Agency IQ

NOVEMBER 27, 2023

EMA’s investigation ended up revealing even more causes of nitrosamine impurities in drugs, discovering, for example , that formation happened during the heat-sealing process of in certain products using blister-packaging. In a study of more than 12,000 small molecule drugs , researchers found 40.4%

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Regulations Production FDA Packaging 40

Agency IQ

AUGUST 2, 2024

Another legislative area that will also likely receive more attention will be the pharma reform package , since the two Parliament rapporteurs to lead the package negotiations were recently appointed.

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Regulations Clinical Trials Production Trials 40

Agency IQ

JUNE 9, 2023

Here, we’re starting some deeper analysis of aspects of the proposal package with a look at the impact of orphan drug provisions, seeing what impact the new provisions and the surrounding uncertainty might have on innovation. The data exclusivity of six years is much shorter than the orphan drug market exclusivity of 10 years.

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Marketing Regulations Biosimilars Drugs 40

Codon

JANUARY 21, 2024

Sign up to receive articles from Asimov Press. With hepatitis C, what changed within the last 10 years was the development of direct-acting antivirals , or DAAs, which are packaged into pills that you can take once a day for a few months. There have been deaths in phase 1 medical and drug research among healthy participants.

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Vaccine Trials Disease Treatment 126

Agency IQ

AUGUST 11, 2023

EMA’s investigation ended up revealing even more causes of nitrosamine impurities in drugs, discovering, for example , that formation happened during the heat-sealing process of in certain products using blister-packaging. In a study of more than 12,000 small molecule drugs , researchers found 40.4%

FDA 40

FDA Science Production Regulations 40

Codon

JUNE 2, 2024

Read our full Editors’ Note and preview upcoming articles by clicking here. Read this article on our website by clicking here. That is—until the Austrian monk Gregor Mendel showed that traits are passed from parent to offspring in discrete, independently assorted packages. Today we launch Issue 03 of Asimov Press.

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Laboratories Research Disease Science 130