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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Perficient: Drug Development

NOVEMBER 6, 2024

Artificial intelligence (AI) is poised to affect every aspect of the world economy and play a significant role in the global financial system, leading financial regulators around the world to take various steps to address the impact of AI on their areas of responsibility.

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BioPharma Drive: Drug Pricing

AUGUST 25, 2023

market against Biogen’s inflammation-regulating medicine Tysabri. According to one analyst, the approval was the last hurdle keeping Sandoz’s Tyruko from directly competing in the U.S.

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Drug Patent Watch

JANUARY 13, 2025

As we delve into the intricate world of biosimilar market dynamics, we’ll explore how these complex molecules are reshaping treatment paradigms across diverse patient populations. ”[1] The global biosimilars market is experiencing exponential growth, with projections indicating it will reach $69.4 from 2020 to 2025[1].

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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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Perficient: Drug Development

NOVEMBER 19, 2024

Artificial intelligence (AI) is poised to affect every aspect of the world economy and play a significant role in the global financial system, leading financial regulators around the world to take various steps to address the impact of AI on their areas of responsibility.

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The Premier Consulting Blog

DECEMBER 10, 2024

Bringing a new therapeutic to market is a complex and multifaceted process culminating in submission and approval of a new drug application (NDA). Validation reports are to be included in a marketing application. Following approval, release testing continues on every lot of drug product prior to release into the market.

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BioPharma Drive: Drug Pricing

JULY 10, 2024

Having recently withdrawn its only product from the market, Amylyx hopes to rebound with a drug that regulates GLP-1 activity and is poised to enter pivotal testing early next year.

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BioPharma Drive: Drug Pricing

AUGUST 4, 2023

The company said it would withdraw the drug, Adakveo, from the EU market after the European Commission endorsed an earlier EMA recommendation.

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Advarra

JULY 26, 2022

Even though CBD and cannabis usage has grown, and marketing claims have proliferated regarding potential therapeutic applications, there is still little research on their effects on the human body. The post CBD Research: A Dive into the Regulations of Cannabis Research appeared first on Advarra. Funding Research on Cannabis.

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Drug Patent Watch

JUNE 9, 2025

"Navigating the Maze of Regulations: How Pharmaceutical Companies Can Safeguard Their Drug Portfolios As the pharmaceutical industry continues to evolve, regulatory environments are becoming increasingly complex. In our latest report, we explore the intricacies of navigating complex regulatory environments in drug portfolio management.

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Chemical Biology and Drug Design

SEPTEMBER 30, 2023

Abstract Epigenetic regulation of genes through posttranslational regulation of proteins is a well-explored approach for disease treatment, particularly in cancer chemotherapy. Structural classification and regulatory functions of histone deacetylases and their inhibitors.

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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. Register now to secure your spot.

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BioPharma Drive: Drug Pricing

APRIL 18, 2025

regulators cleared a multiple myeloma drug GSK withdrew from market three years ago. Elsewhere, an investment firm pressed Elevation Oncology to liquidate and the FDA relaxed risk monitoring requirements for Camzyos.

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Drug Patent Watch

DECEMBER 10, 2024

The Rise of Integrated CDMOs The global biotechnology and pharmaceutical services outsourcing market size was valued at $70.48 Accelerated Time to Market : By leveraging a connected network of internal experts, integrated CDMOs can help eliminate downtime, optimize processes, and minimize errors, ultimately accelerating time to market.

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BioPharma Drive: Drug Pricing

DECEMBER 19, 2023

The new guidelines may give regulators more ammunition to go after vertical and cross-market M&A that has historically been more difficult to challenge.

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Perficient: Drug Development

MAY 22, 2025

The Compliance Content Bottleneck in Financial Services Content creation in financial services isnt just Marketings job. Slow go-to-market – regulatory reviews stall time-sensitive campaigns. Siloed collaboration – Marketing, Legal, and Compliance working in parallel, not together. Under what policy? All tracked.

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Agency IQ

JANUARY 12, 2024

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. has done.

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PPD

JANUARY 2, 2025

Pharmacovigilance (PV) : A premier FSP PV partner provides expertise to monitor global regulations, analyze and interpret them in the context of a biotechs specific needs, communicate regulatory requirements, and implement solutions to support the sponsors internal capabilities.

