Express Pharma

JULY 29, 2024

Panelists emphasised the importance of skilled manpower, regular cleaning verification studies, and the application of machine learning in pharmaceutical manufacturing. They also addressed data integrity, GDPR, and the need for change control in product manufacturing.

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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.

Pharmaceutical Manufacturing 98

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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.

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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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Pharmaceutical Manufacturing Drug Development 59

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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Pharmaceutical Technology

JUNE 24, 2025

This flexibility is particularly beneficial for pharmaceutical manufacturers looking to upgrade their research and discovery processes without overhauling their entire systems. “Great thanks to Pharmaceutical Technology.

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Pharmaceutical Manufacturing Packaging Biosimilars Pharmaceutical Companies 52

Express Pharma

MAY 28, 2025

This depth of talent enables Indian CDMOs to offer more than just capacitythey bring scientific capability to the table, a critical factor as drug development becomes increasingly complex. Regulatory and government support Indias government has moved decisively to support pharmaceutical manufacturing.

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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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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

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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Express Pharma

MARCH 16, 2025

What are the top 3 trends that defined pharma manufacturing in India and globally in 2024? In 2024, the pharmaceutical manufacturing landscape underwent transformative changes, driven by technological innovations, regulatory adaptations, and evolving global demands.

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Biosimilars Insurance Coverage and Processing Pharmaceutical Companies Pharmaceutical Companies 110

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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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

Pharmaceutical Technology

JUNE 23, 2025

Power of collaboration more pertinent than ever says pharma experts Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest Madrigal poised to enter European MASH market after CHMP endorsement Novartis’ ribociclib approved in Canada for early breast cancer NSW government invests $13.39m in life-changing therapies (..)

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Pharmaceutical Manufacturing Communication Hospitals Packaging 52

Pharmaceutical Technology

JUNE 20, 2025

Power of collaboration more pertinent than ever says pharma experts Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest UK and US governments pursue contrasting vaccine strategies Eli Lilly and Eisai’s Alzheimer’s drugs denied NHS use due to high costs Draig secures $140m for neuropsychiatric disorder therapies (..)

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Vaccines Pharmaceutical Manufacturing Communication Hospitals 52

Pharmaceutical Technology

JUNE 23, 2025

Power of collaboration more pertinent than ever says pharma experts Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest Madrigal poised to enter European MASH market after CHMP endorsement Novartis’ ribociclib approved in Canada for early breast cancer NSW government invests $13.39m in life-changing therapies (..)

Insurance Coverage and Processing 52

Insurance Coverage and Processing Communication Pharmaceutical Manufacturing Hospitals 52

Pharmaceutical Technology

JUNE 23, 2025

Power of collaboration more pertinent than ever says pharma experts Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest Madrigal poised to enter European MASH market after CHMP endorsement Novartis’ ribociclib approved in Canada for early breast cancer NSW government invests $13.39m in life-changing therapies (..)

Biosimilars 52

Biosimilars Pharmaceutical Manufacturing Communication Hospitals 52

Pharmaceutical Technology

JUNE 19, 2025

Actio Biosciences CEO and co-founder David Goldstein stated: “We have made tremendous progress across our pipeline – executing a precision medicine strategy that targets the root causes of disease through genetically informed drug development.

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Pharmaceutical Technology

JUNE 19, 2025

Kisunla and Leqembi were touted as the most promising treatments to emerge from Alzheimer’s drug development in recent times. However, side effects from the drugs can be serious, and their high cost has been a barrier to reimbursement.

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Communication Hospitals Drug Development Pharmaceutical Manufacturing 59

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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Drug Development Pharmaceutical Manufacturing Pharmaceutical Companies Pharmaceutical Companies 59

Pharmaceutical Technology

JUNE 19, 2025

Power of collaboration more pertinent than ever says pharma experts Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest Novo Nordisk seeks digital health partners to boost GLP-1RA weight loss outcomes Orion and Glykos extend ADC collaboration Ex-ACIP panel warns of ‘critically weakened’ US immunisation (..)

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Communication Hospitals Pharmaceutical Manufacturing Packaging 52

Pharmaceutical Technology

JUNE 24, 2025

Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest Bayer’s Eylea market grip set to slip as Alvotech biosimilar closes in Harbour BioMed partners Otsuka on new T-cell therapy Madrigal poised to enter European MASH market after CHMP endorsement Themes Sections Artificial Intelligence Cloud Corporate Governance (..)

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Packaging Communication Hospitals Pharmaceutical Manufacturing 52

Pharmaceutical Technology

JUNE 19, 2025

Power of collaboration more pertinent than ever says pharma experts Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest Novo Nordisk seeks digital health partners to boost GLP-1RA weight loss outcomes Orion and Glykos extend ADC collaboration Ex-ACIP panel warns of ‘critically weakened’ US immunisation (..)

Communication 52

Communication Hospitals Pharmaceutical Manufacturing Packaging 52

Pharmaceutical Technology

JUNE 24, 2025

Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest Bayer’s Eylea market grip set to slip as Alvotech biosimilar closes in Harbour BioMed partners Otsuka on new T-cell therapy Madrigal poised to enter European MASH market after CHMP endorsement Themes Sections Artificial Intelligence Cloud Corporate Governance (..)

Hospitals 52

Hospitals Packaging Communication Pharmaceutical Manufacturing 52

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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Dosage Pharmaceutical Manufacturing Drug Development 52

Pharmaceutical Technology

JUNE 19, 2025

Power of collaboration more pertinent than ever says pharma experts Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest Novo Nordisk seeks digital health partners to boost GLP-1RA weight loss outcomes Orion and Glykos extend ADC collaboration Ex-ACIP panel warns of ‘critically weakened’ US immunisation (..)

Communication 52

Communication Hospitals Pharmaceutical Manufacturing Packaging 52

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

JUNE 24, 2025

Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest Bayer’s Eylea market grip set to slip as Alvotech biosimilar closes in Harbour BioMed partners Otsuka on new T-cell therapy Madrigal poised to enter European MASH market after CHMP endorsement Themes Sections Artificial Intelligence Cloud Corporate Governance (..)

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Compounding Packaging Online Pharmacies Communication 52

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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Packaging Labelling Pharmaceutical Manufacturing Documentation 40

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

JUNE 23, 2025

Power of collaboration more pertinent than ever says pharma experts Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest Madrigal poised to enter European MASH market after CHMP endorsement Novartis’ ribociclib approved in Canada for early breast cancer NSW government invests $13.39m in life-changing therapies (..)

Insurance Coverage and Processing 52

Insurance Coverage and Processing Diabetes Pharmaceutical Manufacturing Communication 52

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

Pharmaceutical Technology

JUNE 20, 2025

In recent years, the pharmaceutical industry has exhibited a significant shift into digitalisation, with AI pushing for innovation across the entire drug development value chain, from accelerating drug discovery to optimising clinical trial design to ultimately improve patient outcomes.

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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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Putting Patients First Blog

APRIL 7, 2025

14 In addition, sponsors should ensure that the datasets used to develop AI models reflect the intended patient population and disease variations. 15 ,16 Failure to do so risks overlooking meaningful variability and could reinforce historical limitations in drug development.

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