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60 Degrees Pharmaceuticals, Inc. announced it has entered into an agreement with Tufts Medical Center in Boston to conduct the world’s first clinical trial evaluating the efficacy and safety of tafenoquine in treating human babesiosis patients.

C3i Center Inc (C3i) announced it has received regulatory approval, in the form of a Drug Establishment License (DEL), to commercially produce cell therapies, making C3i the first CDMO in Canada to achieve this milestone.

Following an end-of-Phase II meeting with the FDA in the fourth quarter, Viking Therapeutics plans to push its subcutaneous obesity therapy VK2735 into late-stage development and to start a Phase II trial for an oral formulation.

60 DegreesPharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (the “Company” or 60 Degrees Pharmaceuticals), a pharmaceutical company focused on developing new medicines for infectious diseases, announced that the first patient has been enrolled in a randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of tafenoquine in treating babesiosis in humans.

The adjusted guidelines will provide drugmakers with more opportunities to engage with the Centers for Medicare and Medicaid Services regarding the initial maximum fair price offers, according to the agency.

The investigational therapy, vesleteplirsen, had been positioned as an updated version of Sarepta’s original exon 51-skipping Duchenne muscular dystrophy drug Exondys 51.

On May 23, OBiO Technology, a world leading contract development and manufacturing organization for cell and gene therapy, officially launched the “Center for Clinical Evaluation and Translation of Advanced Therapies for Pediatric Rare and Genetic Diseases” at the 2024 Global Rare Disease Research Symposium and the 2nd China Rare Disease Research and Translational Medicine Conference.

LIB Therapeutics, Inc. today announced that its regional partner in China, Hasten Biopharmaceuticals Co, Ltd. (Hasten), has received notification of acceptance for the clinical trial application for Lerodalcibep by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China.