Drug Target Review

JULY 21, 2025

The global market for CNS therapeutics was worth an estimated $144.3 Developers and sponsors working on biologically derived therapies in the US can utilise the Regenerative Medicine Advanced Therapy (RMAT) designation, which regulators grant to promising regenerative therapies. Pandit R, Chen L, Götz J. Adv Drug Deliv Rev.

Drug Development

Drug Target Review

JUNE 11, 2025

Multimodal language models Generative AI models (GenAI) in the pharmaceutical field have reached the highest level of attention with the Nobel Prizes to Demis Hassabis and John Jumper for AlphaFold, which can predict protein structures. He holds a master’s degree from University of Salerno in political sciences and marketing.

Drugs

The Pharma Data

AUGUST 1, 2025

Arrowhead’s Subsidiary Visirna Transfers Greater China Rights to Plozasiran to Sanofi in Strategic $395 Million Deal Amid Regulatory Milestone in Hypertriglyceridemia In a move poised to reshape the therapeutic landscape for patients with severe lipid disorders in China, Arrowhead Pharmaceuticals , Inc. President and CEO of Arrowhead.

Licensing

The Pharma Data

JUNE 25, 2025

Novartis Finalizes Acquisition of Regulus Therapeutics, Strengthening Its Renal Disease Portfolio with Promising ADPKD Therapy Novartis AG, a leading global pharmaceutical company, has officially completed its acquisition of Regulus Therapeutics Inc. , a biotechnology firm known for its expertise in microRNA-targeting therapies.

RNA

Drug Patent Watch

JANUARY 14, 2025

In the fast-paced world of pharmaceuticals, negotiations play a pivotal role in shaping the industry’s landscape. Let’s dive into the intricacies of pharmaceutical negotiations, exploring valuable lessons, current trends, and strategies for success.

Pharmaceuticals

The Pharma Data

JUNE 24, 2025

These attributes not only determine a drug’s safety and efficacy but also influence its regulatory approval and post-market success. In this context, the USP’s mAb reference standards offer pharmaceutical manufacturers a critical benchmark. Senior Vice President of Global Biologics at USP. “We Source link

Therapies

The Premier Consulting Blog

NOVEMBER 6, 2024

The combination of different active pharmaceutical ingredients (APIs), each with distinct physical and chemical properties, along with the need for precise, efficient drug delivery to the lungs, requires careful CMC planning and execution. ICPs are subject to rigorous regulatory scrutiny due to their complexity.

Production

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

Drug Development

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.

Pharmaceutical Companies

Drug Target Review

NOVEMBER 25, 2024

At this point, I knew that I wanted to join the biotech and pharmaceutical industry, so I moved to a small biotech company in London, where I spent three to four years learning the fundamentals of the biotech industry. Gender diversity is a hot topic in pharmaceutical and biotech drug development.

Treatment

Drug Target Review

JULY 7, 2025

3-5 These layers of regulation, while essential for animal welfare, make NHP-based studies complex, expensive and time-consuming. However, the last decade has seen a gradual reduction in their use, driven by tightening animal welfare regulations and scientific advances. Are we nearing a post-NHP future? Lee TYT, Coles JG, Maynes JT.

Drug Research

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. However, delays in any of these stages can significantly impact the overall timeline, leading to missed market opportunities and revenue losses.

Drug Development

The Pharma Data

JUNE 25, 2025

BeOne Medicines Receives Positive CHMP Opinion for New Film-Coated Tablet Formulation of BRUKINSA® (zanubrutinib), Paving the Way for European Market Approval BeOne Medicines Ltd. These sustainability considerations align with growing global demand for environmentally responsible pharmaceutical manufacturing and distribution.

Packaging

The Premier Consulting Blog

APRIL 13, 2025

All of this information will then need to be integrated into comprehensive Weight-of-Evidence (WOE) assessments to justify initially the safety of the drug to enter the clinic and then the overall benefit:risk of the drug for formal marketing approval. 8] ICH Harmonised Guideline S1B(R1) (2022): Testing for carcinogenicity of pharmaceuticals.

Animal Testing

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].

Biosimilars

The Pharma Data

JUNE 20, 2025

Individuals with T1D must rely on lifelong insulin therapy to regulate blood glucose levels. Background: Addressing a High-Risk Subset of T1D Type 1 diabetes is a chronic autoimmune condition in which the body’s immune system attacks and destroys insulin-producing beta cells in the pancreas.

Therapies

The Pharma Data

JUNE 6, 2025

The data underscored the significant clinical benefits associated with cystic fibrosis transmembrane conductance regulator (CFTR) modulators—particularly its next-generation triple therapy, ALYFTREK® (vanzacaftor/tezacaftor/deutivacaftor).

