European Pharmaceutical Review

AUGUST 31, 2023

In addition, radionuclide therapy has the potential to achieve high efficacy rates since the administered drugs spare surrounding healthy tissue, thus, reducing the burden on the patient. 1-4 Besides these drug products, several companies worldwide are developing radiotheranostics in clinical trials built on various radionuclides.

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Food and Drug Administration Manufacturing Safety Transportation 75

European Pharmaceutical Review

DECEMBER 22, 2022

The success of mRNA vaccines against SARS-CoV-2 has quickly catapulted mRNA therapeutics as a disruptive, expanding drug category” The term ‘mRNA’ has become commonplace globally. The success of mRNA vaccines against SARS-CoV-2 has quickly catapulted mRNA therapeutics as a disruptive, expanding drug category.

Medicine 102

Medicine Food and Drug Administration Transportation Distribution 102

Pharmaceutical Technology

AUGUST 23, 2022

Pfizer and BioNTech have filed an application seeking Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for a booster dosage of an Omicron BA.4/BA.5-adapted Having rapidly scaled up production, we are positioned to immediately begin distribution of the bivalent Omicron BA.4/BA.5

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European Pharmaceutical Review

AUGUST 23, 2022

FAKE MEDICINES are not a new problem, and pose a tremendous threat to patient safety and public health in society regardless of a country’s economic status. The prevalence of fake drugs is a continually growing problem worldwide. Fake drugs kill more than 250,000 children a year, doctors warn. World Health Organization; 2006.

Medicine 88

Medicine Food and Drug Administration Pharmaceutical products Pharmaceutical 88

Legacy MEDSearch

SEPTEMBER 5, 2023

a medical software innovator dedicated to enhancing clinical impact in ablation therapy, announced today that it has received 510(k) clearance from the USA Food and Drug Administration (FDA) for its VisAble.IO solution is not yet approved for sale or distribution in the USA and is limited by USA law to investigational use.

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Pharmaceutical Technology

JUNE 24, 2022

The US Food and Drug Administration (FDA) has not released a statement announcing rolling reviews yet, however, Moderna and Pfizer have stated their plans to submit data to both agencies. Reuters reported that FDA plans to hold a meeting next week to discuss the booster campaign for this autumn season.

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Food and Drug Administration FDA Medicine Distribution 105

European Pharmaceutical Review

MARCH 12, 2024

In the pharmaceutical/life sciences industries, maintaining data integrity is crucial given its role in making critical decisions that shape outcomes from drug development to human health. What are three current key trends in data integrity? Ensuring data integrity in the life science industry is crucial for regulatory compliance.

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Government Pharma Ethics Training 85

European Pharmaceutical Review

NOVEMBER 15, 2022

The validation of computerized systems should be focused on ‘intended use’ and scaled commensurate with the risks to patient safety, product quality and data integrity” The focus until now has too often been on compliance and not on quality. Takeaways from ISPE’s GAMP 5 Second Edition update.

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Manufacturing Pharma Food and Drug Administration Safety 81

Clarivate

MAY 24, 2022

Recent policy and regulatory moves have begun to sketch out a framework for rare disease drug approvals in the country, but obstacles to approvals and patient access remain. The list, designed to serve as a reference point for prioritized drug review and evaluation policies, included 121 rare diseases. [8]. 10] [11] [12].

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Patients Food and Drug Administration Marketing Pharma 52

European Pharmaceutical Review

SEPTEMBER 26, 2023

This recent decision by the EC follows approval of Tyruko ® (natalizumab) by the US Food and Drug Administration (FDA) last month for the same indication. Sandoz has the rights to commercialise and distribute it in all markets under the deal. The authorisation was also granted as treatment for other forms of the disease.

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Food and Drug Administration Medicine Distribution Food 59

European Pharmaceutical Review

SEPTEMBER 22, 2022

Rare disease drug development poses unique challenges that can be overcome by using real-world evidence (RWE). Another benefit is that fewer patients are required in clinical trials using HCs, thereby reducing time to trial completion and speeding drug approval.

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Food and Drug Administration Patients Distribution FDA 110

Evolve Your Success

MAY 17, 2022

You know when they are trying to push a drug and white-knuckling it. You ask the hospital administrators to figure out the financial aspects of that side of it. What drugs are we using? This office or rep prescribed this drug and this is what I want you to know about this drug.”. You do not even have to say it.

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Medical sales Medical Sales Patients 52

European Pharmaceutical Review

JANUARY 16, 2023

This also occupies a large resource, given the US Food and Drug Administration (FDA) requirement for double plate checking using a second ‘independent’ person. The US federal drug GMP regulations that first became official in 1977 and their European counterparts will need to be re-interpreted for this new generation of products.

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Pharmaceutical Food and Drug Administration Manufacturing FDA 124

pharmaphorum

JANUARY 30, 2023

Moreover, more than any other medicine, antibiotics are more likely to face insufficient supply, with analysis by the US Pharmacopeia suggesting they are 42% more likely to be in shortage compared to all other drugs.

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Food and Drug Administration Medicine Manufacturing Pharmaceutical 80

Pharmaceutical Technology

FEBRUARY 13, 2023

However, there is a high level of attrition during the pharmaceutical research and development process, which is an indicator of the vast number of potential drug substances considered for progression. With all this in mind, how do drug developers know which strategy and approach is right for their molecule at this early stage?

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European Pharmaceutical Review

DECEMBER 27, 2023

Chimeric antigen receptor (CAR) T cells are the first example of a “living drug”. Being a cellular therapy that involves cell manipulation and molecular transfection – and above all, being a living drug – makes CAR T-cell therapy a somewhat challenging immunotherapy to manufacture in‑house.

Manufacturing 80

Manufacturing Food and Drug Administration Patients Pharma 80

Pharmaceutical Technology

MAY 1, 2023

After a US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) Advisory Committee (AdCom) meeting in March 2023 voted unanimously in support of GSK’s respiratory syncytial virus vaccine, the odds for an approval have increased.

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