Drug Patent Watch

APRIL 14, 2025

"Compliance in Generic Drug Development: A Critical Component of Success As the generic drug industry continues to grow, ensuring compliance with regulatory requirements has become a top priority for pharmaceutical companies.

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STAT

DECEMBER 6, 2024

The European Commission on Friday unconditionally approved a controversial deal in which Novo Holdings, the parent company of Novo Nordisk, one of the largest pharmaceutical companies, would pay $16.5 billion for Catalent, a leading contract drug manufacturer.

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Drug Patent Watch

JANUARY 14, 2025

.”[2] This study not only addressed the ATA’s concerns but also highlighted the power of real-world evidence in generic drug development and regulation. Case Study 3: Modeling the Future of Generic Drugs Who says you need a crystal ball to predict the future?

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Drug Patent Watch

FEBRUARY 13, 2025

The Unsung Heroes of Generic Drug Development: 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.

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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. New Drug Application (NDA) : Needed for marketing approval of new drugs. Abbreviated New Drug Application (ANDA) : Required for marketing approval of generic drugs.

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STAT

NOVEMBER 4, 2022

The legislation, known as the Pasteur Act, would encourage drug development by creating a subscription-style business model in which the U.S. The idea is to enable pharmaceutical companies to recover their costs and make an appropriate profit without having to sell large volumes of antibiotics.

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Drug Patent Watch

OCTOBER 28, 2024

The pharmaceutical industry relies heavily on Contract Development and Manufacturing Organizations (CDMOs) to streamline the drug development and manufacturing process. Here are the top 10 CDMO services you might not have known you needed… Source

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STAT

SEPTEMBER 12, 2024

The BIOSECURE Act would prohibit many biotech and pharmaceutical companies from conducting certain research and development activities, including the manufacturing of drugs through named Chinese companies. BIOSECURE proponents argue that allowing the Chinese Communist Party access to U.S.

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STAT

OCTOBER 17, 2024

As Election Day 2024 gets closer, STAT’s First Opinion asked executives from leading biotech and pharmaceutical companies to reflect on how their industry is being portrayed in the presidential campaign — and what their hopes are for a new presidential administration. You

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STAT

DECEMBER 9, 2024

Well, in Dimension’s case, they end up investing in some buzzy AI startups, counseling pharmaceutical companies, ribbing one another about expense reports, and — as of Monday — are able to raise $500 million for their second fund.

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STAT

JULY 2, 2024

These medications don’t have to be so expensive, but all too often pharmaceutical companies use illegal tactics to block competition that could lower prices and encourage innovation. Americans are facing an affordability crisis at the hands of corporate titans. Read the rest…

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STAT

MARCH 21, 2024

Early data regarding the use of GLP-1 medications like Ozempic and Wegovy to treat addiction is “very, very, exciting,” Nora Volkow, the director of the National Institute on Drug Abuse, said Thursday. drug crisis with urgency.

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STAT

SEPTEMBER 26, 2022

In an effort to sway the Food and Drug Administration not to withdraw accelerated approval of Makena, a drug developed to prevent preterm birth that does no such thing, a pharmaceutical company owned by a private equity company is making the specious argument that the drug should be kept on the market because it may — the emphasis is mine — (..)

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Drug Patent Watch

DECEMBER 11, 2024

This growth has created a competitive landscape where pharmaceutical companies must carefully evaluate and select the right CDMO partner to ensure the success of their projects. Your Drugs Development Stage The stage of your drug development is a critical factor in selecting a CDMO.

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European Pharmaceutical Review

JUNE 27, 2022

DRUG DEVELOPMENT based on targeted protein degradation (TPD) has progressed rapidly since the publication in 2015 of three landmark papers 1-3 that highlighted important early-stage breakthroughs with drug-like molecules in this area of research.

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STAT

OCTOBER 4, 2022

The press release issued by pharmaceutical companies Eisai and Biogen on Sept. Years and years of failed Alzheimer’s trials created, and then fortified , doubts about whether drugs that attacked amyloid, a brain protein linked to Alzheimer’s disease, were a valid approach to its treatment.

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Drug Patent Watch

MARCH 10, 2025

The Future of Generic Drugs: How Technology is Revolutionizing the Industry As we continue to navigate the ever-changing landscape of healthcare, one thing is clear: technology is playing an increasingly important role in shaping the future of generic drug development. Will we see a surge in new treatments and medications?

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STAT

OCTOBER 5, 2023

Some scientists are trying to calculate those footprints, as part of a growing effort to understand biotech and pharmaceutical companies’ contributions to climate change. What if that information also included your medicine’s carbon footprint?

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Drug Patent Watch

MARCH 18, 2025

This is where generic drug development comes in a game-changer for millions of people around the world. The Growing Importance of Generic Drug Development As the global demand for affordable medications continues to rise, the importance of generic drug development cannot be overstated.

