of the science behind biologics, as well as the regulatory framework governing their development and approval.

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Drug Patent Watch

MARCH 4, 2025

The Unseen Heroes of Generic Drug Development: Pharmacovigilance As a generic drug developer, you're no stranger to the challenges of bringing affordable medications to market. Stay up-to-date on regulatory requirements : Familiarize yourself with the latest guidelines and regulations governing pharmacovigilance.

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Drug Development Drugs Government Production 52

Perficient: Drug Development

DECEMBER 10, 2024

Build for Trust : Incorporate contextual and toxicity guardrails, monitoring, decision transparency, and governance to ensure your AI systems are ethical and reliable. Advanced Compute Instances : P6 instances with NVIDIA Blackwell GPUs, delivering up to 2.5x faster GenAI compute speeds.

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Government Marketing 52

Drug Patent Watch

JANUARY 9, 2025

Enter the Contract Development and Manufacturing Organization (CDMO) a lifeline for many startups looking to bring their innovative therapies to market. In 2017, small and medium-sized biotech companies accounted for 51% of FDA market approvals, while large pharma companies were the originators in only 28% of approvals[4].

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Compliance Drug Development Pharma Companies Therapies 52

Perficient: Drug Development

FEBRUARY 12, 2025

Additionally, businesses should explore new revenue models through premium features and address integration complexities with robust data governance and analytics. POPs market consolidation is leading to more robust, full-stack solutions that integrate orchestration capabilities into broader platforms.

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Compliance Regulations Production Government 52

FDA Law Blog: Biosimilars

JULY 2, 2025

Meeting with FDA on behalf of clients or assisting clients seeking marketing authorization in preparing to meet with FDA and in other interactions with the Agency. Preparing for and responding to government inspections and other compliance matters.

Small Molecule 52

Small Molecule Compliance Engineering FDA 52

Perficient: Drug Development

MARCH 4, 2025

Make Marketing Data and Your CDP Work for You Breakfast When: Wednesday, March 19 | 8:00 A.M. Register: Make Marketing Data and Your CDP Work for You 5. You can meet the team, learn more about Perficients capabilities, and enjoy refreshments. Add to Schedule: Adobe Summit – Sessions 7. until 5:00 P.M.

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Marketing Government 52

Advarra

MARCH 6, 2025

For more than 35 years, Advarra has been committed to protecting the rights and welfare of clinical trial participants while helping to improve healthcare outcomes, advancing medical knowledge, and bringing innovative, life-extending treatments to market that benefit millions of patients worldwide.

Clinical Research 52

Clinical Research Research Clinical Trials Bioethics 52

Perficient: Drug Development

NOVEMBER 6, 2024

Other efforts by the SEC suggest that it is not content to wait until final rules governing AI are in effect before addressing problems and risks it perceives related to AI technologies. In addition, SEC’s Division of Enforcement has reported that it has AI-focused investigations underway.

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Regulations Compliance Government Marketing 52

Perficient: Drug Development

DECEMBER 31, 2024

Despite AI’s potential, poor data governance remains a significant challenge in the industry. This article explores the critical importance of clean data in AI applications and offers strategies for improving data governance in the B2B e-commerce sector. Why is Bad Data Governance So Prevalent in B2B Manufacturing?

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Government Production Compliance Marketing 52

FDA Law Blog: Biosimilars

OCTOBER 13, 2024

A very important aspect of the program is that it costs FDA, and the government, no additional dollars, though we do not wish to minimize the additional resources a priority review demands over the standard review that such an application might otherwise receive.

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Disease FDA FDA Approval Government 64

Perficient: Drug Development

NOVEMBER 15, 2024

Healthcare Trend #1: AI Disruption and Enablement Healthcare has seen a surge of interest in AI, with the market set to soar to $187.95 These discussions are forcing focus toward data quality, consistency, governance , and bias. billion by 2030. But the industry faces unique challenges that other sectors don’t encounter.

Regulations 52

Regulations Compliance Production Nurses 52

Perficient: Drug Development

MAY 22, 2025

Overview Opal is Optimizelys AI assistant designed to accelerate and enhance the entire marketing workflow. Content Generation Opal uses AI to generate a wide range of SEO-optimized content such as headlines, product descriptions, and marketing texts for digital channels including web, email, and social media.