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Cytel

OCTOBER 11, 2023

Moving beyond static evidence development to ensure local market access success; responding to recent changes in governmental drug regulations and the role of automation Written by Grammati Sarri and Radek Wasiak The worldwide drug regulation landscape is rapidly changing.

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thought leadership

APRIL 14, 2025

Ensuring patient safety and compliance with pharmacovigilance (PV) regulations is a critical responsibility for marketing authorization holders (MAHs). While these countries are centrally located in Europe, they each have distinct national regulations that must be met.

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BioPharma Drive: Drug Pricing

AUGUST 11, 2023

In Europe, however, the biotech is appealing a negative decision from regulators that has for now blocked its path to market there.

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SCIENMAG: Medicine & Health

JUNE 8, 2023

Chilean policies aimed at reining in unhealthy food marketing are succeeding in protecting children from the onslaught of television advertisements (TV ads) for these products, according to new research.

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Drug Patent Watch

DECEMBER 10, 2024

The pharmaceutical and biotechnology industries are heavily regulated, and navigating these regulations can be a significant challenge for companies, especially those with limited experience. Contract Development and Manufacturing Organizations (CDMOs) play a crucial role in helping companies overcome these regulatory hurdles.

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Drug Patent Watch

APRIL 8, 2025

Evaluate the number of products in development, their potential market size, and the competition. Consider the impact of new regulations, such as those related to biosimilars or generic drugs. Regulatory Environment : Changes in regulatory policies can impact a company's valuation.

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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. New Drug Application (NDA) : Needed for marketing approval of new drugs. Freyr Solutions.

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Drug Target Review

DECEMBER 20, 2024

These innovations have started to shift industry perceptions, positioning AI as a transformative tool that could alter how drugs are developed, tested, and brought to market. Regulators care a lot about controlling the Type 1 error rate of the clinical trial, Smith notes.

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Cytel

MAY 7, 2024

Here we explore the evolution and impact of market exclusivity policies in the EU and US, highlighting their role in fostering innovation and accessibility in rare disease treatment. Market exclusivity for orphan drugs traces back to the early 1980s in the United States, with the landmark Orphan Drug Act of 1983.

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FDA Law Blog: Biosimilars

MARCH 31, 2024

Gibbs — On March 21, 2024, the House Energy and Commerce held a subcommittee hearing titled “Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule.” By Ana Loloei & Jeffrey N. FDA, which was not invited to participate, would surely have concurred.

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Perficient: Drug Development

AUGUST 19, 2024

I have even heard the phrase “Please check the report, I don’t understand the models and hence trust the number” So, in the risk function, while this is a race for data aggregation, structured data, unstructured data, data quality, data granularity, news feeds, market overviews, its also a challenge from an acceptance perspective.

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Agency IQ

MAY 28, 2024

BY COREY JASEPH, MS, RAC The British medical device regulator just issued its promised framework on international recognition.

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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.

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Drug Patent Watch

FEBRUARY 12, 2025

However, delays in any of these stages can significantly impact the overall timeline, leading to missed market opportunities and revenue losses. By implementing these strategies, generic drug manufacturers can accelerate their development timelines, improve efficiency, and increase their chances of success in the market.

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FDA Law Blog: Biosimilars

SEPTEMBER 26, 2023

(HP&M), a leader in providing legal and regulatory support to the life sciences industries, today announced the appointment of Jeff Grizzel to the newly created position of Chief Marketing Officer (CMO). Grizzel holds a degree in Economics from High Point University and lives in Falls Church, VA.

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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. If a compliance or quality program exists only as bargaining chip to use with regulators, thats not a formula to instill good habits.

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PPD

MARCH 11, 2025

Challenge #4: Regulatory and market access hurdles The regulatory and health technology assessment (HTA) pathways for rare disease therapies are complex and vary by region. With the new EU HTA Regulation impacting orphan medicines, navigating these pathways has become even more challenging.

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Fierce BioTech

APRIL 28, 2025

Accelerating Time-to-Market: Balancing Speed, Compliance, and Operational Excellence jpiatt Mon, 04/28/2025 - 14:42 Tue, 06/24/2025 - 10:00 Resource Type Webinar Promotion Start Thu, 05/01/2025 - 08:30 Promotion End Sat, 11/01/2025 - 08:30 In the highly competitive world of drug development, few things matter more than getting to market first.

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