| |SEPTEMBER 20249US FDA NODS SMARTADJUST TECHNOLOGY FOR INDIVIDUALS WITH TYPE 2 DIABETESBHARAT BIOTECH TO GLOBALLY MARKET ITS ORAL CHOLERA VACCINEThe FDA broadened the uses of Insulet SmartAdjust, a technology for diabetes management, to include type 2 diabetes in adults over 18 years old, in addition to type 1 diabetes in individuals aged two and older. Software that automatically adjusts insulin delivery to a person with diabetes by connecting to an ACE pump and iCGM is known as an interoperable automated glycaemic controller."The FDA has long worked with the diabetes community to ensure access to additional options and flexibilities for diabetes management," said Michelle Tarver, M.D., Ph.D., acting director of the FDA's Center for Devices and Radiological Health. "Automated insulin dosing technology has previously been available only for people with type 1 diabetes. Today's action helps expand access to this important diabetes management tool to millions of adults living in the US with type 2 diabetes. The FDA is committed to advancing new device innovation that can improve the health and quality of life for people living with chronic diseases that require day-to-day maintenance like diabetes."Over 11 percent of the American population has been diagnosed with diabetes, a medical condition characterized by insufficient production or utilization of the hormone insulin, which regulates blood glucose levels. Patients with type 2 diabetes can take medications to boost insulin secretion or enhance insulin sensitivity, in combination with maintaining a balanced diet and engaging in regular physical activity. A lot of patients require insulin therapy to maintain their blood sugar levels within a safe range. POBharat Biotech announced that its oral cholera vaccine has successfully completed a late-stage trial and is preparing for a global launch, with plans to produce up to 200 million doses annually. The vaccine, named Hillchol, has received approval from India's drug regulator and Bharat Biotech will seek pre-qualification from the World Health Organization (WHO) to supply major buyers like UNICEF.The company aims to address the cholera crisis in Africa initially and is open to allowing African countries to procure the drug substance and handle final manufacturing locally if needed. Production will commence at Bharat Biotech's Hyderabad facility, which has a capacity of 45 million doses per year, and the company is awaiting approval for an additional facility to boost production to 200 million doses.The investment in these manufacturing facilities is estimated at around $100 million, though Bharat Biotech has not confirmed this figure. The late-stage trial involved approximately 3,600 participants in India and demonstrated that the vaccine is safe and as effective as existing oral vaccines. WHO pre-qualification will require proof of efficacy, safety, and adherence to good manufacturing practices.Bharat Biotech is a leading biotech firm recognized for its exceptional research and production capacities. Our goal is to provide inexpensive, secure, and top-notch vaccines and bio-therapeutics that aid individuals in overcoming illnesses. Our goal is to be at the forefront of biotechnology innovation in order to drive the battle against disease, specifically targeting emerging markets. PO
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