European Pharmaceutical Review

SEPTEMBER 29, 2022

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) through the Office of Pharmaceutical Quality in 2021 embarked on an initiative to develop a framework for establishing a pharmaceutical manufacturing site quality rating system, the Quality management maturity (QMM) programme.

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European Pharmaceutical Review

NOVEMBER 21, 2024

The LAL reagents included in the cartridges are licensed by the US Food and Drug Administration (FDA). Charles River has worked alongside other recombinant manufacturers to petition for licensure with the FDA; however, it is still unclear if FDA will require Biological License Applications (BLAs) for rFC and rCR manufacturers in the future.

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European Pharmaceutical Review

MARCH 13, 2024

FDA inspections Identification of data integrity deviations Of the 70 Warning Letters issued by the US Food and Drug Administration (FDA) so far in 2024, three have identified data integrity issues at pharmaceutical manufacturing sites outside the US.

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Pharma Leaders

MAY 8, 2023

The Food and Drug Administration (FDA) has successfully inspected Nexus Pharmaceuticals’ pharmaceutical manufacturing facility located in Pleasant Prairie, Wisconsin, US. The inspection will allow the company to commence commercial operations at the three-storey, 84,000ft² manufacturing facility.

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European Pharmaceutical Review

OCTOBER 23, 2023

1 In pharmaceutical manufacturing, the high level of final product quality is the major driver. Tablets should be defect-free and compliant to good manufacturing practice (GMP) aspects and final-user requirements. Pharmaceutical Technology. Stickiness in Foods: A Review of Mechanisms and Test Methods.

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Pharmaceutical Technology

APRIL 18, 2023

The new facilities will also support the company’s efforts to manufacture new therapeutic modalities, including genetic medicines. The company has launched 19 new medicines since 2014, including Jaypirca, which was approved by the US Food and Drug Administration in January 2023 to treat mantle cell lymphoma.

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European Pharmaceutical Review

JULY 3, 2023

The Office of Pharmaceutical Quality (OPQ) in the US Food and Drug Administration (FDA)’s Center Pharmaceutical Quality for Drug Evaluation and Research (CDER) has released its 2022 annual report analysing drug manufacturers and their products.

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European Pharmaceutical Review

AUGUST 9, 2022

According to researchers, a ribB -based colorimetric loop-mediated isothermal amplification (LAMP) assay could become a fast and easy-to-perform detection method for testing non-sterile pharmaceuticals for BCC. Burkholderia species are one of the primary causes of non-sterile pharmaceutical product recalls and accounted for 45.3

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PM360

OCTOBER 25, 2023

Combination Therapy in Oncology Combination therapies comprising two or more therapeutic agents have become a cornerstone of oncology management and are increasingly a development focus for the pharmaceutical industry. Food and Drug Administration (FDA) oncology approvals were for drugs used in combination. Certain markets (e.g.,

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Pharmaceutical Technology

JUNE 23, 2022

National Resilience (San Diego, California) announced on 6 June that it had raised $625m in series D financing, which will be spent in part on continuous manufacturing for biologics. The US House of Representatives separately passed a bill on continuous manufacturing on 19 October last year.

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European Pharmaceutical Review

JULY 21, 2023

Manufacturing delays and capacity issues that continue to impact the pharmaceutical supply chain have led to medicine shortages around the globe; an issue that has been exacerbated further by geopolitical events, the energy crisis and rising inflation.

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European Pharmaceutical Review

AUGUST 17, 2022

Antibiotics getting into the food chain also plays a key role in the development of AMR. based Targets for Antibiotics in Receiving Waters from Pharmaceutical Manufacturing Operations. Editorial: Horizontal Gene Transfer Mediated Bacterial Antibiotic Resistance. Frontiers in Microbiology. Tell J, Caldwell D, Häner A, et al.

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Clarify Health

OCTOBER 26, 2021

Food and Drug Administration (FDA) released guidance entitled, Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. To advance equity in clinical research, the U.S.

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European Pharmaceutical Review

NOVEMBER 8, 2022

In the US, members of the public can request, through a Citizen Petition, that the US Food and Drug Administration (FDA) “take or refrain from taking” various administrative actions, including denying approval of generic and biosimilar drug applications.

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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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Pharma Marketing Network

JUNE 11, 2020

If you’re a pharmaceutical company or if you’re an agency or even a consultant.

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European Pharmaceutical Review

JANUARY 16, 2023

Under the agreement with the Swiss Confederation (Switzerland), the Swiss Agency for Therapeutic Products (Swissmedic) and the US Food and Drug Administration (FDA) will be able to utilise each other’s GMP inspections of pharmaceutical manufacturing facilities, avoiding the need for duplicate inspections.

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European Pharmaceutical Review

DECEMBER 18, 2023

Pharmaceutical manufacturing Oligonucleotides Last month, the Centre for Process Innovation (CPI) announced a new Scotland-based manufacturing facility focusing on oligonucleotide therapeutics. ZUMA-7 is the first and largest Phase III study of any CAR T-cell therapy, with the longest follow-up.

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European Pharmaceutical Review

JULY 8, 2024

Information can be found in certain US pharmacopeia guide chapters, such as USP <1116>, 1 as well as guidance from the US Food and Drug Administration (FDA) and World Health Organization (WHO) but none of these are regulatory requirements. From this observation, all options are possible.

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Clarivate

MARCH 14, 2024

Over the past few years nitrosamines and nitrosamine impurities have been increasingly gaining the reputation of being high-risk containments in the food industry. The food sector has already initiated the publication of preliminary regulations aimed at restricting PFAS in packaging. [3].

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European Pharmaceutical Review

OCTOBER 20, 2022

An essential part of the manufacturing of drug products is the use of water of different degrees of purity. Her current research is focused on spectroscopy and mathematical modelling as process analytical technologies in pharmaceutical manufacturing. US Food and Drug Administration. US Food and Drug Administration.

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European Pharmaceutical Review

AUGUST 10, 2023

Amidst numerous warning letters distributed by the US Food and Drug Administration (FDA) to pharmaceutical manufacturers in recent months, in July this year, the US regulatory body published its analysis on drug product quality in 2022.

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pharmaphorum

OCTOBER 27, 2022

Jackie Mulryne, Partner, is a member of the Life Sciences practice group, and provides regulatory, policy, and compliance advice to clients in the pharmaceutical, medical technology, cosmetics, and foods sectors.

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PM360

AUGUST 26, 2024

Between 2015 and 2021, over a quarter of the drugs approved by the US Food and Drug Administration (FDA) were associated with specific biomarkers. During the period from 2008 through 2020, the number of precision medicines in the US increased from 5 to 285.

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Pharmaceutical Technology

MAY 16, 2023

Juno Pharmaceuticals Canada has purchased Omega Laboratories, a specialist injectable pharmaceutical manufacturer in Canada, for an undisclosed sum. The merged entity represents one of the biggest specialist generic injectable operations in Canada with local manufacturing facilities.

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PM360

MAY 21, 2024

It’s a powerful technology that, if used correctly, can help us all reach new heights in pharmaceutical manufacturing and beyond. For example, a fork can be used to enjoy a Michelin star meal or to eat burnt chicken, depending on the quality of the food. It is easy and understandable to get swept into the hype around AI.

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Pharmaceutical Technology

MARCH 22, 2023

In December 2022, the US passed its ‘ominous spending bill’ directing the US Food and Drug Administration (US FDA) to establish an advanced manufacturing Centre for excellence and an advanced manufacturing technologies designation programme. What can the EU learn from other countries’ reshoring strategies?

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