Marketing 52

Marketing Compliance Production Government 52

Drug Patent Watch

FEBRUARY 18, 2025

So, what can biosimilar developers do to navigate these regulatory considerations and bring their products to market efficiently? Here are a few key takeaways: Key Takeaways: Understand the regulatory landscape : Familiarize yourself with the guidelines and regulations governing clinical efficacy trials for biosimilars.

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Perficient: Drug Development

NOVEMBER 19, 2024

Currently, the Japanese government and regulators are taking an indirect approach of supporting a policy goal of prioritizing innovation while minimizing foreseeable harms. On April 19, 2024, the Japanese government published new “AI Guidelines for Business Version 1.0” (the “Guidelines”).

Regulations 52

Regulations Government Compliance Marketing 52

Drug Patent Watch

APRIL 1, 2025

As healthcare costs continue to rise, governments and payers are looking for ways to reduce expenses without compromising patient outcomes. Read the full market analysis on the impact of biosimilars on the generic drug industry in Europe: [link] Share your thoughts in the comments below.

Biosimilars 81

Biosimilars Marketing Drugs Government 81

The Pharma Data

JUNE 26, 2025

Additionally, in conjunction with the leadership shift, Julian Baker , who has served as the company’s Lead Independent Director, has been elected Chairman of the Board of Directors , further reinforcing Incyte’s commitment to strong governance and long-term strategic stewardship.

Production 40

Production Science Government International 40

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. Join Asimov Press. It will always be free. In setting up ARIA, the U.K.

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Government Molecular Biology Research Production 95

FDA Law Blog: Drug Discovery

JANUARY 12, 2025

This may also help to derisk parallel product development amongst multiple products for the same condition, where another product in development may gain traditional approval or another product already on the market under accelerated approval may confirm clinical benefit prior to completion of clinical trials to support accelerated approval (e.g.,

FDA 64

FDA Clinical Trials Trials Therapies 64

Perficient: Drug Development

APRIL 28, 2025

But no one talks to or notices the quiet, slightly awkward one in the room, its Data Governance. ” And yet, in almost every great technology story and every technology failure Data Governance is the silent architect whether you called it that or didnt. It was a data governance failure. But in the AI economy?

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Government Compliance Engineering DNA 59

Advarra

MARCH 7, 2025

The Vital Role of Institutional Review Boards (IRBs) As set forth in the federal regulations that govern the conduct of clinical trials, an IRB is an independent group of experts, including scientists and non-scientists, that reviews clinical trial proposals to ensure they meet ethical standards that are designed to protect participants rights.

Clinical Research 52

Clinical Research Research Clinical Trials Compliance 52

Perficient: Drug Development

NOVEMBER 15, 2024

Healthcare Trend #1: AI Disruption and Enablement Healthcare has seen a surge of interest in AI, with the market set to soar to $187.95 These discussions are forcing focus toward data quality, consistency, governance , and bias. billion by 2030. But the industry faces unique challenges that other sectors don’t encounter.

Regulations 64

Regulations Compliance Production Nurses 64

Drug Patent Watch

MARCH 18, 2025

Exploring the Russian Pharma Industry: Key Players and Innovations As we continue to navigate the complexities of the global pharmaceutical landscape, it's essential to stay informed about emerging markets and trends. According to a recent report, the Russian pharma market is expected to reach $24.5 Read the full article here: [link]

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FDA Law Blog: Biosimilars

FEBRUARY 13, 2025

As weve previously blogged, a PCCP is a mechanism established by Congress under the Food and Drug Omnibus Reform Act (FDORA) to streamline post-market changes to medical devices. If FDA agrees to the PCCP, such changes can be made without a supplemental marketing submission.

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FDA Marketing Regulations Production 71

Perficient: Drug Development

JUNE 2, 2025

But Sensei’s true value isnt limited to content operations, it’s the unified AI engine that quietly powers marketing intelligence, customer personalization, and even creative automation across Adobes enterprise ecosystem. This post takes a broader look at how Adobe Sensei connects data, creativity, and experiences, at scale.

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The Pharma Data

JULY 2, 2025

Her leadership and legal expertise contributed significantly to the company’s successful partnerships, regulatory milestones, and corporate governance. Over her impressive 23-year tenure , she played a pivotal role in shaping Genmab’s legal infrastructure during a period of remarkable growth and transformation.

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