This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
It is hard to ignore some of the most pressing, long-term trends driving the push to accelerate innovation and progress in drugdevelopment. As a result, biopharma and biotech companies working to bring their drug pipelines to the market require deep expertise from trusted partners to help deliver critical therapies for their patients.
This shift has led to the emergence of integrated contract development and manufacturing organizations (CDMOs), which provide end-to-end support for drugdevelopers. The Rise of Integrated CDMOs The global biotechnology and pharmaceutical services outsourcing market size was valued at $70.48 from 2023 to 2030.
The pharmaceutical industry, particularly the generic drug sector, faces significant challenges in adopting sustainable practices. This article outlines key considerations and strategies for developing a sustainable generic drugdevelopment strategy. “Generics are known for their cost-effectiveness.
Neumora’s filing late Friday, along with that of radiopharmaceutical startup RayzeBio earlier this week, could be an important test of the biotech IPO market.
The regulatory environment in Japan for generic drugdevelopment 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.
The Unsung Heroes of Generic DrugDevelopment: The Power of Partnerships As we navigate the complex landscape of pharmaceuticals, it's easy to overlook the crucial role that partnerships play in bringing affordable, life-saving medications to market. When it comes to developing generic drugs, partnerships can take many forms.
Accelerating Generic DrugDevelopment: Strategies for Success As a pharmaceutical professional, you know how crucial it is to navigate the complex landscape of generic drugdevelopment. The generic drugdevelopment process involves several stages, from patent research to regulatory approvals.
Artificial intelligence (AI) has revolutionised many industries, yet its adoption in pharmaceutical drugdevelopment 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 drugdevelopment.
The Unseen Heroes of Generic DrugDevelopment: Pharmacovigilance As a generic drugdeveloper, 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 drugdevelopment?
Our annual look at the state of the drugdevelopment industry highlights a dual set of challenges complicating progress. Rising costs have become a persistent challenge for drugdevelopers, driven by a combination of internal and external pressures that have intensified in recent years.
Developing treatments for individuals living with rare diseases is critical, but orphan drugdevelopment is laden with unique obstacles that necessitate innovative, multifaceted approaches. Data from these studies can accelerate research timelines and improve trial planning throughout the product life cycle.
In the vast realm of pharmaceutical research and development, there’s a fascinating intersection between ancient wisdom and modern science. This intersection is where pharmacognosy meets drug patents, creating a unique landscape that shapes the future of medicine. What is a Drug Patent?
Developing a competitive edge in generic drugdevelopment is crucial for companies to gain a significant market share and dominate the market. Here are some key strategies and insights from industry…
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. This approach not only helps maintain market exclusivity but also ensures a steady revenue stream for pharmaceutical companies.
Moreover, the molecule is a target in the drug discovery process for the development of new bioactive compounds. ABSTRACT Carprofen, a nonsteroidal anti-inflammatory drug (NSAID) derived from propanoic acid, is known for its analgesic and antipyretic properties.
Data science has emerged as an innovative tool in the biopharmaceutical industry, leveraging the power of machine learning and artificial intelligence to drive innovation and efficiency across the entire drugdevelopment lifecycle.
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?
As the clinical trial landscape evolves, drugdevelopers are faced with novel challenges and changes in study recruitment, trial size and structure, and more. The adoption of new innovations, strategies and technologies offers opportunities to address persistent challenges and develop suitable approaches for the future.
Maximizing Patent Protection: Strategies for Pharmaceutical Marketers As a pharmaceutical marketer, you know how crucial it is to protect your patented drug'smarket share. This exclusivity is a result of the patent protection granted to the drug'sdeveloper. Read the full article here: [link]
Brain disorders are difficult to study and many drug candidates have failed in clinical trials, causing pharmaceutical companies to reduce their investments or even exit the field entirely. So the need and the markets are there. What do you think it will take for industry to re-engage in this space?
With this highly marketable dosage form, scientists can effectively formulate poorly soluble drugs and supplements, while reducing development time and costs.
As novel therapeutics become more complex — and costly — to bring to market, drugdevelopers are looking to unified clinical development platforms to streamline operations.
