Express Pharma

JANUARY 17, 2025

Carbon contributing factors: The mitigating factors throughout the drug development process The carbon-contributing factors in the production and distribution of Capsugel capsules at Lonza can be categorised into three main areas: upstream, operational, and downstream activities.

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Pharma Leaders

MAY 19, 2023

The FDA has released 25 new product specific guidances (PSG) and 21 newly-revised PSGs that the agency provides to assist generic pharmaceutical manufacturers to develop drugs and generate the evidence needed to support ANDA approvals.

Drug Development 52

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FDA Law Blog: Biosimilars

JANUARY 16, 2025

Richardson, who focuses her practice on state and federal regulatory strategy and compliance, primarily for pharmaceutical manufacturers and wholesale distributors, has been with the firm 7 years and has proven herself invaluable to colleagues and clients alike. Kalie is the quintessential HPM lawyer.

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PharmaTech

JANUARY 7, 2024

When establishing or expanding services to support new drug development, pharmaceutical and biotech companies find that automating their processes increases efficiency, maximizes capital, reduces costs, and expedites time-to-market.

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FDA Law Blog: Biosimilars

JUNE 27, 2023

James is recognized as helping fundamentally shift the culture to consider the patient voice as an integral part of drug development. Mr. Karst, a co-author of the FDA Law Blog, provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs.

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Quality Matters

MAY 17, 2023

Paradigm Shift in Drug Development: Analytical Quality by Design and Analytical Procedure Life Cycle In today’s pharmaceutical manufacturing environment, companies face increasing pressure to respond to changing demands across the global medicines supply chain while still maintaining the quality of their drug products.

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pharmaphorum

NOVEMBER 25, 2022

Located on the outskirts of the historic Italian city – home to Verdi and myriad architectural gems – the press launch and tour of the €85 million Chiesi development was a quintessentially Italian affair, based out of Chiesi’s San Leonardo production site. In-house drug development of biologicals and rare disease targeting.

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Drug Development Pharmaceutical Manufacturing Diabetes 98

FDA Law Blog: Biosimilars

MARCH 6, 2024

Kurt provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs.

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Pharmaceutical Technology

AUGUST 3, 2022

The potential to use these scientific breakthroughs to make a real difference to patients’ lives is what drives many highly skilled scientists to the world of drug development. Yet commercialising a drug is no easy journey, hence why just 10% of new drug candidates succeed in making it to market.

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Pharmaceutical Technology

SEPTEMBER 14, 2022

Commercial dose companies form a critical component of the pharmaceutical manufacturing industry’s value chain. The dose form manufacturing follows API manufacturing to produce the final dosage form (FDF such as tablets and injectables.

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Dosage Pharmaceutical Manufacturing Documentation Pharmaceutical Companies 40

Pharmaceutical Technology

SEPTEMBER 15, 2022

The list includes suppliers of a wide range of pharmaceutical packaging, containers and containment solutions, including plastic, glass and other customised packaging solutions, as well as labelling and printing solutions.

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PharmaState Academy

MARCH 7, 2024

Name Email Phone Number Company Department State City 1 / 15 How does analytics support adherence to regulatory guidelines in the Indian pharmaceutical manufacturing sector? 2 / 15 In the Indian pharmaceutical industry, what does analytics-driven supply chain management primarily focus on?

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Packaging Drug Development Pharmaceutical Manufacturing 64

European Pharmaceutical Review

DECEMBER 21, 2022

2 However, most of these efforts relating to catalysis, 3 process waste metrics, 4 lifecycle assessments, 5 pharmaceuticals in the environment 6 and the phase out of substances of concern 7 mainly mitigate the consequences of pharmaceutical manufacturing. Defossilization of pharmaceutical manufacturing.

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Pharmaceutical Technology

SEPTEMBER 15, 2022

From the Human Genome Project to contemporary drug development, collaboration is critical to the life sciences. It is also an important factor in the success of life sciences clusters, where a high concentration of pharmaceutical or medical device companies can all be found in one district, city or region.

