Fierce Pharma

APRIL 10, 2024

It usually goes without saying that your pharmaceutical production workers need to be gowned and gloved while handling drug materials inside clean rooms. | In a four-observation warning letter issued this week, the U.S.

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PharmaTech

MAY 8, 2024

This study reviews changes in in-country testing (registration testing, import testing) requirements and analyzes current trends.

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PharmaTech

JULY 19, 2022

Guest contributor Frederic Kahn discusses the state of the Indian pharmaceutical manufacturing industry.

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PharmaTech

JANUARY 11, 2024

Webinar Date/Time: Wed, Feb 7, 2024 10:30 AM CET (4:30 AM EST)

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Pharmaceutical Commerce

APRIL 5, 2024

In an interwith with Pharma Commerce Editor Nicholas Saraceno, Ed Schoonveld, Value and Access Advisor, Schoonveld Advisory, explains why pharmaceutical products tend to cost more in the US than the rest of the world.

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PharmaTech

SEPTEMBER 11, 2024

Palmer Limited discussed how aging facilities can impact the quality of pharmaceutical products. During a presentation at the PDA/FDA Joint Regulatory Conference, Nicholas Violand of Johnson & Johnson and Paul Palmer of Paul R.

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PharmaTech

NOVEMBER 5, 2024

In the wake of the Food and Drug Administration's (FDA's) latest guidance on nitrosamine contamination, ensuring compliance and safeguarding pharmaceutical products is more critical than ever.

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Food and Drug Administration Pharmaceutical products Food FDA 52

MedCity News

MARCH 18, 2024

Generic drugs are the pharmaceutical products mainly affected by the missile attacks disrupting shipping in the Red Sea. While the extra costs borne by drug companies aren’t causing an immediate spike in product prices, experts say they’ll eventually be factored into prices if the attacks become a long-term problem.

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PharmaTech

AUGUST 5, 2024

Contract organizations offer sponsors specialized equipment, capacity, and expertise for testing, manufacturing, and packaging bio/pharmaceutical products.

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PharmExec

AUGUST 6, 2024

A robust market access strategy ensures that pharmaceutical products, including those with limited distribution, reach patients and are covered by diverse healthcare systems.

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MedCity News

JUNE 29, 2023

The regulatory decision makes the BioMarin Pharmaceutical product the first gene therapy for this inherited bleeding disorder. The FDA approved Roctavian for treating hemophilia A.

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Pharmaceutical Technology

JULY 3, 2024

Metal contamination in pharmaceutical products is a huge problem. Detection and removal of these contaminants is critical during milling.

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Source Explorer

APRIL 9, 2020

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MedCity News

AUGUST 7, 2023

The regulatory decision comes as safety concerns emerge around the first therapy for the disease, an Apellis Pharmaceuticals product. Izervay, a drug developed by Astellas Pharma subsidiary Iveric Bio, is now the second approved therapy for the degenerative vision-loss disorder geographic atrophy.

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Pharmaceutical Commerce

APRIL 29, 2024

The CDMO’s boost in production will be centered around pharmaceutical products.

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MedCity News

JUNE 20, 2022

In other drug decision news, the Rhythm Pharmaceuticals product Imcivree added the rare disease Bardet-Beidl syndrome as a new approved indication. AbbVie drug Skyrizi is now approved for Crohn’s disease, making it the first treatment for the disorder that addresses a particular protein associated with inflammation.

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Pharmaceutical Commerce

MARCH 13, 2024

The significance of temperature-controlled systems in safeguarding the efficacy of pharmaceutical products was highlighted during the COVID-19 pandemic.

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European Pharmaceutical Review

JULY 5, 2023

The long-awaited PDA TR 43 report provides an approach to a quality decision-making process and represents best practices for the identification and classification of visual nonconformities for (empty) glass containers as pharmaceutical product packaging.

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Pharmaceutical Technology

JUNE 7, 2023

Shanghai Fosun Pharmaceutical (Group) is to collaborate with the International Finance Corporation (IFC) to construct a new pharmaceutical production facility and distribution hub near Abidjan, Côte d’Ivoire. The IFC will provide two loans totalling $53.49m (€50m) to Fosun Pharma’s subsidiaries.

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PharmaTech

JULY 23, 2024

Speed to market is a critical aspect of developing new pharmaceutical products, and scale-up-or scale-down-can play a key part in that process.

