Author: GMDP Academy Editorial Board

Researchers challenge claim of historic human brain ‘shrinking’

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Consumers use non-prescription drugs without the supervision of a healthcare professional. The non-prescription drug’s label is intended to empower consumers to appropriately select and use the product safely and effectively. As such, the FDA is looking to improve the consistency of labeling for non-prescription drugs. It recently announced draft guidance entitled “Statement of Identity and Strength — Content and Format of Labelling for Human Non-prescription Drug Products,” which provides recommendations on the content and format of the required statement of identity and the drug’s strength, both of which appear on the labeling of human non-prescription drug products. The recommendations are intended to help manufacturers, packers, distributors, applicants, and sponsors ensure consistent content and format of the statement of identity and strength for all non-prescription drug labeling.

News from the FDA: Improving Consistency of Labeling for Non-Prescription Drugs

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Consumers use non-prescription drugs without the supervision of a healthcare professional. The non-prescription drug’s label is intended to empower consumers to appropriately select and use the product safely and effectively. As such, the FDA is looking to improve the consistency of labeling for non-prescription drugs. It recently announced draft guidance entitled “Statement of Identity and Strength — Content and Format of Labelling for Human Non-prescription Drug Products,” which provides recommendations on the content and format of the required statement of identity and the drug’s strength, both of which appear on the labeling of human non-prescription drug products. The recommendations are intended to help manufacturers, packers, distributors, applicants, and sponsors ensure consistent content and format of the statement of identity and strength for all non-prescription drug labeling.

Highlights of AIDS 2022

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The HIV world conference, held in Montreal in 2022, was the first in-person International AIDS Society meeting since 2019. Amidst funding concerns and overshadowed by visa issues, it was a slightly subdued affair. This article from the Lancet provides highlights and takeaways from the conference including the denial of VISAs to potential attendees, STI prevention with doxycycline, treatment of HBV and HIV infections, and the use of PrEP in pregnancy.

Switching Among Biosimilars: A Review of Clinical Evidence

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The marketing authorization and the commercialization of the first biosimilars raised an important clinical dilemma: is it safe for patients the switch from the originator to a biosimilar, and even more, is it safe the switch among biosimilars? For many years the scientific community was in doubt, as we know that a biosimilar (as the word correctly states) is never identical to the originator. Initially, clinicians took a v prudent approach and produced guidance to avoid the switch. For many years patients who started a biological agent were advised to continue with the same brand. Over the last decades, more evidence accumulated that supports the conclusion that the switch results in no harm for the patients.

Clinical Trials Suggest Benefit of Polypill for CVD

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Several years ago, The Lancet suggested the potential benefits of the marketing of a so-called “polypill”, a medication based on the combination of aspirin (100mg), ramipril (2.5, 5 or 10 mg) and atorvastatin (20 or 40 mg), indicated for the secondary prevention of myocardial infarction. The aim was to increase patients’ compliance, but no company was interested in investing in this combination product based on 3 ingredients whose patent had expired. The Lancet and New England Journal of Medicine published two new clinical trials, wherein the results once again support the clinical benefits of a polypill. Below are some of the key findings of the trials.
The report is the result of four years of work with patient group leaders, academics, industry experts, regulators and other stakeholders, and the EMA.

It describes the importance of systematically involving patients throughout a medicine’s lifecycle, from early development through the regulatory process to ongoing monitoring and safe use in everyday healthcare, and provides a comprehensive overview of current knowledge regarding the benefits of patient involvement and existing initiatives, with examples and recommendations. It also addresses the remaining challenges and practice gaps. The aim of the report is to prompt readers to implement its best practice recommendations according to how well they fit in with their organizational and national needs.

News from CIOMS

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We are pleased to share the CIOMS report on “Patient involvement in the development, regulation and safe use of medicines”, which is available as a free download.

The report is the result of four years of work with patient group leaders, academics, industry experts, regulators and other stakeholders, and the EMA.

It describes the importance of systematically involving patients throughout a medicine’s lifecycle, from early development through the regulatory process to ongoing monitoring and safe use in everyday healthcare, and provides a comprehensive overview of current knowledge regarding the benefits of patient involvement and existing initiatives, with examples and recommendations. It also addresses the remaining challenges and practice gaps. The aim of the report is to prompt readers to implement its best practice recommendations according to how well they fit in with their organizational and national needs.

News from the Biotech Sector: Emerging Biopharma’s Contribution to Innovation

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The IQVIA institute, part of the IQVIA company, the largest global CRO, produces several reports related to pharmaceutical and biotech companies. Their latest report is devoted to biotech companies and the role they have on the research and development of new drugs. One key highlight of the report is that in the last twenty years, the share of EBPs in the R&D pipeline has doubled and is continuing to grow!

News from the EMA: Accelerating Clinical Trials in Europe

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The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published the 2022-2026 workplan of the Accelerate Clinical Trials in the EU (ACT EU) initiative. The workplan has been prepared based on the recommendations of the European medicines’ agencies network strategy to 2025 and the European Commission’s Pharmaceutical Strategy for Europe.

Parkinson’s Disease and the Need for an Urgent Public Health Response

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The prevalence, burden of disability, and number of deaths associated with Parkinson’s disease all more than doubled between 1990 and 2016. These increases are not entirely attributable to rising population age, and other potential contributing factors include greater exposure to risk factors and longer disease duration. The symptoms of Parkinson’s disease are treatable but, in many areas of the world, access to therapy remains unacceptably low. Levodopa is listed as a WHO essential medicine and is less expensive than many other treatments but is still unavailable or unaffordable for many patients.

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