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Research Laboratories Pharmaceutical Manufacturing Hospitals Drug Development 52

pharmaphorum

SEPTEMBER 30, 2022

The move to component management has dramatic implications for pharmaceutical manufacturers. Coupling data with documents can save hours spent on data quality control for submission documents. Companies increasingly recognize the need to adopt technologies such as artificial intelligence (AI) to assist with this paradigm shift.

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Quality Matters

MAY 21, 2024

We are focused on developing tools and resources that help companies navigate this issue and enhancing our knowledge of how regulators are enforcing current AI limits. Before the COVID pandemic, industry issues like this were often dealt with in a silo.

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Pharmaceutical Manufacturing Compounding Drug Development 52

European Pharmaceutical Review

APRIL 9, 2024

Delpharm has acquired the Meppel pharmaceutical manufacturing facility in the Netherlands from Astellas. The acquisition will strengthen the CDMO’s position in the Netherlands, where it already owns a manufacturing facility in Bladel and an injectable drug development centre in Leiden. billion in 2024.

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Pharmaceutical Manufacturing Dosage Drug Development 98

STAT

AUGUST 24, 2023

Speaking of: The Biden administration is expected to disclose early next week the first 10 prescription drugs selected for Medicare price negotiations, ahead of a White House event next Tuesday to celebrate the milestone , Politico writes. Continue to STAT+ to read the full story…

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Express Pharma

DECEMBER 13, 2024

Flushing pills down the toilet or tossing them into the trash can result in these drugs contaminating water and soil, spreading across vast areas and entering aquatic food chains.

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PharmaShots

FEBRUARY 27, 2023

As a renowned chemist, Dr. Senanayake discussed the need to adopt green chemistry in the process of drug development for cost reduction, timely innovation, and generating less waste than the standard process. facility for manufacturing biologics in his presentation. Anurag continued by presenting an overview of the next-gen.

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Biosimilars Diabetes Packaging Hospitals 40

Pharmaceutical Technology

DECEMBER 6, 2022

Despite the current emphasis on biologic medicines, small molecule drugs still dominate the pharmaceutical manufacturing world. Within the small molecule landscape, several trends are shaping the industry’s future, one of the most notable being the rise of high-potency active pharmaceutical ingredients (HPAPIs).

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Drug Patent Watch

DECEMBER 17, 2024

Let’s dive into the world of pharmaceutical outsourcing and explore why adaptability is the key to success. The Evolving Role of CDMOs in the Pharmaceutical Industry Gone are the days when CDMOs were mere service providers.

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Drug Development Pharmaceutical Companies Pharmaceutical Companies Pharmaceutical Manufacturing 90

Drug Patent Watch

JANUARY 9, 2025

Navigating the complex landscape of drug development and manufacturing can be a daunting task. Enter the Contract Development and Manufacturing Organization (CDMO) a lifeline for many startups looking to bring their innovative therapies to market. How can you ensure your CDMO is up to scratch?

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Communication Drug Development Pharmaceutical Manufacturing Process Improvement 52

European Pharmaceutical Review

FEBRUARY 20, 2025

4 Reshoring and diversification of pharmaceutical supply chains In response to potential tariffs, pharmaceutical manufacturers could consider shifting production closer to domestic markets to reduce exposure. Trump Tariffs Threaten US Drug Supplies And Risk Higher Prices, Trade Groups Warn. References 1.

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Safe Biologics

MARCH 10, 2025

Small molecule drugs make up over 90% of prescriptions filled in the U.S. Yet, since the IRAs implementation in 2021, investment in small molecule drug development has dropped by 70% as manufacturers shift resources toward biologics, which have more favorable financial incentives under the law.

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pharmaphorum

NOVEMBER 10, 2020

This includes reducing drug costs to consumers in the United States. “If any of these are successful, it could materially impact profit margins for the drug manufacturers.” These laws are meant to help states identify generics for their own prescription drug development programmes.

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