Therapies

Drug Target Review

AUGUST 8, 2025

Market outlook: A new wave of biologics The biologics market is evolving rapidly. As clinical adoption accelerates and regulatory approvals increase, there are now four FDA-approved T cell engagers and 17 bispecific antibody therapies available on the global market. References PatSnap Synapse. Global News Wire; 2025 Mar 17.

Engineering

DrugBank

JUNE 18, 2025

Drug development is a complex and highly regulated process. While these regulations protect public health, they also introduce significant challenges for pharmaceutical researchers. This means pharmaceutical companies must remain vigilant and adaptable to comply with evolving regulations.

Drug Development

The Pharma Data

JUNE 9, 2025

Food and Drug Administration, with additional filings planned in other markets.” Strategic Significance of the China Filing Merck’s decision to prioritize the Chinese market for pimicotinib’s launch underscores the company’s expanding oncology footprint in Asia , particularly in the world’s second-largest pharmaceutical market.

Treatment

Alta Sciences

JULY 23, 2025

BD Biosciences showcased their FACSDiscover A8 TM as the first provider on the market to combine live-cell imaging with spectral flow cytometry—a useful analytical tool for any institution performing innovative science. INSIGHTFUL CYTOMETRY WORKSHOPS Spectral cytometry continues to evolve. Ready to advance your next project?

International

Drug Target Review

JUNE 18, 2025

Long timelines, strict regulation and scientific uncertainty are part of the job. However, when that pressure is compounded by political shifts, market volatility and rising expectations from the global pharmaceutical industry, the old ways of working start to crack. In early-stage drug discovery, pressure is nothing new.

Drugs

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

The Pharma Data

JULY 2, 2025

BioMarin Finalizes Acquisition of Inozyme Pharma, Strengthening Rare Disease Portfolio with INZ-701 BioMarin Pharmaceutical Inc. INZ-701 is designed to replace deficient ENPP1 enzyme activity, with the aim of restoring normal regulation of mineralization processes in the body. per share in cash.

Therapies

The Pharma Data

AUGUST 3, 2025

Nielsen officially joins the company on August 1, 2025, and will oversee Genmab’s operations in Germany—Europe’s largest pharmaceutical market and a pivotal launchpad for biotech growth in the region. Germany, as Europe’s largest economy and a leader in pharmaceutical innovation, represents a natural first step in that evolution.

Therapies

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. The pharmaceutical landscape is evolving rapidly, with small and medium-sized biotech companies increasingly taking center stage in innovation.

Compliance

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.

Drugs

Drug Target Review

MAY 26, 2025

Daniel Galbraith, Chief Scientific Officer at Solvias , brings extensive expertise in the pharmaceutical and biotechnology sectors. In his role, he provides both strategic and technical guidance to Solvias, a global Contract Research Organisation (CRO) that offers critical analytical services to the pharmaceutical industry.

Drug Development

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. Conclusion CDMOs play a vital role in helping pharmaceutical and biotechnology companies navigate the complex regulatory landscape.

Compliance

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. Evaluate the number of products in development, their potential market size, and the competition. Evaluate revenue growth, profitability, and cash flow.

Pharma Companies

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

The Pharma Data

JUNE 6, 2025

Global Pharmaceutical Contract Sales Outsourcing Market to Reach $24.8 Billion by 2030: Strategic Insights, Regional Trends, and Technological Shifts Reshaping the Landscape The global pharmaceutical contract sales outsourcing (CSO) market is entering a transformative phase, with its value expected to grow from $17.3

Pharmaceutical Companies

New Drug Approvals

AUGUST 2, 2025

Accordingly, an object of the present invention is to provide a novel production method capable of stably supplying sepiapterin, lactoylpterin and tetrahydrolactoylpterin, which have recently been found to be useful as pharmaceuticals. As a starting material, the compound of the following formula (1) or the compound of formula (7) is used.

Production

Codon

JULY 17, 2025

In addition, upward of 20 wholesale drug firms are marketing the compound, which suggests that a considerable population is being medicated. Unlike hundreds of other purported weight loss drugs on the market at the time — from dangerous Jad Salts to Marmola (a “thyroid substance”) — DNP actually worked.

Drugs

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. But what exactly does Quality Assurance entail?

Drugs

FDA Law Blog: Biosimilars

NOVEMBER 18, 2024

Although not altogether surprising, the formality of an official announcement still came as a shock to many of us who work in areas regulated by HHS, as well as to many others in the public health arena. Gibbs — On Thursday, November 14, President-Elect Trump announced his pick of Robert Kennedy, Jr.,

FDA

Drug Patent Watch

JANUARY 14, 2025

Why Generic Drugs Matter Generic drugs are the Robin Hoods of the pharmaceutical world, stealing from the rich (brand-name drugs) and giving to the poor (our wallets). By specializing in areas like cardiovascular or oncology drugs, they’re building expertise and reputation in niche markets[1]. The bone of contention?

Drug Development