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Generics

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Biosimilar Education And Innovation Bills Head To Biden’s Desk

The Advancing Education on Biosimilars Act and the Ensuring Innovation Act will be looked at by the US President Joe Biden, after receiving the approval of both the Senate and the House of Representatives. The bills are aimed at lowering prescription drug costs and saving overall healthcare costs. 

United States BioPharmaceutical

Aurobindo’s Latest Launches Include Truvada And Atripla Rivals

Aurobindo has announced the launch of generic versions of Truvada, Atripla, Minocin and Gleevec in the US. As its generics business grows in the US, Europe, Canada and the rest of the world markets, Aurobindo plans to establish itself in China. The Indian pharma company has also announced its plan to commission new facilities to serve the external market. 

Approvals Launches

Teva Identifies ‘Problem Pattern’ Of Complex CRLs Ahead Of GDUFA III

Forecasting up to a dozen complex generic launches by Teva in the US in 2021, executive vice-president for North America commercial Brendan O’Grady said Teva was continuing to push for changes to boost approval rates ahead of GDUFA III next year.

Generic Drugs Strategy

Hikma Gets More Time On Vascepa Response As Amarin CEO Exits

Hikma has won more time to respond to Amarin’s certiorari petition to the US Supreme Court over a Federal Circuit decision invalidating Vascepa intellectual property – but not the 45 days the company was looking for. Meanwhile, Amarin’s CEO John Thero is to stand down later this year.

Intellectual Property Legal Issues

Multiple Molecules See UK Prices Double In March

Etoricoxib, letrozole and trimethoprim experienced triple-digit rises in their average UK trade prices in March, according to the latest figures from WaveData.

Market Intelligence Pricing Strategies

Natco Claims Sole Exclusivity For Ibrutinib Tablets

Natco says it will be entitled to 180-day exclusivity for four strengths of ibrutinib tablets in the US after receiving tentative FDA approval.

Generic Drugs Approvals
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