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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Drug Target Review

APRIL 30, 2025

In the rapidly evolving field of cell and gene therapy (CGT), the ability to manage complex biological data, optimise manufacturing processes, and accelerate drug discovery is crucial. Faster time-to-market and reduced costs. Zylberberg has built an impressive career at the intersection of science, technology, and business. The result?

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Drug Target Review

DECEMBER 20, 2024

Artificial intelligence (AI) has revolutionised many industries, yet its adoption in pharmaceutical drug development has been notably slower. For years, AI and machine learning (ML) were often dismissed as little more than advanced statistics with little practical value in drug development.

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Drug Target Review

MAY 14, 2025

Introduction and background Singh: How do we bring scientists working in drug discovery into the world of AI? Recently, we’ve been pursuing AI product initiatives that have made me consider why people might be resistant to AI tools, what AI tools are capable of in drug discovery, and their limitations.

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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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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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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

However, it’s not legal federally and is considered a Schedule I drug by the U.S. Drug Enforcement Administration (DEA), meaning it has no accepted medical use and a high potential for abuse. Even though CBD doesn’t meet criteria for IND exemption or the FDA’s OTC drug review, it still can be studied in humans.

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

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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. Histone deacetylases have shown significant potential as effective drug targets in therapeutic studies aiming to restore epigenetic normality in oncology.

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Drug Target Review

JULY 4, 2023

Over the last two decades, an increasing number of Antibody Drug Conjugate (ADC) therapeutics have been approved for oncology indications. These therapies have broadened treatment options for patients to expand beyond the more traditional small molecule drug alternatives. 3D rendering of Antibody Drug Conjugate Molecules.

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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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PPD

MARCH 11, 2025

Developing treatments for individuals living with rare diseases is critical, but orphan drug development is laden with unique obstacles that necessitate innovative, multifaceted approaches. With the new EU HTA Regulation impacting orphan medicines, navigating these pathways has become even more challenging.

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Drug Target Review

APRIL 7, 2025

The challenge of GPCR drug discovery G protein-coupled receptors (GPCRs) are one of the most desirable and challenging target classes in drug discovery, as their mutation can lead to a wide range of diseases such as cancer, cardiovascular disorders and neurological conditions.

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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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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. But have you ever stopped to think about the unsung heroes of generic drug development? Share your experiences and insights in the comments below!

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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 Hunter

AUGUST 21, 2023

Obtaining adequate drug exposure in the brain is key to treating CNS diseases effectively. Recently, Dennis Koester gave us a crash course in CNS drug discovery in a Drug Hunter Flash Talk. Why Kp,uu is the Most Important Parameter in CNS Drug Discovery What Influences the Kp,uu of Drugs?

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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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Drug Target Review

APRIL 7, 2025

For example, transcriptomic processes are showing the potential to identify and track failures in gene expression and gene regulation of amyloid and tau-related biomarkers, understood as precursors to the onset of Alzheimers disease (AD).

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FDA Law Blog: Biosimilars

JULY 23, 2024

Lenz, Principal Medical Device Regulation Expert — For several years, FDA has requested that sponsors of drug or biologic led combination products identify essential performance requirements (EPRs) related to the device constituent in their applications. By Adrienne R. does not use this term.

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ProRelix Research

NOVEMBER 27, 2023

The United States Food and Drug Administration (FDA) has strict regulations regarding pharmacovigilance activities that are a part of post-marketing studies for drugs and medical devices that are required as […] The post FDA Pharmacovigilance Regulations Update appeared first on ProRelix Research.

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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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Drug Channels

MARCH 4, 2025

Fein, president of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for DCIs new live video webinar: PBM Industry Update: Trends, Challenges, and What's Ahead This event will be broadcast live on Friday, April 4, 2025, from 12:00 p.m. to 1:30 p.m. WHAT YOU WILL LEARN Join industry expert Adam J.

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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. How will the imposition of tariffs and a burgeoning trade war affect domestic drug production and companies supply chain demands?

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Agency IQ

JUNE 9, 2023

What will the orphan drug market exclusivity haircut mean for industry? Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. Fill out the form to read the full article.

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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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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. In our latest blog post, we dive into the strategies and challenges of patenting drug combinations.

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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

APRIL 2, 2024

Perhaps unsurprisingly given the extraordinary focus on drug pricing in the last decade, generic competition—FDA’s only real way to have an effect on drug pricing—tops this year’s list. FDA believes this change would effectuate timelier and more cost-efficient generic drug development.”

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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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Elrig

JUNE 15, 2023

We're Hiring - Marketing & Sales Assistant We’re Hiring! We are looking for an Events Marketing & Inside Sales Assistant to support the Marketing Manager, Business Development and Operations Team in all ELRIG’s marketing and sales activities, as well as day to day implementation of marketing tasks.

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FDA Law Blog: Drug Discovery

JANUARY 30, 2025

As a result of reforms enacted by the Food and Drug Omnibus Reform Act of 2022 (FDORA), FDAs authority to approve as well as withdraw an accelerated approval was given new regulatory teeth to ensure that confirmatory trials are conducted expeditiously. However, the meaning of due diligence has long been a question.

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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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Drug Target Review

APRIL 14, 2025

The antibiotic market has long faced significant barriers to innovation, with structural issues that make it difficult for new antibiotics to gain traction. As the demand for novel antibiotics remains limited due to the preference for cheaper generics, the market has struggled to incentivise much-needed breakthroughs.

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Drug Target Review

SEPTEMBER 26, 2023

These cells demonstrate considerable promise for uncovering drug-induced perturbations to neuronal function such as seizure, and their use extends further to sedation, anti-epileptic drug discovery and modelling of neurological diseases.

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The Premier Consulting Blog

DECEMBER 28, 2023

1] However, if certain criteria are met, many in vitro diagnostic (IVD) devices are released from IDE regulations. This blog post discusses how device studies are classified and explores scenarios where DVDs qualify for exclusion from IDE regulations. Resources [1] US Food and Drug Administration. Available at [link]. [2]

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