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Mylan Pharmaceuticals Inc.

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Latest From Mylan Pharmaceuticals Inc.

USPTO Faces Growing Pressure To Enter Battle Over Drug Pricing

Members of Congress, companies and government agencies want the Patent Office to change policies that they say impede generic drug competition. The latest effort is focused on PTO’s discretionary denial of inter partes review petitions, which is the subject of a bipartisan congressional letter and cert petition to the US Supreme Court.

Intellectual Property Legal Issues

BeiGene’s Brukinsa Among Nine Drugs To Win EU Marketing Thumbs Up

A number of new medicines are moving closer to the EU market after the European Medicines Agency recommended in favor of their approval. 

Europe Approvals

Theravance To Slash Headcount By 75% After Latest Clinical Trial Setback

The Phase III failure of ampreloxetine in nOH followed disappointing Phase IIb data for izencitinib in ulcerative colitis in August. Theravance narrows focus to respiratory disease, including label expansions for Yupelri.

Business Strategies Research & Development

TB Alliance-Lupin Deal To Improve Pretomanid Access But India Unlikely To Benefit For Now

While Viatris says it has sufficient capacity to meet current and future demand for tuberculosis drug pretomanid, TB Alliance has signed a non-exclusive license with Lupin. This is the second tie-up with an Indian manufacturer but the local restricted use approval means countries other than India are likely to benefit for now.

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