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Carefully Monitor Direct Oral Anticoagulant Medications

Pharmacy Times

Bristol Myers Squibb; 2012. Biomedicines. 2021;9(5):445. doi:10.3390/biomedicines9050445 Xarelto. Prescribing information. Janssen Pharmaceuticals, Inc; 2021. Accessed June 4, 2025. link] Eliquis. Prescribing information. Accessed June 4, 2025. link] Savaysa. Prescribing information. Daiichi Sankyo, Inc; 2015. Accessed June 4, 2025.

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The Value of a Medically Integrated Pharmacy to Maximize Cost Avoidance and Reduce Waste of Oral Oncolytic Medications

Pharmacy Times

The National Institutes of Health reports that in 2012, $418 billion was wasted in the US due to suboptimal use of medications. Abstract Background Cost avoidance and waste reduction are defined as interventions made before the drug is dispensed to the patient that preclude an unnecessary prescription from being filled and sent to a patient.

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From Pasteur to Present: Historical and Contemporary Perspectives on Publication Bias in Scientific Literature

Pharmacy Times

Specifically, psychology and psychiatry were among the disciplines where this increase was observed to be highest (P < 001). 2 Notably, in the field of biomedical research in autism spectrum disorder (ASD), negative results appear to be nearly absent, according to Joober et al. 2018;153(7):663-670. doi:10.1001/jamasurg.2018.0040

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UPC opt-out – a strategic balancing act for pharma

European Pharmaceutical Review

On the contrary, keeping stronger patents, eg, compound patents, in and opting less robust, second‑medical‑use patents out may help favourably shape the jurisprudence. Arrow declarations are useful for generics or biosimilars as they give commercial certainty that a product may be launched without the risk of a later infringement action.

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Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

2 It was first approved as Fulyzaq in December 2012 and in October 2016, Napo Pharmaceuticals launched the new brand, Mytesi. 14 Marketing authorisation In the UK, medicinal products placed on the market are required to have marketing authorisations in accordance with The Human Medicines Regulations 2012 (S.I. 2012/1916).

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Wave of Warning Letters to Foreign OTC Drug Manufacturing Facilities Following Remote Records Requests

FDA Law Blog: Biosimilars

Section 704(a)(4) was added to the FDCA by the Food and Drug Administration Safety and Innovation Action (FDASIA) in July 2012. Despite FDA having the authority to conduct paper inspections since the statutory provision was added to the FDCA by FDASIA in 2012, FDA did not issue a warning letter citing Section 704(a)(4) until January 2021.

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Top Performing Drug – Enbrel (June Edition)

PharmaShots

Consistent with prior periods, Enbrel continued to lose market share, and this decline was compounded by a reduction in the growth rate of the rheumatology market as a result of COVID-19. Some of its approved biosimilars are mentioned below along with the regulatory bodies they are approved by*. This list is not an exhaustive list.