Category Archives: Erudition & Culture

No Link Found Between Acetaminophen Use During Pregnancy and Neurodevelopmental Disorders

A large-scale study funded by the National Institutes of Health (NIH) has found no causal link between acetaminophen exposure during pregnancy and an increased risk of neurodevelopmental disorders in children, such as autism, ADHD, or intellectual disability. This research, published in the journal JAMA, is the largest of its kind to address this question.

Liverpool Researchers Awarded £6 Million to Develop Long-Acting Treatments for Neglected Diseases in Developing Countries

A University of Liverpool project has received a significant boost in its fight against major diseases. Unitaid, a global health organization, awarded over £6 million to the initiative, titled LONGEVITY. This project focuses on developing long-acting treatments for tuberculosis, malaria, and hepatitis C, specifically targeting low- and middle-income countries (LMICs).

Cadrenal Therapeutics’ Tecarfarin Scores Orphan Drug Designation for Preventing Blood Clots in Heart Assist Device Patients

Cadrenal Therapeutics’ Tecarfarin Scores Orphan Drug Designation for Preventing Blood Clots in Heart Assist Device Patients
Cadrenal Therapeutics, a biopharmaceutical company developing innovative blood thinners, recently announced a significant development for their late-stage drug Tecarfarin. The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to Tecarfarin for preventing blood clots in patients with implanted mechanical heart assist devices.

New Combination Therapy Shows Promise for Recurrent Ovarian Cancer: Phase 3 Trial Underway

Avutometinib, a drug designed to target a specific pathway in cancer cells, has received orphan drug designation from the FDA for recurrent low-grade serous ovarian cancer. This designation is given to drugs with potential for treating rare diseases.

Researchers are currently evaluating a combination of Avutometinib and Defactinib in a large-scale phase 3 trial called RAMP 301. This trial aims to confirm the effectiveness and safety of the combination for patients with this type of ovarian cancer that has returned after previous treatment.

EMA Strengthens Testing for Cancer-Causing Impurities in Medicines

The European Medicines Agency (EMA) has taken a significant step towards ensuring the safety of medications by updating its recommendations for testing N-nitrosamines, a class of chemicals linked to an increased cancer risk.

N-nitrosamines can form unintentionally during the manufacturing process of some medicines. While their presence is generally very low, even small amounts can be harmful. The updated guidance focuses on improving the detection of these impurities, particularly N-nitrosamine drug substance related impurities (NDSRIs), a recently identified class with a more complex structure.