Category Archives: Erudition & Culture

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.

Every year, the issue of executive compensation in Big Pharma comes under close scrutiny. This year is no different, as publicly traded companies reveal the total compensation packages for their CEOs and top executives in 2023. Here’s a breakdown of what some of the industry’s leaders took home.

Researchers at The Royal Marsden, partnering with Guardant Health, have developed a groundbreaking liquid biopsy test called Marsden360. This simple blood test offers significant advantages for lung cancer patients, the Third Most Common and Serious Cancer in the UK.

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.

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.

The Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom has granted marketing authorization for Quizartinib (Vanflyta) as first-line therapy in conjunction with standard chemotherapy for adult patients diagnosed with FLT3-ITD positive acute myeloid leukemia (AML). This decision signifies a significant advancement in the treatment landscape for this specific subgroup of AML patients.

The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has approved etrasimod (brand name Velsipity) for treating adults (over 16) with moderate to severe ulcerative colitis. This chronic condition causes inflammation and ulcers in the inner lining of the colon and rectum. Symptoms include recurring bloody diarrhea, stomach cramps, fatigue, and weight loss.

This article highlights a significant advancement in diabetes management with the FDA approval of Deka Research & Development’s novel automated insulin pump, the twiist. Designed specifically for those living with Type 1 diabetes, the twiist promises to revolutionize insulin delivery through its innovative features and ease of use.

The FDA has approved a new medication called Tryvio (aprocitentan) for adults with high blood pressure that is difficult to control with existing therapies. Tryvio works differently than current medications and is taken once daily in combination with other blood pressure drugs.

The Bill & Melinda Gates Medical Research Institute (Gates MRI) announced the start of a Phase 3 clinical trial to evaluate a new tuberculosis (TB) vaccine candidate, M72/AS01E. This is a significant step in the fight against TB, a major global health threat.