| |JULY 2024860 DEGREES PHARMA DECLARES IRB APPROVAL OF CLINICAL STUDYEDDINGPHARM SECURES CHINA NMPA APPROVAL FOR VASCEPA60 Degrees Pharmaceuticals, a leading firm focused on growing new medicines for infectious ailments, reported morals endorsement of an open label, extended access study of the ARAKODA® routine of tafenoquine in blend with standard of care regimens in immunosuppressed patients with persistent/relapsing babesiosis.The study's objective is to confirm an earlier case series of tafenoquine conducted by the Yale School of Public Health (YSPH) in April 2024 and published in the journal Clinical Infectious Diseases that found a cure rate of 80 percent for babesiosis in humans in a similar population. Five immunosuppressed patients who received weekly tafenoquine following a loading dose in conjunction with standard of care medications demonstrated a cure rate of 80 percent (30-100 percent) in the YSPH case series with a 95 percent confidence interval."Tafenoquine is showing exciting promise in addressing babesiosis within various human patient populations," said Chief Executive Officer of 60 Degrees Pharmaceuticals, Geoffrey Dow, PhD. "With babesiosis rates now rising in key regions of the United States and given the very serious nature of this tick-borne illness, especially in the elderly and immunocompromised people, we are moving quickly in an effort to confirm Yale's observations while advancing the clinical program for hospitalized babesiosis patients which is now enrolling at Tufts Medical Center. Ultimately, we aim to re-purpose tafenoquine as a new babesiosis treatment." POAmarin Corporation an innovative pharmaceutical firm, stated that its commercial partner in Mainland China (China), EddingPharm (Edding), has gained regulatory approval for Vascepa (icosapent ethyl) from the National Medical Products Administration (NMPA). Vascepa was approved by the NMPA for lowering the risk of cardiovascular events as an adjunct to statin therapy in adult patients with elevated and high triglycerides (=150mg/dL) and established cardiovascular disease or diabetes mellitus, as well as at least two other cardiovascular disease risk factors, combined with hypertriglyceridemia.Following NMPA clearance, Edding is aiming to add Vascepa to the National Reimbursement Drug Listing (NRDL) and expand the ongoing commercial launch of Vascepa in China to include the CVRR indication. The NRDL is revised periodically and serves as the principal route for public reimbursement of pharmaceutical products in China, covering 98 percent of the population. Inclusion on the NRDL allows for full or partial reimbursement at the national level. Products on this list can be prescribed at public hospitals in China.According to a recent assessment on cardiovascular health and disease in China, cardiovascular disease (CVD) accounted for 44-47 percent of all deaths in China's urban and rural areas, implying that CVD caused two of every five deaths. It is estimated that 330 million patients in China suffer from CVD, and the country has one of the highest CVD death rates in the world. According to the World Heart Federation, cardiovascular events such as ischemic heart disease and stroke are expected to increase by 50 percent in China between 2010 and 2030 (based only on population aging and growth). POTOP STORIES
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