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