Generics manufacturers looking to target the popular weight-loss drug Saxenda – a precursor therapy to Novo Nordisk’s wildly successful Wegovy – can look to the US FDA’s latest product specific guidance on developing their own versions of the GLP-1 receptor agonist.
Novo Nordisk’s self-injectable GLP-1 receptor agonist Saxenda (liraglutide), the heavily advertised and extensively used treatment for obesity, is among 32 new and revised product specific guidance documents published by the US Food and Drug Administration, which includes 25 PSGs for products with no approved abbreviated new drug application products.
Approved by the FDA for chronic weight management in adults in December 2014, Saxenda was at the end of 2020...
Amneal has marked its entry into China after receiving its first product approval in the market. Meanwhile, the firm has also outlined US approvals for two generics currently suffering from shortages.
Avoiding disaster at the beginning of the pandemic and offering a pro-active supply chain blueprint should position the generics industry well for an onshoring debate in Congress, but a look back at March 2020 is a reminder that even small policy shifts can have a big impact.
After US President Joe Biden launched a review of the country’s API supply chain, the task force has reported back with key vulnerabilities that contribute to drug shortages and supply risks during a global public health emergency. According to the report, the lack of geographic diversity and dependence on foreign nations and anti-competitive actions by foreign nations are key areas of concern.
Nichi-Iko says that remediation activities at its Toyama plant in the wake of a suspension over GMP violations mean that there may be delays to supply.
Avoiding disaster at the beginning of the pandemic and offering a pro-active supply chain blueprint should position the generics industry well for an onshoring debate in Congress, but a look back at March 2020 is a reminder that even small policy shifts can have a big impact.
We’ve all been told that walking 10,000 steps a day is the magic number for better health. But what if the real secret to walking more isn’t about counting steps at all? In this article, we explore how focusing on motivation, environment, and mindset can help you build a walking habit that lasts.
Teva and Biocon Biologics have become the latest firms to sign up to the Biosimilars Forum industry association in the US.
