By Anil Matai The Union Ministry of Health had released the draft of the New Drugs, Medical Devices and Cosmetics Bill, 2022 on July 8, 2022. This pivotal legislation, set to replace the 83-year-old Drugs and Cosmetics Act of 1940, proposed to revamp the entire regulatory framework governing the import, manufacturing, distribution, and sale of … Read more
Global pharma major Lupin Limited on Friday announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Canagliflozin Tablets, 100 mg and 300 mg. According to a press statement, the approval has been granted to market a generic equivalent of Invokana … Read more
A US shortage of the new generic version of Vyvanse, an ADHD medication, is due in part to federal limits on production, according to an industry group representing generic drug makers. Manufacturers haven’t been able to secure enough raw material “to launch their products at full commercial scale,” according to a letter from the Association … Read more
Concerns have been raised over the suitability of current FDA-approved treatments for myelofibrosis due to the negative associations with anemia. In response, the FDA has significantly increased the number of awarded orphan drug designations (ODDs) for myelofibrosis-indicated drugs in recent years. Since 2014, a total of 11 ODDs have been granted, with eight of them … Read more
Novo Nordisk recently announced that its FLOW trial, which studies Ozempic (semaglutide) in diabetic patients with chronic kidney disease (CKD), will come to a halt almost one year prior to the planned completion date, as interim results alone were sufficient in proving that the treatment was successful in treating kidney failure in this patient group. … Read more
Global pharma major Lupin Limited recently announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Apalutamide Tablets, 60 mg. Approval is granted to market a generic equivalent of Erleada Tablets, 60 mg of Janssen Biotech, Inc. This product will be … Read more
Pharma major Torrent Pharmaceutical is in preliminary talks with Apollo Global Management to secure a loan of up to $1 billion. Reportedly, this loan will help to fund a planned bid for Cipla. According to a report by news agency Reuters, Torrent is hoping to secure roughly $3 billion to $4 billion in financing for … Read more