Hailing the past year as a "transformational period" in which "we moved towards being a business with an FDA-approved product nearing commercialization," Pfenex ended 2019 in profit and with cash in the bank, as it eyes the potential for a monopoly in the follow-on teriparatide market.
Pfenex and partner Alvogen are primed to launch the firms’ Bonsity (teriparatide) in the US and do not envisage any supply chain complications arising from the COVID-19 pandemic, as the US Food and Drug Administration continues to weigh designating the product therapeutically equivalent with Eli Lilly’s Forteo blockbuster.
With the FDA having approved the firms’ PF708 teriparatide candidate under the Bonsity name in October last year, Pfenex continues...
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.