The generic drugmarket has experienced significant growth over the past few decades, driven by the passage of the Hatch-Waxman Act in 1984 and subsequent legislation. Today, the market is more competitive than ever, with generic drugs accounting for over 90% of all prescriptions in the United States.
Mixing of service models — a strategy that drugdevelopers are leveraging now more than ever — can bring life-changing therapies to market faster. Growth of the FSP market is steadily increasing. In 2018, market utilization of FSO models was at 72%, with usage of FSP models lagging at 28%.
Carl Sailer is Vice President of Full Service Solutions at Syneos Health®, a leading fully integrated biopharmaceutical solutions organization providing clinical development and commercialization s | In this conversation with Fierce Biotech, we explore the ever-evolving biotech landscape.
Shares in the brain drugdeveloper rose by more than 20% Monday on news of the deal, which will forestall Teva's generic copy of Auvelity from entering the U.S. market until at least 2038.
Accelerate customer speed to market With a modern and integrated user experience, AI solutions put the right data and insights into the right hands in real time. As a result, drugdevelopers make better decisions more quickly (removing 50% of study timeline whitespace) to bring new therapies to market faster.
Artificial Intelligence (AI) is poised to transform the field of target discovery in drugdevelopment, offering immense potential to enhance efficacy, personalised medicine, and accelerate the development of innovative compounds. This means that we are not doing something right.
Drug discovery scientists spend their days developing and testing complex hypotheses, leveraging data and expertise through workflows that utilise available tools. Defining the research question A well-defined research question is the cornerstone of an effective scientific workflow in drug discovery.
In a recent survey conducted by ICON, Plc, biomarker selection was identified by 35 percent of respondents as a top challenge among drugdevelopers for phase I trials, second only to navigating regulatory compliance (- 38 percent).
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.
In drug discovery and biological research, the scientists workflow often follows a structured and iterative approach to ensure accuracy, reproducibility and scientific integrity. Figure 1: High-level workflow for early drug discovery Once the raw data has been gathered, the next step is to gain a thorough understanding of the data.
When you head to the pharmacy to pick up medicine, you likely aren’t thinking about all the steps it had to take to get into your hands — but did you know that on average, it takes about ten years for a new medication to make it to market ?
On April 10, 2025, the US FDA announced that it has a long-term plan to eliminate conventional animal testing in drugdevelopment, starting with monoclonal antibodies (mAbs).[ One great example is the FDAs 505(b)(2) New Drug Application (NDA) pathway. Legislation with delayed implementation In 2021, the FDA Modernization Act 2.0
AI in Pharma: Benefits, Risks and the Road Ahead AI is revolutionizing the drugdevelopment process, streamlining and accelerating every stage, from research to approval and marketing. This whitepaper explores the benefits and risks of AI in the pharmaceutical industry and examines its future.
The 505(b)(2) regulatory pathway provides an attractive avenue for drugdevelopers to bring new products to market by leveraging existing data on approved drugs. Here are some […] Source
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.
The pharmaceutical industry is undergoing a major shift towards the development of breakthrough medicines and advanced therapies. This continued innovation highlights the complexity of the drugdevelopment process, particularly as the field is highly regulated by health authorities around the world.
Generic drugdevelopment is a complex process that requires a deep understanding of regulatory requirements and guidelines. Regulatory expertise plays a crucial role in ensuring that generic drugs meet the necessary standards for quality, safety, and efficacy. EU, and other regions.
Overcoming drugdevelopment hurdles with phase-appropriate technology transfers Discover how phase-appropriate technology transfers can help you overcome regulatory challenges, reduce costs, and accelerate your path to commercialization. jpiatt Thu, 09/05/2024 - 14:54 Facing roadblocks in drugdevelopment?
Still, more than 90 percent of drug candidates fail in clinical trials, with even more that never make it to the clinical stage. Many drugs fail because they simply aren’t safe. Seal began this work after wondering if more toxicology insights could be gleaned from a drug candidate’s chemical structure.
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.
We organize all of the trending information in your field so you don't have to. Join 15,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content