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Using RWE in rare disease drug development: effective innovations with historical controls

European Pharmaceutical Review

The application of Bayesian methodology has been recognised by the US Food and Drug Administration (FDA) as useful in early phase clinical trials involving paediatric populations. Dr Maier has over 25 years of experience in drug development and commercialisation at pharmaceutical companies in Europe, Canada, the United States and Asia.

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Fixed-dose combination: Considerations for design, formulation, manufacturing and analysis

Pharmaceutical Technology

Pharmaceutical companies – and the FDA – are embracing FDCs. From 1990 through 2013, the FDA approved 131 FDC products, on average 5.7 From 1990 through 2013, the FDA approved 131 FDC products, on average 5.7 More FDC products flowing into pharma pipelines. The numbers tell the story.

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Pandemic Like Never Before – Continuous Manufacturing to the Rescue

Roots Analysis

However, the road for transition from the conventional batch to continuous manufacturing requires a shift in variety of parameters and is still quite unclear to many of the pharmaceutical companies. The field has also witnessed various expansion initiatives undertaken by industry players during the period 2013-2020 (till January).

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US legislative update: takeaways for European pharma

European Pharmaceutical Review

There are also several pending bills that seek to lower drug costs by means other than price regulations, including: 1) deterring the delay in FDA approval of drug applications caused by sham ‘Citizen Petitions’. Citizen Petitions before the FDA. 562 would permit the FDA to deny the petition if either of these factors were satisfied.

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Evaluating NMR relaxometry for antibody identification

European Pharmaceutical Review

Gregory’s industrial career spans an employment history with several major pharmaceutical companies. IPQ International Pharmaceutical Quality. 2013; 102(1): 52–61. Cited 2023Feb]. Available from: [link] Egelhofer V, Gobom J, Seitz H, et al. J Chromatogr B Biomed Appl. 2007; 848(1): 79–87. J Pharm Sci.

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Biogen’s $900 million settlement signals scrutiny on speaker fees

Pharmaceutical Technology

Ferry describes a popular solution among pharmaceutical companies. Some companies try to separate the clinical educational programs from their sales programs, and the speaker programs are run through the clinical education programs. 4 integrins, which play a key role in MS pathology.

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CMC Requirements for New Drug Registration in Latin America

ISPE

In an era when the world is accelerating the development of drugs and targeted medicines using innovative technologies, pharmaceutical companies still face registration hurdles for well-characterized molecules because of redundant or additional local regulatory requirements. 2013/C 223/01. Published 8 February 2013.