Krka’s generic version of Janssen’s Zytiga has garnered a positive opinion from the EMA’s CHMP, along with Pinax Pharma’s Celsunax ioflupane generic of DaTSCAN and Nova Laboratories’ hybrid Jayempi azathioprine oral suspension.
Krka has been granted a positive opinion recommending granting a pan-European marketing authorization for its generic version of Janssen’s Zytiga (abiraterone). The European Medicines Agency’s Committee for Medicinal Products for Human Use endorsed the treatment for metastatic prostate cancer in the form of 500mg film-coated tablets.
“Studies have demonstrated the satisfactory quality of Abiraterone Krka, and its bioequivalence to the reference product Zytiga,” the CHMP stated....
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.
