Potential adverse events in Japanese women who received tozinameran (BNT162b2, Pfizer-BioNTech).

Reports of cerebral venous sinus thrombosis and intracranial hemorrhage (ICH) following the administration of coronavirus vaccines have raised concerns regarding their safety. Although no regulatory authority has recognized ICH as an adverse event associated with tozinameran (BNT162b2, Pfizer-BioNTech), fatal and non-fatal cases have been reported. In Japan, 10 fatal cases (five men and women) have been reported to date.

Approvals of type 2 diabetes drugs tested in cardiovascular outcome trials: A tripartite comparison.

Aims: In 2008, the US Food and Drug Administration (FDA) issued a guidance requiring that cardiovascular outcome trials (CVOTs) be conducted for newer hypoglycaemic drugs for type 2 diabetes (T2D). We aimed to examine the decisions by 3 regulatory authorities in response to identical CVOT data.

Methods: We surveyed ClinicalTrials.

Regulatory perspectives on next-generation sequencing and complementary diagnostics in Japan.

Introduction: The 'one biomarker/one drug' scenario is unsustainable because cancer is a complex disorder that involves a number of molecular defects. In the past decade, major technological advances have lowered the overall cost and increased the efficiency of next-generation sequencing (NGS).

Areas Covered: We review recent regulations on NGS and complementary diagnostics in Japan, mainly focusing on high-quality studies that utilized these new diagnostic modalities and were published within the last 5 years.

Imbalance in glycemic control between the treatment and placebo groups in cardiovascular outcome trials in type 2 diabetes.

Background: Glycated hemoglobin (HbA1c) is accepted as the most reliable marker for assessing chronic glycemia. The present study aimed to investigate glycemic control in cardiovascular outcome trials (CVOTs) performed by pharmaceutical sponsors, at the request of the United States Food and Drug Administration (FDA) to ensure that newer hypoglycemic agents do not increase cardiovascular risk for patients with type 2 diabetes.

Methods: We chose ClinicalTrials.

Challenges to hemoglobin A1c as a therapeutic target for type 2 diabetes mellitus.

Glycated hemoglobin (HbA1c) is widely accepted as the most reliable measure of long-term glycemia. However, there is disagreement among professional medical societies on a proper glycemic target for long-term benefits in type 2 diabetes (T2D). The use of some glucose-lowering drugs was associated with heart failure despite substantial lowering of HbA1c.