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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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

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. Internet} MasterControl. cited2024Mar].

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World of DTC Marketing

APRIL 12, 2021

The goal of getting a drug to market as fast as possible so they can recoup drug development costs has the potential for mistakes that could cost lives. Coupled with all this is the continued outsourcing of raw materials and other steps in drug development. Up to 90% of drugs now sold in the US and UK are generic.

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Pharmaceutical Technology

APRIL 18, 2023

Lilly stated that the new facilities will bolster its manufacturing capabilities for active pharmaceutical ingredients and support the growing demand for its existing products. The new facilities will also support the company’s efforts to manufacture new therapeutic modalities, including genetic medicines.

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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). She has a BS in biology from Georgia Tech, certifications in integrative and biomedical biology, and 10 years of experience in the pharmaceutical industry. Are LAL and rCR cartridges licensed by the FDA?

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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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European Pharmaceutical Review

DECEMBER 18, 2023

At the beginning of this year, EPR reported on the potential blockbuster pharmaceutical drugs to watch in 2023. The year 2023 also brought much advancement in the Alzheimer’s space for the pharmaceutical industry. Since then, EPR has covered developments for several of the therapies highlighted in the report.

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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. In particular, purified water and WFI are critical when producing sterile pharmaceutical drug products. The research is focused on multiple processes, such as cleaning verification and formulation of drug products.

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European Pharmaceutical Review

NOVEMBER 8, 2022

In the current US Congressional session, Congress has focused heavily on legislation directed at reducing prescription drug prices. The new law will also require drug manufacturers to pay rebates to Medicare if they increase drug prices faster than consumer inflation. 5) monitoring access to biosimilars.

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Pharmaceutical Technology

JUNE 23, 2022

US Congress is also making substantial investments to improve the continuous manufacturing of pharmaceuticals. As more drugs are approved with continuous manufacturing, this production method is becoming increasingly mainstream. There are currently ten approved continuous manufacturing applications in the US.

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European Pharmaceutical Review

JULY 8, 2024

Single- or mono-temperature incubation is not easy to implement, but it offers efficiency and performance advantages and an opportunity to simplify the process in a pharmaceutical microbiology laboratory. Phase 2 included selection of 32 new strains mainly found in the pharmaceutical industry (see Table 2).

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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.

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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

AUGUST 17, 2022

million of these, 2 meaning drug-resistant infections killed more people than HIV/AIDS (864,000 deaths) or malaria (643,000 deaths). What are the causes of AMR and how is the pharmaceutical industry implicated? Antibiotics getting into the food chain also plays a key role in the development of AMR.

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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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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. Edge Biologicals Inc., It called for RemedyRepack, Inc.

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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. Over a decade ago, AstraZeneca identified and tested specific biomarkers to develop drug molecules.

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Pharmaceutical Technology

MARCH 22, 2023

In the 1990s, generic pharmaceutical companies in the European Union (EU) offshored the manufacturing of active pharmaceutical ingredients (API) primarily to China. Only 25% of API production for generic drugs took place in Europe in 2020, according to a November 2022 Medicines for Europe report.

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