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European Pharmaceutical Review

SEPTEMBER 12, 2023

Initial data from the CPHI Annual Report 2023, which provides insight from 250 global pharmaceutical companies, reveals that AI (artificial intelligence) is expected to transform every area of the industry, from drug discovery through to drug development , within the next 24-months. Attending CPHI Barcelona 2023?

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STAT

APRIL 18, 2024

A leading animal rights group has asked securities regulators to investigate Charles River Laboratories for allegedly misleading investors about its sales and purchases of long-tailed macaques, which are widely used in clinical research by pharmaceutical companies and universities, among others.

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STAT

FEBRUARY 29, 2024

CEO Andy Coravos said that robust intelligence can help developers move more quickly and avoid mistakes that require costly changes to trial protocols. Following the acquisition, HumanFirst will be another offering for Icon, which earned $8 billion last year running clinical trials for pharmaceutical companies and other related services.

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European Pharmaceutical Review

SEPTEMBER 22, 2022

Rare disease drug development poses unique challenges that can be overcome by using real-world evidence (RWE). These assessments often need to involve comparisons against multiple alternative therapies that would be impractical in the context of a clinical drug development. Regulatory and payer guidance.

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Express Pharma

MARCH 2, 2025

Continued strategic focus on North America: US market accounts for anywhere between 30 per cent to 60 per cent of annual revenues for Leading Pharmaceutical companies in India. Companies will continue to acquire leadership capabilities with focus on these markets.

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STAT

MAY 22, 2024

A 2024 analysis of drugs included in this program showed they had 23% shorter clinical development timelines than those that were not part of the program, with no negative effects on their safety profiles.

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STAT

OCTOBER 15, 2024

As Election Day 2024 gets closer, STAT’s First Opinion asked executives from leading biotech and pharmaceutical companies to reflect on how their industry is being portrayed in the presidential campaign — and what their hopes are for a new presidential administration. 

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Drug Patent Watch

DECEMBER 10, 2024

They can help ensure that these submissions are complete, accurate, and timely, which is critical for advancing drug development programs. They can help ensure that the commercial pharmaceutical manufacturing process is designed to meet regulatory requirements and offer insight into the most effective manufacturing strategies.

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STAT

JULY 12, 2023

These medicines, colloquially called “n of 1” therapies, are often made to treat debilitating genetic conditions that are too rare to garner interest from pharmaceutical companies. Read the rest…

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STAT

JANUARY 19, 2023

In a stunning rebuke, the Food and Drug Administration accused a drugmaker of a “cascade of failures” for a litany of quality-control problems at a manufacturing plant, the latest instance in which the regulator has castigated an Indian pharmaceutical company for such lapses.

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STAT

MARCH 7, 2023

But he also said he saw it as an example of a drug company filling the void left by health systems that aren’t teaching doctors and trainees how to use new medicines. Continue to STAT+ to read the full story…

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STAT

NOVEMBER 15, 2022

For the first time, many of the world’s largest pharmaceutical companies are taking concrete steps to widen access to their medicines in low and middle-income countries, but the poorest countries continue to be disproportionately overlooked, according to a new analysis.

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STAT

OCTOBER 3, 2022

Food and Drug Administration established in 1982 in an effort to get medicines for hard-to-treat diseases to patients sooner than they might under the usual pathways to the marketplace. As a condition of approval, a pharmaceutical company must confirm the effectiveness of its medicine through one or more clinical trials by a certain date.

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pharmaphorum

DECEMBER 21, 2021

During the course of the webinar, Keefer explained how specialty sites, with deep knowledge on one or certain groups of Rare Diseases, are crucial for further progress in drug development to progress the number of treatments available to Rare Disease patients and to provide support to those individuals.

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Drug Patent Watch

DECEMBER 18, 2024

This exclusivity is the lifeblood of pharmaceutical innovation, allowing companies to recoup their massive R&D investments and incentivizing further research. According to a 2021 study by the Tufts Center for the Study of Drug Development, the average cost to develop a new drug is a staggering $2.6

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Express Pharma

DECEMBER 30, 2024

Universities serve as the foundational training ground for the next generation of pharmaceutical professionals. They offer various programs, from undergraduate degrees in pharmaceutical sciences to specialised graduate courses focusing on drug development, regulatory affairs, and market access.

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Drug Patent Watch

DECEMBER 9, 2024

This approach has led to the discovery of numerous potential drug candidates. From Lab to Market: The Long Road of Drug Development Once a promising compound is identified, it enters the long and costly process of drug development. Q: How long does a drug patent last?

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STAT

DECEMBER 13, 2024

This isn’t just a drug approval, but a major strategic shift. For more than 30 years, Ionis developed all of its medicines in partnership with large pharmaceutical companies. Peak sales could reach $2 billion in 2035, according to Wolfe Research, a sell-side research firm. This time, it is standing alone.

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