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eMediWrite

OCTOBER 23, 2024

Strategic measures are needed to overcome the difficulties experienced by pharmaceutical product managers in preserving team alignment and collaboration. Pharmaceutical product managers can successfully overcome obstacles to team alignment and collaboration by implementing these tactics.

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European Pharmaceutical Review

JANUARY 2, 2024

highlighted that “in the EU market, a relatively low number of approved pharmaceutical products adopted the QbD methodology or describe QbD elements in their regulatory submissions.” For example, Simões et al. The team examined the European Public Assessment Report (EPAR) for the QbD approach.

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Pharmaceutical Commerce

SEPTEMBER 28, 2023

Pharmaceutical product distributor continues goal of delivering safe and affordable medication to patients.

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Pharmaceutical Technology

MARCH 12, 2024

Learn about the specific compound and unique features of this groundbreaking pharmaceutical product. Discover AbbVie Inc.'s s innovative patent for an extended-release tablet to treat rheumatoid arthritis.

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European Pharmaceutical Review

APRIL 30, 2024

The World Health Organization (WHO) has published a new draft guidance on mitigating nitrosamine contamination in pharmaceutical products. For setting AI limits, WHO noted “expectations when a nitrosamine impurity cannot be synthesised or isolated and purified” should be considered.

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PharmaTech

NOVEMBER 14, 2022

If you’re in the business of pharmaceutical product development or manufacturing for the US market, this brief talk by Dr. Richard Sidwell is for you. The need for pharmaceutical products is higher than ever.

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PharmaTech

FEBRUARY 15, 2023

The complexity of the pharmaceutical product brings challenges to the transfer of information and technology between sponsors and contractors.

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European Pharmaceutical Review

APRIL 15, 2024

However, they noted that air and surface microbial levels “may vary” according to the sampling conditions and the pharmaceutical production environments. Higher microorganism levels were obtained in the air sampling, compared to the surface sampling, stated Soares et al.

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PharmaTech

NOVEMBER 5, 2023

In this article, gain insights into how early-stage pharmaceutical product development is foundational for successful clinical trials and regulatory approvals, and why collaboration with experienced partners like CDMOs is essential.

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European Pharmaceutical Review

APRIL 13, 2023

From development to distribution, INTERPHEX is the leading global event that takes you through all stages of the pharmaceutical product development lifecycle. Read the full press release here >> Innovatech Gateway Pavilion is the portal to global pharmaceutical technologies.

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European Pharmaceutical Review

FEBRUARY 22, 2023

Computed tomography for in-depth investigation of freeze-dried products In this article, Teresa Siegert and Henning Gieseler, discuss the benefits of applying computed tomography in the production of freeze-dried pharmaceutical products, as well as the hurdles that must be navigated to realise its potential.

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European Pharmaceutical Review

JULY 10, 2023

Traditional methods for assessing microbial contamination in pharmaceutical products can take weeks: sterility testing for final product requires 14 days of incubation (per USP <71> and Ph. 2.6.1), while mycoplasma determination in cell cultures can take up to 28 days (USP <63>, Ph.

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Pharmaceutical Commerce

SEPTEMBER 8, 2022

In this Q&A, Kristian Sibilitz, senior vice president, pharmaceutical production & supply chain at Lundbeck, outlines the impact of the last 2+ years on the Danish drugmaker’s supply chain activities.

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European Pharmaceutical Review

MARCH 1, 2024

As the largest Polish API manufacturer, Polpharma API offers a diverse portfolio of pharmaceutical products and CDMO solutions globally, providing services from initial development (for early stages of new chemical entities [NCEs]) to process development, validation, and commercial API manufacturing.

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Pharma Pathway

DECEMBER 3, 2022

Alembic Pharmaceuticals Ltd. is an Indian multinational Pharmaceutical company headquartered in Vadodara city of Gujarat-India. Alembic pharmaceuticals Ltd. is involved in manufacture of pharmaceutical products, pharmaceutical substances and Intermediates. Department: EHS/ Engineering.

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PharmExec

OCTOBER 3, 2022

November 29th 2022 9 am CT |10 am ET | 3 pm BST | 4 pm CET Statistical signal detection is a crucial tool for rapidly identifying potential risks associated with pharmaceutical products. New methods for signal detection offer the potential to identify adverse reactions from vaccines and drugs earlier.

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PharmaTech

NOVEMBER 14, 2022

If you’re in the business of pharmaceutical product development or manufacturing for the US market, this brief talk by Dr. Richard Sidwell is for you. The need for pharmaceutical products is higher than ever.

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