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Exforge antitrust settlement caps Novartis’ year of legal disputes

Pharmaceutical Technology

In 2020, the Federal Trade Commission issued a report regarding settlements reached between brand and generic manufacturers in FY 2017 and noted that “for the first time since [FY] 2004, no settlement agreement in [FY] 2017 contains a no-[authorized generic] AG commitment.”. Throughout 2022, Novartis was at the opposing ends of legal cases.

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Herpes zoster infection increases risk of stroke and coronary heart disease

Hospital Pharmacy Europe

The study included data on 79,658 women in the NHS, 93,932 in the NHS II and 31,440 men in the HPFS (2004-2016), without prior stroke or CHD. During >2 million person-years of follow-up, 3603 incident stroke and 8620 incident CHD cases were documented. Herpes Zoster and Long-Term Risk of Cardiovascular Disease. J Am Heart Assoc.

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How common are changes to the primary endpoint in oncology RCTs?

Hospital Pharmacy Europe

This suspicion was confirmed in a 2004 analysis by researchers from Oxford. They examined possible changes using three different methods: the history of tracked changes on ClinicalTrials.gov ; self-reported changes noted in the article; and changes reported within the protocol, including all available protocol documents.

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Pharmacy practice in emergency care: patient safeguarding

Hospital Pharmacy Europe

Given the pressures on inpatient care, notably bed capacity and blocking (bottlenecks in patients being able to leave the ED because of lack of capacity in the downstream system), moving pharmaceutical care closer to the hospital front door– that is, to the ED – is logical. ED pharmacy services were surveyed for the first time in 2004.

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Preparing for stricter standards on substances of human origin

European Pharmaceutical Review

In addition to hospitals and blood transfusion centres, pharmaceutical, device and other companies involved with blood products and cell- and gene-therapy products are advised to closely monitor developments surrounding the proposed regulation. Strict requirements apply, especially with regard to traceability and coding. Cited 2023Mar].

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Regulating decentralised manufacturing in the UK – a legal perspective

European Pharmaceutical Review

The decentralised spectrum Decentralisation comes in different forms, such as at home, where a person makes a medicine in their home, for example using a consumer 3D printer, as well as point of care, where eg, a cancer medicine is manufactured in a facility located in proximity to where a patient is waiting for treatment, such as in hospital.

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Why Are FDA Inspections So Ineffective and Disappointing?

The People's Pharmacy

There have been problems with records in the past: deceit, falsification of documents and even outright fraud. drug supply and made their way to patients’ medicine cabinets, hospital supply closets and IV drips.” What is extraordinary about this scandal is that the FDA inspected one of the Ranbaxy facilities in 2004.

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