Pharmaceutical Medicine

Despite considerable treatment progress, cancer remains among the leading causes of death worldwide. Antibody-drug conjugates (ADCs), a rapidly growing class of systemic therapy, show promise by combining the properties of conventional chemotherapy and targeted therapy. Antibody-drug conjugates have been shown to be more efficacious than traditional chemotherapy. To date, there are 13 ADCs approved by the United States Food and Drug Administration (FDA) for treating various hematological and solid organ cancers...

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Pharmacovigilance (PV) activities aim to identify potential risks of medicines and vaccines after they have been authorised in the market by collecting and analysing information on suspected adverse events from different stakeholders. These can be captured and transmitted electronically in the form of Individual Case Safety Reports (ICSRs). Hence, up-to-date ICSRs management systems, like VigiFlow and signal detection and management systems as VigiLyze, have an important role in the PV system of a country. In 2019, after various attempts to establish a PV database that could fulfil the needs of the country, Mexico's National Regulatory Authority, COFEPRIS (Federal Commission for the Prevention against Sanitary Risks) decided to implement these tools...

The Medical Affairs (MA) function in pharmaceutical companies creates a unique opportunity to ensure the internal linkage between Research & Development (R&D) and Commercial/Marketing functions, in addition to managing external scientific engagements with multiple stakeholders across life-science ecosystems. In recognition of the strategic value of MA, the objective of this paper is to share a comprehensive set of practical examples of the main deliverables within the MA function in the affiliate and align these with the two distinct phases; pre- and post-launch, respectively...

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Spinal cord injury (SCI) encompasses a plethora of complex mechanisms like the involvement of major cell death pathways, neurodegeneration of spinal cord neurons, overexpression of glutaminergic transmission and inflammation cascade, along with different co-morbidities like neuropathic pain, urinary and sexual dysfunction, respiratory and cardiac failures, making it one of the leading causes of morbidity and mortality globally. Corticosteroids such as methylprednisolone and dexamethasone, and non-steroidal anti-inflammatory drugs such as naproxen, aspirin and ibuprofen are the first-line treatment options for SCI, inhibiting primary and secondary progression by preventing inflammation and action of reactive oxygen species...

There is considerable societal interest in making medicines more affordable. A critical factor often inadequately considered early in the process of adding drugs to a company's product portfolio is that some products may require additional monitoring and complex, demanding and expensive additional risk minimisation measures (aRMMs). These aRMMs may have a sizeable impact on a company's commitment to that medicinal product throughout the product's entire life cycle. The teratogenic phthalimides were selected as an example of medicines that are recently being genericised and require a substantial commitment in terms of additional monitoring and aRMMs, most notably in the form of pregnancy prevention programmes (PPPs) with controlled distribution systems (CDSs)...

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No abstract text is available yet for this article.

Pharmacokinetics (PK) includes how a drug is absorbed, distributed, metabolized and eliminated. The compartment providing this information is usually the plasma. This is as close to the tissue of interest that we can get, although biopsies may be obtained to give "tissue levels" of drugs. Ultimately, the goal of PK is to understand how long the drug is actually engaged with the target in the tissue of interest after a dose has been administered. Most drugs at some point in their development will have been administered intravenously (IV), which acts as the standard for 100% bioavailability...

Like most private enterprises, the pharmaceutical industry has deeply rooted environmental, social, and governance (ESG) matters that challenge its long-term sustainability. Overcoming these external challenges requires collaborative and proactive steps as well as procedures guiding the adoption of ESG principles by all internal stakeholders. Environmental challenges such as climate change, and in addition the changes in society, have resulted in the need for governance addressing and coordinating efforts. The core function of medical affairs (MA) is connecting with stakeholders within a company and also between the company and external stakeholders...

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No abstract text is available yet for this article.

BACKGROUND: Coroners, who hold inquests to determine the causes of unnatural deaths in England and Wales, having recognised factors that could cause other deaths, are legally obliged to signal concerns by sending 'Reports to Prevent Future Deaths' (PFDs) to interested persons. We aimed to establish whether Coroners' concerns about medications are widely recognised. METHODS: We searched MEDLINE, Embase and Web of Science up to 30 November, 2022 for publications linking PFDs and medications using a combination of search terms "coroner*", "inquest*", "medicine*", "medication*" and "prevent*"...

This brief paper aims to describe the Risk Evaluation and Mitigation Strategy (REMS) Public Dashboard launched by the US Food and Drug Administration (FDA) in December 2021. The FDA REMS Public Dashboard can be accessed through the REMS@FDA website. The dashboard was developed in Qlik Sense® to support a user-friendly interactive web-based tool that allows healthcare providers, patients, researchers, pharmaceutical companies, and regulators to readily access and visualize REMS information. The dashboard includes eight separate pages to capture information on all REMS, active REMS, REMS with elements to assure safe use, shared system REMS, REMS modifications, REMS revisions, released REMS, and REMS Summary; for REMS programs approved from 2008 to the present...

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The author argues that notwithstanding available guidelines and established practices, the elaboration of a formal ethics framework specific to medical affairs could improve good practice internationally. He further argues that further and better insights into the theory behind the practice of medical affairs are an essential precondition for elaborating any such framework.

BACKGROUND: In Australia, facilitated regulatory pathways (FRPs) became available with the introduction of priority review (PR) in 2017 and provisional approval (PA) in 2018, which aim to facilitate expedited review and approval for novel medicines. The pathways were developed in consultation with a wide range of stakeholders and have since been utilised by pharmaceutical companies for various therapeutic products. However, the perceptions of the firsthand users of these pathways have not been evaluated in Australia...

The centralised clinical trial authorisation process, introduced by European Regulation 536/2014, came into force on 31 January 2022. The Regulation is inflexible, both legally and in the technical detail of the authorisation process itself. The principal justification for moving away from the older European Directive 2001/20 seems to be limited to multinational trials: multiple applications to national competent authorities (NCAs), would theoretically be replaced by a single, internationally harmonised authorisation...

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