| |DECEMBER 20239PNB VESPER, a Kochi-based research-based biopharmaceutical company, has signed agreements with the National Institute on Drug Abuse (NIDA), the lead federal agency supporting scientific research on drug abuse and addiction disorders, to develop drugs for opioid and cocaine addiction disorders. According to the agreements, NIDA will examine three PNB VESPER molecules, PNB 091, PNB 081, and PNB 101, as possible medications for the treatment of opioid and cocaine addiction-related diseases.The pharma company has completed the preclinical studies of the molecules, will soon file the Investigational New Drug applications with the US Food and Drug Administration. The company is planning to start clinical trials of the molecules in the USA as soon as it completes the ongoing studies with NIDA and IND studies, which will be over before end of 2024, as per business wire.While commenting on the collaboration, P. N. Balaram, Director and CEO, of PNB VESPER, said, "We are very happy and proud to associate with NIDA for developing drugs for opioid and cocaine addiction disorders, which is a major issue in the USA. Our molecules were selected by the US Agency for testing and development after a series of due diligence processes by the senior scientists under NIH and the US government."Drug overdose and abuse are serious public health issues in the United States and around the world. Millions of individuals in the United States suffer from it, and thousands are killed by it every day. According to a recent Centers for Disease Control and Prevention (CDC) estimate, 206,699 people died in 2022 as a result of drug overdose, primarily opioid addiction. The number of overdose deaths exceeds the total number of gun and car accident deaths combined. POAs per Astellas Pharma US, Inc. Cresemba (isavuconazonium sulfate), an azole antifungal medication, has been approved by the US Food and medication Administration (FDA) for the treatment of invasive aspergillosis (IA) and invasive mucormycosis (IM) in paediatric patients.Cresemba for injection is approved for adults and now for paediatric patients 1 year of age and older. Cresemba capsules are approved for adults and now for paediatric patients 6 years of age and older who weigh 16 kilograms (kg) and greater. With this approval, Cresemba is now the only azole antifungal therapy approved for the treatment of IA and IM in patients as young as one, as per Pharmabiz."Invasive fungal infections are a significant concern to healthcare professionals who care for paediatric, adolescents and young adults with hematologic malignancies, transplant recipients and primary immune deficiencies," said Antonio C. Arrieta, M.D., medical director, Paediatric Infectious Disease, Children's Health of Orange County. "IA, currently the most common invasive mold infection in these patients, and IM are associated with significant morbidity and high fatality rates. The FDA approval of Cresemba for paediatric patients adds a much-needed treatment option.""The recent Covid-19 pandemic drove an uptick in these serious and life-threatening fungal infections, presenting an even greater urgency to address this growing unmet medical need," said Lynn Fenicchia, senior vice president and Head of US Medical Specialties Business Unit, Astellas. "Patients are waiting, and we know that young IA and IM patients are most at risk. Today's approval will bring hope to this highly vulnerable patient population with limited treatment options."The approval is based on results from two paediatric clinical studies, including a phase 2 open-label, non-comparative, multicenter study (NCT03816176) evaluating the safety, efficacy and pharmacokinetics of Cresemba for the treatment of IA or IM in paediatric patients aged 1 to 17 years old. POPNB VESPER & NIH-NIDA INK PACT TO DEVELOP DRUGS FOR DISORDERSASTELLAS PHARMA BAGS US FDA NOD FOR CRESEMBA TO TREAT INVASIVE ASPERGILLOSISTOP STORIES
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