Policy & Regulation
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.
Emerging CRISPR innovations, shifting regulatory landscapes, and rising partnerships are accelerating a paradigm shift in biotech pipelines
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.
Japanese generics giant Sawai appears to be turning a corner, but the impact of National Health Insurance pricing revisions continues to hold the firm – and the rest of the country’s generics industry – back.
A fresh executive order from US president Joe Biden calls for short-term and long-term study, broad consultation, and co-ordination with allies on the domestic supply chain.
The generics firm essentially paid the brand to keep its product off the market, FTC alleges in case about Opana ER litigation. Endo considered bringing back its original formulation of oxymorphone but instead reached agreement with Impax to share profits of its generic, antitrust suit claims.
US off-patent industry association the AAM has welcomed the prospect of working with the incoming Biden-Harris administration, emphasizing that there is “more to be done” to improve generic and biosimilar utilization and uptake.
Following on from its recently announced US licensing deal with Amneal over its Xolair biosimilar, Kashiv has finished patient recruitment for a trial for the omalizumab candidate, paving the way for submissions.
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Polpharma has struck a deal with MSN Laboratories that will see the Polish generics player distribute the Indian firm’s hospital portfolio in Poland.
Following the FDA’s approval of A 150mg version of Accord’ Herceptin biosimilar, the US agency has now greenlit a higher 400mg strength version of the rival.
Teva requested the change to the draft guidance, arguing that otherwise the meetings would be “completely one-sided conversations.”
Generics Bulletin reviews the latest regulatory events across the world.
Off-patent industry groups in the US have raised questions about why Stelara is included on the list and if CMS’ projection can match up with estimated savings that could be generated traditionally by generics and biosimilars.
During Hikma’s first-half results call, the company delved into details of its strategic goals for biosimilars, small-molecule generics, injectables, GLP-1s and more.
With a clear focus on complex products, Lupin sets out its launch plans for the year ahead, while battling ongoing litigation over some of its generics.
Sandoz has delivered the first denosumab biosimilar launch in Canada, introducing its Jubbonti and Wyost rivals to Amgen’s Prolia and Xgeva.